In a post by Mr. Kurt R. Karst at FDA LAW BLOG, reported that, FDA announced that the Agency has taken enforcement action against several manufacturers of unapproved prescription narcotics. The 9 Warning Letters issued by FDA concern 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone. The Warning Letters direct the companies to stop manufacturing and distributing the specific narcotic drug products in certain dosage forms that lack FDA approval.
The details can be read here.
Tuesday, March 31, 2009
Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers
Wyeth Pharmaceuticals, a division of Wyeth , announced today that it has submitted a Biologic License Application (BLA) to the U.S. FDA for Prevnar 13(TM), Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein).
The details can be read here.
The details can be read here.
Ipsen: AZZALURE is Approved in France for Aesthetic Use in the Treatment of Frown Lines
Galderma, the leading pharmaceutical company in dermatology, and Ipsen, an innovation-driven international specialty pharmaceutical group, today announced that Azzalure (botulinum toxin Type A manufactured by Ipsen), a muscle relaxant specifically developed for aesthetic use, has received a marketing authorization in France from the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS).
The details can be read here.
The details can be read here.
Intercell Announces FDA Approval of Ixiaro, a Novel Vaccine to Prevent Japanese Encephalitis
Intercell AG today announced that the U.S. FDA approved IXIARO(R), a new vaccine for the prevention of Japanese Encephalitis (JE).
the details can be read here.
the details can be read here.
Peregrine Pharmaceuticals Awarded New U.S. Patent Further Strengthening Its Anti-Phospholipid Patent Portfolio
Peregrine Pharmaceuticals, Inc. today reported the issuance of a U.S. patent that further strengthens the company's intellectual property leadership in the field of phospholipid-targeting agents for the treatment of life-threatening diseases.
The details can be read here.
The details can be read here.
Osteologix Prevails in European Patent Opposition for Osteoporosis Drug
Mar 31, 2009 - Osteologix, Inc. today announced that the European Patent Office (EPO) has upheld the validity of the company's European Patent No. EP 1,534,305 B9, "Treating Cartilage and Bone Conditions with Water Soluble Strontium Salts".
The details can be read here.
The details can be read here.
Delaware Court Rules That Watson Does Not Infringe Patent Related to Generic Version of Concerta and Declares Patent Invalid
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the United States District Court for the District of Delaware has ruled that Watson's generic version of Concerta (methylphenidate hydrochloride extended-release tablets) does not infringe United States Patent No. 6,919,373 (the '373 Patent) and that the '373 Patent is invalid.
The details can be read here.
The details can be read here.
Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability
Caraco Pharmaceutical Laboratories, Ltd. , a generic pharmaceutical company, announced today that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level.
The details can be read here.
The details can be read here.
HIV/AIDS Update - Tentative approval emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg
March 31, 2009--On March 30, FDA granted tentative approval for emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, manufactured by Matrix Laboratories Ltd. of Hyderabad, India,under the expedited review provisions of the President's Emergency Plan for AIDS Relief
The details can be read here.
The details can be read here.
Monday, March 30, 2009
Schinopharm failed to revoke the process patent on Gemcitabine
In a Judgement by Hon'ble Judge MR. JUSTICE KITCHIN on the revocation case of EP (UK) No 0,577,303 ("the Patent") which is owned by Eli Lilly & Company, the Judge held that the "The allegations of obviousness and insufficiency have not been made out. The Patent is valid and the action must be dismissed".
The Patent has an earliest priority date of 22 June 1992 and relates to a new process for making a compound called gemcitabine, which is a drug used for the treatment of cancer and sold by Lilly under the name GEMZAR. It is of considerable commercial significance with worldwide sales in 2007 of about US $ 1.36 billion.
Gemcitabine is a nucleoside analogue. Nucleosides themselves are the building blocks of DNA and RNA and are composed of a sugar component linked to a nucleobase component by a glycosidic linkage. Gemcitabine has a very similar structure to a nucleoside called deoxycytidine.
The validity of patent was challenged on the basis of obviousness and insufficiency of disclosure grounds.
Prior Arts:
The obviousness allegation relies upon the following eight prior publications:
i) United States Patent 4,526,988 ("Hertel 1");
ii) European Patent 0,122,707 ("Hertel 2");
iii) A paper entitled "Synthesis of 2-Deoxy-2,2-difluro-D-ribose and 2-Deoxy-2,2-difluoro-D-ribofuranosyl Nucleosides" by L. W. Hertel et al (Journal Organic Chemistry, 1988) ("Hertel 3");
iv) A paper entitled "Stereospecific Synthesis of 2-Deoxy-2,2-difluororibonolactone and Its Use in the Preparation of 2'-Deoxy-2',2'-difluoro-ß-D-ribofuranosyl Pyrimidine Nucleosides: The Key Role of Selective Crystallization" by T. S. Chou et al (Synthesis, 1992) ("Chou");
v) A paper entitled "An Investigation by H NMR spectroscopy into the factors determining the ß:a ratio of the product in 2'-deoxynucleoside synthesis" by A.J Hubbard et al (Nucleic Acids Research, 1984) ("Hubbard");
vi) A paper entitled "The Synthesis of 2'-Deoxy-5- Trifluoromethyluridine Utilizing a Coupling Reaction" by H. Kawakami et al (Heterocycles, 1990) ("Kawakami");
vii) European Patent Application 0,428,109 ("Vemishetti");
viii) A paper entitled "Antiviral Nucleosides. A Stereospecific, Total Synthesis of 2'-Fluoro-2'-deoxy-ß-D-arabinofuranosyl Nucleosides" (Journal Organic Chemistry, 1988) by H.G. Howell et al ("Howell").
The attack was founded primarily upon Chou, which explicity refers to Hertel 3.
Findings on Obviousness:
I can take all these publications together. Once again, the allegation of obviousness is not founded on any one of these papers as such. Rather, it is said that the invention of the Patent was obvious in the light of these papers when read with Hertel and Chou. However, there was no evidence or attempt to prove that a skilled person would have found any of these papers in the light of his common general knowledge or on a reading of Hertel and Chou. In my judgment it is not permissible to present to an expert different items of prior art which are not said to be common general knowledge and ask him whether it would have been obvious to read them together. It may well be the case that the skilled person, presented with Hertel and Chou, would not have considered it necessary to supplement his common general knowledge and, even if he did, he may never have found these further publications. I therefore reject the submission it is permissible to read them, individually or collectively, together with Hertel or Chou. The allegation of obviousness based on these publications fails at the outset.
Findings on Insufficiency: The question then is whether the claim is enabled across its width. Here I have some sympathy with Scinopharm in that the claims certainly do not identify all those process steps which are necessary to achieve that result and, as I have indicated, both sides contend that having at least a molar equivalent of nucleobase is not itself a sufficient condition. However, Professor Boons has explained in his unchallenged evidence that the Patent provides a large number of examples and the skilled person would be able to identify the general conditions which would enable him to work the invention and he would certainly have been able to follow the teaching to produce a ß enriched product, and gemcitabine in particular. The allegation of insufficiency therefore fails on the evidence.
The whole judgement can be read here.
The Patent has an earliest priority date of 22 June 1992 and relates to a new process for making a compound called gemcitabine, which is a drug used for the treatment of cancer and sold by Lilly under the name GEMZAR. It is of considerable commercial significance with worldwide sales in 2007 of about US $ 1.36 billion.
Gemcitabine is a nucleoside analogue. Nucleosides themselves are the building blocks of DNA and RNA and are composed of a sugar component linked to a nucleobase component by a glycosidic linkage. Gemcitabine has a very similar structure to a nucleoside called deoxycytidine.
The validity of patent was challenged on the basis of obviousness and insufficiency of disclosure grounds.
Prior Arts:
The obviousness allegation relies upon the following eight prior publications:
i) United States Patent 4,526,988 ("Hertel 1");
ii) European Patent 0,122,707 ("Hertel 2");
iii) A paper entitled "Synthesis of 2-Deoxy-2,2-difluro-D-ribose and 2-Deoxy-2,2-difluoro-D-ribofuranosyl Nucleosides" by L. W. Hertel et al (Journal Organic Chemistry, 1988) ("Hertel 3");
iv) A paper entitled "Stereospecific Synthesis of 2-Deoxy-2,2-difluororibonolactone and Its Use in the Preparation of 2'-Deoxy-2',2'-difluoro-ß-D-ribofuranosyl Pyrimidine Nucleosides: The Key Role of Selective Crystallization" by T. S. Chou et al (Synthesis, 1992) ("Chou");
v) A paper entitled "An Investigation by H NMR spectroscopy into the factors determining the ß:a ratio of the product in 2'-deoxynucleoside synthesis" by A.J Hubbard et al (Nucleic Acids Research, 1984) ("Hubbard");
vi) A paper entitled "The Synthesis of 2'-Deoxy-5- Trifluoromethyluridine Utilizing a Coupling Reaction" by H. Kawakami et al (Heterocycles, 1990) ("Kawakami");
vii) European Patent Application 0,428,109 ("Vemishetti");
viii) A paper entitled "Antiviral Nucleosides. A Stereospecific, Total Synthesis of 2'-Fluoro-2'-deoxy-ß-D-arabinofuranosyl Nucleosides" (Journal Organic Chemistry, 1988) by H.G. Howell et al ("Howell").
