India to move WTO dispute settlement body over seizure of drugs at EU ports

India will soon take up the issue of seizure of drug consignments from the country en route to Brazil and Africa by European authorities, especially the Dutch officials, on the grounds of alleged patent violation recently to the dispute settlement body of the World Trade Organisation (WTO).

The details can be read here.

Phase III trial of Nexavar to treat melanoma fails to meet endpoint, study stopped

Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. announced that a phase III trial evaluating Nexavar (sorafenib) tablets in patients with unresectable stage III or stage IV melanoma was stopped early following a planned interim analysis by an independent Data Monitoring Committee (DMC).

The details can be read here.

.S. FDA Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months

United Therapeutics Corporation announced today that the U.S. FDA will require additional time to complete its review of the New Drug Application for Tyvaso (inhaled treprostinil). In a notice received today, the FDA extended the Prescription Drug User Fee Act date from April 30, 2009, to July 30, 2009.

The details can be read here.

Surveyed Neurologists in Both the US and EU Indicate That a Once-Daily Transdermal Formulation of Levodopa Would Earn a 30 Percent Patient share

April 28 -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a once-daily transdermal formulation of levodopa would earn a 30 percent patient share in Parkinson's disease in both the United States and in Europe, according to surveyed U.S. and European neurologists.

The details can be read here.

Genta Announces Allowance of Two Key European Patents for Genasense

Apr 28, 2009 - Genta Incorporated announced today that the European Patent Office intends to grant two key patents related to the Company's intellectual property position on Genasense (oblimersen sodium) Injection. The Company has proceeded with grant formalities and validation of the patents.

the details can be read here.

Generic Substitutes Less Effective/Safe Than Branded Medications in Treating Lower Urinary Tract Symptoms

April 27 -- Men taking generic drugs may be more likely to have less effective results and more adverse events than if they were using branded medications, according to new data from researchers in New York. Researchers presented a study at the 104th Annual Scientific Meeting of the American Urological Association (AUA) showing that generic substitutes for alpha blockers and 5-alpha reductase inhibitors (5-ARIs), two classes of medications used to treat lower urinary tract symptoms (LUTS) in men, are less effective than their branded counterparts.

The details can be read here.

Watson Confirms Filing of Abbreviated New Drug Application for Generic Enablex

April 28, 2009 -- Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application with the U.S. FDA seeking approval to market its darifenacin hydrobromide extended-release 7.5 mg and 15 mg product prior to the expiration of a patent owned by Novartis AG.

The details can be read here.

Dr. Reddy's Launches Nexret

Apr 28, 2009 - Dr. Reddy's Laboratories Ltd. has launched NexretTM (Tretinoin 0.04% & 0.1% as microspheres) in India. It marks the entry of Dr. Reddy's into the topical anti-acne segment, a commonly diagnosed condition by dermatologist.

The details can be read here.

Novel Once Daily Anti-Epileptic Zebinix(R) Approved in the European Union

Bial-Portela & CA, S.A., and Eisai Europe Limited, the European subsidiary of Eisai Co., Ltd. today announced that the novel once dailyanti-epileptic Zebinix(R) (eslicarbazepine acetate) received marketingauthorisation from the European Commission as adjunctive therapy in adultswith partial-onset seizures, with or without secondary generalisation.

the details can be read here.

Study shows NKTR-105's superior anti-tumour activity over docetaxel

Nektar Therapeutics presented data at the American Association for Cancer Research (AACR) 100th Annual Meeting demonstrating that NKTR-105, a novel PEGylated form of docetaxel, has superior anti-tumour activity, as well as greater and sustained exposure in plasma and tumour tissue, over docetaxel in preclinical models.

The details can be read here.

New TB vaccine candidate enters phase IIb proof-of-concept trial in South Africa

The Aeras Global TB Vaccine Foundation, the Oxford-Emergent Tuberculosis Consortium Ltd, Isis Innovation Ltd, the Wellcome Trust and the University of Cape Town (UCT) announce the start of a phase-IIb proof-of-concept clinical trial of a promising new TB vaccine developed at the University of Oxford called MVA85A/AERAS-485.

the details can be read here.

Glenmark's cholesterol-lowering agent ezetimibe gets US FDA tentative approval

Glenmark Generics Ltd's US subsidiary announced that the US FDA has granted tentative approval for the generic version of Schering Plough and MSP Singapore Company LLC's hypercholesterolemia treatment Zetia (ezetimibe).

The details can be read here.

Archimedes Announces European Filing of NasalFent for the treatment of Breakthrough Cancer Pain

27 April 2009 - Archimedes Pharma, the pan-European specialty pharmaceutical company, today announced that it has submitted a centralised Marketing Authorisation Application with the European Medicines Evaluation Agency (EMEA) for approval of its lead development product, NasalFent, an innovative and highly differentiated fentanyl nasal spray for the rapid relief of breakthrough cancer pain.

The details can be read here.

Ligand Announces Approval in Europe of Conbriza for Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture

Apr 27, 2009 - Ligand Pharmaceuticals Incorporated today announced that its partner Wyeth has received approval from the European Commission (EC) for CONBRIZA™ (bazedoxifene), a selective estrogen receptor modulator (SERM) for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.

The details can be read here.

Risperdal Consta Approved in Japan

Apr 27, 2009 - Alkermes, Inc. today announced that Janssen Pharmaceutica K.K. received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to market RISPERDAL CONSTA [(risperidone) long-acting injection] for the treatment of schizophrenia.

The details can be read here.

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.

