Glenmark scrip plunges on suspension of pain drug trials

Glenmark Pharmaceuticals on Friday said the clinical trials for its experimental pain treatment molecule has been suspended, following which its scrips plunged 20 per cent on the bourse.

The details can be read here.
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GSK to acquire Laclede's dry mouth brand Biotene for $170 mn

GlaxoSmithKline (GSK) Consumer Healthcare announced that it has reached an agreement with Laclede, a privately held company, to purchase the leading Dry Mouth brand Biotene for $170 million. The transaction is subject to regulatory review by competition authorities in the United States and Europe, and is expected to complete by early 2009.

The details can be read here.

Lilly, Amylin enter into supply agreement for exenatide

Amylin Pharmaceuticals, Inc and Eli Lilly and Company have entered into a product supply agreement for exenatide once weekly, a development compound that, if approved, would become the first once weekly therapy to treat type-2 diabetes.

The details can be read here.

Marketing Authorization Application for Lipsovir submitted to European regulatory authorities

Oct. 23, 2008-Medivir has now submitted an application for marketing authorization to the European regulatory authorities for Lipsovir®, a topical product for prevention and treatment of cold sores.
Lipsovir® is a patented combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral agent) in a proprietary cream base developed by Medivir.

The details can be read here.

Teva Introduces Fentanyl Transdermal System, CII

October 23, 2008 – Teva Pharmaceuticals is pleased to announce the FDA approval of Fentanyl Transdermal System, CII, 25 mcg, 50 mcg, 75 mcg and 100 mcg. This product is AB rated and bioequivalent to Duragesic®* Transdermal System. Fentanyl Transdermal System is available in cartons containing 5 patches each.

The details can be read here.

New data shows liraglutide is more effective than exenatide in treatment of type-2 diabetes

Canadian Diabetes Association and Canadian Society of Endocrinology and Metabolism Professional Conference and Annual Meetings, physicians will get a first-time look at more detailed results from a phase-3b clinical study Liraglutide Effect and Action in Diabetes (LEAD) 6 comparing the investigational new drug liraglutide to exenatide. The study showed that liraglutide, a human GLP-1 analog administered once daily was significantly more effective at improving blood glucose control (as measured by HbA1c) than exenatide, a GLP-1 mimetic administered twice daily.

The details can be read here.

Valeant Pharma, GSK close worldwide pact for retigabine

Valeant Pharmaceuticals International announced that it has closed on its exclusive worldwide collaboration agreement with GlaxoSmithKline (GSK) for the investigational drug retigabine, a first-in-class neuronal potassium channel opener for the treatment of adult epilepsy patients with refractory partial onset seizures. Under the terms of the agreement, Valeant received an upfront payment of $125 million from GSK.

NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN)

NeurogesX, Inc. , a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its investigational product candidate, NGX-4010, for the management of pain due to postherpetic neuralgia (PHN). NeurogesX anticipates that the application, which is subject to acceptance by the FDA, will be subject to a standard review with a Prescription Drug User Fee Act (PDUFA) date in the second half of 2009.

The details can be read here.

Antigenics Submits Oncophage Application for European Approval

Oct. 22, 2008 - Antigenics Inc. today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) requesting approval for Oncophage(R) in earlier-stage, localized renal cell carcinoma (kidney cancer) under the conditional authorization provision. Currently, there are no EMEA-approved drug therapies for this patient population.

The details can be read here.

U.S. FDA Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1

The FDA has granted PREZISTA (darunavir) tablets, a protease inhibitor, approval for an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naive adults (those who have never taken HIV medication before). The FDA also granted traditional (full) approval to PREZISTA as twice-daily for use in treatment-experienced adult patients.

The details can be read here.

FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia

October 22, 2008 -- Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new premixed formulation of Vaprisol: Vaprisol(R) (conivaptan hydrochloride injection) Premixed in 5% Dextrose. Discovered and developed by Astellas, Vaprisol, an arginine vasopressin (AVP) receptor antagonist, is the first and only approved drug indicated for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients.

The details can be read here.

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

Mylan Inc. today confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis' Lescol(R) Capsules.

The details can be read here.

Mylan Receives Tentative FDA Approval for First-to-File Generic Version of Blood Pressure Drug Benicar HCT

October 22, 2008 -- Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg.

The details can be read here.

US FDA seeks approval for setting up offices in India for better monitoring of exports

The US Food and Drug Administration (FDA) has sent a proposal to India to set up its first liaison office in Delhi for better coordination with the regulatory authorities and the industry on ensuring safety of food and medicinal products being exported from here.

The details can be read here.

Eisai of Japan setting up manufacturing, R&D facilities at Vizag, to be operational by March 2011

Eisai Co of Japan is entering India by setting up a manufacturing and R&D base at Vizag in south India. The company is setting up a pharmaceutical manufacturing plant for producing API and drug and formulation research facility.

The details can be read here.

FDA Approves Orphan Drug Status for Revolutionary Cancer Drug for Children

The Cure Our Children Foundation, a nonprofit charitable foundation dedicated to children, announced today that the U.S. Food and Drug Administration (FDA) has approved the Orphan Drug Designation of the foundation's unique drug product for children with Ewing's Sarcoma cancer. The efforts to develop this drug were made possible by the generous volunteers and researchers in private industry and at two universities.

The details can be read here.

Abbott Receives Complete Response Letter From FDA for Controlled-Release Hydrocodone With Acetaminophen

Abbott has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for a controlled-release form of hydrocodone with acetaminophen. Abbott is evaluating the FDA Complete Response Letter, will discuss the letter with the FDA, and will provide an update when appropriate.

