Cadila Pharma to launch products for adult pulmonary tuberculosis soon

The Ahmedabad-based Cadila Pharmaceuticals Ltd is all set to launch two new products for treating pulmonary tuberculosis in adult patients. The products have been developed in collaboration with the Jammu-based Indian Institute of Integrative Medicine (IIIM), it is learnt.

the details can be read here.

FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India

Feb. 25, 2009--The U.S. FDA today announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.

the details can be read here.

Winston Pharmaceuticals, Inc. Receives Orphan Drug Designation for Novel Patch to Treat Post-Herpetic Neuralgia

Feb 24, 2009 - Winston Pharmaceuticals, Inc. today announced that it has received orphan drug designation from the U.S. FDA for its lead compound, Civamide, a novel TRPV-1 receptor modulator, being developed as a dermal patch for the treatment of post-herpetic neuralgia.

The details can be read here.

FDA Approves Apidra SoloSTAR - a Prefilled Disposable Insulin Pen

Sanofi-aventis announced today that the U.S. FDA approved Apidra SoloSTAR (insulin glulisine [rDNA origin] injection), a prefilled disposable pen containing rapid-acting insulin analog Apidra, which is indicated to improve glycemic control in adults and children (4 years and older) with type 1 diabetes or adults with type 2 diabetes.

The details can be read here.

FDA Approves Genzyme's Synvisc-One for Osteoarthritis of the Knee

Feb 26, 2009 - Genzyme Corporation today announced that the U.S. FDA has granted marketing approval for Synvisc-One™ (hylan G-F 20), a product intended for the relief of pain associated with osteoarthritis (OA) of the knee.

The details can be read here.

European Authorities Approve Larger-Scale Production of Genzyme's Myozyme

Feb 26, 2009 - Genzyme Corporation announced today that the European Commission has approved the production of Myozyme (alglucosidase alfa) at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. The product will be made commercially available immediately. Myozyme is the only approved treatment for Pompe disease, a progressively debilitating and often fatal inherited disorder.

The details can be read here.

Alexion's Soliris (eculizumab) Receives Marketing Approval in Australia for All Patients with PNH

Feb 25, 2009 - Alexion Pharmaceuticals, Inc., today announced that the Australian Government's Therapeutic Goods Administration has approved the use of Soliris (eculizumab) for the treatment of all patients in Australia with paroxysmal nocturnal hemoglobinuria (PNH), a rare, debilitating and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris is the first therapy approved in Australia for the treatment of PNH.

the details can be read here.

Ark patents novel gene regulation technology as potential successor to RNA silencing

26 February 2009 - Ark Therapeutics Group plc today announces that it has filed a patent application relating to a breakthrough small hairpin RNA (shRNA) based technology that allows both the up- and down-regulation of multiple genes via Ark's existing method of gene delivery.

The details can be read here.

On the Heels of Court Ruling Denying Autism-Vaccine Link, U.S. Federal Court Declares MMR Vaccine Caused Autism in a Young Boy

The following release was issued today by the National Autism Association:
Less than two weeks after federal vaccine court ruled against three families claiming vaccines caused autism in their children, writers Robert F Kennedy, JR and David Kirby reported Tuesday on the story of Bailey Banks, a 10-year-old who regressed into autism following the MMR vaccine.

The details can be read here.

Bedford Laboratories to Begin Shipping Sumatriptan Succinate Injection

Bedford Laboratories, a division of Ben Venue Laboratories, Inc., today announced the launch of Sumatriptan Succinate Injection. This product is AP rated and is equivalent to Imitrex(R) by GlaxoSmithKline.

The details can be read here.

Mylan's Matrix Receives WHO Approval for First Generic, Heat-Stable Version of HIV Protease Inhibitor

Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.

The details can be read here.

Federal Circuit Affirms Extension of 30-Month Stay Against Teva's Generic Evista

According to the post on Orange Book Blog:

Under the Hatch-Waxman Act, final FDA approval of an ANDA is automatically stayed for thirty months when a patent owner files suit for patent infringement within 45 days of receiving a Paragraph IV notice letter. The purpose of the stay is to allow the parties to litigate the patent infringement claims while the ANDA filer pursues FDA approval of its generic drug. Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), a district court may shorten or lengthen the thirty–month stay if "either party to the action failed to reasonably cooperate in expediting the action."

The details can be read here.

the whole judgement can be read here.

Basilea Pharmaceutica Ltd. (CH) - Zevtera Review Process Delayed in EU

February 24, 2009 - Basilea Pharmaceutica Ltd. announces that the EU Committee for Medicinal Products for Human Use has indicated that the European Commission decision process on Zevtera (ceftobiprole) for the treatment of complicated skin and soft tissue infections is delayed.

the details can be read here.

International NGOs voice concern over seizure of Indian generic drugs at EU ports

Several international NGOs have raised a banner of protest against the seizure of Indian drug shipments at the European Union ports on charges of counterfeiting and patents infringement. In separate letters to the heads of the World Health Organization (WHO) and the World Trade Organization (WTO), these organisations have voiced concern over the recent seizures by Dutch customs authorities of Indian generic drugs shipped through the Netherlands en route to Brazil, Colombia and Peru.

