King Pharmaceuticals Provides Update on Embeda NDA Review

Dec 31, 2008 - King Pharmaceuticals, Inc. (NYSE: KG) today announced that the U.S. Food and Drug Administration (FDA) is continuing its review of the New Drug Application (NDA) for EMBEDA™ (morphine sulfate and naltrexone hydrochloride) extended release capsules.

Labopharm Announces FDA Approval of Once-Daily Tramadol HCL Extended Release Tablets for Management of Moderate to Moderately Severe Chronic Pain

December 31, 2008 - Labopharm Inc. today announced that RYZOLT (tramadol HCl extended release tablets), Labopharm's once-daily formulation of the analgesic tramadol, has been approved by the U.S. FDA. RYZOLT is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

The details can be read here.

Nektar Announces Closing of Sale of Specific Pulmonary Delivery Assets to Novartis for $115 Million

Nektar Therapeutics today announced that it has successfully closed the divestiture of specific Nektar pulmonary delivery assets, technology, and intellectual property to Novartis for $115 million in cash. The transaction was completed on December 31, 2008, 2008.

The details can be read here.

FDA Approves for Sterile Vancomycin HCl USP, 500 mg/Vial; 1 g/Vial and Sterile Vancomycin HCl USP, 5 g/Vial Pharmacy Bulk Package

Dec 31, 2008 - Akorn-Strides, LLC today announced that the U.S. Food and Drug Administration has granted approvals for two Abbreviated New Drug Applications (ANDAs) for Sterile Vancomycin HCl USP, 500 mg/vial, 1 g/vial and Sterile Vancomycin HCl USP, 5 g/vial Pharmacy Bulk Package.

The details can be read here.

HAPPY NEW YEAR

Dear Subscribers and Viewers,

WISHING YOU ALL A VERY HAPPY AND PROSPEROUS NEW YEAR 2009.

Thanks for your kind support and overwhelming response.

Amit Bansal

Warner Chilcott, Barr settle Femcon Fe patent challenge

Warner Chilcott Limited announced that its subsidiary Warner Chilcott Company, Inc and Barr Laboratories, Inc, a subsidiary of Barr Pharmaceuticals, Inc, have entered into a settlement and license agreement to resolve the pending patent litigation involving Warner Chilcott's oral contraceptive product, Femcon Fe.

The details can be read here.

Alnylam seeks approval for liver cancer drug, files IND with US FDA

Alnylam Pharmaceuticals, Inc, a leading RNAi therapeutics company, announced that it has submitted an investigational new drug application to the US FDA for ALN-VSP, an RNAi therapeutic for the treatment of liver cancers, including hepatocellular carcinoma and other solid tumours with liver involvement.

The details can be read here.

BLA for PolyHeme Accepted for Filing and Granted Priority Review

Dec 30, 2008 - Northfield Laboratories Inc. announced today that the U.S. FDA has accepted for filing its Biologics License Application (BLA) for PolyHeme, the Company's investigative human hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available.

The details can be read here.

GTx Submits New Drug Application for Toremifene 80 mg for the Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy

Dec 30, 2008 - GTx, Inc. today announced the submission of a New Drug Application with the U.S. FDA for toremifene 80 mg, an oral selective estrogen receptor modulator (SERM), for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.

The details can be read here.

FDA Approval of Three Generic Stavudine Formulations

On December 29, 2008 FDA granted approval for three generic fomulations of stavudine. Stavudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI), which helps keep HIV, the virus that causes AIDS, from reproducing. It is intended to be used in combination with other anti-retroviral agents for the treatment of HIV-1 infection.

The details can be read here.

Mylan's Matrix Receives Final FDA Approval for the Generic Version of the Antiretroviral Zerit Capsules

Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received final approval from the U.S. FDA on December 29, for its Abbreviated New Drug Application for Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg.

The details can be read here.

Watson Pharmaceuticals Receives FDA Final Approval for Generic Mircette

Watson Pharmaceuticals, Inc. , today announced that its subsidiary, Watson Laboratories, Inc., has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for desogestrel/ethinyl estradiol and ethinyl estradiol tablets, 0.15 mg / 0.02 mg and 0.01 mg and placebo tablets (28- day regimen).

The details can be read here.

UK: EWHC Patents Court rules Oxycodone patents valid but not infringed: ratiopharm & Sandoz v Napp Pharmaceuticals

Mr Justice Floyd delivered his judgment in the case of ratiopharm & Sandoz v Napp Pharmaceuticals that Oxycodone patents are valid but not infringed by Ratiopharm and Sandoz. The case related to two of Napp's EP(UK) patents for sustained release formulations for the painkiller drug oxycodone (OxyContin).

Sandoz and ratiopharm had applied to revoke the two patents, EP0722730 and EP1258246 as both the patents are derived from a common priority application and on the grounds that the claimed invention in both was obvious. Napp Pharma counter-claimed for infringement.

Judge Floyd J concluded, after extensive claim construction, that the claims in question required either all the oxycodone to be included in the matrix, and not in the outer layer, or that a spheronising agent was required in the formulation. Neither of these constructions could be used to cover the alleged infringement, since the particle did not have a spheronising agent and a significant proportion of the active ingredient was in the outer layer of the particle.

Judge Floyd finally conclude that the patents related to oxycodone formulation are valid but not infringed by Ratio and Sandoz.

The whole Judgement can be read here.

FDA Sends Abbott Letter About Humira

Dec. 24, 2008--The FDA posted on its web site yesterday a letter it sent to Abbott Laboratories about a review of an American Academy of Dermatology (AAD) Post Meeting News Ad for Humira. According to the FDA, "This AAD Post Meeting News Ad broadens the approved indication......

The details can be read here.

FDA Issues Complete Response Letter to Ipsen for Dysport BLA

Dec 29, 2008 - Ipsen today announced that the US FDA issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport. The application, submitted by the Group in late 2007, seeks approval to market Dysport for the treatment of cervical dystonia.

The details can be read here.

Salix Receives FDA Complete Response Letter for Balsalazide Tablet

Dec 29, 2008 - Salix Pharmaceuticals, Ltd. today announced that the Company has received a complete response letter from the U.S. Food and Drug Administration for its New Drug Application for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

The details can be read here.

Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse

Dec 26, 2008 - Allergan, Inc. today announced the U.S. Food and Drug Administration has approved LATISSE (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes.

The details can be read here.

FDA Approves Ferring Pharmaceuticals' Degarelix for Treatment of Advanced Prostate Cancer

Ferring Pharmaceuticals, USA today received approval from the U.S. FDA for degarelix, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, indicated for patients with advanced prostate cancer. Potential trade names are still under review with the FDA.

The details can be read here.