The details can be read here.

AstraZeneca Announces European Seroquel XR Submission for the Treatment of Generalised Anxiety Disorder

Oct. 21, 2008- AstraZeneca today announced its submission of SEROQUEL XR (quetiapine fumarate extended release tablets) to European regulatory authorities seeking approval for both short-term and maintenance treatment of Generalised Anxiety Disorder (GAD). This is the first time approval has been sought in Europe for an atypical antipsychotic medicine for the treatment of GAD.

The details can be read here.

Pharmaxis Aridol Approved for Sale in Switzerland

Pharmaceutical company Pharmaxis today announced that it had received approval to market Aridol from the Swiss therapeutic regulatory agency Swissmedic.

The details can be read here.

Basilea's Toctino (alitretinoin) Receives Marketing Authorization in France

October 21, 2008 - Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the French Health Products Safety Agency....

The details can be read here.

ImmunoCellular Therapeutics Granted Patents Covering Its Lead Monoclonal Antibody Cancer Product Candidate

Oct 21, 2008 - ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) (IMUC), a biotechnology company, announced the issuance of two separate U.S. patents relating to the company's monoclonal antibody therapeutics. Patents No. 7,435,415 and No. 7,435,554 are both entitled "Monoclonal Antibodies and Cell Surface Antigens for the Detection and Treatment of Small Cell Lung Cancer (SCLC)."

The details can be read here.

Key Fondaparinux Patent Allowed by U.S. Patent Office

Oct 21, 2008 - Australian drug developer Alchemia Limited (ASX:ACL) today announced it had received a 'notice of allowance' for the United States patent application titled Synthetic Heparin Pentasaccharides (number 10/488,677). A notice of allowance is a notification to the patent applicant that they are entitled to a patent under the law and is issued for applications that have been filed based on "intent to use." The patent number will be assigned on payment of the grant fees.

The details can be read here.

Teva Announces FDA Approval and Commercial Launch of Fentanyl Transdermal System

Oct 20, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic pain treatment Duragesic(R). Shipment of this product has commenced.

The details can be read here.

Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Release Capsules

Cephalon, Inc. and Eurand NV today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. FDA by Mylan Pharmaceuticals, Inc., requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX(R) (Cyclobenzaprine Hydrochloride Extended-Release Capsules).

The details can be read here.

Barr Confirms Patent Challenge of Opana ER Extended-Release Tablets, 5 mg, 10 mg, 20 mg and 40 mg

Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Endo Pharmaceuticals Inc. in connection with its Opana(R) ER (oxymorphone hydrochloride) extended-release tablets, 5 mg, 10 mg, 20 mg and 40 mg.

The details can be read here.

US FDA approves Eisai's Ontak sBLA for cutaneous T-cell lymphoma

Eisai Corporation of North America announced that the US Food and Drug Administration (FDA) has approved an efficacy supplemental biologics license application (sBLA) for Ontak (denileukin diftitox) solution for intravenous injection for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor (CD25+). A separate efficacy supplement that included data from patients with CTCL whose malignant cells did not test positive for the CD25 component of the IL-2 receptor received a complete response letter.

The details can be read here.

AstraZeneca and Pozen Informed of FDA Internal Review of Gastric Ulcers as a Primary Endpoint in Trials

Oct. 17, 2008-AstraZeneca and POZEN Inc., co-development partner for the investigational compound PN 400, have announced today that the U.S. Food and Drug Administration (FDA) has informed POZEN that it is conducting an internal review on the acceptability of endoscopic gastric ulcers as a primary endpoint in clinical studies. The FDA has not indicated when their internal review will be completed, although an FDA internal meeting has been scheduled to review this subject during the first quarter of 2009.

The details can be read here.

FDA Advisory Panel to Discuss Genzyme's Myozyme BLA on Tuesday

Oct 17, 2008 - Genzyme Corporation (Nasdaq: GENZ) today announced that its U.S. Biologic License Application (BLA) for Myozyme(R) (alglucosidase alfa) produced at the 2000 L bioreactor scale will be discussed this Tuesday, October 21st, at a public meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in Silver Spring, Maryland. This product is intended for the treatment of Pompe disease, a progressive, debilitating and life-threatening inherited disorder affecting approximately 2,000 people in the United States. The meeting will focus on the clinical outcomes of the Late Onset Treatment Study (LOTS), including statistical analyses of the study results, safety and the indication for alglucosidase alfa.

The details can be read here.

FDA Approves Astepro

Oct 17, 2008The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray. The active substance in these products is azelastine - the leading nasal antihistamine in the treatment of rhinitis in the U.S.

The details can be read here.

POZEN Confirms ANDA Filing for Treximet Tablets

Oct 17, 2008 - POZEN Inc. (NASDAQ: POZN), today announced that POZEN and GlaxoSmithKline (GSK), the holder of the New Drug Application for Treximet, received a letter from Par Pharmaceutical, Inc. (Par) notifying POZEN and GSK that Par submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market sumatriptan 85 mg/naproxen sodium 500 mg tablets, a generic version of the drug sold by GSK under the trade name, Treximet. Par's letter advised POZEN and GSK that it intended to market a generic version of Treximet tablets before the expiration of U.S. Patent Nos. 6,060,499, 6,586,458 and 7,332,183.

The details can be read here.