The details can be read here.

MSD Pharma to launch 13 products in 2 years, enters cardiovascular segment

MSD Pharmaceuticals, the wholly-owned subsidiary of global leader Merck, has entered into the cardiovascular segment with the launch of 'zocor' (simvastatin) and is planning to tap the potentials in the biologicals in the coming years with the target of emerging as one of the top five players in the country by 2015.

The details can be read here.

China Sky One Medical, Inc. Signs Exclusive Distribution Agreement with Shaanxi Buchang Group for Naftopidil Dispersible Tablets

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 its wholly owned subsidiary, Peng Lai Jin Chuang Pharmaceutical Company, signed an exclusive distribution agreement with Shaanxi Buchang Group for Naftopidil Dispersible tablets with an expected sales target of 100 million RMB (US $14.6 million) over five years.

The details can be read here.

Bone Biologics Announces Major US Patent Issuances for Its Recombinant Protein Process

Bone Biologics Inc. announced today that it has received a US Patent Office Notice of Allowance of patent claims which protect a method of production for the UCB-1 (NELL-1) recombinant protein that Bone Biologics uses in the bone repair/regeneration technology in its lead product.

The details can be read here.

Mindset BioPharmaceuticals (USA) Inc Obtains Notice of Allowance for European Patent Related to Use of Insulin Sensitizers in Senile Dementia,Dementia

Mindset BioPharmaceuticals Inc a company privately held by MPM Capital and other shareholders announced today that it has received a Notice of Allowance in Europe related to patent applications describing the use of insulin sensitizer drugs for the prevention and treatment of memory loss. Drugs of this type include Rosiglitazone and Pioglitazone which have been approved for the treatment of type II diabetes mellitus.

The details can be read here.

QLT petition for rehearing of Massachusetts Eye and Ear Infirmary litigation is denied

QLT Inc. announced that the United States Court of Appeals for the First Circuit today denied its Petition for Panel Rehearing and Rehearing En Banc of the January 12, 2009 Court of Appeals decision.

The details can be read here.

Fed. Circ. Takes On Prior Claim Construction Issue

A federal appeals court has agreed to hear an interlocutory appeal of Shire LLC’s patent infringement case against Sandoz Inc. over hyperactivity disorder drug Adderall XR that raises a question of whether a patentee is precluded from relitigating claim construction issues determined in a previous case.

The details can be read here.

The order can be read here.

US FDA warns public of serious adverse event with psoriasis drug Raptiva

The US Food and Drug Administration issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab).

The details can be read here.

Shire acquires rights to UCB's Equasym IR & XL to treat ADHD

Shire plc, the global specialty biopharmaceutical company, has signed an agreement with UCB to acquire the worldwide rights to Equasym IR and XL (methylphenidate hydrochloride) (excluding the USA, Canada and Barbados) used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The details can be read here.

MedWatch - Zonisamide (marketed as Zonegran, and generics) Can Cause Metabolic Acidosis in Some Patients

FDA ALERT [February 23, 2009]: Following a review of updated clinical data, the FDA has determined that treatment with zonisamide can cause metabolic acidosis in some patients. Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

The details can be read here.

Schering-Plough Submits Response to FDA for Saphris (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

February 20, 2009 -- Schering-Plough Corporation today announced that it has responded to the U.S. FDA complete response letter for SAPHRIS (asenapine) sublingual tablets, which was received in January 2009.

The details can be read here.

European Commission Approves Efient (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI

February 23, 2009-Daiichi Sankyo Company, Limited and Eli Lilly and Company announced today that the European Commission has granted marketing authorization for EFIENT(pronounced Ef-ee-ent) (prasugrel) for the prevention of atherothrombotic events in patients with ACS undergoing percutaneous coronary intervention (PCI).

The details can be read here.

European Commisssion Grants Ferring Pharmaceuticals Approval of Firmagon (Degarelix) for Treatment of Prostate Cancer

February 19/PRNewswire/ -- Ferring Pharmaceuticals announced today that it has received marketing authorisation from the European Commission, for FIRMAGON (degarelix), a new GnRH receptor antagonist indicated for patients with advanced, hormone-dependent prostate cancer.

The details can be read here.

Schering-Plough Announces Collaboration With World Health Organization to Provide Access Pandemic Influenza Vaccine Technology to Developing Countries

Schering-Plough Corporation today announced a license agreement between Nobilon, Schering-Plough's human vaccine business unit, and the World Health Organization (WHO) to provide access to pandemic influenza vaccine manufacturing technology to developing countries.

The details can be read here.

AstraZeneca Announces Seroquel XR is Now Available to Treat Bipolar Depression

AstraZeneca today launched its once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder and the manic and mixed episodes associated with bipolar I disorder, as well as the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.

The details can be read here.