Bone Care International LLC et al. v. Eagle Pharmaceuticals Inc.1:09-cv-00285; filed April 23, 2009 in the District Court of Delaware (doxercalciferol)

Pronova BioPharma Norge AS v. Teva Pharamceuticals USA, Inc. et al.1:09-cv-00286; filed April 23, 2009 in the District Court of Delaware (omega-3-acid ethyl esters)

Eli Lilly and Company et al. v. Barr Laboratories Inc.1:09-cv-00272; filed April 22, 2009 in the District Court of Delaware (pemetrexed for injection)

Sepracor Inc. v. Alphapharm Pty. Ltd et al.1:09-cv-03987; filed April 22, 2009 in the Southern District of New York (eszopiclone, used to treat insomnia)

Pfizer, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al.1:09-cv-03965; filed April 21, 2009 in the Southern District of New York (diclofenac sodium/misoprostol)

Reckitt Benckiser Inc. v. Watson Laboratories, Inc. - Florida et al.1:09-cv-03933; filed April 20, 2009 in the Southern District of New York (guaifenesin, and guaifenesin/dextromethorphan)

OptiGen, LLC v. Texas A&M University System et al.5:09-cv-00457; filed April 17, 2009 in the Northern District of New York

The details and the complaints can be read here.

India goes offensive to counter MNC propaganda on generic drugs in African countries

Pitted against the multi-pronged propaganda by multinationals and the western countries to choke the Indian generic drugs in the developing world, the Commerce Ministry has launched an aggressive campaign by holding a meeting of Indian ambassadors to different countries and briefing the ambassadors and High Commissioners of African countries on the issue and India's strength.

The details can be read here.

FDA Accepts for Review Theravance's Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections

April 24, 2009 - Theravance, Inc. announced today that the U.S. FDA accepted as complete for review Theravance's response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections.

The details can be read here.

Bosentan (Tracleer) receives positive CHMP opinion for pediatric formulation

24 April 2009 - Actelion Ltd announced today that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines, issued a positive opinion for the pediatric formulation of bosentan (Tracleer) for the treatment of pulmonary arterial hypertension (PAH).

the details can be read here.

Cangene's Hepatitis B Therapeutic approved in Canada for a second indication

Cangene Corporation today reports that its HepaGam B(R) (Hepatitis B Immune Globulin (Human) Injection) has been approved by the Biologics and Genetic Therapies Directorate of Health Canada for treating acute exposure to hepatitis B virus.

the details can be read here.

Iressa (Gefitinib) Recommended for Approval for the Treatment of Non-Small Cell Lung Cancer in Europe

AstraZeneca announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory committee of the European Medicines Agency (EMEA), has issued a positive opinion supporting approval of the targeted oral anti-cancer drug, IRESSA (gefitinib).

The details can be read here.

Golimumab Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Centocor Ortho Biotech Inc. announced today that the U.S. FDA has approved SIMPONI (golimumab) for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. SIMPONI is the first patient-administered anti-tumor necrosis factor (TNF)-alpha therapy that offers an effective once-monthly treatment option.

The details can be read here.

Pronova BioPharma ASA (NO) - Pronova BioPharma Norge AS files lawsuit against Teva Pharmaceuticals USA, Inc. relating to lovaza

24 April 2009 -- Pronova BioPharma ASA today announces that Pronova BioPharma Norge AS has filed a lawsuit against Teva Pharmaceuticals USA, Inc. in the United States District Court for the District of Delaware asserting infringement of Pronova BioPharma's U.S. Patents Nos. 5,502,077 and 5,656,667 relating to omega-3-acid ethyl ester compositions and methods of using omega-3-acid ethyl esters.

The details can be read here.

Roche's phase III study of Avastin plus chemotherapy in colon cancer fails

Roche announced the results of the first phase-III trial evaluating the use of Avastin (bevacizumab) plus chemotherapy (FOLFOX) for the treatment of colon cancer immediately following surgery (adjuvant therapy) compared to chemotherapy alone. The study, known as NSABP C-08, did not meet its primary endpoint of lowering the risk of the cancer returning (disease-free survival). This is the first trial of Avastin in early-stage cancer and results do not affect approved indications in advanced (metastatic) disease.

The details can be read here.

Sandoz gets Canadian nod to market Omnitrope

Sandoz Canada has received market authorization for Omnitrope in Canada. Omnitrope is the first version of a previously approved recombinant biotechnology drug to be approved by Health Canada under the regulatory term Subsequent Entry Biologic (SEB).

the details can be read here.

Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis

Apr 23, 2009 - Acorda Therapeutics, Inc. today announced the resubmission of its New Drug Application for Fampridine-SR to the U.S. FDA. Fampridine-SR is a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS).

the details can be read here.

U.S. Food and Drug Administration Extends Review Timeline for Onglyza (saxagliptin) New Drug Application

Apr 23, 2009 - Bristol-Myers Squibb Company and AstraZeneca reported today that the U.S. FDA has determined it needs additional time to complete the review of the New Drug Application for ONGLYZA (saxagliptin) for the treatment of type 2 diabetes.

the details can be read here.

Rwanda Becomes First Developing Nation to Introduce Vaccine for World's Leading Infectious Child Killer

Apr 23, 2009 - International leaders in global health will join Rwandan government officials at a press conference in the coming days in Kigali to announce the first national immunisation programme against pneumococcal disease in a developing country. Pneumococcal disease, which can cause potentially life-threatening illnesses such as pneumonia, meningitis and sepsis, is the leading vaccine-preventable killer of children younger than five worldwide.

the details can be read here.

Teva Comments on Generic Evista Preliminary Injunction

Apr 23, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the Southern District of Indiana has granted Eli Lilly's motion for a preliminary injunction related to Teva's abbreviated new drug application to market its generic version of Evista Tablets. Teva plans to appeal the decision.

The details can be read here.

Lilly Granted Preliminary Injunction to Prevent Launch of Generic Raloxifene

Eli Lilly and Company announced that the U.S. District Court for the Southern District of Indiana today issued a preliminary injunction to prevent the launch of a generic version of Lilly's medicine Evista(R) (raloxifene HCl tablets) by Teva Pharmaceuticals until the Court renders its final ruling. Teva had indicated it was prepared to launch the generic version prior to the resolution of outstanding patent litigation currently being considered by the U.S. District Court for the Southern District of Indiana. Lilly had previously sought and been granted a temporary restraining order to prevent the generic launch.

The details can be read here.

Gilead initiates phase II trial of integrase-based single-tablet for HIV treatment

Gilead Sciences, Inc has begun enrolling patients in a phase-II clinical trial of its investigational integrase-based, single-tablet, once-daily regimen of elvitegravir, GS 9350 and Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection.