Acura, King Pharma announce positive topline results of Acurox tabs

Acura Pharmaceuticals, Inc and King Pharmaceuticals, Inc announced top-line results from Study AP-ADF-111 (Study 111) entitled 'A phase-II, Single-Center, Randomized, Double-Blind, Assessment of the Abuse Liability of Acurox (oxycodone HCl and niacin) tablets in subjects with a History of Opioid Abuse'.

The details can be read here.

Orchid gets US FDA nod for three Cefuroxime Inj ANDAs

The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals, has received approvals from the US FDA for three of its ANDAs (Abbreviated New Drug Application) for Cefuroxime for Injection, 750 mg & 1.5 g vials (infusion packs), 7.5 g (pharmacy bulk pack) and 1.5 g vial. Cumulatively, Orchid has secured 28 ANDA approvals.

Biocon consolidated net dips by 54% in Q2 due to M&M

Biocon, a leading biopharmaceuticals major from Bangalore, has suffered setback during the second quarter ended September 2008 and its consolidated net profit after exceptional items declined sharply by 53.6 per cent to Rs 25.02 crore from Rs 53.95 crore in the corresponding period of last year.

The details can be read here.

DCGI okays Ranbaxy's anti-malarial for phase-III

Ranbaxy Laboratories Limited (Ranbaxy) announced today that the company has obtained approval from the Drug Controller General of India (DCGI) to initiate phase-III human clinical trials in India for its new Anti-Malaria combination molecule, RBx 11160 (Arterolane maleate and piperaquine phosphate). The clinical trial will be conducted on patients from India, Africa and South and South-East Asian countries.

The details can be read here.

Wockhardt gets US FDA nod for ceftazidime injectable

The Mumbai based Wockhardt has received US FDA approval to market ceftazidime injections containing 1 gm/vial, the generic version of GlaxoSmithKline's Fortaz. Ceftazidime is used for treating various kinds of infections. Wockhardt is expected to launch the product in the US market shortly.

The details can be read here.

A New Oral Contraceptive Providing The Same Estrogen Produced By The Female Body

October 16, 2008 - Bayer Schering Pharma AG has successfully completed the decentralized drug approval procedure in Europe for its new oral contraceptive Qlaira® (dienogest/estradiol valerate). Qlaira® is an oral contraceptive whose estrogen component is based on estradiol, the same estrogen that is produced by the female body. For the first time, the use of estradiol in oral contraceptives is made possible with Qlaira® through the combination of estradiol with the progestin dienogest in a unique dosing regimen. With Qlaira®, Bayer Schering Pharma offers women a new choice of estrogen and establishes a new class of oral contraceptives.

The details can be read here.

InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF

InterMune, Inc. today reported that on October 16, 2008, 2008, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved the New Drug Application (J-NDA) submitted by Shionogi & Co. Ltd. to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in Japan. Pirfenidone was developed in Japan for the treatment of IPF by Shionogi, which has rights to pirfenidone in Japan, Taiwan and South Korea.

The details can be read here.

Abraxis BioScience and Specialised Therapeutics Australia Announce Approval to Market ABRAXANE for Metastatic Breast Cancer in Australia

Oct. 16, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Australia Pty Ltd, today announced that approval has been received from the Therapeutic Goods Administration (TGA) in Australia to market ABRAXANE(R) (nanoparticle albumin-bound paclitaxel) 100 mg powder for injection (suspension) for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol(R) in the approved indication. With this approval, ABRAXANE is now cleared for marketing in 36 countries.

The details can be read here.

Barr Says Court of Appeals Upholds 2005 District Court Decision on 1997 Cipro Settlement

Barr Pharmaceuticals, Inc. today announced that the U.S. Court of Appeals for the Federal Circuit has upheld the 2005 decision of the U.S. District Court for the Eastern District of New York, which rejected a challenge to the lawfulness of a 1997 patent litigation settlement between its wholly owned subsidiary, Barr Laboratories, Inc., and Bayer Corporation related to the antibiotic Cipro(R).

The details can be read here.

The whole judgement can be read here.

Roxane Laboratories, Inc. Announces the Launch of Calcium Acetate Capsules, 667mg

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Calcium Acetate Capsules, 667mg by the U.S. Food and Drug Administration. The product is available in bottles of 200 capsules for immediate shipment to wholesalers and pharmacies nationwide.

The details can be read here.

King Pharma extends tender offer for shares of Class A common stock of Alpharma

King Pharmaceuticals, Inc announced that it is extending its previously announced tender offer for all outstanding shares of Class A Common Stock of Alpharma Inc until 5:00 pm, New York City time, on November 21, 2008, unless the offer is further extended. The tender offer was originally scheduled to expire at 5:00 pm, New York City time, on Friday, October 10, 2008. All other terms and conditions of the tender offer remain unchanged.

The details can be read here.

FDA Grants Orphan Drug Status to Reata's RTA 402 for Treatment of Pancreatic Cancer

Oct 15, 2008 - Reata Pharmaceuticals, Inc. announces that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease.

The details can be read here.

Wyeth Europa Ltd Withdraws Its Marketing Authorisation Application for Ellefore

Oct. 15, 2008-The European Medicines Agency (EMEA) has been formally notified by Wyeth Europa Ltd of its decision to withdraw the application for a centralised marketing authorisation for the medicine Ellefore (desvenlafaxine) 50 mg, 100 mg and 200 mg prolonged-release tablets.

The details can be read here.

ZIOPHARM Receives Orphan Medicinal Product Designation for Palifosfamide (ZIO-201) in the Treatment of Soft Tissue Sarcoma

Oct 15, 2008 - ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today that the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion regarding ZIOPHARM's application for orphan medicinal product designation for palifosfamide in the treatment of soft tissue sarcoma (STS).