GeneraMedix, Inc. Announces Sale of Innovative Epoprostenol Formulation to Actelion Ltd.

February 23, 2009 -- GeneraMedix, Inc. announced today that it has entered into a definitive agreement to sell its improved formulation of epoprostenol sodium for the intravenous treatment of pulmonary arterial hypertension to Actelion LTD., a biopharmaceutical company with its headquarters in Allschwil/Basel, Switzerland.

The details can be read here.

KAPIDEX (dexlansoprazole) Delayed Release Capsules Now Available for the Treatment of GERD

Takeda Pharmaceuticals North America, Inc. today announced that KAPIDEX (dexlansoprazole) delayed release capsules are now available in pharmacies across the U.S. KAPIDEX, available in 30 mg and 60 mg doses, was recently approved by the U.S. FDA for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE.

The details can be read here.

Shionogi Files Patent Infringement Actions Against a Bulk Powder Import Company and Files Suspension of Import With Customs for Flomox

February 19, 2009 -- Shionogi & Co., Ltd. today announced the filing of patent infringement actions and provisional disposition order in Osaka District Court against ITOCHU CHEMICAL FRONTIER Corporation for the crystal patent of Flomox (Oral cephem antibiotic agent) on February 19. The Company also filed suspension of import of its bulk powder by ITOCHU CHEMICAL and other import companies with the chief inspector of Osaka Customs.

The details can be read here.

Endo and Penwest Announce Settlement of Opana ER Litigation

Endo Pharmaceuticals, and Penwest Pharmaceuticals announced today that the companies have settled litigation with Actavis South Atlantic LLC regarding the production and sale of generic formulations of Opana ER (oxymorphone hydrochloride) Extended Release Tablets CII.

The details can be read here.

Ratio Pharma successfully invalidated Alza's fentanyl transdermal patch related patent

In a decision by Honorable Judge Mr. Justice Kitchin, ratio pharma has successfully invalidated the patent (European Patent (UK) No 1 381 352) related to transdermal patch of fentanyl, assigned to Alza Corporation and exclusively licensed to Janssen Cilag Ltd.

Grounds of Invalidation:
i) Anticipation by:
a) International Patent Application WO 01/26705 A2 ("Samyang");
b) a 1996 article by Roy et al. ("Roy").
ii) Obviousness in the light of common general knowledge, Roy and the following further publications:
a) a 2000 conference poster by Yu et al. ("the Yu Poster").
b) a 2000 conference abstract by Yu et al. ("the Yu Abstract");
c) European Patent Application 0 913 158 A1 ("Permatec");
d) United States Patent 5 006 342 ("Cygnus");
e) European Patent Application 0 622 075 A1 ("Hercon").
iii) Insufficiency: The defendants contend the claims of the Patent are so uncertain it is not possible to determine their scope and they are therefore uninfringeable or insufficient. They also contend it requires undue experimentation to determine whether a product infringes. Both allegations depend upon the proper interpretation of the claims.

Conclusion: The Patent is anticipated by Comparative Example 2 of Samyang and is obvious over the common general knowledge, Roy, the Yu Poster and the Yu Abstract.

The whole Judgement can be read here.

BioAlliance seeks European marketing nod for ondansetron RapidFilm

BioAlliance Pharma SA, the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and AIDS, announced the initiation of its European marketing application for ondansetron RapidFilm, the fast-dissolving oral film strip formulation of ondansetron (which until now has been used in tablet form).

The details can be read here.

Sanofi Pasteur begins phase-II study of Clostridium difficile vaccine

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced that it is sponsoring a phase II clinical study of a vaccine against Clostridium difficile, which is among the most common causes of hospital-acquired infection in Europe and North America.

The details can be read here.

Health ministry may exempt marketing of controversial FDCs without fresh applications

Health Ministry will take a final call soon on granting exemption to the pharma companies to continue marketing of those controversial fixed dose combination (FDC) drugs after clearance from the DTAB.

The details can be read here.

FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab

Amgen Inc. today announced that the U.S. FDA has accepted Amgen's submission and filed a Biologics License Application (BLA) for denosumab, an investigational RANK Ligand inhibitor.

The details can be read here.

Zogenix Reports FDA Provides New PDUFA Date for Sumavel DosePro

February 18, 2009 -- Zogenix, Inc., a private, specialty pharmaceutical company, announced that the U.S. FDA has provided a target date of July 15, 2009 for completion of its review of the NDA for Sumavel DosePro(sumatriptan injection) needle-free delivery system.

The details can be read here.

GTx Announces Toremifene 80 mg NDA Accepted for Review by FDA

Feb 18, 2009 - GTx, Inc. announced today that the USFDA has accepted for filing and review the New Drug Application for toremifene 80 mg, an oral selective estrogen receptor modulator, which GTx seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT).

The details can be read here.