The details can be read here.

USPTO combines 3 patent interferences into single interference between Sepracor & Wyeth

Sepracor Inc announced that the Board of Patent Appeals and Interferences (BPAI) of the US Patent and Trademark Office has combined three patent interferences into a single interference between Sepracor and Wyeth and set a date for oral arguments. The interference seeks to determine the priority of inventorship of claims directed to racemic O-desmethylvenlafaxine (ODMV) succinate. Wyeth markets racemic ODMV succinate in the US under the brand name Pristiq for the treatment of major depressive disorder in adults.


The details can be read here.

Meda Pharma sues Sun Pharma on generic antihistamine nasal spray

The Meda Pharmaceutical Inc, the US subsidiary of Sweden-based Meda AB, has filed a patent infringement suit against Mumbai-based Sun Pharmaceuticals Ltd in the United States District Court for the District of Delaware on the latter's Para IV filing to market the generic antihistamine nasal spray product in US.

The details can be read here.

Daiichi Sankyo Obtains Manufacturing and Marketing Approval for New Cravit Formulations

Daiichi Sankyo Company, Limited, today obtained manufacturing and marketing approval in Japan for new formulations of Cravit (Levofloxacin Hydrate), a broad-spectrum oral anti-bacterial agent. These formulations are 250mg and 500mg tablets, and a 10% fine granular preparation.

The details can be read here.

Micombi Combination Tablets Approved for Manufacturing and Marketing

April 22, 2009--Nippon Boehringer Ingelheim Co., Ltd. and Astellas Pharma Inc. announced today that on 22 April the approval of manufacture and marketing of Micombi Combination Tablets was obtained. Micombi is a combination drug of telmisartan, an angiotensin II receptor blocker, and hydrochlorothiazide, a diuretic of the thiazide class.

The details can be read here.

febit Receives European Patent for Gene Extraction Procedure

April 22, 2009 – febit holding gmbh announced today, that the company has been granted the first European patent (EP1436609) for a microarray-based nucleic acid extraction procedure.

the details can be read here.

Watson Files FDA Applications for Generic Mucinex

April 22, 2009 -- Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that it has filed two Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration seeking approval to market its guaifenesin extended-release 600mg and 1200mg tablets and its dextromethorphan HBr/guaifenesin extended-release 30mg/600mg and 60mg/1200mg tablets prior to the expiration of patents owned by Reckitt Benckiser Inc.

The details can be read here.

Johnson & Johnson launches late-phase NCE research facility in Mumbai

Johnson & Johnson Pharmaceutical Research & Development, LLC, a part of Johnson & Johnson, the world's most broadly based producer of healthcare products, has launched its late-phase new chemical entity (NCE) Analytical & Pharmaceutical Development Centre (APDC) at Mulund in Mumbai.

The details can be read here.

Photocure ASA (NO) - Metvix and Aktilite CL128 Approved By Health Canada

April 21, 2009 --Photocure ASA announces today that Metvix® in combination with Aktilite® CL128, the LED based narrow band (630 nm) red light technology device, has been approved by Health Canada for the treatment of actinic keratosis and superficial basal cell carcinoma.

The details can be read here.

Merck Serono Launches Kuvan in Europe

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Kuvan (sapropterin dihydrochloride), indicated for the treatment of hyperphenylalaninaemia due to phenylketonuria or tetrahydrobiopterin deficiency, is now commercially available in Europe.

The details can be read here.

Par Pharmaceutical Enters Into Agreement With Reliant Pharmaceuticals to Settle Patent Litigation Over Rythmol SR

Par Pharmaceutical Companies, Inc. today announced it has entered into a settlement agreement with Reliant Pharmaceuticals, Inc. that resolves patent litigation related to Reliant's Rythmol(R) SR product, thereby eliminating the inherent uncertainty and costs of litigation.

The details can be read here.

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.

Par Pharmaceutical, Inc. v. Novartis Pharmaceuticals Corp. et al.
2:09-cv-01592; filed April 16, 2009 in the Eastern District of Pennsylvania (Nateglinide)

Meda Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Ltd.
1:09-cv-00241; filed April 9, 2008 in the District Court of Delaware (Azelastine)

Hoffmann-La Roche Inc. v. Mylan Inc. et al.
2:09-cv-01692; filed April 8, 2009 in the District Court of Delaware (Capecitabine)

AsymmetRx, Inc. et al. v. Dako Denmark A/S et al.
1:09-cv-10396; filed March 13, 2009 in the District Court of Massachusetts

The details can be read here.

Mashelkar Committee resubmits report on patent with more reasoning

The Technical Expert Group (TEG) on Patent Law Issues headed by Dr Mashelkar, assigned by the government to resubmit its report on two contentious issues - limiting patent to new innovations and the patentability of micro organisms - has put forward the revised report reaffirming its earlier findings with more reasoning.

The details can be read here.

Achillion's NS4A antagonists in hep C gets US patent

Achillion Pharmaceuticals, Inc, a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, announced that the US Patent & Trademark Office has granted Achillion US Patent No 7,476,686 related to the Achillion NS4A antagonists to treat the hepatitis C virus (HCV). This new patent, entitled 'Substituted Aryl Thioureas and related compounds; inhibitors of viral replication', includes novel mechanism of action claims and expires in 2025.

The details can be read here.

GSK to acquire Stiefel Labs for $3.6 billion

GlaxoSmithKline plc and Stiefel Laboratories Inc announced that they have signed an agreement to create a new world-leading specialist dermatology business.

Under the terms of the agreement GSK will acquire the total share capital of Stiefel for a cash consideration of $2.9 billion. GSK also expects to assume $0.4 billion of net debt upon closing. A potential further $0.3 billion cash payment is contingent on future performance.

The details can be read here.

Discovery Labs Receives Complete Response From FDA for Surfaxin for Prevention of RDS

April 20, 2009 -- Discovery Laboratories, Inc. today announced that, on April 17, 2009, it received a Complete Response letter from the U.S. FDA for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome in premature infants. In its letter, the FDA focuses primarily on certain aspects of a Surfaxin biological activity test (BAT, a quality control stability and release test) that must be addressed before the Surfaxin application can be approved.