HIV/AIDS Update - Tentative Approval of Generic Emtricitabine Capsule Formulation

On December 23, 2008, FDA granted tentative approval for a generic version of emtricitabine capsules 200 mg, manufactured by Matrix Laboratories, Ltd., of Hyderabad, India, reviewed under the expedited review provisions for the President’s Emergency Plan for AIDS Relief. Emtricitabine is a Nuceloside Reverse Transcriptase Inhibitor (NRTI) indicated in combination with other antiretroviral medications for teatment of HIV infection.

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.

Bayer HealthCare LLC v. Abbott Laboratories et al.6:08-cv-00507; filed December 24, 2008 in the Eastern District of Texas - Adalimumab

Eli Lilly and Company v. Lupin Pharmaceuticals, Inc. et al.3:08-cv-06261; filed December 22, 2008 in the District Court of New Jersey - Duloxetine

Eli Lilly and Company v. Sun Pharmaceutical Industries, Inc. et al.3:08-cv-06266; filed December 22, 2008 in the District Court of New Jersey - Duloxetine

Sanofi-Aventis U.S. LLC et al. v. Ebewe Pharma GES.M.B.H. NFG.KG3:08-cv-06243; filed December 19, 2008 in the District Court of New Jersey - Oxaliplatin

Novartis Corp. et al. v. Teva Parenteral Medicines Inc. et al.1:08-cv-00952; filed December 18, 2008 in the District Court of Delaware - Zoledronic acid

Novartis Corp. et al. v. Cobalt Laboratories, Inc. et al.2:08-cv-06223; filed December 18, 2008 in the District Court of New Jersey - amlodipine besylate/benazepril hydrochloride

The details and the complaints can be read here.

Dynavax terminates hepatitis B vaccine license pact with Merck

Dynavax Technologies Corporation has terminated a global license and development collaboration agreement with Merck & Co, Inc for Heplisav, a phase-3 hepatitis B virus (HBV) vaccine. All rights to develop and commercialize Heplisav revert to Dynavax.

The details can be read here.

Merck acquires manufacturing rights & facility for Stimuvax from Oncothyreon

Merck Serono, a division of Merck KGaA, has modified the license from Oncothyreon to include the right to manufacture Stimuvax (BLP25 liposome vaccine) and also has purchased current inventory and certain assets used for the manufacture of Stimuvax from Oncothyreon Inc for a total amount of approximately US$13 million.

The details can be read here.

Takeda Receives New Action Date for Alogliptin (SYR-322) NDA

December 24, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification that the U.S. Food and Drug Administration (FDA) will respond to the alogliptin New Drug Application (NDA) by June 26, 2009.

The details can be read here.

AstraZeneca Receives FDA Complete Response Letter on Seroquel XR for Major Depressive Disorder

24 December 2008 -- AstraZeneca today announced the company has received a Complete Response Letter from the U.S. FDA asking for additional information for the supplemental New Drug Application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of Major Depressive Disorder (MDD) in adult patients.

The details can be read here.

New Indication For Fast-Acting Postprandial Hypoglicemic Agent FasticTablet / StarsisTablet Was Approved For Combination Therapy With Thiazolidines

December 24, 2008- Ajinomoto Co., Inc. and Astellas Pharma Inc. announced today that an additional indication for FASTIC Tablet / STARSIS Tablet, a fast-acting postprandial hypoglycemic agent, jointly developed by the two companies for use in combination therapy with thiazolidines has been approved on December 22.

The details can be read here.

Warner Chilcott Files Lawsuits for Infringement of Doryx Patent

Warner Chilcott Limited announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd. ("Mayne"), a subsidiary of Hospira, Inc., have filed lawsuits against each of Mutual Pharmaceutical Company, Inc. ("Mutual"), Mylan Pharmaceuticals Inc. ("Mylan") and Impax Laboratories, Inc. ("Impax") in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the "'161 Patent") which covers DORYX, a tetracycline-class oral antibiotic.

The details can be read here.

Breckenridge Pharmaceutical Enters Agreement With Helm AG (Hamburg, Germany) to Develop Third ANDA Project

Breckenridge announced today that it has entered into another separate agreement with Helm AG to develop and manufacture an ANDA for an asthma drug product. Under terms of this new agreement, Breckenridge will submit an ANDA to the U.S. Food and Drug Administration (FDA) in 2009 for the product which is in development by Helm AG. The product currently shows U.S. sales of approximately $4 billion, and is patent protected until 2012.

The details can be read here.

Teva Announces Tentative Approval of Generic Seroquel Tablets

Dec 23, 2008 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. FDA has granted tentative approval for the Company's Abbreviated New Drug Application to market its generic version of AstraZeneca's antipsychotic agent Seroquel (Quetiapine Fumarate) Tablets, Eq. 25 mg base, 50 mg base, 100 mg base, 150 mg base, 200 mg base, 300 mg base and 400 mg base.

The details can be read here.

Teva Introduces New Thinner 29-Gauge Needle for Copaxone Pre-Filled Syringe

Dec 23, 2008 - Teva today announced the launch of a new, thinner, 29-gauge pre-filled syringe for its multiple sclerosis treatment, COPAXONE (glatiramer acetate injection). A recent survey of 562 MS patients found the new thinner needle was significantly preferred by 77 percent of patients over the previous 27-gauge needle.

The details can be read here.

KV Pharmaceutical Voluntarily Suspends All Shipments of Its Approved Tablet-Form Drugs

December 23, 2008 -- KV Pharmaceutical has advised the U.S. FDA that, effective midnight Dec. 19, 2008, the company voluntarily suspended all shipments of all FDA approved drug products in tablet form.

the details can be read here.

Dr. Reddy's Laboratories Announce Settlement of Clarinex (Desloratadine) ANDA Patent litigation With Schering Corporation and Sepracor Inc.

)--Dec 23, 2008 - Dr. Reddy's Laboratories today announced that it has entered into agreements with Schering and Sepracor which will allow Dr. Reddy's to manufacture and market generic versions of the CLARINEX-D-12 Hour and CLARINEX-D® -24 Hour products, with six months marketing exclusivity, and the CLARINEX® REDITABS® product, with six months marketing co-exclusivity, starting in 2012. Dr. Reddy's will also market a generic version of the CLARINEX® 5 milligram tablet six months after the launch of the first generic version of that product.

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.