Cipher Receives Tentative FDA Approval for Extended-Release Tramadol Capsules

February 17, 2009 - Cipher Pharmaceuticals Inc. today announced that it has received tentative approval from the U.S. FDA for CIP-TRAMADOL ER, the Company's extended-release formulation of the analgesic tramadol, which is indicated for the management of moderate to moderately severe chronic pain such as osteoarthritis.

The details can be read here.

Orexo signs agreement for Abstral in Israel

Feb. 18, 2009--Orexo and Neopharm Ltd of Israel have signed an exclusive distribution agreement that grants Neopharm rights to market and sell Abstral, Orexo's product for treatment of breakthrough cancer pain, in Israel.

The details can be read here.

Lotus Pharmaceuticals, Inc. Purchases Intellectual Property Rights to an Established Prescription Drug

Lotus Pharmaceuticals, Inc., today announced that contractually controlled Beijing Liang Fang Pharmaceutical Co., Ltd. entered into an intellectual rights transfer contract with Beijing Yipuan Bio-Medical Technology Co., Ltd. in December 2008 to acquire the drug Yipubishan, a highly effective and stable octreotide acetate injection solution, according to a clinical research report issued by Beijing Union Medical College Hospital Center for Clinical Pharmacology, used to treat the symptoms of gastric ulcers and hemorrhages of the upper digestive tract since 2004.

Pharmos Announces Agreement to Sell Certain CB2 Selective Agonists

Pharmos Corporation announced today that it has entered into an agreement with an Israel based company, Reperio Pharmaceuticals Ltd. (Reperio) for the sale of the patent rights and technical know how related to the compound known as PRS-639,058 and some follow on molecules.

The details can be read here.

arGentis Receives Orphan Drug Designation for European Union

Feb 16, 2009 - arGentis Pharmaceuticals, LLC announced today that the European Medicines Agency (EMEA) accepted the company's product candidate ARG201 (native type 1 bovine collagen) for the treatment of diffuse systemic sclerosis, also known as systemic scleroderma (SSc) for designation as an orphan medicinal product in the European Union.

The details can be read here.

Merck Sharp & Dohme Ltd Withdraws Its Marketing Authorisation Application For Vorinostat MSD (Vorinostat)

The European Medicines Agency has been notified by Merck Sharp & Dohme Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Vorinostat MSD (Vorinostat), 100 mg hard capsules.

The details can be read here.

Vion Pharmaceuticals Submits New Drug Application for Onrigin

February 17, 2009 Vion Pharmaceuticals, announced today that it has filed a New Drug Application with the U.S. FDA for its lead oncology therapeutic Onrigin (laromustine) Injection as a single agent for remission induction treatment for patients sixty years of age or older with poor-risk acute myeloid leukemia.

The details can be read here.

Expanded Indication for Nycomed’s TachoSil

Feb. 17, 2009--Today Nycomed received an expanded indication for TachoSil, its innovative surgical patch, from the European Medicines Agency. To date, TachoSil was approved for haemostasis (control of bleeding) in surgery. With the new expanded indication, it becomes the first and only dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.

The details can be read here.

ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients

ViroPharma Incorporated today announced that its Phase 3 trial evaluating maribavir used as prophylaxis against cytomegalovirus (CMV) disease in liver transplant patients has been discontinued, and that all patients on study drug are being moved to the current standard of care.

The details can be read here.

France gives first approval for Named Patient Supply of Cerepro

16 February 2009 - Ark Therapeutics Group today announces that the first Named Patient Supply for Cerepro has been approved by the French Medicines Control Agency (AFSSAPS) following a 'nominative' ATU application made by a neuro-surgeon in France.

The details can be read here.

Synthon announces European approvals for generic Montelukast

16 February 2009--Synthon is pleased to announce that it has successfully completed multiple decentralized procedures (DCP) for its newest product within its comprehensive portfolio: Montelukast. Regulatory clearance has been obtained for Synthon's product in sixteen European countries. Registration has been obtained for multiple dosage forms including a filmcoated tablet, intended for adults aged 15 years and above, and a chewable dosage form, intended for children aged 2 -14 years.

The details can be read here.

Profit of 50 pharma cos fall by 18% in April-Dec despite 27% growth in sales

The net profit of top 50 pharmaceutical companies in the country declined by 18 per cent in nine months of the current year mainly on account of the provision of foreign exchange loss. The aggregate profit of these 50 companies, as per a Pharmabiz study, dropped to Rs 4615 crore during April-December, 2008 from Rs 5630 crore reported in the same period of the previous year.

The details can be read here.

Recession affects staff recruitments in domestic pharma industry

The global financial meltdown, which has resulted in massive loss of jobs all over the world cutting across all the industrial sectors, has affected the employment opportunities in Indian pharmaceutical industry too, as per pharma head hunting firms.

The details can be read here.

Sandoz Receives European Commission Approval for Biosimilar Filgrastim

February 13, 2009 - Sandoz has received final approval for its third biosimilar, filgrastim, paving the way for this important oncology medicine to be made available to patients across the European Union.

The details can be read here.