The details can be read here.

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets

ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

The details can be read here.

Inspire Announces Issuance of Patent for Elestat

Oct 15, 2008 - Inspire Pharmaceuticals, Inc. announced today that the U.S. Patent and Trademark Office has issued a method of treatment patent related to Elestat(R) (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis. This patent, U.S. Patent No. 7,429,602, entitled "Treating Conjunctivitis by Administering an Epinastine Solution to the Conjunctiva," was issued to Boehringer Ingelheim International GmbH, the developer of the invention, and expires on November 29, 2020.

The details can be read here.

neuMirRx Corp. Obtains Rights to Novel Drug Formulation Technology

Oct 15, 2008 - neuMirRx Corp today welcomed the issuance of U.S. patent 7,345,093, entitled "Methods for Enhancing Solubility of Compounds" which covers novel formulation methods to enhance the solubility of hydrophobic compounds. The rights to this patent and related proprietary technology, the neuNanoParticle(TM), have been obtained by neuMirRx Corp through an exclusive license arrangement with Formatech, Inc. of Andover, Massachusetts.

The details can be read here.

Cypress Pharmaceutical, Inc. Receives FDA Approval of Cetirizine Hydrochloride Oral Solution

Oct 15, 2008 - Cypress Pharmaceutical, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the company's abbreviated new drug application (ANDA) for the prescription and over-the-counter versions of Cetirizine Hydrochloride Oral Solution, 1 mg/1 mL.

The details can be read here.

Merck launches HPV vaccine Gardasil in India

MSD Pharmaceuticals (India), the local affiliate of Merck & Co, has launched Gardasil (quadrivalent human papillomavirus recombinant vaccine), as India's first vaccine to help prevent cervical cancer.The vaccine, first launched globally in 2006 and approved in more than 100 countries worldwide, is touted to be the only vaccine that helps protect against 4 types (type 6,11,16,18) of HPV.
The details can be read here.

Jubilant's consolidated net loss at Rs 62.72 cr in Q2

Jubilant Organosys, a Rs 2489 crore pharmaceutical and chemical giant, has suffered heavy setback during the second quarter ended September 2008 on account of unrealised exchange loss of Rs 174 crore and lower other income. ....

The whole story can be read here.

Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008

Arpida Ltd. today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee will discuss the New Drug Application (NDA) for intravenous iclaprim in complicated Skin and Skin Structure Infections (cSSSI) during its meeting on 18-20 November 2008. An Advisory Committee can be requested by FDA as part of the review process of an NDA or supplemental NDA.

The details can be read here.

Omrix Biopharmaceuticals Receives Approval from European Medicines Agency for Evicel Liquid Fibrin Sealant (Human)

Oct 14, 2008 - OMRIX Biopharmaceuticals, Inc., a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received approval from the European Medicines Agency (EMEA) for Evicel, the Company's liquid fibrin sealant.

The details can be read here.

Dr. Reddy's Wholly-Owned Subsidiary Promius Pharma Launches EpiCeram Skin Barrier Emulsion

Oct 14, 2008 - Promius Pharma, LLC, a wholly owned subsidiary of Dr. Reddy's Laboratories (NYSE:RDY) announced the launch of its first product, EpiCeram(R) Skin Barrier Emulsion. EpiCeram(R) Emulsion is a novel prescription therapy for the treatment of atopic dermatitis, a skin disease that affects more than 15 million patients in the United States.

The details can be read here.

Biosimilar Monoclonal Antibodies in Oncology Will Approach Blockbuster Status by 2017

October 14, 2008 -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the rapid uptake of biosimilar monoclonal antibodies (MAbs) in oncology will drive robust sales of drugs within this class. The most notable near-term biosimilar targets for MAbs in oncology are Genentech/Roche's Herceptin and Rituxan/MabThera.

The details can be read here.

Orexigen Therapeutics Announces Receipt of Notice of Allowance for Its Fourth U.S. Patent on Contrave

Orexigen(R) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for what the Company refers to as the "Weber/Cowley methods patent" (U.S. patent application no.11/356,839) which provides coverage for Contrave(R), the Company's lead obesity product candidate now in Phase 3 clinical trials.

The details can be read here.

Tianyin Pharmaceutical Co., Inc. to Launch Azithromycin Dispersible Tablets

October 14, 2008 -- Tianyin Pharmaceutical, Co., Inc. , a manufacturer and supplier of modernized traditional Chinese medicine ("TCM") based in Chengdu, China, today announced that it launched the production of Azithromycin Dispersible Tablets in August 2008 and is due to market the new product in October 2008.

The details can be read here.

Ranbaxy seeks DCGI nod for phase 1 trial of respiratory inflammation drug

Ranbaxy Laboratories Limited has submitted an Investigational New Drug (IND) application to the Drug Controller General of India for permission to initiate phase-I human clinical trials. The IND application is for the respiratory inflammation candidate that the joint GSK-Ranbaxy steering committee had identified earlier last year.

The details can be read here.

Wanbury launches Nitrofur to enter Nitrofurantoin market

Wanbury Ltd, one of the fastest growing pharma companies in the domestic market, has launched its New Drug Delivery System (NDDS) product Nitrofur SR (Nitrofurantoin-100mg, sustained release) targeted at Urinary Tract Infections (UTI), for the first time in India. Wanbury is the third company in India to have entered the unexplored market of Nitrofurantoin.

The details can be read here.