The attack was founded primarily upon Chou, which explicity refers to Hertel 3.
Findings on Obviousness:
I can take all these publications together. Once again, the allegation of obviousness is not founded on any one of these papers as such. Rather, it is said that the invention of the Patent was obvious in the light of these papers when read with Hertel and Chou. However, there was no evidence or attempt to prove that a skilled person would have found any of these papers in the light of his common general knowledge or on a reading of Hertel and Chou. In my judgment it is not permissible to present to an expert different items of prior art which are not said to be common general knowledge and ask him whether it would have been obvious to read them together. It may well be the case that the skilled person, presented with Hertel and Chou, would not have considered it necessary to supplement his common general knowledge and, even if he did, he may never have found these further publications. I therefore reject the submission it is permissible to read them, individually or collectively, together with Hertel or Chou. The allegation of obviousness based on these publications fails at the outset.
Findings on Insufficiency: The question then is whether the claim is enabled across its width. Here I have some sympathy with Scinopharm in that the claims certainly do not identify all those process steps which are necessary to achieve that result and, as I have indicated, both sides contend that having at least a molar equivalent of nucleobase is not itself a sufficient condition. However, Professor Boons has explained in his unchallenged evidence that the Patent provides a large number of examples and the skilled person would be able to identify the general conditions which would enable him to work the invention and he would certainly have been able to follow the teaching to produce a ß enriched product, and gemcitabine in particular. The allegation of insufficiency therefore fails on the evidence.
The whole judgement can be read here.
Exenatide shows no rise of cardiovascular event in type-2 diabetes
Amylin Pharmaceuticals, Inc, Eli Lilly and Company and Alkermes, Inc announced that a meta-analysis of primary cardiovascular events across controlled clinical studies of three months or greater, from the Byetta (exenatide) injection database, showed no increased risk of cardiovascular events associated with exenatide use.
The details can be read here.
The details can be read here.
Seattle Genetics Receives FDA Fast Track Designation for SGN-35 for the Treatment of Hodgkin Lymphoma
Mar 30, 2009 - Seattle Genetics, Inc. today announced that the U.S. FDA has granted fast track designation to SGN-35 for the treatment of Hodgkin lymphoma. SGN-35, an antibody-drug conjugate (ADC), is in an ongoing pivotal trial under a Special Protocol Assessment (SPA) from the FDA for relapsed or refractory Hodgkin lymphoma.
The details can be read here.
The details can be read here.
Takeda Submitted a New Drug Application in Japan for Fixed Dose Combination of Blopress® and Amlodipine Besylate
March 30, 2009 – Takeda Pharmaceutical Company Limited announced today that it submitted a New Drug Application to the Ministry of Health, Labour and Welfare for a fixed dose combination of Blopress (generic name: candesartan cilexetil) and amlodipine besylate for treatment of hypertension.
The details can be read here.
The details can be read here.
Medtronic Receives Regulatory Approval For Endeavor Drug-Eluting Coronary Stent in Japan
Mar 30, 2009 - Medtronic, Inc., today announced approval of its Endeavor drug-eluting coronary stent system by the Japanese Ministry of Health, Labor and Welfare (MHLW), clearing the way for the highly anticipated launch of the product in the world's second largest market for advanced medical technology.
The details can be read here.
The details can be read here.
BioMarin Receives Notice of Allowance for Once Daily Dosing Patent for Kuvan
BioMarin Pharmaceutical Inc. announced today that it has received a notice from the United States Patent Office reporting allowance of claims covering once daily dosing methods for Kuvan(R) (sapropterin dihydrochloride) in the treatment of phenylketonuria (PKU).
The details can be read here.
The details can be read here.
Sun Pharma announces USFDA approval to market generic Topamax tablets
March 28, 2009: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market generic Topamax, topiramate tablets.
The details can be read here.
The details can be read here.
Sunday, March 29, 2009
COURT REPORT
About Court Report: Every week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.
Cubist Pharmaceuticals Inc. v. Teva Parenteral Medicines Inc. et al.1:09-cv-00189; filed March 23. 2009 in the District Court of Delaware (daptomycin for injection)
Sepracor Inc. v. Teva Pharmaceuticals USA, Inc. et al.2:09-cv-01302; filed March 20, 2009 in the District Court of New Jersey (eszopiclone, used to treat insomnia)
OSI Pharmaceuticals Inc. et al. v. Mylan Pharmaceuticals Inc.1:09-cv-00186; filed March 19, 2009 in the District Court of Delaware
&
OSI Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals USA Inc. 1:09-cv-00185; filed March 19, 2009 in the District Court of Delaware (erlotinib)
Research Foundation of State University of New York et al. v. Mylan Pharmaceuticals Inc.1:09-cv-00184; filed March 19, 2009 in the District Court of Delaware (doxycyline delayed release capsules)
Shire Canada Inc. et al. v. Mylan Inc. et al. 1:09-cv-02555; filed March 19, 2009 in the Southern District of New York (Lanthanum Carbonate)
The detailed complaints can be read here.
Friday, March 27, 2009
Spectrum Pharmaceuticals Announces That FDA Has Accepted Fusilev sNDA for Colorectal Cancer Indication
Mar 26, 2009 - Spectrum Pharmaceuticals, Inc. announced today that it received notification that the U.S. FDA has accepted for filing and review the supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer.
the details can be read here.
the details can be read here.
Dyax Receives Complete Response Letter from FDA for DX-88 in Acute Attacks of Hereditary Angioedema
Mar 26, 2009 - Dyax Corp. announced today that it has received a complete response letter from the U.S. FDA pertaining to the Company's Biologic License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE).
The details can be read here.
The details can be read here.
Takeda Submitted an Application for an Additional Indication of “Takepron Capsules 15” and “Takepron OD Tablets 15” in Japan
March 26, 2009 -Takeda Pharmaceutical Company Limited today announced its submission of an application of the additional indication of “Takepron® Capsules 15” and “Takepron® OD Tablets 15” to the Ministry of Health, Labour and Welfare for prevention of onset of low-dose aspirin related gastric and duodenal ulcer. Takepron is a proton pump inhibitor discovered by Takeda and has been launched since 1992 in Japan.
the details can be read here.
the details can be read here.
The Medicines Company EU Filing Accepted for Cleviprex for the Treatment of Acute Hypertension
The Medicines Company today announced that the Marketing Authorization Application (MAA) for Cleviprex has been accepted for review in the European Union for the reduction of blood pressure when rapid and predictable control is desired.
The details can be read here.
The details can be read here.
Emerflu, Pandemic Influenza Vaccine For Humans, Approved in Australia
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that its pandemic influenza vaccine for human use Emerflu®*, has been granted marketing authorization from the Australian Therapeutic Goods Administration (TGA).
The details can be read here.
The details can be read here.
Bayer Offers New Betaferon Titration Pack
Bayer will launch a titration pack for patients with multiple sclerosis (MS) that is specially designed to make it easier for them to start Betaferon® (interferon beta-1b) therapy. From now on, the titration pack will be available in Germany.
The details can be read here.
The details can be read here.
Teva Announces Approval and Launch of Generic Topamax Tablets
Mar 27, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. FDA granted approval for the Company's Abbreviated New Drug Application to market its generic version for Ortho-McNeil's anticonvulsant Topamax (Topiramate) Tablets, 25 mg, 50 mg, 100 mg and 200 mg. Shipment of this product has commenced.
The details can be read here.
The details can be read here.
Zydus Pharmaceuticals (USA) Inc. Announces FDA Final Approval for the Generic Version of Topamax Tablets
Zydus Pharmaceuticals announced today that it has received final approval from the U.S.
FDA for its Abbreviated New Drug Application for Topiramate Tablets USP, 25mg, 50mg, 100mg, and 200mg. This product is available for immediate shipment.
the details can be read here.
FDA for its Abbreviated New Drug Application for Topiramate Tablets USP, 25mg, 50mg, 100mg, and 200mg. This product is available for immediate shipment.
the details can be read here.
Wednesday, March 25, 2009
Ranbaxy's Ozidal Risperidone tab gets TGA-Australian approval
Ranbaxy Laboratories has received an approval from the Therapeutic Goods Administration (TGA), Department of Health and Ageing of the Australian Government, for the registration of Ozidal Risperidone 0.5, 1, 2, 3 and 4 mg tablets in Australia.
The details can be read here.
The details can be read here.
