FDA

Insufficient advisory board members due to conflict-of-interest rules

Wednesday, July 27, 2011 01:19 PM

Conflict-of-interest rules restricting scientists with financial ties to drug and device- makers from advising U.S. regulators may loosen next year, said FDA Commissioner Margaret Hamburg, according to Bloomberg News.

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FDA, EMA reviewing Sanofi’s Multaq

Monday, July 25, 2011 01:54 PM

U.S. drug regulators are reviewing data from a halted clinical trial of Sanofi's key heart drug Multaq to determine how it may affect patients taking it for approved indications, according to Reuters.

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FDA approves XEOMINR

Friday, July 22, 2011 10:19 AM

Merz Aesthetics said the FDA has approved XEOMINR (incobotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows, in adult patients.

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Editors: FDA medical-device approval studies flawed

Friday, July 22, 2011 10:10 AM

Studies concluding U.S. reviews of medical devices lag behind those in Europe and drive up costs for makers are flawed, according to editors of three medical journals, Bloomberg News reported.

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Venture capital funding for biotech soars 46%

Wednesday, July 20, 2011 01:52 PM

Venture capital funding in biotechnology companies jumped 46% in the second quarter, as investors looked to replenish their portfolios after an increase in acquisitions and initial public offerings, according to Bloomberg News.

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Medical Device Consultants names senior regulatory consultant

Wednesday, July 20, 2011 11:55 AM

Medical Device Consultants has named Brian Edwards senior regulatory staff consultant of its regulatory services group. He will be based in Minneapolis, Minn., where he will support clients with U.S. FDA and international medical device submissions.

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Aeterna Zentaris to present phase II AEZS-108 results

Wednesday, July 20, 2011 11:25 AM

Aeterna Zentaris will present the final phase II  results in endometrial cancer on its anticancer compound, AEZS-108, during a poster session at the upcoming 17th International Meeting of the European Society of Gynaecological  Oncology ("ESGO"), Sept. 11-14 in Milan, Italy.

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QRxPharma files NDA for MoxDuoR IR

Wednesday, July 20, 2011 11:16 AM

QRxPharma reported the initiation of the New Drug Application (NDA) approval process for MoxDuo IR with the FDA.

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FDA approves LialdaR

Wednesday, July 20, 2011 11:13 AM

Shire, a global biopharmaceutical company, reported the FDA approved LialdaR (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult patients. This approval follows the previous indication of Lialda approved by the FDA in 2007 for the induction of remission in patients with active, mild-to-moderate ulcerative colitis.

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Upsher-Smith launches phase III epilepsy study

Wednesday, July 20, 2011 11:08 AM

Upsher-Smith Laboratories initiated a phase III clinical trial to evaluate the safety and efficacy of USL261, an investigational intranasal midazolam, for the rescue treatment of seizures in patients on stable anti-epileptic drug (AED) regimens who require control of intermittent bouts of increased seizure activity, frequently referred to as seizure clusters. USL261 has been granted Orphan Drug designation for this use by the FDA.

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