Pfizer Inc. et al. v. Apotex Inc. et al.1:08-cv-00948; filed December 17, 2008 in the District Court of Delaware

Pfizer Inc. et al. v. Apotex Inc. et al.1:08-cv-07231; filed December 17, 2008 in the Northern District of Illinois

Medimmune, LLC v. PDL Biopharma, Inc.5:08-cv-05590; filed December 16, 2008 in the Northern District of California

Schering Corp. v. Orgenus Pharma Inc. et al.3:08-cv-06102; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Wockhardt USA, Inc. et al.3:08-cv-06135; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Actavis Elizabeth LLC3:08-cv-06136; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Aurobindo Pharma USA, Inc. et al.3:08-cv-06137; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Cobalt Laboratories, Inc.3:08-cv-06138; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Sandoz, Inc.3:08-cv-06124; filed December 12, 2008 in the District Court of New Jersey

Eli Lilly and Company v. Impax Laboratories, Inc.3:08-cv-06139; filed December 12, 2008 in the District Court of New Jersey

Gilead Sciences, Inc., v. Teva Pharmaceuticals USA, Inc. et al.1:08-cv-10838; filed December 12, 2008 in the Southern District of New York

Intervet Inc. v. Merial Ltd.1:08-cv-02162; filed December 11, 2008 in the District Court of the District of Columbia

The details of the case and the complaints can be read here.

Glenmark's Crofelemer slated to be launched in ROW markets by 2010

Glenmark Pharmaceuticals Limited announced new developments that should accelerate the launch of Crofelemer, a novel drug in development for multiple indications including HIV-associated diarrhoea by a consortium of partners including Glenmark.

The details can be read here.

TransMolecular Receives Orphan Drug Designation for 131I-TM601 for the Treatment of Melanoma

Dec 22, 2008 - TransMolecular, Inc., a biotechnology company focused on targeted therapies for cancer, today announced that the U.S. FDA has granted Orphan Drug Designation for its anti-cancer compound 131I-TM601 for the treatment of Stage IIb-IV melanoma.

The whole story can be read here.

UCB receives U.S. FDA Complete Response Letter for Neupro in Restless Legs Syndrome and Advanced Parkinson's disease

UCB announced today that it has received a Complete Response Letter from the U.S FDA for its transdermal patch, Neupro (rotigotine transdermal system) to treat the signs and symptoms of advanced Parkinson's disease, and as a treatment for the signs and symptoms of moderate to severe primary Restless Legs Syndrome.

the details can be read here.

Amgen Submits Biologics License Application for FDA Approval of Denosumab

Amgen Inc. today announced submission of a Biologics License Application (BLA) with the U.S. FDA for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer.

The details can be read here.

FDA Issues Complete Response Letter to Centocor for Ustekinumab BLA

Centocor, Inc., announced today that the U.S. FDA issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab.

The details can be read here.

Gendux Molecular Limited withdraws its marketing authorisation application for Advexin (contusugene ladenovec)

Dec. 19, 2008-The European Medicines Agency has been formally notified by Gendux Molecular Limited of its decision to withdraw its application for a centralised marketing authorisation for the medicinal product Advexin (contusugene ladenovec) suspension for injection.

The details can be read here.

AstraZeneca Submits sNDA for Nexium for the Short-Term Treatment of GERD in Infants 0 to 1 Year Old

AstraZeneca today announced the submission of a supplemental New Drug Application to the U.S. FDA for NEXIUM (esomeprazole magnesium) to seek approval for the short-term (up to 6 weeks) treatment of gastroesophageal reflux disease (GERD) in pediatric patients ages 0 to 1 year old.

The details can be read here.

NeurogesX Announces FDA Acceptance to Review New Drug Application for NGX-4010 to Treat Post-Herpetic Neuralgia

NeurogesX, Inc. , a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that the U.S. FDA has accepted its New Drug Application to review its investigational product candidate, NGX-4010, for the management of pain due to post-herpetic neuralgia.

the details can be read here.

Antisoma Receives FDA Approval for Oral Fludarabine

19 December 2008 – Antisoma plc today announced that the United States FDA has approved its tablet formulation of fludarabine phosphate (‘oral fludarabine’) as a second-line treatment for chronic lymphocytic leukaemia.

The details can be read here.

FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer

Dec. 19, 2008--The U.S. FDA today approved Gleevec (imatinib mesylate) for a new indication – keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST.

The details can be read here.

NovaDel Pharma Receives FDA Approval of Zolpimist

Dec 22, 2008 - NovaDel Pharma Inc. today announced that Zolpimist (zolpidem tartrate) 5 mg and 10 mg Oral Spray has been approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

The details can be read here.

EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium)

Dec 22, 2008 - EPIX Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, today announced that the U.S. FDA has approved for marketing its novel blood pool magnetic resonance angiography agent, Vasovist (gadofosveset trisodium), to evaluate aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease.

The details can be read here.

Biovail Enters into Commercial Alliance for Aplenzin

Dec 22, 2008 - Biovail Corporation today announced that a subsidiary, Biovail Laboratories International SRL, has entered into a supply agreement with sanofi aventis US for the marketing and distribution of Aplenzin (bupropion hydrobromide tablets) in the United States and Puerto Rico.

The details can be read here.

Jazz Pharmaceuticals Announces Issuance of Key Patent for Once-A-Day Luvox CR

Jazz Pharmaceuticals, Inc. announced today that the U.S. PTO has issued U.S. Patent No. 7,465,462 covering its Once-A-Day LUVOX CR(R) (fluvoxamine maleate) Extended-Release Capsule product. The patent was assigned to Elan Pharma International Limited and is exclusively licensed to Jazz Pharmaceuticals in the United States through a product license agreement with Solvay Pharmaceuticals, Inc.

The details can be read here.

Tianyin Pharmaceutical Co., Inc. Receives Production License to Launch Tongbianling Capsules

December 22, -- Tianyin Pharmaceutical, Co., Inc. , a manufacturer and supplier of modernized traditional Chinese medicine ("TCM") based in Chengdu, China, today announced that it had recently received the production license of Tongbianling Capsules in dosage form of 0.25 gram/capsule (SFDA approval number 2008S02868) and is due to market the new product in February 2009.

The details can be read here.

Tentative Approval of Abacavir Sulfate and Lamivudine Fixed-dose Combination

On December 19, 2008, FDA granted tentative approval for fixed-dose combination scored tablets, made by Aurobindo Pharma Limited' of Hyderabad, India, containing abacavir sulfate and lamivudine, 60mg/30mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection. The tablets are dispersable in water, intended for pediatric patients 3 months - 16 years of age.

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.