MedWatch - Myfortic (mycophenolic acid) Medication Guide released
March 24, 2009--FDA and Novartis notified healthcare professionals of the introduction of a Myfortic Medication Guide to provide important safety information in language that patients can easily comprehend. By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle.
the details can be read here.
the details can be read here.
Allos Therapeutics Submits New Drug Application for Pralatrexate for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
Mar 25, 2009 - Allos Therapeutics, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. FDA for the use of pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Company has requested a priority review of the application, which, if granted, would give the FDA six months from receipt of the submission to take action on the application.
The details can be read here.
The details can be read here.
Amicus Therapeutics Announces Issuance of New Plicera Composition of Matter Patent
Amicus Therapeutics today announced the issuance on March 10, 2009 of United States Patent No. 7,501,439, titled "Tartrate Salt of Isofagomine and Methods of Use." The patent covers the tartrate salt form of isofagomine, the active ingredient in the Company's investigational drug Plicera (afegostat tartrate), and its use for the treatment of Gaucher disease. The patent will expire in 2027.
The details can be read here.
The details can be read here.
Perrigo Announces FDA Approval for Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)
Perrigo Company today announced that it has received final approval from the U.S. FDA to market Sulfacetamide Sodium Topical Suspension, 10% (Lotion).
The details can be read here.
The details can be read here.
Tuesday, March 24, 2009
Celsion Receives Orphan Drug Designation for ThermoDox to Treat Primary Liver Cancer
Mar 24, 2009 - Celsion Corporation, a leading oncology drug development company, today announced that the U.S. FDA) has granted orphan drug designation for its lead compound, ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer.
the details can be read here.
the details can be read here.
Toyama Chemical and Eisai Decide to Conduct Additional Study
March 24, 2009--Toyama Chemical Co., Ltd. and Eisai Co., Ltd. announced today that the companies have decided to withdraw temporarily the New Drug Application (NDA) of anti-rheumatic drug T-614 (generic name: iguratimod), which have been developed jointly by the two companies in Japan.
the details can be read here.
the details can be read here.
Fablyn Approved in Europe for the Treatment of Osteoporosis
Mar 24, 2009 - Ligand Pharmaceuticals Incorporated today announced that its partner, Pfizer, Inc. (NYSE: PFE) has received approval from the European Commission(EC) for FABLYN (lasofoxifene) Tablets, a selective estrogen receptor modulator (SERM) for the treatment of osteoporosis in post-menopausal women at increased risk of fracture. FABLYN was submitted for approval in Europe in January 2008.
The details can be read here.
The details can be read here.
FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia
March 24, 2009 -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. FDA approved TYGACIL (tigecycline), for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible strains of indicated pathogens
The details can be read here.
The details can be read here.
Approval of an Additional Indication for Actos in Japan; Concomitant Therapy with Insulin for Type 2 Diabetes
Takeda Pharmaceutical Company Limited announced today that an additional indication of concomitant therapy with insulin for ACTOS (pioglitazone hydrochloride), a medicine for the treatment of type 2 diabetes, was approved on March 24 by the Ministry of Health, Labour and Welfare.
The details can be read here.
The details can be read here.
Dainippon Sumitomo Pharma: Announcement of a Judgment of the Suit (an Appeal Court Decision)
March 24, 2009--The Company was involved in litigation with Wakunaga Pharmaceutical Co., Ltd. (“the plaintiff”) at the Osaka High Court (a trial on appeal) with respect to a suit filed for damages associated with termination of a license agreement concluded between the two companies on a new quinolone compound.
The details can be read here.
The details can be read here.
Pronova BioPharma ASA (NO) - Pronova BioPharma receives Lovaza Paragraph IV Notice Letter from Apotex Inc.
25 March, 2009 -- Pronova BioPharma ASA today announces that it and its U.S. marketing partner GlaxoSmithKline Inc. have received a Paragraph IV Notice Letter dated March 20 2009 from Apotex Inc. advising that Apotex has submitted an Abbreviated New Drug Application to the US FDA for approval to market a generic version of Lovaza(TM).
The details can be read here.
The details can be read here.
Cubist Pharmaceuticals Files Patent Infringement Lawsuit Against Teva Parenteral Medicines, Inc.
In continuation to the post on Febraury 10, 2009, Mar 23, 2009 - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) confirmed today that it has filed a patent infringement lawsuit against Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. The complaint, which was filed in the U.S. District Court for the District of Delaware, alleges infringement of US Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and US Patent No. RE39,071, which expires on June 15, 2016.
the details can be read here.
the details can be read here.
Monday, March 23, 2009
Daiichi files patent infringement actions against 13 generics cos for Cravit tablets
Daiichi Sankyo Company has brought patent infringement litigation against 13 generics companies for the substance patent (2008845) and usage patent (1659502) for Levofloxacin Hydrate (brand name: Cravit tablets and Cravit fine granules). Levofloxacin Hydrate broad-spectrum oral anti-bacterial agents originated by Daiichi Sankyo, has been marketed by the company in Japan since 1993.
The details can be read here.
The details can be read here.
Morphotek, Inc. and Eisai Corporation of North America Announce FDA Special Protocol Assessment (SPA) for Phase III Trial Evaluating Farletuzumab
Morphotek, Inc., a subsidiary of Eisai Corporation of North America, announced today that the U.S. FDA has agreed to and approved the design of a single, pivotal, Phase III clinical trial evaluating farletuzumab (also known as MORAb-003) in platinum-sensitive ovarian cancer patients experiencing their first relapse. The agreement was made under the Special Protocol Assessment (SPA) procedure.
the details can be read here.
the details can be read here.
FDA Approves Symbyax as First Medication for Treatment-Resistant Depression
The U.S. FDA has approved a new indication for Symbyax (olanzapine and fluoxetine HCl capsules), Eli Lilly and Company announced today. Symbyax is now the first drug approved by the FDA for the acute treatment of treatment-resistant depression (TRD).
The details can be read here.
The details can be read here.
Arana granted patents in Australia
March 23, 2009 -- Arana Therapeutics Ltd today announced that it has been awarded patents by the Australian Patent Office covering PMX53 and related compounds.
The details can be read here.
The details can be read here.
Sepracor Files Patent Infringement Lawsuit Against Eszopiclone ANDA Filers
Mar 20, 2009 - Sepracor Inc. today announced that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against those companies who have filed abbreviated new drug applications (ANDAs) with Paragraph IV certifications for generic copies of eszopiclone.
The details can be read here.
The details can be read here.
Impax Confirms Patent Lawsuit Relating to Doryx Tablets 150 mg
Mar 20, 2009 - Impax Laboratories, Inc. today confirms that Warner Chilcott Laboratories Ireland Limited, Warner Chilcott Company, Inc., Warner Chilcott (US), LLC, and Mayne Pharma International Pty. Ltd. filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey in response to Impax's challenge of the patent listed in connection with Doryx (doxycycline hyclate) delayed-release tablets, 150 mg.
The details can be read here.
The details can be read here.
Ranbaxy gets nod for Poanta Sahib facility from UK, Australia
Source: http://www.business-standard.com/india/news/ranbaxy-gets-nod-for-poanta-sahib-facilityuk-aus/57133/on
Business standard reported today that:
Ranbaxy Laboratories, the country's largest pharmaceutical company, today announced that the Medicines and Healthcare products Regulatory agency (MHRA) of the UK and the Therapeutic Goods Administration (TGA), Department of Health and Aging of the Australian government, have issued Good Manufacturing Practice (GMP) certificates for its manufacturing site at Paonta Sahib (India), following a joint audit conducted in October 2008.
the details can be read at above link.
Business standard reported today that:
Ranbaxy Laboratories, the country's largest pharmaceutical company, today announced that the Medicines and Healthcare products Regulatory agency (MHRA) of the UK and the Therapeutic Goods Administration (TGA), Department of Health and Aging of the Australian government, have issued Good Manufacturing Practice (GMP) certificates for its manufacturing site at Paonta Sahib (India), following a joint audit conducted in October 2008.
the details can be read at above link.
Sunday, March 22, 2009
India may file complaint with WTO against EU on seizure of Indian drugs at EU ports
The Indian government may file a complaint at the World Trade Organisation (WTO) against the European Union (EU) on the issue of seizure of Indian drug shipments at EU ports, if the ongoing efforts at different international forums fail to find an amicable solution to the nagging issue. The government is currently engaged in hectic activities to resolve the issue.
The details can be read here.
The details can be read here.
New Treatment For Generalized Anxiety Disorder Approved By Health Canada
Health Canada has approved Cymbalta® (duloxetine HCl) for the symptomatic relief of anxiety causing clinically significant distress in patients with generalized anxiety disorder (GAD), Eli Lilly Canada Inc. and Boehringer Ingelheim (Canada) Ltd. announced today.
The details can be read here.
The details can be read here.