Piramal receives DCGI nod for phase-I trial of new cancer molecule

Piramal Life Sciences Limited, part of the Piramal Group of companies, has received regulatory approval for the initiation of a phase-I study in India by Drug Controller General of India (DCGI) of a new cancer compound, P-1446A-05.

The details can be read here.

NeoBiocon & Abraxis launch breast cancer drug Abraxane in UAE

NeoBiocon and Abraxis BioScience, Inc have introduced Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in the UAE for the treatment of breast cancer. The drug is recommended for those patients who have failed after combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

The details can be read here.

Aurobindo gets US FDA nod for risperidone tablets

Aurobindo Pharma, engaged in manufacture of generic pharmaceuticals and active pharmaceutical ingredients with consolidated net sales of Rs 2,435 crore in 2007-08, has received US FDA approval to manufacture and market risperidone tablets 0.25mg, 0.5mg, 1mg, 2 mg, 3mg and 4mg. This is Aurobindo's 81st ANDA approval from the US FDA.

Ranbaxy seeks DCGI nod for phase 1 trial of respiratory inflammation drug

Ranbaxy Laboratories Limited has submitted an Investigational New Drug (IND) application to the Drug Controller General of India for permission to initiate phase-I human clinical trials. The IND application is for the respiratory inflammation candidate that the joint GSK-Ranbaxy steering committee had identified earlier last year.

The details can be read here.

Arbor Pharmaceuticals Launches Neotic – A New Prescription Treatment for the Painful Symptoms of Common Middle Ear Infections

Arbor Pharmaceuticals announced today that the company’s second prescription product, NEOTIC™, has been launched in the U.S. and is now available for the treatment of pain and inflammation associated with middle ear infections (also called Acute Otitis Media, or AOM). Acute otitis media represents the second most common infection among children in the US and the number one reason antibiotics are prescribed by U.S. pediatricians.

The details can be read here.

Biodel Receives Notice of Allowance for Insulin Patent Claims in Europe

Oct 13, 2008 - Biodel Inc. announced today that it has received a notice of allowance from the European Patent Office for patent claims covering compositions and uses of formulations of insulin for Biodel's two lead product candidates, VIAject(TM) and VIAtab(TM), in the treatment of diabetes. After their publication and once they are issued, the patent claims will have a term of 20 years from the international filing date of March 11, 2005.

The details can be read here.

Akorn, Inc. Enters into a Commercial Manufacturing Supply Agreement

Oct 13, 2008 - Akorn, Inc., a specialty pharmaceutical company and an undisclosed ophthalmic company have entered into a five year supply agreement for an ophthalmic product. Akorn is the ANDA holder of the product.

The details can be read here.

Heritage Introduces Propranolol Tablets

Heritage Pharmaceuticals Inc. announced the immediate availability of Propranolol HCl Oral Tablets in 10, 20, 40, 60 and 80 mg strength. Heritage's development and manufacturing partner, Ipca Laboratories Ltd., received final approval of its Abbreviated New Drug Application (ANDA) for an AB Rated equivalent of Inderal(R) on June 2, 2008.

The details can be read here.

Data shows potential of imatinib in pulmonary artery disease treatment

An early proof-of-concept study presented shows promising results for imatinib in the treatment of pulmonary arterial hypertension (PAH), a severe, incurable blood vessel disorder.

The details can be read here.

FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes

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 not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

The details can be read here.

FDA Approves Bayer HealthCare's Kogenate FS Treatment for Routine Prophylaxis in Children with Hemophilia A

October 10, 2008 /PRNewswire/ -- Bayer HealthCare LLC announced today that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate(R) FS Antihemophilic Factor (Recombinant) to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage.

The details can be read here.

FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment

October 09, 2008, Patients with schizophrenia now have a new administration option for RISPERDAL(R) CONSTA(R) ([risperidone] Long-Acting Injection). The U.S. Food and Drug Administration (FDA) has approved a new injection site, the deltoid muscle in the arm, for RISPERDAL CONSTA for the treatment of patients with schizophrenia. RISPERDAL CONSTA was previously approved as a gluteal injection only.

The details can be read here.

FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US

Oct. 10, 2008--AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex. SEROQUEL XR is the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder.

The details can be read here.

Teva sues Astrazeneca over Crestor

Teva, the generic maker, is suing AstraZeneca, the holder of the original Crestor patent, claiming that AZ is somehow infringing on rights (US RE39502) Teva acquired to the drug back in March 2007.

The whole story can be read here.
The complaint can be read here.

EpiCept Receives Ceplene Marketing Approval in Europe

Oct 9, 2008 - Regulatory News: EpiCept Corporation today announced that the European Commission has granted a full marketing authorization in the form of a positive Commission Decision, for Ceplene(R) (histamine dihydrochloride) for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission.

The details can be read here.

Watson Receives US FDA Approval for Rapaflo (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)

Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the U.S. FDA has approved RAPAFLO (silodosin), the company's new alpha blocker for the treatment of the signs and symptoms of BPH.

The details can be read here.

Osmotica Pharmaceutical Corp and Upstate Pharma, LLC, a subsidiary of UCB, Inc., Announce the Availability of Venlafaxine Extended-Release Tablets

Oct 9, 2008 - Osmotica Pharmaceutical Corp. is announcing that Venlafaxine Extended-Release Tablets, 37.5 mg, 75 mg, 150 mg, and 225 mg, which was approved by the U.S. Food and Drug Administration in May, is now commercially available through its marketing partner, Upstate Pharma, LLC, a subsidiary of UCB, Inc. Shipments of the product to wholesalers and other commercial outlets began September 30, 2008 and promotion of the product will commence later in the month.