Merial Ltd. v. Intervet, Inc.3:08-cv-00121; filed December 10, 2008 in the Middle District of GeorgiaMerial Ltd. v. Boehringer Ingelheim Vetmedica, Inc.3:08-cv-00116; filed December 8, 2008 in the Middle District of Georgia

AstraZeneca Pharmaceuticals LP et al. v. Handa Pharmaceuticals, LLC et al.3:08-cv-05997; filed December 8, 2008

Orion Corp. v. Wockhardt USA Inc. et al.1:08-cv-00917; filed December 8, 2008 in the District Court of Delaware

King Pharmaceuticals, Inc. et al. v. Sandoz Inc.3:08-cv-05974; filed December 5, 2008 in the District Court of New Jersey

Auxilium Pharmaceuticals, Inc. et al. v. Upsher-Smith Laboratories, Inc. 1:08-cv-02651; filed December 5, 2008 in the District Court of Colorado

Auxilium Pharmaceuticals Inc. et al. v. Upsher-Smith Laboratories Inc.1:08-cv-00908; filed December 4, 2008 in the District Court of Delaware

The details of the case and complaints can be read here.

Janssen-Cilag International N.V. Withdraws its Application for an Extension of Indication for Invega

Dec. 17, 2008-The European Medicines Agency has been formally notified by Janssen-Cilag International N.V. of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Invega (paliperidone) prolonged-release tablets.

The details can be read here.

Significant Milestone on Path to Commercialisation of Fondaparinux

Dec 17, 2008 - Australian drug developer, Alchemia Limited, today announced the achievement of a significant milestone towards the commercialisation of its lead product, generic fondaparinux. As a consequence, Alchemia will receive payments from its manufacturing and marketing partner Dr Reddy's Limited (DRL) totaling US$1,625,000 (A$2,400,000). US$1 million will be received in December 2008 and a further US$625,000 upon the earlier of the approval of the Abbreviated New Drug Application (ANDA) and 31 December 2009.

The details can be read here.

Celesio AG (FRA:CLS) Advocate General of the European Court of Justice publishes final opinion on third-party ownership of pharmacies in Germany.

Dec 17, 2008 - - Celesio AG Three months after the oral hearings were held at the European Court of Justice (ECJ), the Advocate General Yves Bot today published his opinion on the issue of third-party ownership in the case of the German branch of the Celesio subsidiary DocMorris (AZ C-171-07).

The details can be read here.

Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo

Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has received confirmation from the U.S. FDA that the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual lozenge) has been accepted for review by the agency.

The details can be read here.

FDA Approves Genzyme's Mozobil

Dec 15, 2008 - Genzyme Corporation announced today that the U.S. Food and Drug Administration has granted marketing approval for Mozobil™ (plerixafor injection), a drug intended to be used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).

The details can be read here.

Epeius Biotech Awarded Patents in Europe for Targeted Genetic Anti-Cancer Medicine: Company Expands Impressive Intellectual Property Estate

Epeius Biotechnologies Corporation, a leader in tumor-targeted gene delivery systems, has received two additional European patents for the platform targeting technologies and molecular designs that enable precision gene delivery to primary cancers and metastatic lesions that have spread throughout the body.

The details can be read here.

FDA Submission of Isosulfan Blue Injection ANDA

Dec 16, 2008 - Synerx Pharma, LLC announces the submission to the FDA of Isosulfan Blue Injection (generic equivalent to Lymphazurin Covidien (formerly US Surgical)). This ANDA submission is the culmination of a four year joint effort by Synerx Pharma, LLC and its exclusive raw material supplier Apicore, LLC. According to Synerx Pharma and Apicore, the active ingredient is extremely difficult to synthesize.

The details can be read here.

Watson Pharmaceuticals Receives FDA Approval for Generic Razadyne ER Capsules

Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for galantamine hydrobromide extended-release capsules, eq. to 8 mg, 16 mg and 24 mg (galantamine base).

The details can be read here.

Lannett Company Receives FDA Approval for Ursodiol 300 mg Capsules

Dec 16, 2008 - Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. FDA of its Abbreviated New Drug Application for Ursodiol 300 mg Capsules, the generic equivalent of Actigall marketed by Watson Pharmaceuticals. According to Wolters Kluwer, combined sales of generic and brand Ursodiol were $128.2 million for the 12 months ending October 2008.

The details can be read here.

Schering-Plough Announces FDA Approval of PegIntron and Rebetol Combination Therapy for Treating Pediatric Hepatitis C

Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval to PEGINTRON (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy for use in previously untreated patients 3 years of age and older with chronic hepatitis C.

The details can be read here.

FDA Approves Lusedra (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation

Eisai Corporation of North America today announced that the U.S. FDA has approved LUSEDRA (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

The details can be read here.

Abbott Receives FDA Approval for Trilplix (fenofibric acid), First and Fibrate Indicated for Use in Combination With Statin for Cholesterol Management

December 15, 2008 -- Today, the U.S. FDA approved Abbott's TRILIPIX (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. TRILIPIX is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels. TRILIPIX has not been shown to prevent heart disease or heart attack.

The details can be read here.

Abraxis BioScience Launches Abraxane in European Union

Dec 15, 2008 - Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced the launch in the European Union of Abraxane® Paclitaxel 5 mg/ml powder for suspension for infusion. Abraxane® is an albumin-bound nanoparticle formulation of paclitaxel. In the EU, Abraxane® is indicated for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated.

The details can be read here.

Generex Awarded New Patent in Europe

December 15, 2008 -- Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has received a new European patent.

the details can be read here.

Lannett Announces Launch of Two Products

Dec 15, 2008 - Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced it has launched a certain topical anesthetic product used in a variety of hospital and outpatient settings. Sales of the topical anesthetic product were $10 million in 2007, according to Wolters Kluwer.

The details can be read here.

Gilead Sciences Files Patent Infringement Lawsuit Against Teva Pharmaceuticals

Dec 12, 2008 - Gilead Sciences, Inc. today announced that it has filed a lawsuit in U.S. District Court in New York against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. for infringement of U.S. Patent Numbers 6,642,245 and 6,703,396. Both patents are associated with emtricitabine, a component of Truvada (emtricitabine and tenofovir disoproxil fumarate), and are licensed exclusively to Gilead Sciences by Emory University.

The details can be read here.

Gilead Sciences Files Patent Infringement Lawsuit Against Teva Pharmaceuticals

Dec 12, 2008 - Gilead Sciences, Inc. today announced that it has filed a lawsuit in U.S. District Court in New York against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. for infringement of U.S. Patent Numbers 6,642,245 and 6,703,396.

The details can be read here.

Court Denies Hi-Tech Pharmacal's Motion Regarding Dorzolamide and Timolol Ophthalmic Solution Exclusivity

Hi-Tech Pharmacal Co., Inc. announced that the United States District Court denied Hi-Tech's motion for a preliminary injunction, permanent injunction, and declaratory judgment, and granted Apotex's motion for summary judgment, and entered summary judgment in favor of the FDA. Hi-Tech had challenged the FDA's ruling that the Company had forfeited an exclusive generic marketing period for the Company's Dorzolamide and Timolol ophthalmic solution ANDA.