Forest Laboratories, Inc. Announces FDA Approval of Lexapro for the Treatment of Major Depressive Disorder in Adolescents
Forest Laboratories, Inc. today announced that the U.S. FDA has approved the Company's supplemental New Drug Application for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents, 12 - 17 years of age. Lexapro is only the second antidepressant to be approved for the treatment of MDD in adolescents, a medical condition that affects approximately 2 million adolescents in the U.S.
The details can be read here.
The details can be read here.
Flamel Technologies to Receive $4 Million Milestone Payment from GlaxoSmithKline
Mar 20, 2009 - Flamel Technologies announced today that it has earned an additional $4 million milestone from GlaxoSmithKline pursuant to its Micropump license agreement for Coreg CR (carvedilol phosphate extended release capsules).
The details can be read here.
The details can be read here.
OSI Pharmaceuticals Files Patent Infringement Lawsuits Against Teva Pharmaceuticals USA and Mylan Pharmaceuticals
Mar 20, 2009 - OSI Pharmaceuticals, Inc. announced today that the Company has filed two lawsuits in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. and Mylan Pharmaceuticals, Inc. for infringement of US Patent No. 5,747,498, US Patent No. 6,900,221 and US Patent No. 7,087,613. All three patents are associated with Tarceva (erlotinib).
The details can be read here.
The details can be read here.
Shire Files Lawsuit Against Mylan for Infringement of Fosrenol (Lanthanum Carbonate) Patent
Shire plc announces that it has filed a lawsuit in the U.S. District Court of the Southern District of New York against Mylan Inc., Mylan Pharmaceuticals Inc. and Matrix Laboratories Limited for infringement of Shire's patent: U.S. Patent No. 5,968,976
The details can be read here.
The details can be read here.
Pronova BioPharma ASA (NO) - Pronova BioPharma receives Lovaza Paragraph IV Notice Letter from Par Pharmaceutical Inc.
20 March, 2009 -- Pronova BioPharma ASA today announces that it and its U.S. marketing partner GlaxoSmithKline Inc. have received a Paragraph IV Notice Letter dated March 17 2009 from Par Pharmaceutical Inc. advising that Par has submitted an ANDA to the US FDA for approval to market a generic version of Lovaza (omega-3-acid ethyl esters).
The details can be read here.
The details can be read here.
Thursday, March 19, 2009
US FDA panel recommends approval of Multaq for atrial fibrillation
Sanofi-aventis announced that the Cardiovascular and Renal Drugs Advisory Committee voted 10 to 3 in favour of the approval of Multaq (dronedarone) by the US Food and Drug Administration (FDA) to treat patients with non-permanent atrial fibrillation (AF).
The details can be read here.
The details can be read here.
Committee For Medicinal Products For Human Use Summary Of Positive Opinion For Modigraf
On 19 March 2009 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Modigraf, 0.2 mg and 1 mg granules for oral suspension intended for: “Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.
the details can be read here.
the details can be read here.
Triax Pharmaceuticals, Providers of the No. 1 Prescribed Mid-Potency Corticosteroid Brand, Introduce a New Size of Locoid Lotion 0.1%
Triax Pharmaceuticals, the marketers of Locoid Lipocream (hydrocortisone butyrate 0.1%) the leading mid-potency corticosteroid brand, introduces a new 4 oz. size of its recently launchedLocoid Lotion Launched at the Locoid Lotion(hydrocortisone butyrate 0.1%) contains a moisturizing vehicle to cover larger areas and hairy areas of affected skin with an elegant, non-greasy application; and is indicatedto treat mild-to-moderate atopic dermatitis in patients as young as 3 months of age.
The details can be read here.
The details can be read here.
Teva and Medicis Announce Settlement Agreement
Teva Pharmaceutical Industries Ltd. and Medicis Pharmaceutical Corporation today announced they have agreed to terminate all legal disputes between them relating to SOLODYN (minocycline HCl, USP) Extended Release Tablets.
the details can be read here.
the details can be read here.
Warner Chilcott Files New Lawsuit for Infringement of DORYX Patent
Warner Chilcott Limited announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd. have filed a second lawsuit against Impax Laboratories, Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 which covers DORYX, a tetracycline-class oral antibiotic.
The details can be read here.
The details can be read here.
Wednesday, March 18, 2009
Teva Announces Approval and Launch of Generic Solodyn Extended-Release Tablets
Mar 18, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Medicis Pharmaceutical Corporation's acne treatment Solodyn® (Minocycline HCl) Extended-Release Tablets, 45 mg, 90 mg and 135 mg. Shipment of this product has commenced.
The details can be read here.
The details can be read here.
Zenvia Phase III PBA Trial Completes Patient Enrollment
Mar 16, 2009 - AVANIR Pharmaceuticals today announced that it has completed targeted enrollment of patients into the STAR trial, a confirmatory Phase III trial of Zenvia™ (dextromethorphan/quinidine [DM/Q]) in patients exhibiting signs and symptoms of pseudobulbar affect (PBA).
The details can be read here.
The details can be read here.
Basilea's Toctino Receives Marketing Authorization in Austria
March 17, 2009 - Basilea Pharmaceutica Ltd. announces that Toctino (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the Austrian Agency for Health and Food Safety (AGES).
The details can be read here.
The details can be read here.
U.S. Patent & Trademark Office Grants Reissue Patent Relating to Lipitor
Pfizer Inc announced today that the USPTO has granted reissue patent RE40667, relating to Lipitor. The company had applied for the reissue patent in January 2007, in order to correct a technical defect in the ‘995 enantiomer patent for atorvastatin calcium, the salt form of atorvastatin sold as Lipitor. On January 6, 2009, the company announced that the U.S. Patent & Trademark Office had issued a “Notice of Allowance” accepting the company’s application to correct the technical defect in the ‘995 patent. The reissue patent will have the same force and effect as the original ‘995 patent and the same June 2011 expiration date (including the six-month pediatric exclusivity period).
The details can be read here.
Tianyin Pharmaceutical Co., Inc. Adopts New Sales Strategy for Azithromycin Dispersible Tablets
March 17, 2009 -- Tianyin Pharmaceutical, Co., Inc., , a manufacturer and supplier of modernized traditional Chinese medicine based in Chengdu, China, today announced it has adopted a new sales strategy for Azithromycin Dispersible Tablets.
The detials can be read here.
The detials can be read here.
Perrigo and Partner Cobrek Confirms Filing for Generic Version of Evoclin and Announcement of Lawsuit by Stiefel
Perrigo Company today announced that its partner Cobrek Pharmaceuticals, Inc. has filed an ANDA for Clindamycin Phosphate Foam 1%, a generic version of Evoclin Foam 1%. The Company believes that Cobrek is the first to file an ANDA with a Paragraph IV certification against Evoclin.
The details can be read here.
The details can be read here.
Impax Confirms Patent Challenge Relating to RENAGEL Tablets, 400 mg and 800 mg
Mar 17, 2009 - Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Genzyme Corporation in connection with its RENAGEL (sevelamer hydrochloride) tablets, 400 mg and 800 mg.
The details can be read here.
The details can be read here.
HIV/AIDS Update - Tentative approval of lamivudine Tablets, 150 mg
On March 16, 2009, the Food and Drug Administration granted tentative approval to a generic formulation of lamivudine tablets, 150 mg, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. The drug is manufactured by Alkem Labs Ltd., of Mumbai, India.
The details can be read here.
The details can be read here.
Monday, March 16, 2009
Court report
About Court Report: Every week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.
Sanofi-Aventis U.S. LLC et al. v. Ebewe Pharma Ges.M.B.H. NFG.KG3:09-cv-01116; filed March 11, 2009 in the District Court of New Jersey (oxaliplatin for injection)
Abbott Laboratories et al. v. Lupin Ltd. et al.1:09-cv-00152; filed March 6, 2009 in the District Court of Delaware (niacin)
Abbott Laboratories et al. v Lupin Ltd. et al.1:09-cv-00564; filed March 6, 2009 in the District Court of Maryland (Niacin)
Genzyme Corp. v. Lupin Ltd. et al.1:09-cv-00563; filed March 6, 2009 in the District Court of Maryland (sevelamer hydrochloride)
Abbott Laboratories et al. v. Lupin Ltd. et al.2:09-cv-01007; filed March 6, 2009 in the District Court of New Jersey (fenofibrate)
Elan Pharma International Ltd. et al. v. Lupin Ltd. et al.2:09-cv-01008; filed March 6, 2009 in the District Court of New Jersey (fenofibrate)
Procter & Gamble Co. et al. v. Apotex Inc. et al.1:09-cv-00281; filed March 5, 2009 in the Southern District of Indiana (Risedronate sodium)
The detailed complaint and the other details can be read here.