Oral Laquinimod for Multiple Sclerosis Granted Fast Track Status by FDA

Feb 12, 2009 - Teva Pharmaceutical Industries Ltd. and Active Biotech today announced that oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS), has received a Fast Track designation from the U.S. FDA.

The details can be read here.

Savient Provides Update on Pegloticase BLA

Savient Pharmaceuticals, Inc. today announced that the Company filed amendments to strengthen and clarify the data included in the previously submitted pegloticase Biologics License Application (BLA), which was granted priority review.

The details can be read here.

Emergent BioSolutions Announces That BioThrax (Anthrax Vaccine Adsorbed) Receives Market Authorization in India

Feb 12, 2009 - Emergent BioSolutions Inc. announced today that the Drugs Controller General of India (DCGI) has issued a registration certificate for BioThrax® (Anthrax Vaccine Adsorbed), which enables the marketing and sale of the vaccine in India to help prevent anthrax infection.

The details can be read here.

Revised Relenza Royalty for December 2008

13 February 2009--Biota Holdings Limited today reported that it had received revised advice from GlaxoSmithKline regarding Relenza sales for the December 2008 quarter. The revised sales were $27.1 million ($20.8 million) and indicative royalties were $1.9 million ($1.46 million). This revision represents an additional $0.44 million in royalties to Biota.

The details can be read here.

Federal Court Declares Vaccines Do Not Cause Autism

The U.S. Court of Federal Claims today exonerated vaccines in the debate over the causes of autism. The three judges ruled that the measles-mumps-rubella vaccine (MMR), given in combination with thimerosal-containing vaccines, does not cause autism. The ruling is consistent with 18 major scientific studies which have failed to show a link between vaccines and the widely-diagnosed neurodevelopmental disorder.

The details can be read here.

U.S District Court confirms positive patent case ruling in favour of Biotec Pharmacon

Feb. 12, 2009--Biotec Pharmacon reports that Biothera has been denied permission to file a motion to reconsider the U.S District Court Order of 28 January, 2009, which largely ruled in Biotec Pharmacon's favour in a patent infringement suit. The Court's decision confirms that all of Biothera's claims under 12 of 14 U.S. patents at issue have been dismissed from the case without even requiring a trial.

The details can be read here.

China Pharma Holdings, Inc. Announces Clinical Trials Already Underway for Candesartan

February 11, 2009 -- China Pharma Holdings, Inc., which develops, manufactures, and markets specialty pharmaceutical products in China, announced today that the company has initiated clinical trials for the generic version of the leading hypertension drug Candesartan.

The details can be read here.

Taro Receives FDA Approval for Levetiracetam Oral Solution

Feb 11, 2009 - Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. FDA for its Abbreviated New Drug Application for Levetiracetam Oral Solution, 100 mg/mL (“levetiracetam oral solution”).

The details can be read here.

Court Report

About Court Report: Each week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.

Boehringer Ingelheim Vetmedica Inc. v. Merial Ltd. et al.3:09-cv-00212; filed February 4, 2009 in the District Court of Connecticut (porcine circovirus vaccines)

Alcon Research, Ltd. et al. v. Apotex Inc. et al.1:09-cv-00102; filed February 2, 2009 in the Southern District of Indiana &
Alcon Research, Ltd. et al. v. Sandoz Inc.1:09-cv-00103; filed February 2, 2009 in the Southern District of Indiana (olopatadine hydrochloride ophthalmic solution, used to treat ocular itching associated with allergic conjunctivitis)

Cephalon Inc. et al. v. Barr Pharmaceuticals Inc. et al.1:09-cv-00074; filed January 30, 2009 in the District Court of Delaware (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer)

Warner Chilcott Laboratories Ireland Ltd. et al. v. Actavis Elizabeth LLC et al.2:09-cv-00469; filed January 30, 2009 in the District Court of New Jersey (modified release doxycycline hyclate, used for adjunctive treatment of severe acne)

Eli Lilly & Co. v. Invagen Pharmaceuticals, Inc.2:09-cv-00392; filed January 29, 2009 in the Eastern District of New York (raloxifene)

Boehringer Ingelheim International GmBH et al. v. Mylan Pharmeceuticals Inc. et al.2:09-cv-00366; filed January 26, 2009 in the District Court of New Jersey (pramipexole dihydrochloride)

The details of the complaints can be read here.

Lundbeck to acquire US-based Ovation Pharma for US$ 900 mn

H. Lundbeck A/S (Lundbeck) and Ovation Pharmaceuticals, Inc. (Ovation) announced that they have entered into a definitive transaction agreement under which Lundbeck, through the wholly owned subsidiary Lundbeck, Inc., will acquire Ovation in an all cash transaction valuing Ovation at up to USD 900 million or approximately DKK 5.2 billion.

The details can be read here.

Taro receives US FDA warning letter for its Canadian facility

Taro Pharmaceutical Industries Ltd. announced that the company has received a warning letter on February 5, 2009 from the US Food and Drug Administration (FDA) regarding the inspection of the company's Canadian manufacturing facility in July 2008.