The details can be read here.

Akorn, Inc. Announces FDA Approval of Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%

Dec 12, 2008 - Akorn, Inc. today announced that the U.S. Food and Drug Administration has granted approval for Akorn's Abbreviated New Drug Application for Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%.

The details can be read here.

Glenmark crowned best pharma co in the world by SCRIP

The Glenmark Pharmaceuticals Ltd was recognised as 'best pharma company in the world - SME' at the SCRIP Awards 2008 in London, hosted by the UK broadcaster Peter Sissons on December 10. The awardees are recognised by SCRIP magazine.

The details can be read here.

GLP Rules notified, pharma cos directed to implement by Nov, 2010

Union ministry of health has notified the Schedule L-I of Rules 74, 78 and 150 E under Drugs and Cosmetics Third Amendment Rules 2008 giving the pharmaceutical industry time till November 1, 2010 for compliance of Good Laboratory Practices.

Under the notification of the Ministry of Health and Family Welfare, Department of Health, No G.S.R.634(E), sections 12 and 33 of the D&C Act, has now inserted 'Good Laboratory Practices' as in Schedule L-I and in Rule 78, in clause (p), and in Rule 150 E, in clause (a).

The details can be read here.

Daiichi Sankyo Submits Application for Approval of CS-866AZ Antihypertensive Combination Drug in Japan

December 11, 2008 – DAIICHI SANKYO COMPANY, LIMITED today announced that it has submitted an application for manufacturing and marketing approval to the Japanese Ministry of Health, Labour and Welfare for CS-866AZ, which it developed as a hypertension treatment.

The details can be read here.

Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy

Pain Therapeutics, Inc. has received a Complete Response Letter from the U.S. FDA for its New Drug Application for REMOXY, an abuse-resistant controlled-release form of oxycodone. Based on its review, the FDA has determined that the NDA is not approved in its present form.

The details can be read here.

Barr's BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for Filing by FDA

Barr Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral Vaccines Biologics License Application (BLA). These oral vaccines represent Barr's first in-house biologics development initiative and demonstrate the Company's ability to develop, manufacture and conduct clinical trials for biologic products.

The details can be read here.

Abstral Receives Marketing Approval in Germany

Dec. 11, 2008--Orexo confirms the announcement made by ProStrakan Group plc, Orexo's partner for Abstral in Europe and North America, that it has received a Marketing Authorisation from the German regulatory authority, BfArM for Abstral (for breakthrough cancer pain).

The details can be read here.

BioSante Pharmaceuticals Signs Elestrin U.S. Marketing Agreement With Azur Pharma

Azur Pharmaceuticals Deal: BioSante Pharmaceuticals, Inc for the marketing of Elestrin (estradiol gel) to treat moderate-to-severe hot flashes in menopausal women in the United States. Upon execution of the agreement, BioSante received $3.325 million comprised of a $0.5 million product licensing fee and $2.825 million for transfer of the Elestrin trademark and inventories, among other items.

The details can be read here.

Hybrigenics Receives First Patent Grant on Chemical Inhibitors of Ubiquitin-Specific Proteases

Hybrigenics, a bio-pharmaceutical company with a focus on research and development of new cancer treatments and specialized in protein interactions, announced today it has been granted the first in a series of patent applications covering the company's proprietary chemical inhibitors of Ubiquitin-Specific Proteases.

The details can be read here.

Dr. Reddy's (betapharm) Receives Preliminary Results on AOK Tender in Germany

Dec 10, 2008 - Dr. Reddy's Laboratories today announced that betapharm AG, its wholly owned subsidiary, has received complete information on the preliminary result of the tender by the Allgemeine Ortskrankenkassen for discount agreements for 47 of the 48 products pertaining to betapharm, pursuant to § 130a SGB V. betapharm has been tentatively offered 8 products in different regions of Germany covering the AOK-insured persons.

The details can be read here.

Orion Comments on ANDA Filed by Wockhardt Limited for a Generic Version of Orion's Proprietary Drug Stalevo in US

Dec. 11, 2008--Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed by Wockhardt Limited with the U.S. FDA seeking authorisation to produce and market generic versions of Stalevo (specifically the 25/200/100; 37.5/200/150 and 50/200/200 mg strengths) in the United States.

The details can be read here.

Oncoscience withdraws application to EMEA for nimontuzumab

YM BioSciences Inc, an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, reported that Oncoscience AG, the European licensee of nimotuzumab from YM's subsidiary, CIMYM BioSciences Inc., has withdrawn its application to the European Medicines Agency for marketing authorization of nimotuzumab.

The details can be read here.

Kuvan Receives Marketing Approval in the European Union

BioMarin Pharmaceutical Inc. announced today that its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has received marketing approval for Kuvan (sapropterin dihydrochloride) for the treatment of hyperphenylalaninemia in phenylketonuria or BH4 deficient patients from the European Commission.

The details can be read here.

Cambridge Laboratories Announces Approval of Tetrabenazine in Spain

December 08, 2008 --Cambridge Laboratories Limited, the privately-owned specialty pharmaceutical company, today announces that its flagship product Tetrabenazine, has received marketing approval in Spain from the Agencia Espanola de Medicamentos y Productos Sanitarios.

The details can be read here.

Intralytix Awarded Patent by USPTO for Bacteriophage Treatment of Colonization by Pathogenic Bacteria, Including MRSA

Dec 9, 2008 - Intralytix, Inc., announced today that it has been issued a patent by the U.S. Patent & Trademark Office covering the use of bacteriophages to reduce the risk of bacterial infection in persons colonized with pathogenic bacteria including MRSA.

The details can be read here.

Warner Chilcott Announces Receipt of Paragraph IV Certification Notices

Warner Chilcott Limited announced today that one of the Company's subsidiaries and Hospira, Inc. have received Paragraph IV Certification Notices from Mutual Pharmaceutical Company, Inc. and Mylan Pharmaceuticals Inc. advising that each such company has filed an Abbreviated New Drug Application (ANDA) for generic versions of DORYX 100 and 75 mg delayed-release tablets.

The details can be read here.

Award of Takeda’s Attorney’s Fees in Takeda’s Patent Case on ACTOS Patent Case Upheld on Appeal

December 9, 2008: Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the U.S. Court of Appeals for the Federal Circuit affirmed Takeda’s award of attorneys’ fees against generic drug manufacturers, Mylan Inc. and Alphapharm Pty, Ltd., arising out of Takeda’s successful enforcement of its patent covering the active ingredient in ACTOS® (pioglitazone hydrochloride). Mylan Inc. must pay Takeda and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. (“TPNA”) $11.4 million plus interest, and Alphapharm Pty, Ltd. must pay $5.4 million plus interest.