The details can be read here.

ImmunoCellular Therapeutics Announces Filing of Patent Application for a Novel Cancer Stem Cell Vaccine Technology

Oct. 9, 2008 - ImmunoCellular Therapeutics, Ltd., a biotechnology company, announced the filing of a provisional U.S. patent application relating to its novel vaccine technology targeting cancer stem cells. The vaccine technology is exclusively licensed from Cedars-Sinai Medical Center.

The details can be read here.

Ranbaxy upbeat as US Dept of Justice withdraws motion

Pharmaceutical major Ranbaxy Labortaories today said it remained confident that its products were safe and effective as the US Department of Justice (DoJ) withdrew a legal motion against it that charged fraudlent practice.

"Ranbaxy remains confident that its pharmaceutical products are safe and effective and remains committed to cooperatively working with all regulatory and legislative authorities," a company spokesperson said reacting to the news of the US DoJ withdrawing its motion filed at the District Court of Maryland.

The details can be read here.

Lilly to acquire ImClone Systems for $6.5 billion

Eli Lilly and Company and ImClone Systems Inc announced that the boards of directors of both companies have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion.

The details can be read here.

Strides' oral dosage facility at Bangalore gets US FDA nod

Strides Arcolab has received US FDA approval for its oral dosage forms manufacturing site in Bangalore (KRS Gardens) for manufacturing oral products for the US markets.

The whole story can be read here.

Phase-III study of Avastin-Tarceva combo for lung cancer fails to meet primary endpoint

Genentech, Inc and OSI Pharmaceuticals, Inc announced that a randomized phase-III study (BeTa Lung) evaluating Avastin (bevacizumab) in combination with Tarceva (erlotinib) in patients with advanced non-small cell lung cancer (NSCLC) whose disease had progressed following platinum-based chemotherapy did not meet its primary endpoint of improving overall survival compared to Tarceva in combination with placebo.
The details can be read here.

OPKO acquires worldwide ophthalmic rights to Teva's Budesonide

OPKO Health, Inc announced that it has acquired exclusive worldwide rights from Teva Pharmaceuticals Industries Ltd (TEVA) to Teva's proprietary formulation of budesonide for the treatment of various inflammatory and allergic conditions of the eye.

The details can be read here.

Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5%

Oct. 8, 2008 - Akorn, Inc. today announced the FDA approval of NDA 22-221 for Akten(TM) Ophthalmic Gel 3.5%, a topical, ocular anesthetic formulation. The NDA was filed June 29, 2007 following the results from a randomized, placebo controlled, Phase III clinical trial in 209 subjects who met the primary endpoint in all three dosing arms (p less than 0.001). Akten(TM) is the first NDA ocular anesthetic approved by the FDA in four decades, and will be launched in October 2008.
The details can be read here.

Circassia Acquires North American and Japanese Rights to Dopexamine

Circassia Ltd, a specialty biopharmaceutical company focused on the fields of allergy and critical care, announced today that it has acquired the US, Canadian and Japanese development and commercialization rights to dopexamine from the international speciality pharmaceutical company Ipsen.

The details can be read here.

Intellect Neurosciences, Inc. Grants to Top Tier Global Pharmaceutical Company an Option to License Certain Alzheimer's Patents and Patent Application

Intellect Neurosciences, Inc., a biopharmaceutical company focused on development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease (AD), announced today that it has entered into an Option Agreement with a top-tier global pharmaceutical company regarding the right to purchase a license to certain of Intellect's patents and patent applications related to antibodies and methods of treatment for Alzheimer's disease.
The details can be read here.

Lannett Receives Patent Approval for Method of Manufacturing Certain Morphine Derivatives

Oct 8, 2008 - Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that its wholly owned subsidiary, Cody Laboratories, a manufacturer/supplier of bulk active pharmaceutical ingredients (API), has received approval from the USPTO for its patent (US 7,399,859 B1) regarding a method for the preparation of Hydromorphone and Hydrocodone.

The details can be read here.

FDCs from analgesics, orthopaedics categories lead list to be withdrawn from market

The fixed dose combinations in the categories of analgesics and orthopaedics lead the list of FDCs to be withdrawn from the market following the agreement between the industry and the DCGI over the vexed issue, according to the minutes of the first meeting released recently.

The largest number of number of combinations to be banned or discontinued from the market had aspirin as a component, followed by paracetamol, according to the minutes of the meeting held on July 14, but belatedly released in the second meeting held on October 1.

The details of the Banned and absurd FDC's can be read here.

deCODE files IND for Alzheimer's & other cognitive disorders

deCODE genetics announced the filing of an investigational new drug (IND) application for DG071, the company's novel small-molecule modulator of phosphodiesterase 4 (PDE4), with the US Food and Drug Administration (FDA). The compound is being developed as a new and potentially safer means of targeting PDE4 to combat memory loss and cognitive deficits associated with Alzheimer's disease and other disorders in which neural signalling is reduced or impaired.
The details can be read here.

MedWatch - Tiotropium (Spiriva): updated information on risk of stroke and reports of cardiovascular adverse outcomes

Oct. 7, 2008-FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease.

The details can be read here.

Orion comments on new ANDA by Sun Pharma Global, Inc. for generic entacapone in the United States

Oct. 7, 2008-Orion Corporation has been informed that Sun Pharma Global, Inc. has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market a generic version of entacapone (200 mg tablets) in the United States. Entacapone is the active ingredient in Comtan®, a product originated by Orion Corporation for Parkinson's disease and marketed in the United States by its exclusive licensee, Novartis.