The details can be read here.

Mylan's Matrix Selected by the Clinton HIV/AIDS Initiative and UNITAID as the Primary Supplier of Five Second-Line & Seven Pediatric HIV/AIDS Treatmen

Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has been selected by the Clinton HIV/AIDS Initiative (CHAI) under its UNITAID-funded projects as the primary supplier of five antiretroviral (ARV) drugs used in second-line HIV/AIDS treatment regimens. Matrix also has been selected as the primary supplier of seven ARVs used for pediatric treatment.

The details can be read here.

SpePharm Announces the European Launches of Two New Products: MuGard and Xerotin

Apr 20, 2009 - SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care, today announced the European introduction of two new products; MuGard® & Xerotin®, aimed at relieving some of the most debilitating side effects experienced by cancer patients. The European roll-out of MuGard® and Xerotin® starting this month with Germany, Italy, UK , Nordic countries and Greece. The rest of Europe will follow over the coming 12 to 18 months.

The details can be read here.

Teva Introduces Topiramate Capsules (Sprinkle)

April 17, 2009 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Topiramate Capsules (Sprinkle). This product is AB rated and bioequivalent to Topamax Sprinkle Capsules. Topiramate Capsules (Sprinkle) are available in 15 mg and 25 mg strengths, in bottle sizes of 60.

The details can be read here.

Patent application for Tamiflu rejected on pre grant opposition from Cipla

The Delhi Patent Office has rejected the patent application of the California-based Gilead Science Inc for its anti-influenza drug, Tamiflu (oseltamivir phosphate), in favour of a pre-grant opposition filed by the Mumbai-based Cipla Ltd. The refusal of patent gives a green signal for Cipla to go ahead with their marketing operations of oseltamivir phosphate, it is learnt.

The details can be read here.

Actavis Inc. Reintroduces Oxycodone

Apr 17, 2009 - Actavis Inc. today announced the reintroduction by its Actavis Totowa subsidiary of Oxycodone 15 mg and 30 mg tablet products to pharmacies and customers. Oxycodone is the first product to be manufactured at Actavis' Little Falls, NJ facility following a recently completed FDA inspection.

The details can be read here.

Court Grants AstraZeneca Temporary Restraining Order Against Apotex in Pulmicort Respules Patent Litigation

On 16 April 2009, the US District Court for the District of New Jersey granted AstraZeneca's request for a temporary restraining order, barring Apotex from launching a generic version of AstraZeneca's PULMICORT RESPULES until further order of the court. On 27 April 2009, the court will commence a hearing to determine whether the injunction should be continued.

the details can be read here.

Sepracor Announces Patent Interference Proceedings Against Wyeth for Claims Related to O-desmethylvenlafaxine Succinate

Apr 17, 2009 - Sepracor Inc. (Nasdaq: SEPR) today announced that the Board of Patent Appeals and Interferences (BPAI) of the U.S. Patent and Trademark Office has combined three patent interferences into a single interference between Sepracor and Wyeth and set a date for oral arguments. The interference seeks to determine the priority of inventorship of claims directed to racemic O-desmethylvenlafaxine (ODMV) succinate.

The details can be read here.

Vanderbilt aims to develop vaccine for serious prenatal infection

A study at Vanderbilt aims to develop a vaccine against cytomegalovirus (CMV), an infection that can cause serious complications for unborn children.CMV, which causes few problems for healthy people, can have devastating effects on a foetus. According to the Centers for Disease Control and Prevention CMV is the most common virus transmitted to a pregnant woman's unborn child.

The details can be read here.

AstraZeneca to market Crestor in India

AstraZeneca India has introduced Crestor (rosuvastatin) as 5, 10, 20 and 40 mg tablets. The drug is indicated for use in the treatment of dyslipidemia, atherosclerosis and primary hypercholesterolaemia.

The details can be read here.

Troikaa Pharma Introduces Trofentyl OTFC

15th April, 2009: Troikaa Pharmaceuticals Ltd has introduced Trofentyl OTFC, lozenge (tablet) for “breakthrough pains” in cancer patients. The new drug will substantially alleviate cancer patients pain suffered due to the disease.

The details can be read here.

Rib-X Granted Key Antibiotic Patent in China

Rib-X Pharmaceuticals, Inc., a development-stage company focused on the discovery and development of novel antibiotics for the treatment of antibiotic-resistant infections, today announced the issuance of a key antibiotic patent in China. The State Intellectual Property Office of the People's Republic of China has issued Chinese Patent Number ZL 2004 8 0021883.9 to Rib-X. This patent provides composition of matter protection for Rib-X's novel oxazolidinone antibiotic, radezolid. Rib-X has established a broad patent portfolio related to radezolid, including the issuance of composition of matter for radezolid in the US. The Company anticipates issuance of additional patents in all major and emerging markets.

The details can be read here.

DCGI to appoint 63 more drug inspectors by July to strengthen CDSCO

The Drug Controller General (India) office will be strengthened by inducting more staff and filling up the remaining vacant posts, with a view to further streamline the functioning of the CDSCO and deliver better and faster service to the industry, according to DCGI Dr Surinder Singh.

the details can be read here.

Premier Research submits 50th Investigational New Drug Application

Premier Research Group Limited, the international pharmaceutical services company, has submitted an Investigational New Drug Application which represents the 50th IND under management. The milestone IND was submitted to the FDA's Division of Anaesthesia, Analgesia and Rheumatology Products (DAARP), and is intended to support the clinical development of a novel formulation of a non-steroidal anti-inflammatory drug for the treatment of pain.

The details can be read here.

Myriad Pharma gets IND approval for new cancer drug

Myriad Pharmaceuticals, Inc. announced that the FDA has approved an Investigational New Drug (IND) application to begin a phase 1 clinical study with its Hsp90 inhibitor, MPC-3100, for the treatment of cancer.

The details can be read here.

