FDA

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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Report: U.S. medical innovation at risk without funding

Thursday, October 6, 2011 12:03 PM

U.S. venture capitalists are decreasing their investments in biopharmaceutical and medical device companies, reducing their concentration in prevalent disease areas and shifting investment away from the United States towards Europe and Asia, according to a report by the National Venture Capital Association'sMedIC Coalition.

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Boston Scientific begins patient enrollment for OMEGA trial

Thursday, October 6, 2011 10:32 AM

Boston Scientific has started patient enrollment in the OMEGA clinical trial, designed to evaluate the safety and effectiveness of the company's OMEGA platinum chromium bare-metal coronary stent system in treating patients with a single coronary artery lesion.  This prospective, single-arm trial will enroll 328 patients at 40 sites in the U.S. and Europe.  The first patient was enrolled this week by Andrejs Erglis, M.D., OMEGA principal investigator, at Paul Stradins Clinical University Hospital in Riga, Latvia.  The trial's coordinating principal investigators are John Wang, M.D., of Union Memorial Hospital in Baltimore, Maryland, and Christian Hamm, M.D., of the Kerckhoff Heart and Thorax Center in Bad Nauheim, Germany.

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PointCross awarded IDIQ contract by FDA

Monday, October 3, 2011 11:26 AM

PointCross Life Sciences has been awarded an Indefinite Delivery Indefinite Quantity (IDIQ) contract by the FDA to provide an integrated off-the-shelf software environment comprising of a hosting repository, visualization and analysis functions, and search and discovery capabilities.  This environment will enable FDA pharmacologists / toxicologist reviewers and statisticians to access, manipulate, and analyze nonclinical regulatory submissions in electronic formats including the CDISC Standard for the Exchange of Nonclinical Data (SEND).  The software will also facilitate search and discovery across multiple studies for signal identification and validation of toxicity findings in order to better support science-based regulatory decision making.

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Survey: Mid-tier CROs shut out of post-marketing

Monday, October 3, 2011 08:02 AM

Large CROs garner 57% of the post-marketing studies currently being outsourced, while another 25% of that work is awarded to the few firms that specialize in safety. The remaining 19%? That’s scattered among numerous mid-sized CROs.

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FDA approves REMICADER for pediatric UC

Tuesday, September 27, 2011 12:02 PM

FDA has approved Janssen Biotech’s REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.  This marks the 16th approval of REMICADER in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC.  It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease.  An estimated 150,000 children under age 17 are living with symptoms of IBD.

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