The details can be read here.

Daiichi Sankyo Propharma to close Osaka plant

Daiichi Sankyo Company, Limited and its subsidiary Daiichi Sankyo Propharma Co, Ltd (hereafter DSPP) have announced the closure of the Osaka plant of DSPP. The Boards of directors of Daiichi Sankyo and DSPP each reached the decision at the meetings held recently.

The whole story can be read here.

SC appoints Dr P C Chakraborti as technical member to IPAB in Glivec case

The Supreme Court has appointed Dr P C Chakraborti as a new technical member to the Intellectual Property Appellate Board (IPAB) to consider the Novartis appeal against the rejection of the Glivec beta patent by the Indian Patent Office.

The details can be read here.

Eli Lilly, Jubilant to set up JV for new drug discovery

Jubilant Organosys and Eli Lilly and Company have entered into an agreement to form an equally-owned joint venture in India that will focus on providing drug development services exclusively to Jubilant- and Lilly-partnered molecules.

The details can be read here.

ATryn (antithrombin alfa) BLA Filing Accepted by FDA

OVATION Pharmaceuticals, Inc. announced today that the U.S. FDA has accepted for review the Biologics License Application (BLA) for ATryn (antithrombin alfa). OVATION acquired the exclusive U.S. license to ATryn in August from GTC Biotherapeutics.........

The details can be read here.

Oral Cancer Drug Revlimid Receives Marketing Authorization from Health Canada for Treatment of Multiple Myeloma

Celgene International SArl announced that its oral cancer drug REVLIMID (lenalidomide) has received marketing authorization approval from Health Canada for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

The details can be read here.

Sirion Therapeutics Launches Durezol for Postoperative Ocular Inflammation and Pain

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% is now commercially available. Durezol, which was approved by the U.S. Food and Drug Administration in June 2008, is a topical ophthalmic corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery.

The details can be read here.

Ariad Announces Favorable Ruling Permitting Immediate Appeal of District Court Findings on NF-(kappa)B Patent in Amgen Litigation

ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced that the U.S. District Court for the District of Delaware granted ARIAD's motion to permit an immediate appeal of the Court's summary judgment ruling of non-infringement by Amgen's drug, Enbrel(R) (etanercept), of seven claims of U.S. Patent No. 6,410,516 (the '516 patent). The Court also cancelled the trial scheduled for November 2008 and administratively closed the case at this time.

The details can be read here.

Impax Laboratories Inc. vs. Aventis Pharmaceuticals Inc. (Riluzole)

October 3, 2008, In an appeal from a District Court's remand decision holding ’940 patent does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the ’814 patent, the Federal Circuit affirmed the District Court's finding
the ’940 patent is not an enabling prior art reference and that it does not anticipate claims 1-5 of the ’814 patent.

The whole judgement can be read here.

Other links related to this post are as follows:
http://www.patentdocs.net/patent_docs/2006/12/impax_laborator.html
http://www.orangebookblog.com/2006/12/federal_circuit.html

A breif history of the case.

Impax Laboratories, Inc. (Impax) filed an ANDA with the FDA pursuant to 21 U.S.C. 355(j) seeking approval to market generic riluzole tablets on May 16, 2001. On June 25, 2002, Impax sued Aventis in the district of Delaware for a declaratory judgment that Impax did not infringe, induce infringement of, or contribute to the infringement of the ’814 patent. In its suit, Impax alleged that the ’814 patent was invalid and unenforceable.

After a bench trial, the district court determined that Impax did not prove that the ’814 patent was unenforceable due to inequitable conduct nor show that claims 1-5 were anticipated by prior art. Impax Labs., Inc. v. Aventis Pharms. Inc., 333 F. Supp. 2d 265 (D. Del. 2004). On March 16, 2005, the court entered final judgment against Impax.

Impax appealed that decision. This court affirmed-in-part, vacated-in-part, and remanded to the district court. Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1384 (Fed. Cir. 2006). On remand, the trial court examined the asserted prior art, the ’940 patent, for evidence that it enables the use of riluzole to treat ALS and thus qualifies as enabling prior art. Impax Labs., Inc. v. Aventis Pharms. Inc., 496 F. Supp. 2d 428, 433 (D. Del. 2007).

In the event that it qualifies as enabling prior art, the trial court also received the opportunity to determine if the disclosure anticipates claims 1-5 of the ’814 patent. Addressing those questions, the district court determined that the ’940 patent does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the ’814 patent. Id. Impax timely appealed the district court’s remand decision to this court.

Advanced Life, Wyeth sign pact for Cethromycin in Asia Pacific region

Advanced Life Sciences Holdings, Inc and Wyeth Pharmaceuticals, a division of Wyeth have signed a development and commercialization agreement for cethromycin in the Asia Pacific region excluding Japan.

The details can be read here.

Bayer's rivaroxaban gets marketing approval in Europe

The European Commission has granted marketing approval for Xarelto (rivaroxaban), a novel anticoagulant taken as one tablet, once-daily, for the prevention of venous blood clots in adult patients undergoing elective (planned) hip or knee replacement surgery.

The details can be read here.

Cell Therapeutics Submits Supplemental Biologics License Application for Zevalin Use in First-Line Consolidation Therapy

Cell Therapeutics, Inc. today announced that it has submitted a supplemental Biologics License Application with the U.S. FDA for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma.

The details can be read here.

Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings

Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge).

The details can be read here.