Sanofi-Aventis U.S. LLC et al. v. Ebewe Pharma Ges.M.B.H. NFG.KG3:09-cv-01116; filed March 11, 2009 in the District Court of New Jersey (oxaliplatin for injection)
Abbott Laboratories et al. v. Lupin Ltd. et al.1:09-cv-00152; filed March 6, 2009 in the District Court of Delaware (niacin)
Abbott Laboratories et al. v Lupin Ltd. et al.1:09-cv-00564; filed March 6, 2009 in the District Court of Maryland (Niacin)
Genzyme Corp. v. Lupin Ltd. et al.1:09-cv-00563; filed March 6, 2009 in the District Court of Maryland (sevelamer hydrochloride)
Abbott Laboratories et al. v. Lupin Ltd. et al.2:09-cv-01007; filed March 6, 2009 in the District Court of New Jersey (fenofibrate)
Elan Pharma International Ltd. et al. v. Lupin Ltd. et al.2:09-cv-01008; filed March 6, 2009 in the District Court of New Jersey (fenofibrate)
Procter & Gamble Co. et al. v. Apotex Inc. et al.1:09-cv-00281; filed March 5, 2009 in the Southern District of Indiana (Risedronate sodium)
The detailed complaint and the other details can be read here.
DTAB recommends ban on ant-obesity drug, Rimonabant in India
Drug Technical Advisory Board has recommended a ban on the use of anti-obesity drug, 'Rimonabant', in the country for the possible side effects it can cause.The highest drug advisory body, in its meeting recently, has advised the Drug Controller General of India to take steps to ban Rimonabant and send instructions to the state licensing authorities to ask the manufacture to stop its production and take steps for issuing notification by the health ministry to formally ban the drug in the country, it is learnt.
The details can be read here.
The details can be read here.
GSK launches cervical cancer vaccine, Cerverix, in India
GlaxoSmithKline (GSK) has launched cervical cancer vaccine, Cerverix, in India. The vaccine, which is proved to be effective and safe without any alarming side effects, is targeted towards the 132000 Indian women diagnosed with human papillomavirus (HPV) that causes cervical cancer. GSK is in talks with the government to make HPV vaccine easily accessible in India. At present, only two HPV vaccines are available in the market - GSK's Cerverix and Merck's Gardasil.
The details cane be read here.
The details cane be read here.
MannKind Submits NDA for Afpesa for Treatment of Diabetes
MannKind Corporation today announced that it has submitted a New Drug Application (NDA) to the U.S. FDA requesting approval of AFRESA(R) (insulin monomer human [rDNA origin]) Inhalation Powder and the AFRESA(R) Inhaler for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia.
the details can be read here.
the details can be read here.
Sirion Therapeutics Supplemental New Drug Application for Durezol to Treat Uveitis is Accepted for Review by the FDA
Sirion Therapeutics, Inc. announced today that its supplemental New Drug Application (sNDA) submitted to the U.S. FDA seeking market approval of Durezol (difluprednate ophthalmic emulsion) 0.05% to treat endogenous anterior uveitis has been accepted for review.
the details can be read here.
the details can be read here.
Shire Withdraws European Application for Daytrana (methylphenidate transdermal system)
16 Mar 2009 - Shire plc, the global specialty biopharmaceutical company, announces that it has decided to withdraw the European Marketing Authorization Application (MAA) for DAYTRANA (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder.
the details can be read here.
the details can be read here.
United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
United Therapeutics Corporation announced today that, based on its most recent interactions with the U.S. FDA, the FDA's pending regulatory review of the New Drug Application (NDA) for Tyvaso(TM) (inhaled treprostinil) will likely extend beyond its originally anticipated April 30, 2009, action date.
the details can be read here.
the details can be read here.
XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA
Mar 16, 2009 - XenoPort, Inc. announced today that the U.S. FDA has accepted for review the new drug application (NDA) filed by GlaxoSmithKline (GSK) for Solzira (gabapentin enacarbil) Extended Release Tablets in the United States as a potential treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).
The details can be read here.
The details can be read here.
Orexo's Edluar (Sublinox) Receives FDA Approval for the Treatment of Insomnia
March 16, 2009--Orexo today announces that the US FDA has approved Edluar (formerly Sublinox) 5 mg and 10 mg sublingual tablets for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
The details can be read here.
The details can be read here.
Spectrum Pharmaceuticals Acquires 100% of Zevalin, an FDA-Approved, Proprietary, Biological Drug for Non-Hodgkin's Lymphoma
Mar 16, 2009 - Spectrum Pharmaceuticals announced today the closing of the transaction whereby Spectrum Pharmaceuticals acquired 100% control of RIT Oncology, LLC™, to commercialize ZEVALIN ([90Y]-ibritumomab tiuxetan) in the US. In connection with the closing, Spectrum Pharmaceuticals will pay its former partner a total of $16.5 million, which is subject to further adjustments based on outstanding liabilities and obligations.
The details can be read here.
The details can be read here.
MiddleBrook Pharmaceuticals Launches Moxatag, the First and Only FDA-Approved Once-Daily Amoxicillin
Mar 16, 2009 - MiddleBrook Pharmaceuticals, Inc. today launched MOXATAG (extended-release amoxicillin) Tablets, 775 mg, the first and only FDA-approved once-daily amoxicillin. MOXATAG is approved for the treatment of pharyngitis/tonsillitis secondary to Streptococcus pyogenes in patients twelve years and older. MOXATAG is dosed once-daily at 775 mg, versus the current most commonly prescribed generic amoxicillin treatment regimen for pharyngitis/tonsillitis which is 500 mg three times per day according to the 2008 IMS Health National Drug Therapeutic Index. There is no AB-rated generic for MOXATAG.
The details can be read here.
The details can be read here.
Shire Files Lawsuit Against Barr Laboratories for Infringement of Fosrenol (Lanthanum Carbonate) Patents
March 16, 2009 -- Shire plc announces that it has filed a lawsuit in the U.S. District Court of the Southern District of New York against Barr Laboratories, Inc. for infringement of three of Shire's patents: U.S. Patent No. 5,968,976; U.S. Patent No. 7,381,428 and U.S. Patent No. 7,465,465.
The details can be read here.
The details can be read here.
Sunday, March 15, 2009
Anastrozole is superior to tamoxifen at reducing risk of breast cancer: Study
A new analysis of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial, presented at the 11th International St Gallen Oncology Conference, Switzerland, shows that during the first two years after surgery, anastrozole is superior to tamoxifen at reducing the risk of breast cancer returning in postmenopausal women with hormone receptor positive early breast cancer (n=5,216). Anastrozole has consistently demonstrated superiority over tamoxifen, both during the five-year treatment period and beyond treatment completion.
The details can be read here.
The details can be read here.
India mounts protest as Dutch govt begins destroying seized drug consignments
India has registered its strong protest against the recent seizures of drugs consignments by the European authorities describing it an act going against the spirit of 'rules based trading system and impeding free trade', even as the Dutch authorities have reportedly begun procedures to destroy the seized consignments.
The details can be read here.
The details can be read here.
FDA Accepts Complete Response Submission to New Drug Application for Nebido
Endo Pharmaceuticals and its majority-owned subsidiary Indevus Pharmaceuticals, Inc. announced today that the U.S. FDA has accepted for review the complete response submission to the new drug application for NEBIDO (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism. FDA is targeting September 2, 2009 as the action date for a decision on this application.
The details can be read here.
The details can be read here.
Approval of Clevudine for the Treatment of Chronic Hepatitis B in the Philippines
March 13, 2009-HI-Eisai Pharmaceutical Inc., a subsidiary in the Philippines of Eisai Co., Ltd. announced today that the Bureau of Food and Drugs (BFAD) approved “Clevudine” for the inhibition of virus replication in chronic hepatitis B patients (HbeAg positive or HbeAg negative) with evidence of active viral replication and elevations in serum aminotransferases (ALT or AST).
The details can be read here.
The details can be read here.
Thursday, March 12, 2009
DTAB clears most of 49 rational FDCs after examination of data
The Drugs Technical Advisory Board (DTAB) has advised the Drugs Controller General of India to take legal opinion on the contentious issue of fixed dose combinations before issuing notification to accord final clearance to those FDCs cleared by the sub-committee on the matter.
The details can be read here.
The details can be read here.
Ipsen: AZZALURE Approved in the UK for Aesthetic Use in the Treatment of Glabellar Lines
Galderma, the leading pharmaceutical company in dermatology, and Ipsen, an international innovation-driven specialty pharmaceutical group, today announced that Azzalure® (botulinum toxin Type A manufactured by Ipsen), a muscle relaxant specifically developed for aesthetic use, has received a marketing authorization in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the temporary improvement in the appearance of moderate to severe glabellar lines seen at the frown (vertical lines between the eyebrows), in adult men and women aged 65 years and under, when the severity of these lines has an important psychological impact on the patient.
the details can be read here.
the details can be read here.