MedWatch - Ceftriaxone: Update to previous alert re: interaction of ceftriaxone with calcium-containing products

April 14, 2009-- FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. At the request of FDA, the manufacturer of ceftriaxone (Roche) conducted two in vitro studies to assess the potential for precipitation of ceftriaxone-calcium when ceftriaxone and calcium-containing products are mixed in vials and in infusion lines.

The details can be read here.

FDA Grants Paclical Orphan Drug Designation for Ovarian Cancer in the USA

Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical(R) for the treatment of ovarian cancer. Orphan Drug designation can entail additional assistance from FDA to expedite and optimize drug development and upon approval a seven year market exclusivity is granted.

The details can be read here.

Cell Therapeutics Initiating Rolling NDA Submission For Pixantrone

Cell Therapeutics, Inc. announced today that it began a rolling submission of a New Drug Application to the U.S. FDA for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma. CTI expects to complete the submission this quarter and will request priority review which if granted could lead to an approval decision from the FDA in Q4 2009.

The details can be read here.

Health Canada Approves Simponi (golimumab) for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

April 13, 2009 Centocor Ortho Biotech Inc. and Schering-Plough Corporation today announced that Health Canada has granted approval of SIMPONI (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.

The details can be read here.

Quinnova Pharmaceuticals, Inc. Launches NEOSALUS CREAM

Apr 14, 2009 - Quinnova Pharmaceuticals, Inc. announced that it has received FDA clearance on the company's new product NEOSALUS CREAM, a line extension to the previously launched NEOSALUS FOAM, the first non-steroidal anti-inflammatory prescription topical foam product for the treatment of various types of dermatoses including atopic dermatitis and hand eczema.

The details can be read here.

SpePharm Announces a Claim in Excess of 35 Million Euros Against BioAlliance Pharma For Breaking up Their Joint-Venture SpeBio

Apr 14, 2009 - SpePharm Holding BV announces it intends to file a claim for financial damages and losses of not less than Thirty Five Million Euros against BioAlliance Pharma SA, a French company listed on Paris Euronext.

The details can be read here.

Mylan Confirms First-to-File Patent Challenge Relating to Xeloda Cancer Treatment

Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Hoffmann-La Roche Inc. in connection with the filing of an Abbreviated New Drug Application with the U.S. FDA for Capecitabine Tablets, 150 mg and 500 mg, the generic version of Xeloda(R) Tablets, a chemotherapy treatment for breast and colorectal cancer.

The details can be read here.

Bedford Laboratories to Begin Shipping Fluconazole Injection in PVC Flexible Containers

Bedford Laboratories, a division of Ben Venue Laboratories, Inc., announced the addition of Fluconazole injection 2 mg / mL in PVC flexible containers to its existing Fluconazole injection line. This product is AP rated and is equivalent to Diflucan by Pfizer.

the details can be read here.

Strides Arcolab to reorganize its operations in three new entities

Strides Arcolab Ltd, a Bangalore based Rs 725 crore pharma major, has decided to undertake major restructuring of its operations into three new entities viz, Specialty Pharmaceuticals, Pharmaceuticals and R&D after the necessary approvals.

The details can be read here.

Glenmark completes phase I trial of GRC 10693 in Europe

Glenmark Pharmaceuticals Limited (GPL) has successfully completed phase I trials of its candidate for neuropathic pain, osteoarthritis and other inflammatory pain disorders - GRC 10693 in Europe.

the details can be read here.

XenoPort Announces Election of Co-Promotion Option for Solzira

Apr 13, 2009 - XenoPort, Inc. announced today that it has exercised the option contained in its Development and Commercialization Agreement with GlaxoSmithKline to co-promote and share profits and losses from the potential future sales of Solzira™ (gabapentin enacarbil) Extended Release Tablets in the United States.

The details can be read here.

Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment

Apr 13, 2009 - Sciele Pharma, Inc., a Shionogi Company, today announced that the U.SFDA has approved Benzyl Alcohol Lotion 5%, the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects.

the details can be read here.

Aegis Therapeutics and Phylogica Collaborate to Deliver Phylomer Peptide Drugs with Patient-Friendly Intranasal Sprays

Aegis Therapeutics LLC and Australian Drug Discovery company Phylogica Limited today announced a collaboration to use Aegis’ proprietary Intravail® transmucosal delivery formulations to deliver Phylogica’s Phylomer® peptide drugs.

The details can be read here.

Optimer Pharmaceuticals Receives Production Patent for Lead Product Candidate Fidaxomicin

Optimer Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office issued a production patent (U.S. Patent No. 7,507,564) covering steps used in the manufacture of fidaxomicin, which is currently in its second Phase 3 clinical trial for the treatment of Clostridium difficile infection, or CDI.

the details can be read here.

Sun Pharma Announces USFDA Approval to Market Generic Roxicodone Tablets

April 13, 2009: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application to market generic Roxicodone ®, oxycodone hydrochloride tablets.

The details can be read here.

Wegner, USPTO both scorched by CAFC in Takeda

A process patent issued as U.S. Patent No. 5,583,216 on December 10, 1996 led to the double patenting issue in the appeal of the Takeda case, argued for Takeda by Harold C. Wegner.

The whole story can be read here.

The whole judgement can be read here.

IntelGenx, Cary Pharma file NDA for antidepressant CPI-300

IntelGenx Corp and Cary Pharmaceuticals Inc announced that a New Drug Application has been submitted to the US FDA for their antidepressant CPI-300, a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder (MDD).

the details can be read here.

FDA Obtains Permanent Injunction Barring Two Companies from Manufacturing and Distributing Unapproved Drugs

April 10, 2009--The U.S. Food and Drug Administration today announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc., of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs.

The details can be read here.

New Keppra XR Dosage Strength Offers Simplified Treatment Option for People Living With Partial-Onset Seizures

Keppra XR (levetiracetam) extended-release tablets are now available in a new dosage strength--750 mg--enabling doctors to simplify patients' treatment plans by decreasing the number of tablets they take each day.

The details can be read here.

