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Biogen Idec first quarter revenues increase 9% to $1.2 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing and commercialization of innovative therapies, today announced its first quarter 2011 results.

21 Apr 2011

Watson Laboratories seeks FDA approval to market Colesevelam HCI tablets

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Colesevelam HCI 625 mg tablets.

21 Apr 2011

Neuralstem signs MoU with BaYi Brain Hospital for ischemic stroke program in China

Neuralstem, Inc. (NYSE Amex: CUR) announced it has signed a Memorandum of Understanding with BaYi Brain Hospital in Beijing, China.

21 Apr 2011

Forest Labs fourth quarter net sales increase 9.7% to $1,091.9 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that reported earnings per share equaled $1.12 in the fourth quarter of fiscal 2011.

19 Apr 2011

FDA approves Taro's Imiquimod Cream ANDA

Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Imiquimod Cream, 5%.

19 Apr 2011

Amylin reports total revenue of $152.7 million for quarter ended March 31, 2011

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended March 31, 2011.

18 Apr 2011

Eli Lilly receives FDA complete response letter for liprotamase NDA

Eli Lilly and Company has received a complete response letter from the U.S. Food and Drug Administration for its New Drug Application for liprotamase, a non-porcine pancreatic enzyme replacement therapy, under investigation for the treatment of exocrine pancreatic insufficiency.

16 Apr 2011

U.S. District Court grants preliminary injunction to POZEN's Treximet patent lawsuit

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, announced today that the U.S. District Court for the Eastern District of Texas has granted a preliminary injunction ordering Par Pharmaceutical Inc. not to make, use, sell, offer to sell, or import into the United States a generic version of sumatriptan/naproxen sodium that competes with Treximet sold by GlaxoSmithKline in the United States under an exclusive license from the Company.

15 Apr 2011

Cytonet initiates clinical trial using liver cell infusion to treat urea cycle disorders in children

International biotechnology firm Cytonet recently launched the first ever clinical trial in the United States using an investigational liver cell infusion to treat urea cycle disorders (UCD) in children. The first patient in the Phase II trial, which will seek to enroll 20 patients in 12 medical centers, is a child with citrullinemia, which is a hereditary UCD. He received six liver cell infusions on six consecutive days at Yale School of Medicine in New Haven, Conn.

15 Apr 2011

QRxPharma receives new U.S. Patent for MoxDuo IR in treatment of acute pain

QRxPharma Limited announced today that the United States Patent and Trademark Office issued the Company a new patent, U.S. Patent #7,923,453, which expires in 2029. This patent covers a proprietary dosing algorithm for converting patients from intravenous opioid administration to orally administered MoxDuo IR, thereby more effectively and safely managing acute pain following surgery.

15 Apr 2011

FDA accepts Teva's NDA filing of Bio-T-Gel for male hypogonadism

BioSante Pharmaceuticals, Inc. today announced that a New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA) following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd.. The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.

15 Apr 2011

FDA panel votes in favour of Sunitib (Sutent) for pancreatic tumors

Pfizer Inc. announced this Tuesday that its oral multi-kinase inhibitor Sutent was determined as having a favorable benefit-risk profile by an oncology advisory committee of the FDA for the treatment of unresectable pancreatic neuroendocrine tumors. The panel voted 8-2 in favor of Sutent – generically called Sunitib malate.

12 Apr 2011

Investigational drug effective for patients with obesity

An investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial, according to researchers at Duke University Medical Center.

11 Apr 2011

FDA grants tentative approval for Hi-Tech Pharmacal's generic Combigan ANDA

Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted tentative approval for the Company's Abbreviated New Drug Application, (ANDA) for brimonidine tartrate with timolol maleate ophthalmic solution, the generic for Allergan's Combigan® ophthalmic solution which had sales of $108 million for the 12 months ended December 2010 according to IMS sales data.

8 Apr 2011

Watson confirms patent challenge by Alcon for generic Vigamox

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Moxifloxacin Hydrochloride Ophthalmic Solution USP, 0.5%. Watson's Moxifloxacin Hydrochloride Ophthalmic Solution USP, 0.5% is a generic version of Alcon, Inc.'s Vigamox®, an antibiotic solution that is indicated for the treatment of bacterial conjunctivitis.

8 Apr 2011

FDA accepts Antares Pharma's Anturol NDA for filing, assigns PDUFA date

Antares Pharma, Inc. today announced the New Drug Application (NDA) for Anturol® Gel in patients with overactive bladder (OAB) was accepted for filing for review by the U.S. Food and Drug Administration (FDA). Anturol is an oxybutynin gel incorporating Antares' ATD Gel technology.

8 Apr 2011

MAP Pharma publishes LEVADEX Phase 3 FREEDOM-301 study data in 'Headache' journal

MAP Pharmaceuticals, Inc. today announced the publication of results from the Phase 3 FREEDOM-301 study of LEVADEX orally inhaled migraine drug in the peer-reviewed journal 'Headache.'

7 Apr 2011

Optimer, Cubist sign deal to market DIFICID for CDI treatment in the U.S.

Optimer Pharmaceuticals, Inc. and Cubist Pharmaceuticals, Inc. today announced the signing of an exclusive two-year co-promotion agreement to market DIFICID, in the United States.

6 Apr 2011

Shire files lawsuit against Watson over ADDERALL XR patent infringement

Shire plc, announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the Southern District of New York against Watson Pharmaceuticals, Inc. and its subsidiaries Watson Laboratories, Inc.-Florida, Watson Pharma, Inc., Andrx Corporation, and Andrx Pharmaceuticals, L.L.C. for infringement of Shire's U.S. Reissue Patent No. RE 41,148, U.S. Reissue Patent No. RE 42,096 and U.S. Patent No. 6,913,768 and also for breach of contract.

6 Apr 2011

Merck enters definitive agreement to acquire Inspire

Merck, known as MSD outside the United States and Canada, and Inspire Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which Merck will acquire Inspire, a specialty pharmaceutical company focused on developing and commercializing ophthalmic products.

6 Apr 2011