Takeda and TPNA sued Mylan and Alphapharm for patent infringement as a result of their filing of Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market a generic version of Takeda’s ACTOS®. Mylan and Alphapharm challenged the validity and enforceability of U.S. Patent No. 4,687,777 which covers pioglitazone, the active ingredient in ACTOS®. The U.S. District Court for the Southern District of New York held that the Mylan and Alphapharm challenges to the ‘777 patent were not certified in good faith, as required by the Hatch-Waxman Act. The Court also found that both Mylan and Alphapharm had engaged in litigation misconduct. The Court awarded Takeda it’s the full amount of attorneys' fees claimed against both Mylan and Alphapharm. That decision was affirmed by the U.S. Court of Appeals for the Federal Circuit on December 8, 2008.

The whole case can be read here.

The district court opinion can be read here and the post on Orange Book Blog for the earlier district court decision can be read here.

The district court opinion on Attorney's fees can be read here.

Erbitux Supplemental Biologics License Application for Advanced Non-Small Cell Lung Cancer Submitted to U.S. Food and Drug Administration

Dec 8, 2008 - ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company announced that they have submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of ERBITUX (cetuximab) to include first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy (cisplatin/vinorelbine).

The details can be read here.

Amylin, Lilly Update on FDA Review of Byetta (exenatide) Injection Monotherapy Submission

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. FDA is continuing with its review of the regulatory application for use of BYETTA (exenatide) injection as stand-alone therapy in people with type 2 diabetes who are not achieving acceptable blood sugar control. It is likely that this review will not be complete by the end of 2008, and may extend into 2009.

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.

Eli Lilly and Company v. Sun Pharmaceutical Industries Ltd. et al.1:08-cv-01629; filed December 4, 2008 in the Southern District of Indiana

Purac Biochem B.V. v. Dudas1:08-cv-02067; filed December 1, 2008 in the District Court of the District of Columbia

Molecular Insight Pharmaceuticals, Inc. et al. v. Dudas1:08-cv-02065; filed December 1, 2008 in the District Court of the District of Columbia

Molecular Insight Pharmaceuticals, Inc. v. Dudas1:08-cv-02068; filed December 1, 2008 in the District Court of the District of Columbia

Solvay Pharmaceuticals GmbH v. Dudas1:08-cv-02053; filed December 1, 2008 in the District Court of the District of Columbia

Biogen Idec Inc. v. Dudas1:08-cv-02061; filed December 1, 2008 in the District Court of the District of Columbia

The details and complaints can be read here.

BioSante Pharmaceuticals Signs Elestrin Marketing Agreement with PharmaSwiss SA for Israel

Dec 8, 2008 - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it has signed an exclusive agreement with PharmaSwiss SA for the marketing of Elestrin (estradiol gel) in Israel. Elestrin is indicated in the U.S. for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. PharmaSwiss is responsible for regulatory and marketing activities in Israel. Financial terms of the agreement were not disclosed.

The details can be read here.

BioLife Solutions Granted European Biopreservation Patent

December 08, 2008 -- BioLife Solutions, Inc. , a leading developer and marketer of proprietary cGMP hypothermic storage and cryopreservation media products for cells, tissues, and organs, today announced that it has been granted a European patent for an application that includes claims related to protecting cells from injury and death caused by cold temperatures used in biopreservation.

The details can be read here.

Orion Sues Wockhardt USA, Inc. and Wockhardt Limited in the U.S. to Enforce Orion's U.S. Patents Covering its Proprietary Drug Stalevo

Dec. 8, 2008--Orion Corporation filed a patent infringement lawsuit in the United States to enforce U.S. Patent Nos. 5,135,950; 5,446,194; and 6,500,867 against Wockhardt USA, Inc. and Wockhardt Limited, who seek to market a generic version of Orion Corporation's proprietary drug, Stalevo® (specifically 12.5/200/50 mg strength of carbidopa/entacapone/levodopa) in the United States. Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease.

The details can be read here.

Unigene Announces Preliminary Injunction Entered in Patent Infringement Lawsuit

Dec 8, 2008 - Unigene Laboratories, Inc. announced today that Judge Robert P. Patterson, Jr. of the United States District Court for the Southern District of New York entered a preliminary injunction, consented to by defendants Apotex, Inc. and Apotex Corp., preliminarily enjoining them from engaging in the commercial manufacture, use, marketing, distribution, selling, transportation or importation of any Fortical® generic equivalent product in the United States. The preliminary injunction will remain in effect until the court renders a final decision on the validity and infringement of Unigene's U.S. Patent.

The details can be read here.

Impax and Medicis Settle Solodyn® Litigation

As per the post published on patentdocs, by Mr. Sherri Oslick,

Earlier this week, Impax Laboratories, Inc. and Medicis Pharmaceutical Corp. announced that they have entered a Joint Development Agreement and a Settlement and License Agreement that brings to an end their pending lawsuit over Impax's plans to manufacture a generic version of Medics' Solodyn............

The details can be read here.

Wockhardt receives US FDA nod for generic version of Augmentin

Wockhardt's Chicago-based subsidiary Morton Grove Pharmaceuticals has received US FDA approval for marketing an oral suspension of a combination containing 250mg/5ml of amoxicillin and 62.5mg/5ml of clavulanate potassium. This combination is used for treating several common infections, especially in children.

The details can be read here.

Orchid gets US FDA nod for divalproex sodium tabs

Orchid Chemicals & Pharmaceuticals Ltd has received approval from the US FDA for its Abbreviated New Drug Application for divalproex sodium delayed-release tablets USP, 125 mg, 250 mg & 500 mg.

Tesetaxel, a Leading Oral Taxane in Clinical Development, Receives FDA Designation as an Orphan Drug for Treatment of Patients with Advanced Melanoma

Dec 4, 2008 - Genta Incorporated announced today that the Company has received notice from the U.S. FDA that tesetaxel, the Company's oral taxane in clinical development, has been granted designation as an “Orphan Drug” for treatment of patients with advanced melanoma.

The details can be read here.

Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab)

Roche today announced that the U.S. FDA has provided further guidance on the requirements for the Biologics License Application for ACTEMRA (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

The details can be read here.

Oncoscience AG Withdraws its Application for Theraloc (nimotuzumab

Dec. 4, 2008-The European Medicines Agency has been formally notified by Oncoscience AG of its decision to withdraw its application for a centralised marketing authorisation for the medicine Theraloc (nimotuzumab), 5 mg/ml concentrate for solution for infusion.

The details can be read here.

Prezista (Darunavir) Receives Expanded Marketing Authorisation In The European Union for Treatment-Experienced Adults With HIV-1

3 December 2008 - Tibotec Pharmaceuticals, announced today that the European Commission adopted the decision to broaden the indication for PREZISTA (darunavir), a protease inhibitor, in combination with ritonavir and other antiretroviral medicinal products to the treatment of HIV-1 infection in all treatment-experienced adult patients.