The details can be read here.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and Invega

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced that the company has submitted multiple applications to the U.S. Food and Drug Administration (FDA) which, if approved, would broaden treatment options for patients diagnosed with schizophrenia or schizoaffective disorder.

The details can be read here.

UCB's meeting with U.S. FDA defines path forward for Cimzia in rheumatoid arthritis

UCB announced today that it met the U.S. FDA and clarified the requirements for the approval of the Biologics License Application (BLA) for Cimzia, the first PEGylated anti-TNF, for the treatment of rheumatoid arthritis (RA).

The details can be read here.

Nutra Pharma Subsidiary, ReceptoPharm, Files Patent Application for Novel Treatment of Arthritis Using RPI-78

Feb 9, 2009 - Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that its wholly-owned drug discovery subsidiary, ReceptoPharm, has filed a patent application with the United States Patent and Trademark Office for the use of RPI-78 as a novel method for treating arthritis in humans. RPI-78 is ReceptoPharm's lead drug candidate being studied for the treatment of pain.

The details can be read here.

OSI Pharmaceuticals Announces Notification of ANDA Filing for Tarceva

Feb 10, 2009 - OSI Pharmaceuticals, Inc. announced today receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application to the U.S. FDA requesting permission to manufacture and market a generic version of Tarceva (erlotinib).

The details can be read here.

Teva Announces Approval and Launch of Generic Imitrex Tablets

Feb 10, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. FDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of GlaxoSmithKline's Imitrex Tablets (sumatriptan succinate), 25 mg, 50 mg and 100 mg for treatment of acute migraine attacks. Shipment of this product has commenced.

The details can be read here.

Cubist Plans to Commence Patent Infringement Litigation against Teva Parenteral Medicines, Inc. In Response To ANDA filing for daptomycin

Feb 10, 2009 - Cubist Pharmaceuticals, Inc. today announced that it has received a Paragraph IV Certification Notice Letter from Teva Parenteral Medicines, Inc. notifying Cubist that TPM had submitted an Abbreviated New Drug Application to the US Food and Drug Administration (FDA) for approval to market a generic version of CUBICIN (daptomycin for injection).

The details can be read here.

Sagent Pharmaceuticals Announces Expansion of Cefazolin Product Line to Include Cefazolin for Injection, USP in 500mg Single-Dose Vial

Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched Cefazolin for injection, USP, an essential antibiotic used to treat serious infections, in a 500mg single-dose vial.

The details can be read here.

Shire Receives Fosrenol Paragraph IV Notice Letters from Barr Laboratories and Mylan

February 09, 2009 -- Shire plc , announces that it has received Paragraph IV Notice letters from Barr Laboratories, Inc. and Mylan, Inc. dated 2 and 4 February 2009 respectively, advising in each case of the filing of an Abbreviated New Drug Application for a generic version of 500mg, 750mg and 1gm FOSRENOL(R), (lanthanum carbonate). Barr and Mylan has filed the para IV against all the patents listed in OB for lanthanum carbonate chewable tablet.

The details can be read here.

HIV/AIDS Update - Traditional Approval of Isentress (raltegravir)

On January 29, 2009, the FDA granted traditional approval for Isentress (raltegravir) 400 mg tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients.

The details can be read here.

GlaxoSmithKline and Genmab Seek European Marketing Authorisation of Arzerra in Advanced Stage Blood Cancer

GlaxoSmithKline (GSK) and Genmab A/S announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Arzerra(TM)(ofatumumab) for the treatment of chronic lymphocytic leukaemia (CLL).

The details can be read here.

Tibotec Submits Application to U.S. FDA Seeking Traditional Approval for Intelence (etravirine)

Tibotec, Inc. today announced it has submitted an application to the U.S. FDA seeking traditional approval for INTELENCE (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI).

The details can be read here.

King Pharmaceuticals Offers New Dosage Strengths of Avinza to Provide More Treatment Options for People with Chronic Pain

Feb 5, 2009 - King Pharmaceuticals, Inc. today announced the launch of two new FDA-approved dosage strengths for AVINZA (morphine sulfate extended-release capsules). The new dosing strengths, 45mg and 75mg, complement the currently available 30mg, 60mg, 90mg and 120mg dosages. AVINZA is a long-acting opioid for patients with moderate to severe chronic pain who require around-the-clock pain relief for an extended period of time.

The details can be read here.

US Patent Office Grants a New Patent to IDEA AG, Which Also Covers the Targeted Analgesic Product Diractin (ketoprofen in Transfersome gel)

IDEA AG today announced the granting of a new US patent (7,473,432) that covers the recently improved Transfersome technology and the Company’s lead product, Diractin, which is already approved in Switzerland and in the final stage (phase III) of clinical development in Europe and the USA.

The details can be read here.