Sanofi-aventis to acquire Medley in Brazil

Sanofi-aventis announced that it has signed an agreement to acquire Medley in Brazil. Medley is the third largest pharmaceutical company and the number one generic company in Brazil. In 2008 Medley's sales amounted to 458 million BRL (around 153 million euros), including two third of those sales in generics. With a generic portfolio of 127 products, Medley is very well positioned to benefit from the growth of the Brazilian generic market, which is expected to remain over 20 per cent per annum in the coming years.

The details can be read here.

Orchid's Aurangabad facility gets Facility of the Year Award

The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd today announced that its Carbapenem API manufacturing facility located in Aurangabad, near Mumbai has been conferred with the Facility of the Year Award in the Regional Excellence Category.

the details can be read here.

Tolera Therapeutics Granted Orphan Drug Designation for Organ Transplant Rejection Drug

Tolera Therapeutics, Inc., was granted orphan drug status by the USFDA for its initial lead candidate, TOL101, for prophylaxis of acute rejection of solid organ transplantation. TOL101 is a biologic protein that is designed to safely and specifically target T cells, components of the immune system that play a key role in the rejection, and ultimate failure, of transplanted organs. Organ transplantation is often the only viable treatment for many end-stage organ diseases.

The details can be read here.

Bioalliance Pharma To Complete NDA For Loramyc With Data on Debossed Mucoadhesive Tablet

BioAlliance Pharma SA, the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and AIDS, today announced that the FDA did not accept the NDA for Loramyc (miconazole) mucoadhesive buccal tablet to be filed based on the lack of a tablet imprint code. Loramyc® was approved in Europe in 2007 and is currently marketed in several EU territories including France, Germany, the UK, Sweden, Finland and Denmark. While the EU does not require a unique tablet identifier, the U.S. FDA does require a tablet imprint code for drug identification purposes. Prior to the initial filing, BioAlliance initiated the development of a debossed tablet to fulfill this requirement. BioAlliance will work closely with the FDA on the introduction of the debossed tablet and will soon after resubmit the Loramyc® application.

The details can be read here.

MonoSol Rx and Strativa Pharmaceuticals Submit New Drug Application for Ondansetron Orally Dissolving Film Strip

April 09, 2009 -- MonoSol Rx, the developers of PharmFilm technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. , today announced the submission on April 7, 2009 of a New Drug Application to the U.S. FDA for the orally dissolving film strip (ODFS) formulation of ondansetron.

The details can be read here.

Health Canada Approves Avastin in Combination with Carboplatin/Paclitaxel for Treatment of Patients with Non-Small Cell Lung Cancer

April 9 - Hoffmann-La Roche Canada announced today that Health Canada has approved AVASTIN (bevacizumab), in combination with paclitaxel-carboplatin chemotherapy regimen, for treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC), the most common form of this devastating disease.

The details can be read here.

Actavis (IS) - Fluvastatin SR from Actavis first to market in UK, Holland

9 April 2009 -- Actavis Group, the international generic pharmaceuticals company, today announced the launch of Fluvastatin SR in the UK and the Netherlands. Actavis was first to market in both countries.

The details can be read here.

Aurobindo gets first approval from Swissmedic for BPH drug

Aurobindo Pharma Ltd, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received its first approval from Swissmedic for the license of Finasteride APL tablets in 5mg strength.

Swissmedic, an agency for therapeutic products, is a surveillance authority for medicines and medical devices registered in Switzerland's capital city Bern. Established in 2002, Swissmedic is affiliated to the federal department of home affairs.

the details can be read here.

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.

Genzyme Corp. v. Impax Laboratories, Inc.1:09-cv-00846; filed April 3, 2009 in the District Court of Maryland (Sevelamer Carbonate)

Abbott Laboratories et al. v. Sandoz Inc. et al.1:09-cv-00215; filed April 1, 2009 in the District Court of Delaware (Paricalcitol)

Shire Canada Inc. et al. v. Natco Pharma Ltd.1:09-cv-03165; filed April 1, 2009 in the District Court of New Jersey (Lanthanum Carbonate)

Millennium Pharmaceuticals Inc. et al. v. Teva Parenteral Medicines Inc. et al.1:09-cv-00204; filed March 27, 2009 in the District Court of Delaware (eptifibatide injection)

The details and the complete complaints can be read here.

FDA Advisory Committee Provides Opinion on Serdolect for the Treatment of Schizophrenia

Lundbeck A/S announced today that the Psychopharmacology Drug Advisory Committee (PDAC) appointed by the U.S. FDA voted unanimously that Serdolect® (sertindole) is efficacious in the treatment of patients with schizophrenia, though they did not find the data robust enough to support an additional regulatory claim related to treatment of suicidal behaviour in schizophrenia.

The details can be read here.

Coartem receives FDA approval becoming first artemisinin-based combination treatment (ACT) for malaria in the US

April 8, 2009 -Coartem (artemether 20 mg/lumefantrine 120 mg), the leading artemisinin-based combination treatment (ACT) for malaria worldwide, has been approved by the US FDA.
Coartem is a fixed-dose combination of two novel antimalarials. It is a highly-effective three-day malaria treatment with cure rates of over 96% even in areas of multi-drug resistance.

The details can be read here.

Genentech Announces Voluntary Withdrawal of Raptiva from the U.S. Market

Apr 8, 2009 - Genentech, Inc. announced today a phased voluntary withdrawal of the psoriasis drug Raptiva® (efalizumab) from the U.S. market. The company's decision is based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. Raptiva is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy.

The details can be read here.

Mylan Announces Clarinex Settlement Agreement

Mylan Inc. today announced the settlement of all patent litigation relating to Desloratadine Tablets, 5 mg, the generic version of Schering- Plough's Clarinex(R) allergy medication. This litigation has been pending in the U.S. District Court of New Jersey since September 2006.

The details can be read here.

Somaxon Provides Update on New Drug Application for Silenor (doxepin) for the Treatment of Insomnia

Apr 7, 2009 - Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application for Silenor (doxepin) for the treatment of insomnia.

The details can be read here.