China Sky One Medical, Inc. Obtains SFDA Approval for Policresulen Vaginal Suppositories
China Sky One Medical, Inc., a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China, today announced that it obtained approval from the State Food and Drug Administration (SFDA) in China for the production of Policresulen vaginal suppositories.
the details can be read here.
the details can be read here.
Uloric (febuxostat) 40-mg and 80-mg Tablets Now Available for the Chronic Management of Hyperuricemia in Patients with Gout
Takeda Pharmaceuticals North America, Inc. announced today that ULORIC(R) (febuxostat) is now available by prescription in pharmacies across the United States for the chronic management of hyperuricemia in patients with gout. Gout is a chronic condition that affects more than five million Americans. This once-daily oral medication, available in 40-mg and 80-mg tablets, is the first new treatment option for hyperuricemia in patients with gout in more than 40 years.
The details can be read here.
The details can be read here.
FDA Advisory Announces Psoriasis Drug Raptiva Increases Rare, Fatal Brain Infection Risk
Mar 12, 2009 - A recent FDA public health advisory announced that psoriasis drug Raptiva can increase the risk of developing a rare, fatal brain infection called progressive multifocal leukoencephalopathy (PML), and confirmed reports of the infection in three deceased patients who had taken the drug for more than three years.
The details can be read here.
The details can be read here.
Dr. Reddy's Receives Favorable Summary Judgment Ruling in the Omeprazole Mg OTC Litigation
Mar 12, 2009 - Dr. Reddy's Laboratories today announced that the U.S. District Court (Southern District, New York) has granted a summary judgment that the Omeprazole Mg OTC ANDA filed by Dr. Reddy's does not infringe the patents in suit related to Astra Zeneca's Prilosec OTC.
The details can be read here.
The details can be read here.
Pronova BioPharma ASA (NO) - Pronova receives Lovaza Paragraph IV Notice Letter from Teva
12 March, 2009 -- Pronova BioPharma ASA today announces that it and its U.S. marketing partner GlaxoSmithKline Inc. have received a Paragraph IV Notice Letter dated March 9 2009 from Teva Pharmaceuticals USA, Inc. advising that Teva has submitted an Abbreviated New Drug Application (ANDA) to the US FDA for approval to market a generic version of Lovaza.
the details can be read here.
the details can be read here.
Actavis ASKA sign legal agreement to establish Japanese generic pharmaceutical business
Following the signature of a preliminary agreement last November, Actavis Group and ASKA Pharmaceutical have now formally signed an agreement establishing a joint company: Actavis ASKA K.K.
The joint company will enter the Japanese generic pharmaceutical market in April 2009. ASKA will hold 55% of shares in the joint venture; Actavis 45%
The details can be read here.
The joint company will enter the Japanese generic pharmaceutical market in April 2009. ASKA will hold 55% of shares in the joint venture; Actavis 45%
The details can be read here.
Wednesday, March 11, 2009
Merck to acquire Schering-Plough for $41.1 bn
US-based Merck & Co, Inc has decided to acquire and merge Schering-Plough Corporation in a stock and cash transaction for total consideration of $41.1 billion. The transaction will be structured as a 'reverse merger' in which Schering-Plough, renamed Merck, will continue as the surviving public corporation.
The details can be read here.
The details can be read here.
CSL Behring Receives ODE for RiaSTAP, First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
CSL Behring has been informed by the U.S. FDA that because RiaSTAP is the first FDA-approved treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, the company is entitled to seven years of orphan-drug exclusivity.
The details can be read here.
The details can be read here.
StemEx, a Gamida Cell-TEVA Joint Venture Cell Therapy Product, Receives Orphan Medicinal Product Designation in the European Union
Mar 11, 2009 - The Gamida Cell-Teva Joint Venture announced today that orphan designation was granted by the European Commission for the investigational medicinal product StemEx for the treatment of acute lymphoblastic leukemia and acute myeloid leukemia.
The details can be read here.
The details can be read here.
FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
March 11, 2009 -- Schering-Plough Corporation today announced that the U.S. FDA has approved new labeling for PEGINTRON (peginterferon alfa-2b) and REBETOL (ribavirin, USP) combination therapy for treating chronic hepatitis C in patients 3 years of age and older with compensated liver disease. With approval of this expanded indication, PEGINTRON and REBETOL is the first and only pegylated interferon combination therapy approved in the United States that is not restricted to treatment-naive patients.
The details can be read here.
The details can be read here.
Basilea's Toctino Receives Marketing Authorization in Belgium and Luxemburg
Basilea Pharmaceutica Ltd. announces that Toctino (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the health authorities in Belgium and in Luxemburg.
The details can be read here.
The details can be read here.
Immune-Based Drug Approved in Europe for Pediatric Cancer Patients
March 10, 2009 – The European Commission, which oversees legislation and regulation for the European Union, has approved a therapy for pediatric patients with non-metastatic, resectable osteosarcoma, a type of bone cancer. The approval is based on clinical studies led by researchers at The University of Texas M. D. Anderson Cancer Center and a national co-operative group.
MEPACT (mifamurtide, L-MTP-PE) is an immune-based therapy, that when combined with chemotherapy, resulted in approximately a 30 percent decrease in the risk of death with 78 percent of patients surviving more than six years following treatment. This therapy is the first in more than 20 years to improve the long-term survival of osteosarcoma patients.
the details can be read here.
MEPACT (mifamurtide, L-MTP-PE) is an immune-based therapy, that when combined with chemotherapy, resulted in approximately a 30 percent decrease in the risk of death with 78 percent of patients surviving more than six years following treatment. This therapy is the first in more than 20 years to improve the long-term survival of osteosarcoma patients.
the details can be read here.
ConjuChem Announces U.S. Patent & Trademark Office Rejects All Claims in Amylin Patent and Issues Action Closing Prosecution
ConjuChem Biotechnologies Inc. announced today that the USPTO has issued an Action Closing Prosecution in the inter partes reexamination of Patent No. 6,924,264. The patent, entitled "Modified Exendins and Exendin Agonists," was issued in August 2005 and is assigned to Amylin Pharmaceuticals, Inc. The Action Closing Prosecution rejected all the claims for obviousness and/or lack of novelty. The inter partes reexamination in the USPTO does not involve any of ConjuChem's patents.
The details can be read here.
The details can be read here.
Prasco Selected as GSK's Generics Marketing and Distribution Agent
March 11, 2009 -- , announced today it has entered into a marketing and distribution agreement with GlaxoSmithKline . FLONASE (fluticasone propionate) Nasal Spray is the first product to be marketed under this agreement.
The details can be read here.
The details can be read here.
Sepracor Announces Final Settlement of XOPENEX Inhalation Solution Patent Infringement Litigation with Barr Laboratories, Inc.
Mar 10, 2009 - Sepracor Inc. today announced that it has entered into a Settlement and License Agreement with Teva Pharmaceuticals USA, Inc. and Barr Laboratories, Inc., a wholly owned subsidiary of Teva, to resolve the patent litigation against Barr involving Sepracor's XOPENEX brand levalbuterol HCl Inhalation Solution products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL) and to grant a license to Barr and Teva. The agreement permits Barr and Teva to launch generic versions of these XOPENEX Inhalation Solution dosages under terms of a non-exclusive license commencing on February 17, 2013.
The details can be read here.
The details can be read here.
HIV/AIDS Update - Tentative approval of lopinavir/ritonavir Tablets , 200 mg/50 mg
On March 10, 2009, FDA granted tentative approval for a generic formulation of lopinavir/ritonavir Tablets, 200 mg/50 mg, manufactured by Matrix Laboratories, Ltd., of Hyderabad, India, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The details can be read here.
The details can be read here.
Synerx Pharma Announces First Approval of Generic Equivalent to Ovide
Synerx Pharma, LLC announces the approval of its Abbreviated New Drug Application for Malathion Lotion, 0.5%. The product represents the first approval of a generic equivalent to Ovide®.
The details can be read here.
The details can be read here.
USPTO Issues Notice of Final Determination for Patent Term Extension for Namenda
Forest Laboratories, Inc. Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co. KGaA, and Merz PharmaceuticalsGmbH announced today that the U.S. PTO has issued a Notice of Final Determination granting the full five years of patent term extension for U.S. Patent No. 5,061,703 (the '703 Patent), which is listed in the U.S. FDA Orange Book for NAMENDA(R) (memantine hydrochloride).
The details can be read here.
The details can be read here.
Monday, March 9, 2009
Ranbaxy gets US FDA approval for ramipril capsules
Ranbaxy Laboratories Limited has received an approval from the US FDA for its Abbreviated New Drug Application, to market and manufacture ramipril capsules 5mg & 10mg.
The details can be read here.
The details can be read here.
Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. FDA
Isolagen, Inc. today announced that the Company has submitted a Biologics License Application (BLA) for Isolagen Therapy, a novel, first-in-class cellular therapy for the treatment of wrinkles/nasolabial folds, to the U.S. FDA.