IMPAX Receives Final FDA Approval for Generic Minocycline hydrochloride Extended-Release Tablets, 45mg, 90mg and 135mg

Feb 5, 2009 - IMPAX Laboratories, Inc. today confirmed that the U.S. FDA has granted final approval of the Company's Abbreviated New Drug Application for generic versions of SOLODYN (minocycline HCI) 45mg, 90mg and 135mg Extended-release Tablets. Medicis markets SOLODYN for the treatment of moderate-to-severe acne.

The details can be read here.

Taro Receives Final FDA Approval for Lamotrigine Chewable Tablets ANDA

Feb 5, 2009 - Taro Pharmaceutical Industries Ltd. reported today that it has received final approval from the U.S. FDA for its Abbreviated New Drug Application for Lamotrigine Tablets (Chewable Dispersible), 5 mg and 25 mg.

The details can be read here.

Dr. Reddy's Announces Five ANDA Approvals and Generic Product Launches in the US Market

Feb 5, 2009 - Dr. Reddy's Laboratories today announced that it has launched the following five products in the US market during the month of January:

Levetiracetam tablets (250mg, 500mg, 750mg & 1000mg
Omeprazole capsules (40mg
Lamotragine CD chewable tablets (5mg & 25mg)
Divalproex capsules & delayed release pellets (125mg)
Lamotrigine tablets (25mg, 100mg, 150mg & 200mg)

The details can be read here.

Glenmark gets US FDA nod for lithium carbonate capsules

Glenmark Generics Inc. USA (GGI), a subsidiary of Glenmark Pharmaceuticals, has received approval from the US FDA for lithium carbonate 150 mg, 300 mg and 600 mg capsules and will immediately commence marketing and distribution of these products in the US market.

The details can be read here.

Wedgewood Pharmacy Continues to Compound 17P Following FDA Rejection of New Drug Application by KV Pharmaceutical Co.

Feb 4, 2009 - Wedgewood Pharmacy will continue to compound 17-AlphaHydroxyprogesterone Caproate (17P) following the Federal Drug Administration's (FDA) January 26 rejection of KV Pharmaceutical Co.'s application to seek New Drug Approval for the substance.

The details can be read here.

Pfizer's Sutent is Recommended as First-Line Treatment for Kidney Cancer Patients by British Health Agency

Feb 4, 2009 - Pfizer Inc said today that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued its final appraisal document recommending the use of Sutent (sunitinib malate) as a first-line treatment for patients with metastatic renal cell carcinoma mRCC (advanced kidney cancer).

The details can be read here.

Copaxone is Approved for Treatment of Patients with a First Clinical Event Suggestive of Multiple Sclerosis

Feb 4, 2009 - Teva Pharmaceutical Industries Ltd. today announced that the Medicines and Healthcare products Regulatory Agency has approved an expanded label for COPAXONE® (glatiramer acetate injection) to include the treatment of patients with clinical isolated syndrome (CIS) suggestive of multiple sclerosis (MS).

The details can be read here.

Once-Daily Prezista (darunavir) for Treatment-Naïve Adults with HIV-1 Receives Approval in the European Union as Part of Combination Therapy

Feb. 3, 2009 - Tibotec Pharmaceuticals announced today that the European Commission approved once-daily dosing of 800 mg PREZISTA(R) (darunavir), a protease inhibitor, with low-dose ritonavir as part of combination therapy in treatment-naïve adults (those who have never taken HIV medication before).

The details can be read here.

PrandiMet, First Repaglinide and Metformin HCl Fixed Dose Combination Therapy, Now Available in the United States

Feb 4, 2009 -Novo Nordisk and Sciele Pharma, Inc., a Shionogi Company, today announced the availability of PrandiMet (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the short-acting secretagogue repaglinide and insulin sensitizer metformin HCl for the treatment of type 2 diabetes in the United States.

The details can be read here.

Abraxis BioScience Launches ABRAXANE in Germany

Feb 4, 2009 - Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced the launch in Germany of ABRAXANE, 5 mg/ml powder for suspension for infusion (paclitaxel).

The details can be read here.

Court Report

About Court Report: Each week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.

Procter & Gamble Co. et al. v. Sun Pharma Global, Inc.2:09-cv-10342; filed January 29, 2009 in the Eastern District of Michigan (Risedronate)

Monsanto Co. et al. v. Manhart4:09-cv-00172; filed January 29, 2009 in the Eastern District of Missouri

Eli Lilly & Co. v. Invagen Pharmaceuticals, Inc.1:09-cv-00087; filed January 28, 2009 in the Southern District of Indiana (Raloxifene)

Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. et al.2:09-cv-10274; filed January 26, 2009 in the Eastern District of Michigan (Escitalopram Oxalate)

Aventis Pharmaceuticals Inc. et al. v. Sun Pharma Global Inc. et al.1:09-cv-00481; filed January 26, 2009 in the Northern District of Illinois
Aventis Pharmaceuticals Inc. et al. v. Sun Pharma Global Inc. et al.2:09-cv-00325; filed January 23, 2009 in the District Court of New Jersey (fexofenadine/pseudoephedrine)

Baxter Healthcare Corp. et al. v. Minrad Inc.1:09-cv-00054; filed January 23, 2009 in the District Court of Delaware

The detailed complaints and other details can be read here.

Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis

February 3, 2009 – Galderma Laboratories, L.P. today announced that the U.S. FDA has approved Vectical (calcitriol) Ointment 3mcg/g, a unique vitamin D3 product for the treatment of mild-to-moderate plaque psoriasis in adults.

The details can be read here.

Acorda Therapeutics Submits NDA for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis

Feb 2, 2009 - Acorda Therapeutics, Inc. today announced the submission of a New Drug Application to the U.S. FDA on January 30, 2009 for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS).

The details can be read here.

EpiCept Receives Permission to File Ceplene NDA

Feb 2, 2009 - EpiCept Corporation announced today that the U.S. FDA indicated that the Company has the necessary pivotal data to file a New Drug Application for Ceplene (histamine dihydrochloride) in conjunction with interleukin-2 (IL-2) as a remission maintenance treatment of acute myeloid leukemia (AML).

The details can be read here.

Takeda: FDA-Approved GERD Treatment

January 30, 2009 – Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. FDA approved KAPIDEX (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first proton pump inhibitor with a Dual Delayed Release (DDR) formulation designed to provide two separate releases of medication.

The details can be read here.

Watson Acknowledges Federal Trade Commission Action Regarding AndroGel Patent Settlement

Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the U.S. Federal Trade Commission (FTC) and the State of California have filed a lawsuit in the United States District Court for the Central District of California alleging that the Company's 2006 patent lawsuit settlement with Solvay Pharmaceuticals Inc. related to AndroGel(R) 1% (testosterone gel) CIII is unlawful.

The details can be read here.

Orexo, NovaMed Pharma sign Abstral licensing agreement

Orexo and the Chinese pharmaceutical company NovaMed Pharmaceuticals have signed an exclusive licensing and distribution agreement that grants NovaMed rights to seek approval for Abstral, Orexo's product for treatment of breakthrough cancer pain, in the People's Republic of China, and if granted, to market and sell the product in that market.

The details can be read here.

ZymoGenetics secures worldwide rights to IL-21 from Novo Nordisk

ZymoGenetics, Inc. announced the acquisition of ex-North American rights to Interleukin 21 (IL-21) from Novo Nordisk A/S, resulting in ZymoGenetics owning worldwide rights to IL-21. Novo Nordisk previously announced that they had reached a corporate decision to exit the oncology therapeutic area, resulting in the suspension of all ongoing oncology programmes.

The details can be read here.

GlaxoSmithKline and Genmab Submit Arzerra (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer

January 30, 2009 -- GlaxoSmithKline and Genmab A/S announced today the submission of a Biologics License Application to the U.S. FDA for Arzerra (ofatumumab) to treat patients whose chronic lymphocytic leukemia (CLL) is resistant (refractory) to previous therapies.
The details can be read here.

Santarus Submits New Drug Application for Zegerid Tablet Product

Jan 30, 2009 - Santarus, Inc., a specialty pharmaceutical company, today announced that it has submitted a New Drug Application to the U.S. FDA for a new tablet formulation to add to its ZEGERID family of branded prescription pharmaceutical products.

The details can be read here.

DA Sends Abbott Letter Regarding Depakote ER/Depakote Continuum Care Pharmacy Formulary Flashcard

Jan. 30, 2009--The FDA posted on its web site yesterday a letter sent to Abbott Laboratories about its review of a Depakote ER/Depakote Continuum Care Pharmacy Formulary Flashcard (744-160303) (Flashcard) for Depakote (divalproex sodium delayed-release) Tablets and Depakote ER (divalproex sodium extended-release) Tablets.

The details can be read here.

Biotec Pharmacon ASA (NO) - Favourable ruling for Biotec Pharmacon in U.S patent case

Jan. 30, 2009-A decision by the U.S district court judge in Minnesota on January 28 largely rules in Biotec Pharmacon's favour in the patent infringement suit brought by Biopolymer Engineering, Inc. d/b/a Biothera against Biotec Pharmacon ASA and its U.S. affiliate, Immunocorp. The decision eliminates from further litigation all of Biothera's claims under 12 of the 14 U.S. patents at issue in the case.

The details can be read here.

Mylan Receives FDA Approval for First-to-File Generic Depakote ER

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. FDA for its Abbreviated New Drug Application for Divalproex Sodium Extended-release (Divalproex ER) Tablets, 250 mg and 500 mg.

The details can be read here.

Teva Announces Approval of Generic Risperdal Oral Solution

Jan 30, 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 to market its generic version of Janssen's antipsychotic agent Risperdal (Risperidone) Oral Solution, 1 mg/mL. Shipment of this product has commenced.

The details can be read here.

Apotex and Intas Biopharmaceuticals extend their collaborative development of biosimilars to include pegfilgrastim

January 30, 2009 -- Apotex Inc. of Canada and Intas Biopharmaceuticals Limited of India have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy).

the details can be read here.