The details can be read here.

European Commission Approval of New Indication for Roche's Pegasys (peginterferon alfa-2a) Offers Hepatitis C Patients a Second Chance for a Cure

4 December 2008 - Roche announced today that the European Commission has approved Pegasys (peginterferon alfa-2a [40 KD]) plus Copegus (ribavirin) for the retreatment of hepatitis C patients who were not successfully treated with an initial course of interferon alpha (pegylated or non-pegylated), either alone or in combination with ribavirin.

The details can be read here.

SYGNIS strengthens IP position in the treatment of acute stroke with AX200 in the US

December 4, 2008 – SYGNIS Pharma AG today announced that the USPTO published a Notice of Allowance for the patent application which protects the treatment of stroke patients with AX200 in the USA. SYGNIS exclusively licensed the respective global rights to this patent application.

The details can be read here.

Perrigo Settles Desloratadine Patent Litigation

The Perrigo Company announced today that all Hatch-Waxman litigation relating to Desloratadine tablets (5 mg) has been settled with Perrigo taking a license under all relevant patents. Perrigo had been sued for patent infringement of US Patent Nos. 6100274, 7214683 and 7214684 based upon its filing of an ANDA containing a Paragraph IV certification. Under the terms of the settlement, Perrigo can commercially launch its generic Desloratadine product on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or over-the-counter (OTC) product depending on its status at the time of launch. The Perrigo product is awaiting FDA approval.

The details can be read here.

Ranbaxy gets DCGI nod to market Gliadel Wafer in India

Ranbaxy Laboratories Limited has received import permission for marketing the US FDA approved product Gliadel (polifeprosan 20 with carmustine implant) Wafer for the treatment of newly diagnosed high-grade malignant gliomas & recurrent glioblastoma multiforme. Ranbaxy has signed an exclusive licensing agreement with BioPro Pharmaceutical, Inc, (BioPro) USA to promote and market Gliadel Wafer in India.

The details can be read here.

Oxarol receives Japanese nod to treat palmoplantar pustulosis

Maruho Co, Ltd and Chugai Pharmaceutical Co, Ltd has announced that the Ministry of Health, Labour and Welfare approved a new indication for Oxarol ointment 25mcg/g and Oxarol Lotion 25mcg/g, treatment drugs for keratosis including psoriasis vulgaris, for extended treatment of palmoplantar pustulosis.

The details can be read here.

Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for Community Acquired Pneumonia

Advanced Life Sciences Holdings, Inc. , today announced that the U.S. FDA has accepted and filed the Company's New Drug Application (NDA) for cethromycin, a novel once-a-day oral antibiotic, for the treatment of mild-to-moderate community acquired pneumonia. The FDA has established a goal of a standard 10-month review such that the anticipated target action date of the cethromycin NDA would be July 31, 2009.

The details can be read here.

Wyeth Submits European Marketing Authorization Application for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease

Wyeth Pharmaceuticals, a division of Wyeth , announced today that it has submitted a marketing authorization application to the European Medicines Agency for approval to market its investigational 13-valent pneumococcal conjugate vaccine (PCV13) for infants and young children. Wyeth is seeking an indication for the prevention of pneumococcal disease (PD) caused by the 13 serotypes included in the investigational vaccine in infants and children from two months to five years of age.

The details can be read here.

Alcon Announces Azarga Ophthalmic Suspension Approved for Treatment of Patients with Glaucoma or Ocular Hypertension in the European Union

Dec 2, 2008 - Alcon, Inc. announced today that the European Medicines Agency (EMEA) has approved Alcon's fixed combination eye drop, AZARGA (brinzolamide 10mg/ml+timolol 5mg/ml) ophthalmic suspension, for treatment of elevated intraocular pressure associated with open-angle glaucoma or ocular hypertension in adult patients for whom monotherapy provides insufficient IOP reduction.

The details can be read here.

CeloNova BioSciences Commercializes CATANIA Coronary Stent With NanoThin Polyzene-F in Europe and Middle East

CeloNova BioSciences, Inc., announced today that it has expanded the areas in which it is commercializing the CATANIA Coronary Stent System with NanoThin Polyzene(R)-F -- a stent system that has not had any stent thrombosis in clinical studies. It is CE Marked and available for purchase throughout Europe and now some Middle Eastern countries with aggressive world-wide expansion ongoing. Concurrently, CeloNova notes that it has received regulatory approval to increase the shelf life for the stent from two years to three years.

The details can be read here.

CytoDyn Awarded Global Patents For Modernizing The Treatment of Infectious Diseases

Dec 3, 2008 - CytoDyn, Inc. has rounded out its European patent portfolio with new patents in Ireland, France, Switzerland, Austria, Luxembourg, Netherlands, and Germany. The Company is also receiving new patents in Hong Kong and Canada.

The details can be read here.

Oscient Pharmaceuticals Receives Paragraph IV Certification Notice for ANTARA

Dec 3, 2008 - Oscient Pharmaceuticals Corporation today announced that the Company and its licensor, Ethypharm SA, have received notice of a Paragraph IV certification on behalf of Lupin Limited, advising of the submission of an Abbreviated New Drug Application with the U.S. FDA for ANTARA (fenofibrate) capsules, 130 and 43 mg doses.

The details can be read here.

Johnson & Johnson to acquire Mentor Corporation for $1.07 bn

Johnson & Johnson (J&J) and Mentor Corporation, a leading supplier of medical products for the global aesthetic market, signed a definitive agreement whereby Mentor will be acquired for approximately $1.07 billion in a cash tender offer.

The details can be read here.

U.S. FDA Grants Orphan Drug Designation for Burzynski Research Institute's Antineoplaston Treatment for Gliomas

Dec 2, 2008 - The Burzynski Research Institute, Inc. (BRI) today announced that its antineoplaston A10 and antineoplaston AS2-1 therapy (ANP) has been granted orphan drug designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of gliomas. It is estimated that in 2008 more than 21,000 men and women in the U.S. will be diagnosed with this type of cancer, with prevalence estimated at approximately 84,000 cases.

The details can be read here.

NanoVector to Commercialize First Biologic Nanoparticle Drug Delivery System

Dec 2, 2008 - NanoVector, Inc. announced today that it has licensed the plant virus nanoparticle drug delivery system developed by Professors' Stefan Franzen and Steven Lommel from North Carolina State University. “This is breakaway technology that will finally provide the highly sought after selective targeting of tumors and intracellular delivery of anti-cancer agents for improved efficacy and fewer unpleasant side effects,” said Albert Bender, Ph.D., NanoVector CEO.

