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J&JPRD receives FDA Complete Response Letter for ceftobiprole

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA) was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.

30 Dec 2009

Liraglutide FDA feedback expected within weeks, says Novo Nordisk

Novo Nordisk today announced that formal feedback from the United States Food and Drug Administration (FDA) regarding liraglutide, a once-daily human GLP-1 analogue, is expected within weeks.

30 Dec 2009

VIVUS submits a NDA to the FDA for obesity drug Qnexa

VIVUS, Inc., a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

30 Dec 2009

Aeolus Pharmaceuticals reports financial results for three months and twelve months ended September 30, 2009

Aeolus Pharmaceuticals, Inc. announced today financial results for the three months and twelve months ended September 30, 2009. The Company reported a net loss of $746,000, or $0.02 per share, for the three months ended September 30, 2009 compared to a loss of $1,055,000, or $0.03 per share, for the three months ended September 30, 2008.

28 Dec 2009

FDA issues Pfizer a Complete Response letter for Lyrica GAD monotherapy treatment

Pfizer Inc. announced today that the Food and Drug Administration (FDA) issued a Complete Response letter regarding the company’s New Drug Application (NDA) for Lyrica® (pregabalin) capsules CV as a monotherapy treatment for generalized anxiety disorder (GAD). The FDA determined that the data contained in the NDA were insufficient to support approval.

24 Dec 2009

Merck discontinues MK-1903 niacin receptor agonist development program with Arena Pharmaceuticals

Arena Pharmaceuticals, Inc. announced today Merck and Co., Inc.'s decision (through an affiliate) to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis being developed under its research collaboration with Arena. Merck also informed Arena that the company will not continue the collaboration.

24 Dec 2009

ARCA biopharma submits Gencaro trial protocol for review under the FDA’s SPA process

ARCA biopharma, Inc. today announced that it has submitted a study protocol for review under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of GencaroTM, in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. Gencaro is the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator.

23 Dec 2009

Arena Pharmaceuticals submits lorcaserin NDA to the FDA

Arena Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The submission is based on an extensive data package from lorcaserin's clinical development program that includes 18 clinical trials totaling 8,576 patients.

22 Dec 2009

Matrix Laboratories receives FDA tentative approval for Efavirenz NDA under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. These innovative pediatric dosages in tablet form were developed by Matrix for use in treating pediatric HIV/AIDS.

22 Dec 2009

Schering and MSP Singapore sue Mylan over generic Vytorin ANDA

Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Schering Corporation and MSP Singapore Company in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. This product is the generic version of Vytorin® Tablets, a cholesterol treatment.

22 Dec 2009

Cell Therapeutics supports Code on Interactions with Healthcare Professionals

Cell Therapeutics, Inc. announced today its support of the Pharmaceutical Research Manufacturers of America's (PhRMA) "Code on Interactions with Healthcare Professionals, revised July 2008" (PhRMA Code). Adherence to the Code is voluntary for commercial biotechnology and pharmaceutical companies.

22 Dec 2009

ZEGERID OTC approval triggers $20M milestone payment to Santarus

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has received the $20 million milestone payment previously announced on December 1, 2009 relating to the approval of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its over-the-counter (OTC) licensing agreement with Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co., Inc. Schering-Plough and Merck merged on November 3, 2009.

22 Dec 2009

MAA for naproxcinod submitted to EMEA through centralized procedure

NicOx S.A. today announced that a Marketing Authorization Application (MAA) for naproxcinod has been submitted to the European Medicines Agency (EMEA) through the centralized procedure, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA).

22 Dec 2009

FDA extends action date for its review of Cephalon's sNDA for NUVIGIL Tablets

Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the action date to March 29, 2010, for its review of the supplemental New Drug Application (sNDA) for NUVIGIL® (armodafinil) Tablets [C-IV].

22 Dec 2009

CombinatoRx and Neuromed Pharmaceuticals complete merger agreement

CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc. announced today that they have merged. This merger brings together the product assets and financial resources of both organizations, including potential Exalgo™ milestone and royalty revenue, CombinatoRx’s portfolio of product candidates and unique drug discovery capabilities.

21 Dec 2009

CSC completes a Series B financing round

California Stem Cell, Inc. (CSC), a leading stem cell company, announced that it has completed a Series B financing round with private investors. The financing will enable the company to support the advancement of its therapeutic products to human clinical trials, as well as the generation and distribution of its tools to aid in stem cell research and drug discovery.

21 Dec 2009

Neurocrine to advance its NBI-98854 VMAT2 Inhibitor into a multiple repeated dose Phase 1 study

Neurocrine Biosciences, Inc. today announced their highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, NBI-98854, will be advanced in clinical development.

21 Dec 2009

EMEA grants orphan drug designation for pixantrone in Europe

Cell Therapeutics, Inc. ("CTI") announced today that the European Medicines Agency (EMEA) has granted pixantrone orphan drug designation for the treatment of DLBCL which accounts for about 80% of aggressive non-Hodgkin's lymphoma.

21 Dec 2009

Vion Pharmaceuticals files for bankruptcy

VION PHARMACEUTICALS, INC., a pharmaceutical company focused on the development of novel cancer therapeutics, announced that it had voluntarily filed for bankruptcy under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware.

18 Dec 2009

ISTA Pharmaceuticals files sNDA for bromfenac ophthalmic solution

ISTA Pharmaceuticals, Inc., today announced the Company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery.

18 Dec 2009