The details can be read here.
The details can be read here.
IDM Pharma's Mepact (Mifamurtide, L-MTP-PE) Receives Approval in Europe for Treatment of Patients with Non-Metastatic, Resectable Osteosarcoma
IDM Pharma, Inc. today announced that the European Commission has formally granted a Centralized marketing authorization for MEPACT (mifamurtide, L-MTP-PE) for the treatment of patients with non-metastatic, resectable osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.
The details can be read here.
The details can be read here.
Watson Pharmaceuticals and Elan Settle Lawsuit Over Naproxen Sodium
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has reached a settlement with Elan Corporation, Plc on outstanding patent litigation related to Watson's generic version of Naprelan(R) (naproxen sodium) tablets.
The details can be read here.
The details can be read here.
Article One Partners Uncovers New Prior Art Impacting the Validity of Merck's Singulair Patent
March 09, 2009 -- Article One Partners LLC has discovered new prior art impacting the validity of Merck & Co.'s SINGULAIR U.S. drug patent. A request is being filed today with the U.S. Patent Office to review the patent in a reexamination proceeding. An independent law firm and an independent expert join Article One's opinion that a substantial new question of patent validity is raised by the success of Article One's research and should be reviewed by the Patent Office.
The details can be read here.
The details can be read here.
Sunday, March 8, 2009
HLL Lifecare to turn into major vaccine producer in 5 yrs with its Rs 900 cr project
Hindustan Latex Ltd, renamed as HLL Lifecare Ltd, is all set to become a multi-faceted health care major with the commissioning of its Rs.900 crore vaccine complex and medical park near Chennai.With that, the public sector undertaking will transform itself from a global leader in condom manufacturing to a major healthcare institution of international standing according to E A Subrahmanian, general manager (projects), HLL Lifecare.
the details can be read here.
the details can be read here.
BMS inks pact with Nissan Chemical & Teijin Pharma for atrial fibrillation compound
Bristol-Myers Squibb Company announced a global collaboration with Nissan Chemical Industries, Ltd and Teijin Pharma Limited for the development and commercialization of NTC-801, a selective inhibitor of the acetylcholine-activated potassium ion channel (IKACh), currently in phase-I development in Japan, for the maintenance of normal sinus rhythm in patients with atrial fibrillation.
The details can be read here.
The details can be read here.
Takeda Receives New Information on Alogliptin (SYR-322) NDA
March 6, 2009 - Takeda Pharmaceutical Company Limited today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States subsidiary, was informed as part of regular discussions about the alogliptin New Drug Application with the USFDA, that although the alogliptin NDA was filed prior to issuance of FDA’s December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.
The details can be read here.
The details can be read here.
Orion withdraws EU application for extending the indication of Stalevo
March 6, 2009--With this release, Orion Corporation updates information provided earlier in the stock exchange release of 24 February 2009 on the regulatory implications of the results of STRIDE-PD, a clinical study aimed to provide support for extending the current EU indication of Orion's proprietary drug Stalevo® (levodopa, carbidopa and entacapone) to early Parkinson's disease. Orion has decided to withdraw its EU application for extending the indication.
The details can be read here.
The details can be read here.
Intendis Inc. and Triax Pharmaceuticals, llc Announce Co-Promotion Agreement
March 6, 2009 – Intendis, Inc., and Triax Pharmaceuticals, LLC announce the Co-Promotion of Locoid Lipocream® (hydrocortisone butyrate) 0.1% cream and Locoid® Lotion (hydrocortisone butyrate) 0.1% lotion at the 67th Annual Meeting of the American Academy of Dermatology.
the details can be read here.
the details can be read here.
Acanya Gel, a New Treatment for Moderate to Severe Acne, Launched by Coria Laboratories
March 06, 2009 -- Coria Laboratories, the newly expanded dermatology division of Valeant Pharmaceuticals International , announced today the commercial launch of Acanya(TM) Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) indicated for the once-daily treatment of acne vulgaris in patients 12 years and older.
The details can be read here.
The details can be read here.
InNexus Biotechnology Announces New Patents Protecting Novel Cell Penetrating DXL Antibodies
March 06, 2009 -- InNexus Biotechnology Inc. , a drug development company commercializing the next generation of monoclonal antibodies based on its Dynamic Cross Linking (DXL(TM)) technology, announces that it has received a notice of allowance on patent claims in the United States (Serial No. 11/119,404) and a patent grant in India (National Phase Application No. 2424/CHENP/2005) further expanding its protection of InNexus' DXL(TM) technology.
The details can be read here.
The details can be read here.
Teva Introduces Amiodarone Hydrochloride Injection in a New 18 mL Vial Size
March 4, 2009 – Teva Health Systems is pleased to announce the introduction and availability of Amiodarone Hydrochloride Injection in a new 18 mL vial size. This Teva product is AP rated to Cordarone Injection.
The details can be read here.
The details can be read here.
Thursday, March 5, 2009
FDA Provides PDUFA Target Agency Action Date For GTx's Toremifene 80 mg NDA
Mar 5, 2009 - GTx, Inc., today announced that the USFDAwill target a Prescription Drug User Fee Act agency action date of October 30, 2009 for the toremifene 80 mg New Drug Application (NDA), which is within 10 months of the submission of the NDA.
The details can be read here.
The details can be read here.
European Commission and United States Food and Drug Administration Both Approve New Options for Patients With Certain Primary Brain Tumors
Schering-Plough Corporation today announced that the European Commission and the US FDA both approved the intravenous (IV) formulation of temozolomide as an alternative to the already approved oral form of the drug. Temozolomide is marketed as TEMODAL in the EU and as TEMODAR in the US.
The details can be read here.
The details can be read here.
Ranbaxy Secures Final FDA Approval for Quinapril Hydrochloride + Hydrochlorothiazide Tablets
Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Quinapril Hydrochloride & Hydrochlorothiazide (Quinapril + HCTZ) Tablets, 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg.
the details can be read here.
the details can be read here.
Wednesday, March 4, 2009
Zydus Research Centre receives lab animal care accreditation from AAALAC
The Ahmedabad-based Zydus Cadila, one of India's leading healthcare companies, announced that the Zydus Research Centre in Ahmedabad has received full accreditation from AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) International.
The details can be read here.
The details can be read here.
Mannkind to extend NDA submission for faster-acting insulin
MannKind Corporation provided an update on the status of its new drug application for Afresa, an ultra rapid-acting insulin that has completed phase-3 clinical trials. As previously announced, the company's internal goal was to submit the NDA to the FDA by the end of February.
The details can be read here.
The details can be read here.
Teva's Azilect Use Dramatically Increases in Second-Line Therapy for the Treatment of Parkinson's Disease
Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that second-line patient share ofMAO-B inhibitors has increased from 14.1 percent to 35.2 percent since last year's report.
The details can be read here.
The details can be read here.
Ferring Pharmaceuticals Announces Immediate Availability of Degarelix for the Treatment of Advanced Prostate Cancer
Ferring Pharmaceuticals, USA today announced the U.S. commercial availability of degarelix for injection, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. FDA for the treatment of hormone sensitive advanced prostate cancer. Degarelix is available for order through traditional and specialty pharmacy distributors.
The details can be read here.
The details can be read here.
Cordex Pharma Files ATPace Formulation Patent
Cordex Pharma, Inc. announced today that it has filed a formulation patent covering its lead product, ATPace.
ATPace is a stable liquid formulation of adenosine triposphate (ATP) for intravenous administration. ATPace is being developed as a therapeutic drug for the acute management of paroxysmal supraventricular tachycardia (PSVT) as well as a diagnostic test for the identification of patients with bradycardic (slow heart rate) syncope who may benefit from pacemaker therapy.
The details can be read here.
ATPace is a stable liquid formulation of adenosine triposphate (ATP) for intravenous administration. ATPace is being developed as a therapeutic drug for the acute management of paroxysmal supraventricular tachycardia (PSVT) as well as a diagnostic test for the identification of patients with bradycardic (slow heart rate) syncope who may benefit from pacemaker therapy.
The details can be read here.
Synthon announces European approvals for Levocetirizine
04 March 2009 -- Synthon announced today that it has successfully concluded its registration procedures for Levocetirizine. Regulatory clearance has been obtained for Synthon's product in fourteen European countries using decentralized procedures. Registration has been established for 5 mg filmcoated tablets. Synthon's product is a fully bioequivalent version of the oral anti-histamine drug Xyzal.
The details can be read here.
The details can be read here.
Tuesday, March 3, 2009
Merck Sues Sandoz Over Plan For Generic Emend
Merck & Co. Inc. has sued Sandoz Inc., Novartis Pharmaceutical Corp.'s generics unit, over its plan to make a generic version of the anti-nausea drug Emend, alleging that the generic drug would infringe four of Merck's patents....
The details can be read here.
The details can be read here.