The details can be read here.

ProtAb, a Wholly Owned Subsidiary of Hadasit Bio Holdings, Receives U.S. Patent for Proximab for the Treatment of RA and Type-1 Diabetes

Dec 2, 2008 - ProtAb Ltd., a wholly owned subsidiary of Hadasit Bio-Holdings (TASE:HDST), announced today the receipt of an allowance of a key patent underlying its technology, an antibody called Proximab. The patent covers its structure as well as its immune and therapeutic activity against rheumatoid arthritis and Type-1 diabetes. Proximab is the basis for what will be the company's flagship product. The company currently has a wide estate of patents registered in the United States, Australia, and European countries.

The details can be read here.

Medegen Prevails on Appeal in ICU Medical Inc. Patent Infringement Case

Dec 2, 2008 - Medegen, a leading innovator in infusion therapy medical products, announced today that it has won an important legal victory in the United States Court of Appeals for the Federal Circuit in Washington, D.C. The appellate court's decision reverses a judgment issued by a district court judge in the Central District of California of patent non-infringement entered in favor of ICU Medical Inc.

The details can be read here.

Genzyme's European Patent on Cross-Linked Gel Slurries Has Been Entirely Revoked by the EPO Board of Appeal

Dec 2, 2008 - Fidia Farmaceutici S.p.A. announces that the opposition they filed against European Patent EP 0466300 B1 to Genzyme Corporation has been entirely successful. Indeed, Genzyme's EP patent has been finally revoked in its entirety by the EPO Board of Appeal (decision T 0450/03 of 12 February 2008).

The details can be read here.

Mylan Announces Settlement Agreement with Novartis Related to Femara First- to-File Opportunity

Mylan Inc. today announced that, it has entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis' Femara(R).

The details can be read here.

Teva Introduces Rocuronium Bromide Injection

Dec, 1, 2008 – Teva Health Systems is pleased to announce the introduction and availability of Rocuronium Bromide Injection. This product is AP rated to Zemuron®* Injection. Rocuronium Bromide Injection is available in 10 mg/mL-50 mg and 10 mg/mL-100 mg, in multiple dose glass vials.

The details can be read here.

Last Call! FDA Issues Draft Guidance on Submission of Patent Information for Certain Old Antibiotics

As per the post published on FDA law blog.....

Late last week while those of us in the U.S. were still digesting our turkey dinners, FDA issued a draft guidance document describing the Agency’s current thinking on the implementation of § 4(b)(1) of the Q1 Program Supplemental Funding Act (Pub. Law No. 110-379) (“the Q1 Act”)........

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.

Eurand, Inc. et al. v. Mylan Pharmaceuticals, Inc. et al.1:08-cv-00210; filed November 26, 2008 in the Northern District of West Virginia

Eurand, Inc. et al. v. Mylan Pharmaceuticals, Inc. et al.1:08-cv-00889; filed November 25, 2008 in the District Court of Delaware

CIMA Labs Inc. et al. v. Novel Laboratories Inc.1:08-cv-00886; filed November 25, 2008 in the District Court of Delaware

Eli Lilly and Company v. Lupin Limited et al.1:08-cv-01596; filed November 24, 2008 in the Southern District of Indiana

Eli Lilly and Company v. Aurobindo Pharma Ltd. et al.1:08-cv-01595; filed November 24, 2008 in the Southern District of Indiana

The details and complaints filed by the applicant can be read here.

Ark files Cerepro Application for Marketing Authorisation with EMEA

1 December 2008 - Ark Therapeutics Group plc today announces that the Marketing Authorisation Application for Cerepro, Ark’s novel gene-based therapy for operable malignant glioma (brain cancer), has been filed with the European medicines regulatory agency (EMEA).

The details can be read here.

MedImmune Receives FDA Complete Response Letter on Motavizumab

Nov. 28, 2008-AstraZeneca today announced that MedImmune, its wholly owned biologics business, has received a Complete Response Letter (CRL) from the U.S. FDA asking for additional information on motavizumab.

The details can be read here.

Lilly Withdraws Application for Additional U.S. Indication for Cymbalta for Chronic Pain

Eli Lilly and Company has withdrawn its supplemental New Drug Application from the U.S. FDA for Cymbalta (duloxetine HCl) for the management of chronic pain. Lilly plans to resubmit the application in the first half of 2009, adding data from a recently completed positive study in chronic osteoarthritis pain of the knee.

The details can be read here.

FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream

Barr Pharmaceuticals, Inc. today announced that the U.S. FDA has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application for Synthetic Conjugated Estrogens-A (SCE-A) 0.625 mg/g Vaginal Cream. SCE-A Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause. It is administered intravaginally at a dose of 1 gram daily for one week, followed by 1 gram intravaginally twice a week.

The details can be read here.

European Commission Approves Erbitux for First-Line Use in Head and Neck Cancer

December 1, 2008 – Merck KGaA announced today that it has received approval from the European Commission to extend the use of its targeted therapy Erbitux (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Erbitux was previously approved for use in combination with radiotherapy for locally advanced disease.

The details can be read here.

DOR Receives $1.5M from Sigma-Tau for Exclusive Negotiation of orBec Alliance

DOR BioPharma, Inc announced today that it has received $1.5 million under a letter of intent with Sigma-Tau Pharmaceuticals, Inc, which grants Sigma-Tau an exclusive right to negotiate terms and conditions for a possible business transaction or strategic alliance regarding orBec (oral beclomethasone dipropionate or oral BDP) and potentially other DOR pipeline compounds until March 1, 2009.

The details can be read here.

Bradmer Issued Patent in Europe for Use of Neuradiab to Treat Lymphoma

Bradmer Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, announced today that it has been granted European Patent, # 1351713, entitled "Anti-Tenascin Monoclonal Antibody Therapy For Lymphoma."

The details can be read here.

Mylan Confirms First-to-File Patent Challenge Relating to AMRIX

Mylan Inc. today confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Cephalon Inc., Eurand Inc. and Anesta AG in connection with the filing of an Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX(R) Capsules.

The details can be read here.

Biovail Announces Filing of ANDA for Quetiapine XR Tablets

Dec 1, 2008 - Biovail Corporation today announced that the USFDA has accepted the Company's abbreviated new drug application for a generic formulation of 200mg, 300mg and 400mg strengths of quetiapine fumarate extended-release tablets. This represents Biovail's third successful ANDA filing in 2008.

The details can be read here.

Actavis Receives Approval of Generic Wellbutrin XL 150mg in the U.S.

Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (XL) 150mg. Distribution of the product has commenced.

The details can be read here.

Also IMPAX and WATSON has received approval from USFDA to market Wellbutrin XL 150mg.