FDA

TOPICA secures $27 million in Series B funding

Tuesday, October 18, 2011 01:52 PM

TOPICA Pharmaceuticals has raised $27 million in a Series B financing, led by Third Rock Ventures and existing investors Prospect Venture Partners and Yasuda Enterprise Development. Proceeds of the financing will be used to advance the company's broad-spectrum topical antifungal agent, luliconazole, for the treatment of onychomycosis, fungal infections of the nail.

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VIVUS resubmits NDA for Qnexa

Monday, October 17, 2011 11:37 AM

VIVUS has resubmitted the New Drug Application (NDA) for Qnexa to the FDA. The resubmission follows an agreement reached in September 2011 with officials of the endocrine and metabolic division of the FDA on the filing strategy for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients or overweight patients with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling for Qnexa includes a contraindication for women of childbearing potential.  The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).

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Pearl IRB expands into compliance and consulting

Monday, October 17, 2011 08:00 AM

Indianapolis-based Pearl IRB is expanding. The commercial institutional review board, launched just last year, is now adding a regulatory and compliance division, as well as a consulting division that will focus on helping life sciences startups.

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Anavex names executive director

Wednesday, October 12, 2011 11:52 AM

Anavex Life Sciences has named Dr. George Tidmarsh executive director. 

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FDA approves Fluoxetine 60mg tablets

Tuesday, October 11, 2011 12:55 PM

Edgemont Pharmaceuticals has reported that the FDA has approved its New Drug Application (NDA) for Fluoxetine tablets 60 mg.

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FDA approves Combivent Respimat for COPD

Tuesday, October 11, 2011 12:11 PM

Boehringer Ingelheim Pharmaceuticals has reported that the FDA has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler (COMBIVENT MDI). COMBIVENT RESPIMAT will be available for patients in mid-2012.

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Massachusetts leads U.S. in biotech R&D jobs

Monday, October 10, 2011 08:00 AM

Though it may be small, the state of Massachusetts continues to lead the U.S. in biotechnology research and development jobs, with 26,807 such positions. And companies in the state garnered almost a quarter of all venture capital flowing into the sector nationally, an all-time high share for Massachusetts. And the pace of employment growth in the overall biopharma industry is second only to much larger California.

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FDA approves Cialis for treatment of BPH

Friday, October 7, 2011 12:01 PM

The FDA has approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction, when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.

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US Army to host pharma industry day for potential contractors

Thursday, October 6, 2011 02:33 PM

The United States Army will be hosting an industry day in the Hyatt hotel in Newport RI, on October 14, 2011. The purpose of the industry day is to inform pharmaceutical contractors about the BSCAV/Nerve Agent prophylactic contract is to select, develop, and manufacture an FDA-approved drug/biologic to increase survival and decrease incapacitation such that forces can maintain operational effectiveness within acontaminated area following nerve agent exposure, irrespective of nerve agent type. The BSCAV project is indented to provide medical countermeasures against the effects of organophosphorous nerve agent chemical warfare threats. The proponent for this effort is The Medical Identification and Treatment Systems (MITS) Joint Product management office of The Chemical Biological Medical Systems (CBMS) Joint Project management office of the Joint Program executive office for chemical and biological defense (JPEO-CBD).

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FDA commissioner outlines steps to spur biomedical innovation

Thursday, October 6, 2011 12:18 PM

FDA Commissioner Margaret A. Hamburg, M.D., has released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans.

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