Health Canada Approves Prezista Once Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1

Tibotec, a division of Janssen-Ortho Inc., announced today that Health Canada has approved PREZISTA* (darunavir) for use in treatment-naive adults (those who have never taken HIV medication before), dosed once daily in combination with other antiretroviral agents. The new indication for PREZISTA includes a new tablet strength of 400 mg to support the recommended dosing regimen.

the details can be read here.

Biovail Announces U.S. Availability of Aplenzin Tablets

Apr 7, 2009 - Biovail Corporation today announced that Aplenzin (bupropion hydrobromide) extended-release tablets are now available by prescription in the United States for adults ages 18 and older. Aplenzin™, which was developed by Biovail, offers prescribers and their patients the benefit of convenience with simple one-tablet, once-daily dosing of bupropion at all doses.

The details can be read here.

Aphios Granted Japanese Patent for Inactivating Viruses and Other Pathogens in Biologics and Human Plasma

Apr 7, 2009 - Aphios Corporation today announced that it was granted a Japanese patent for an improved method of inactivating viruses and other pathogens in biologics such as monoclonal antibodies, recombinant therapeutics, human plasma and plasma proteins.

The details can be read here.

AstraZeneca Files Suit Against Apotex for a Declaratory Judgment of Infringement Against Pulmicort Respules Patents

April 7, 2009--AstraZeneca has filed a lawsuit in the US District Court for the District of New Jersey against Apotex seeking a declaration of patent infringement. On 30 March 2009, the US FDA granted approval for a generic version of AstraZeneca's PULMICORT RESPULES (budesonide inhalation suspension) to Apotex.

The details can be read here.

Gilead Sciences Announces Notification of ANDA Filing for Atripla

Apr 6, 2009 - Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. FDA requesting permission to manufacture and market a generic version of Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Atripla is currently sold in the United States through a joint venture between Bristol-Myers Squibb and Gilead.

The details can be read here.

Teva Introduces Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, CII

April 2, 2009 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Mixed Amphetamine Salt ER Capsules. This new Teva product is the same as Adderall XR®* Capsules. Mixed Amphetamine Salt ER Capsules are available in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, in bottle sizes of 100.

The details can be read here.

Zydus Cadila files IND in US for ZYTI molecule to treat dyslipidemia

Zydus Cadila, a leading healthcare company, has filed the IND application for ZYTI - a novel lipid lowering molecule with the US FDA.

The details can be read here.

Sinobiopharma Applies for Chinese Patent to Develop the Next Generation of Anti-Hypertension Compounds

April 06, 2009 -- Sinobiopharma, Inc. is pleased to announce that it has applied for a single Chinese patent for new drug compounds containing Perindopril, an angiotensin-converting enzyme inhibitor used to treat high blood pressure (hypertension) and heart attack in people with coronary artery disease.

The details can be read here.

Santarus Announces FDA Acceptance of New Drug Application for Zegerid Tablet Product

Apr 6, 2009 - Santarus, Inc., a specialty pharmaceutical company, today announced that the U.S. FDA has accepted for filing the company's New Drug Application for a new tablet formulation to add to its ZEGERID family of branded prescription pharmaceutical products.

the details can be read here.

Bioject Announces FDA Market Clearance for the Zetajet Needle-Free Injection Therapy System

Apr 6, 2009 -Bioject Medical Technologies Inc., a leading developer of needle-free injection therapy systems, today announced that the U.S. FDA has granted market clearance for the Zetajet™ Needle-Free Injection Therapy System.

The details can be read here.

IpAuctions Inc. to Sell Medical Patent and Patent Application on Behalf of CyDex Pharmaceuticals, Inc.

Apr 3, 2009 -IpAuctions, Inc. (www.ipauctions.com) will auction one pharmaceutical patent and one patent application on behalf of specialty pharmaceutical company CyDex Pharmaceuticals, Inc. (www.cydexpharma.com) of Lenexa, Kansas, USA.

The details can be read here.

U.S. Appeals Court Issues Ruling in Support of Lilly in Ariad Patent Litigation

The Court of Appeals for the Federal Circuit in Washington, D.C. today overturned a lower court decision and ruled in favor of Eli Lilly and Company (NYSE:LLY) in the case of Ariad Pharmaceuticals et al. v. Eli Lilly and Company. An earlier jury decision in the U.S. District Court of Massachusetts, and a subsequent bench trial ruling, had deemed that a patent owned by Harvard University, the Massachusetts Institute of Technology and the Whitehead Institute, and licensed to Ariad, was valid and infringed by Lilly's sales of Evista(R) and Xigris(R). Today's ruling by the Court of Appeals overturned that prior decision, concluding that Ariad's patent claims are invalid for failing to meet the written description requirement.

The details can be read here.

The whole judgement can be read here.

Teva Introduces Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, CII

April 2, 2009 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Mixed Amphetamine Salt ER Capsules. This new Teva product is the same as Adderall XR®* Capsules. Mixed Amphetamine Salt ER Capsules are available in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, in bottle sizes of 100.

The details can be read here.

Impax Confirms Patent Challenge Relating to Renvela 800 mg Tablets

Apr 6, 2009 - Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Genzyme Corporation in connection with its Renvela (sevelamer carbonate) 800 mg tablets.

The details can be read here.

Genzyme to acquire worldwide rights of Bayer's alemtuzumab

Genzyme Corporation has entered into an agreement to acquire the worldwide rights to Campath (alemtuzumab) from Bayer HealthCare, giving Genzyme primary responsibility for the development and commercialization of this potential break-though treatment for multiple sclerosis (MS).

The details can be read here.

Pfizer drops one phase-3 study of Sutent in advanced breast cancer

Pfizer Inc announced the discontinuation of one of its phase-3 studies based on statistical assessment for futility: the SUN 1107 phase-3 study of Sutent (sunitinib malate) in advanced breast cancer. SUN 1107 evaluated single-agent sunitinib versus single-agent capecitabine for the treatment of a broad range of patients with advanced breast cancer after failure of standard treatment.

The details can be read here.

Arzerra (Ofatumumab) Granted Priority Review By FDA

Genmab today announced that the US FDA has accepted the Biologics License Application for Arzerra (ofatumumab) to treat patients whose chronic lymphocytic leukemia is resistant (refractory) to previous therapies and has granted ofatumumab priority review status.