FDA Clears Cellectar's IND Application for Lead Oncology Drug Candidate
March 3, 2009 - Cellectar, Inc., a privately held radiopharmaceuticals company that designs and develops products to detect, treat and monitor human cancers, today announced that the U.S. FDA has cleared the Company’s Investigational New Drug application for its 131I-CLR1404 drug candidate for testing in patients with advanced solid malignancies.
The details can be read here.
The details can be read here.
Pharmaxis Announces NDA Filing for Aridol (Mannitol Bronchial Challenge Test)
March 03, 2009 -- Pharmaxis, Inc., a wholly owned subsidiary of Pharmaxis Ltd , an emerging respiratory specialty pharmaceutical company, announced today that it has filed a New Drug Application, electronically, with the U.S. FDA for Aridol (mannitol bronchial challenge test).
The details can be read here.
The details can be read here.
Acurox Tablets New Drug Application Accepted for Filing With a Priority Review Classification
March 3, 2009 – Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. today announced that Acura’s New Drug Application for Acurox (oxycodone HCl/niacin) Tablets was accepted for filing by the US FDA with a Priority review classification. Acurox is an immediate release opioid analgesic, has a proposed indication for relief of moderate-to-severe pain and is designed to deter common methods of misuse and abuse.
The details can be read here.
The details can be read here.
China Sky One Medical Inc. Gets SFDA Approval for Calcium Folinate Injection
March 03, 2009 -- China Sky One Medical, Inc., a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China, today announced that it obtained production approval from the State Food and Drug Administration (SFDA) in China for Calcium Folinate Injection.
The details can be read here.
The details can be read here.
Copaxone Approved by the FDA for Patients with a First Clinical Event Suggestive of Multiple Sclerosis
Mar 3, 2009 - Teva Pharmaceutical Industries Ltd., today announced that the U.S. FDA has approved an expanded indication for COPAXONE (glatiramer acetate injection) to include the treatment of patients who have experienced a first clinical episode and have magnetic resonance imaging features consistent with multiple sclerosis (MS).
the details can be read here.
the details can be read here.
Thrasos Re-Emerges from Stealth with First-in-Class Compounds that Target BMP Pathway
March 3, 2009) – Thrasos Therapeutics, Inc., a biotechnology company developing unique therapeutic agents to treat severe organ failure and other critical medical needs, announced today the issuance of U.S. patent number 7,482,329 covering a proprietary set of small molecules that selectively activate key receptors of the bone morphogenetic protein (BMP) family.
The details can be read here.
The details can be read here.
Pfizer expands generic portfolio through licensing with Aurobindo Pharma
Pfizer Inc has entered into a series of agreements with Aurobindo Pharma Ltd, a pharmaceutical company based in India, to commercialize medicines that are no longer patent protected, and have lost market exclusivity in the United States and Europe, further progressing its Established Products Business Unit (EPBU) strategy.
The details can be read here.
The details can be read here.
US FDA rejects Somaxon's NDA for Silenor in its present form
Somaxon Pharmaceuticals, Inc, has received a Complete Response Letter from the US FDA for its New Drug Application for Silenor (doxepin) for the treatment of insomnia. Based on its review, the FDA has determined that the NDA cannot be approved in its present form.
The details can be read here.
The details can be read here.
Aurobindo Pharma gets nod for Lisinopril pills in Australia
Aurobindo Pharma Limited has announced that its wholly-owned subsidiary Aurobindo Pharma Australia Pty Ltd has received its first approval from Therapeutic Goods Administration, Government of Australia for the registration of Auro-Lisinopril 5, Auro-Lisinopril 10 and Auro-Lisinopril 20 tablets containing Lisinopril (as dehydrate) 5mg, 10mg and 20mg.
The details can be read here.
The details can be read here.
Jubilant gets Canadian nod for generic Sestamibi
Jubilant Organosys Ltd, headquartered in India, announced that its subsidiary in Canada, Draxis has received approval for the generic Sestamibi from Health Canada. Draximage Sestamibi is a generic Kit for the Preparation of Technetium (Tc 99m) Sestamibi Injection, a diagnostic cardiac imaging agent used for the diagnosis and localization of myocardial infarction; and for the diagnosis and localization of ischemic heart disease and coronary artery disease.
The details can be read here.
The details can be read here.
Monday, March 2, 2009
ImClone Systems and Bristol-Myers Squibb Update Status of Supplemental Biologics Application for Erbitux in U.S.
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, and Bristol-Myers Squibb Company today announced that the companies received a complete response letter from the U.S. FDA for the first-line squamous cell carcinoma of the head and neck (SCCHN) supplemental Biologics License Application for ERBITUX (cetuximab).
The details can be read here.
The details can be read here.
US Food and Drug Administration Issues Complete Response Letter Regarding the Tracleer Supplemental New Drug Application
02 March 2009 - Actelion Ltd announced today it has received a complete response letter from the US FDA regarding the supplemental New Drug Application the company filed in August 2007.
The details can be read here.
The details can be read here.
Pharmaxis Announces New Drug Application Submission for Aridol
Pharmaceutical company Pharmaxis today announced it had submitted a New Drug Application with the U.S. FDA for Aridol, a bronchial challenge test. Bronchial challenge tests are designed to help in the correct diagnosis and assessment of asthma.
The details can be read here.
The details can be read here.
Orexo's Abstral receives two further large EU market approvals in France and Spain
March 2, 2009-- Orexo, announces that AbstralTM has received Marketing Authorisation from the French and Spanish regulatory authorities for the treatment of breakthrough cancer pain.
The details can be read here.
The details can be read here.
Actavis Sues FDA Over VYVANSE Exclusivity
Actavis has sued FDA after the Agency refused to accept the company’s ANDA for a generic version of the ADHD drug VYVANSE (lisdexamfetamine dimesylate) Capsules earlier this year. FDA’s Orange Book shows that VYVANSE is a Type 1 new molecular entity covered by a period of 5-year New Chemical Entity exclusivity, as well as another period of 3-year exclusivity and two patents scheduled to expire on June 29, 2023.
The details can be read here.
The details can be read here.
Sunday, March 1, 2009
Belgian SPC case decision on scope of protection conferred by SPC
Last November, the Brussels Court of First Instance handed down a decision on the scope of protection conferred by SPCs. The case relates to a vinorelbine tartrate SPC and whether or not the scope of protection conferred by an SPC extends to the use of an active ingredient as such before it is transformed into a medicinal product.
The details can be read here.
The details can be read here.
Sami Labs bags DCGI clearance for marketing psoriasis drug
Bangalore-based Sami Labs has received approval from the Drugs Control General of India for marketing a herbal formulation to treat psoriasis first time in the country. The drug will be launched in the next six weeks, Dr Muhammed Majeed, managing director, Sami Labs Limited told Pharmabiz.
The details can be read here.
The details can be read here.
FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs
Feb. 26, 2009--The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.
The details can be read here.
The details can be read here.
Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee
February 27, 2009 -- Advanced Life Sciences Holdings, Inc. , announced today that it has received notice from the U.S. FDA that the agency's Anti-Infective Drugs Advisory Committee (AIDAC) is tentatively scheduled to meet on June 2, 2009, and will discuss the New Drug Application for cethromycin, a new once-a-day oral antibiotic for the proposed indication of outpatient treatment of adults with mild-to-moderate community acquired pneumonia.
The details can be read here.
The details can be read here.
AstraZeneca Receives FDA Complete Response Letter On Seroquel XR For Generalised Anxiety Disorder
Feb. 27, 2009--AstraZeneca today announced the company has received a Complete Response Letter from the U.S. FDA asking for additional information for the supplemental New Drug Application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of Generalised Anxiety Disorder in adult patients.
The details can be read here.
The details can be read here.
FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease (COPD)
AstraZeneca today announced that the U.S. FDA has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
The details can be read here.
The details can be read here.
OSI Pharmaceuticals Response to Initial Non-Final Office Action by U.S. Patent and Trademark Office
Feb 27, 2009 - OSI Pharmaceuticals, Inc. announced that the Company received notification from the U.S. PTO that an initial office action has been issued regarding OSI's application for a reissue of the Company's composition of matter patent for Tarceva (erlotinib), U.S. Patent No. 5747498.
The details can be read here.
The details can be read here.
BioAlliance Pharma reacquires the rights to Loramyc in Europe
February 27, 2009 _ BioAlliance Pharma SA, the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and AIDS, today announced the termination of the licensing agreement signed in 2007 with SpeBio.
The details can be read here.
The details can be read here.
Lawsuit Against Amgen's Marketing of Aranesp, Enbrel Unsealed
Feb. 27, 2009 -- A lawsuit has been filed in federal court in Massachusetts against Amgen, Wyeth and other companies accusing them of off-label marketing of blockbuster drugs Enbrel and Aranesp.
The details can be read here.
The details can be read here.
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