New Drug Application (NDA) for Lipsovir submitted to US FDA

Medivir has today submitted an NDA to the US FDA for Lipsovir, a topical product for prevention and treatment of cold sores.

Lipsovir is a patented combination of hydrocortisone (an anti-inflammatory agent) and aciclovir (an antiviral agent) in a proprietary cream base developed by Medivir.

The details can be read here.

AMT Intends to Incorporate Additional Data to its Marketing Authorization Dossier for Glybera

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today that it intends to incorporate additional data into the Marketing Authorization Application (MAA) for Glybera(R) for Lipoprotein Lipase Deficiency (LPLD), a seriously debilitating and potentially lethal disease.

The details can be read here.

USFDA Approved the use of REYATAZ Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients

Bristol-Myers Squibb Company announced today that the USFDA approved the use of REYATAZ (atazanavir sulfate) 300 mg once-daily boosted with ritonavir 100 mg as part of combination therapy in previously untreated (treatment-naive) HIV-1 infected patients.

The details can be read here.

Arriva Pharmaceuticals Granted Protein Production Patent

Arriva Pharmaceuticals, a biopharmaceutical company focused on developing anti-inflammatory therapies, announced today that it had been granted a patent in the U.S. for methods to produce certain proteins in yeast. Among the proteins whose production is covered by the patent (United States Patent 7,419,801) is recombinant alpha 1-antitrypsin (rAAT), the protein used in Respriva™, the company’s lead product.

The details can be read here.

Milestone Scientific Acquires Additional Patent Rights for Painless Injections and Resolves Related Litigations

Milestone Scientific Inc., the recognized leader in advanced injection technologies, today announced that it has acquired additional patent rights with respect to painless anesthetic injections -- specifically rights related to controlling the flow rate or pressures used in providing these injections -- through issuance of 260,000 shares of restricted common stock.

The details can be read here.

Clopidogrel: Court rules in favor of Acino

The Acino Group has won yet another favorable court ruling in the legal proceedings regarding clopidogrel (original product: Plavix® / Iscover® by Sanofi-Aventis / Bristol-Myers Squibb).

The details can be read here.

Bioniche Pharma Receives FDA Approval for 10 mg/mL Strength of Ketamine Hydrochloride Injection, USP

Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, announced today the U.S. Food and Drug Administration's approval of its 10 mg/mL strength of Ketamine Hydrochloride Injection, USP, the generic equivalent of JHP Pharmaceuticals' Ketalar(R)CIII.

The details can be read here.

Watson Notified of OXYTROL Patent Challenge

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed the receipt of a Paragraph IV Certification Notice Letter relating to an ANDA submitted to the USFDA by a generic filer requesting approval to market and sell a generic version of OYXTROL (Oxybutynin Transdermal System). In its Notice Letter, the filer alleges that patents covering OXYTROL are invalid, unenforceable and/or will not be infringed by their manufacture, use or sale of the product described in its ANDA.

The details can be read here.

Court affirms Amgen EPO patents, blocks Roche drug

A U.S. court on Thursday affirmed a jury verdict upholding Amgen Inc patents on its blockbuster anemia drugs, effectively blocking Roche Holding AG from selling a rival drug in the United States, Amgen said.

The details can be read here.

New data shows better efficacy of eslicarbazepine acetate for epilepsy

Sepracor Inc announced that positive data from three phase-III studies presented at the 8th European Congress of Epileptology in Berlin, demonstrated that eslicarbazepine acetate, a novel once-daily anti-epileptic agent, significantly reduced the frequency of partial seizures in patients with refractory partial epilepsy, in combination with other anti-epileptic agents.

The details can be read here.

Once-yearly Aclasta approved in EU to treat osteoporosis in men

The European Commission has approved once-yearly Aclasta (zoledronic acid 5 mg) for the treatment of osteoporosis in men who are at increased risk of fractures, and broadened the Aclasta label to include reduction of new clinical fractures in both men and postmenopausal women with osteoporosis who have recently suffered a hip fracture.

The details can be read here.

PharmAthene gets $84 mn NIAID contract for anthrax vaccine programme

PharmAthene, Inc, a biodefense company developing medical countermeasures against biological and chemical threats, announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a multi-year contract for up to $83.9 million for advanced development of a third generation recombinant protective antigen (rPA) anthrax vaccine.

The details can be read here.

Baxter's Antimicrobial IV Technology Now Shown to Kill Six Common Pathogens, Including MRSA and VRE

Baxter Healthcare Corporation today announced that it received 510(k) clearance for expanded labeling for the first antimicrobial needleless intravenous (IV) connector, V-Link Luer-activated device (LAD) with VitalShield protective coating. With a new federal policy restricting reimbursement for healthcare-associated infections (HAIs) taking effect on October 1, healthcare professionals are seeking effective techniques and technologies to reduce the risk of contamination from a broad array of pathogens (infection-causing agents) within their hospitals.

The details can be read here.

FDA Grants Lilly's Alimta (Pemetrexed for Injection) Third U.S. Approval

Eli Lilly and Company (NYSE:LLY) announced today it received approval from the U.S. Food and Drug Administration for the use of ALIMTA (pemetrexed for injection), in combination with cisplatin, in the first-line treatment of locally-advanced and metastatic non-small cell lung cancer (NSCLC), for patients with nonsquamous histology. ALIMTA is not indicated for treatment of patients with squamous cell non-small cell lung cancer. NSCLC is the most common form of lung cancer, resulting in more than 180,000 new cases in the U.S. each year.

The details can be read here.