The details can be read here.

Taro Receives Final FDA Approval for Carbamazepine Extended-Release Tablets

Apr 3, 2009 - Taro Pharmaceutical Industries Ltd. today reported that it received final approval from the U.S. FDA for its Abbreviated New Drug Application for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg.

The details can be read here.

VA District Court Grants PhotoCure’s Summary Judgment Motion Challenging PTO’s “First Permitted Commercial Marketing” Interpretation for METVIXIA PTE

In a recent post by Mr. Kurt R. Karst at his blog i.e. FDA LAW BLOG, he has reported that ......

As previously reported, by Mr. Kurt R. Karst on FDA LAW BLOG, on a lawsuit filed in July 2008 by PhotoCure ASA against the U.S. Patent and Trademark Office after the PTO denied PhotoCure’s application for a Patent Term Extension for U.S. Patent No. 6,034,267 covering the human drug product METVIXIA (methyl aminoevulinate hydrochloride), which FDA approved on July 27, 2004 under New Drug Application No. 21-415.

The details can be read here.

I thank Mr. Kurt for such informative and updated information with very good interpretation of the case laws. This shows his indepth knowledge about the subject.

HIV/AIDS Update - Tentaive approval of generic nevirapine tablets, 200 mg

March 31, 2009--On March 31, 2009, the FDA granted tentative approval for a generic formulation of nevirapine tablets, USP, 200 mg indicated for combination antiretroviral treatment of HIV-1 infection.
The details can be read here.

Xanodyne's New Drug Application for the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification

Xanodyne Pharmaceuticals, Inc. announced today that the U.S. FDA has accepted for filing and granted priority review status for its investigational proprietary formulation of tranexamic acid for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms. On January 30, 2009, Xanodyne submitted the New Drug Application (NDA) for XP12B, a unique oral therapy which acts as a competitive plasmin inhibitor to prevent fibrinolysis by binding to the lysine receptor sites of plasminogen.

The details can be read here.

ONGLYZA (saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. FDA Endocrinologic and Metabolic Drugs Advisory Committee determined (by a vote of 10 to 2) that the data supporting the new drug application for ONGLYZA (saxagliptin) for the treatment of adults with type 2 diabetes were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the program.

The details can be read here.

GSK Submits Tyverb/Tykerb (lapatinib) for First-line Treatment of Metastatic Breast Cancer in Europe, US

April 1, 2009--GlaxoSmithKline today announced the submission of two simultaneous regulatory applications to expand the use of Tyverb/Tykerb® (lapatinib). If authorised, lapatinib could be used as a first-line therapy regimen combined with anti-hormonal therapy for patients with hormone-sensitive, metastatic (or advanced) breast cancer in Europe and the United States.

The details can be read here.

FDA Advisory Committee Unanimously Recommends Accelerated Approval of Avastin for Previously Treated Brain Cancer (Glioblastoma)

Genentech, Inc. announced today that the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) voted unanimously that the response seen with Avastin (bevacizumab) in people with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit.

The details can be read here.

Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA

Mar 31, 2009 - Acorda Therapeutics, Inc. announced today that the Company received a refuse to file letter from the U.S. FDA regarding its New Drug Application for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS).

The details can be read here.

Pharmaceuticals Acquires Nascobal Nasal Spray from QOL Medical LLC

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc., today announced it has acquired the worldwide rights to Nascobal® (Cyanocobalamin, USP) Nasal Spray from QOL Medical LLC. Nascobal Nasal Spray is an FDA approved prescription vitamin B12 supplement indicated to treat vitamin B12 deficiency.

The details can be read here.

Appeals Court Affirms That J&J Stents Infringe Boston Scientific Patent; Claims Against TAXUS Liberte Dismissed

Boston Scientific Corporation announced today that the Court of Appeals for the Federal Circuit issued a decision in the Company's stent litigation with Johnson and Johnson (J&J). The Court of Appeals upheld the District Court's decision that JNJ's Bx Velocity and Cypher Stent Systems infringe Boston Scientific's patent and that the patent is valid.

The details can be read here.

Photocure ASA (NO) - Photocure wins patent case in USA

April 4 2009 --In September 2004, Photocure submitted to the United States Patent Office (USPTO) an application for patent term extension of its US patent covering its FDA-approved drug product Metvixia. US law permits patent term extension due to the lengthy FDA approval process, which had been the case for Metvixia.

The details can be read here.

Lannett Company Provides Update on Marketing Digoxin Tablets

Apr 2, 2009 - Lannett Company, Inc., a manufacturer of generic pharmaceuticals, said today that it is prepared to supply the U.S. market with an uninterrupted and safe supply of Digoxin Tablets, following the voluntary recall, announced yesterday, of the drug by another generic drug manufacturer.

The details can be read here.

Teva Introduces First Generic Adderall XR Capsules in the United States

Apr 2, 2009 - Teva Pharmaceutical Industries Ltd. announced today that it has commenced commercial shipment of its generic version of Shire Pharmaceuticals' Adderall XR® (mixed salts of a single-entity amphetamine product) Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg. Teva's generic Adderall XR Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The details can be read here.

Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Topamax Tablets

Caraco Pharmaceutical Laboratories, Ltd. has launched Topiramate tablets on behalf of Sun Pharmaceutical Industries Ltd., immediately following Sun Pharma's recently received approval from the US FDA for its Abbreviated New Drug Application for generic Topamax(R) tablets.

The details can be read here.

Teva Announces Approval of Generic Yaz Tablets

Apr 1, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. FDA has granted approval for the Company's Abbreviated New Drug Application to market its generic version for Bayer Healthcare Pharmaceuticals' oral contraceptive Yaz (Drospirenone and Ethinyl Estradiol) Tablets. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.

The details can be read here.

Shire Files Lawsuit Against Natco Pharma for Infringement of FOSRENOL (lanthanum carbonate) Patents

Shire plc announces that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Natco Pharma Limited for infringement of two of Shire's patents: U.S. Patent No. 5,968,976; and U.S. Patent No. 7,381,428.

The details can be read here.