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After losing FDA battle, ReGen files for bankruptcy

A Hackensack-based medical device maker has filed for Chapter 11 bankruptcy protection, succumbing to financial pressure after the federal government yanked approvals for its flagship product. ReGen Biologics Inc., which filed reorganization April 8 in a federal court in Delaware, listed $5.2 million in debt, but only $1.5 million in assets. May 11 Top Selling [...]

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FDA’s fast track medical device approval system under fire

The FDA is falling short in how it handles recalls of risky medical devices, a new report from the Government Accountability Office concluded, adding to the ever-mounting criticisms of the agency’s fast-track, 510(k) approval process. The FDA doesn’t keep track of the reasons devices such as hip implants are recalled, and it doesn’t always follow [...]

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Optimer drug gets 6-month FDA review

Jan. 24, 2011: SAN DIEGO (AP) — Optimer Pharmaceuticals Inc. said Monday the Food and Drug Administration will give the company’s potential bacterial infection drug Fidaxomicin priority review. Under priority review, the FDA aims to review a potential drug within 6 months instead of the usual 10-month period. Optimer expects an FDA decision by May [...]

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Clinical Data gets FDA OK for depression drug

Jan. 25, 2011: NEWTON, Mass. Biotechnology company Clinical Data Inc. said Monday the Food and Drug Administration approved the major depressive disorder treatment Viibryd. Clinical Data shares surged more than 40 percent in pre-market trading. The Newton, Mass, company said the drug should be available in U.S. pharmacies in the second quarter. Clinical Data holds [...]

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FDA Panel to Vote on Risk of AEDs

Jan. 25, 2011: WASHINGTON — Injuries and deaths from malfunctioning automated external defibrillators (AEDs) could have been avoided if the devices were approved through a more stringent review process, FDA staff reviewers said. On Tuesday, an agency advisory committee will vote on whether AEDs, now in the high-risk Class III device category, should be moved [...]

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BioSante gets orphan status for skin cancer vaccine

Jan 25 (Reuters) – BioSante Pharmaceuticals Inc (BPAX.O) said its vaccine to treat skin cancer received orphan drug designation from U.S. health regulators, sending its shares up about 10 percent in pre-market trade. The orphan drug designation for the melanoma cancer vaccine is the specialty pharmaceutical company’s fourth orphan drug designation for its portfolio of cancer [...]

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Teva Receives FDA Action Letter For Generic Lovenox®

Jan. 25, 2011: JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s abbreviated new drug application (ANDA) for generic Lovenox® (enoxaparin sodium) injection. The receipt of this action letter, called a Minor Deficiency letter, indicates that the FDA has [...]

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Federal Government to Assist Pharmaceutical Developments

Jan. 25, 2011: National Institutes of Health has approved Obama’s decision to assist with funding for drug research and development through a Federal Research Center. The Obama administration has decided to go forward with a decision to develop a drug development center. The announcement, initially made in December 2010, revealed that the administration was considering such [...]

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Angiotech Pharmaceuticals Inc., unable to regain compliance with NASDAQ listing standards, is delisted from the exchange

Angiotech Pharmaceuticals Inc., unable to regain compliance with NASDAQ listing standards, is delisted from the exchange Jan. 26, 2011: Angiotech Pharmaceuticals Inc.’s (OTC:ANPI) shares are no longer traded on NASDAQ as of today. The Vancouver-based company failed to regain compliance with the stock exchange’s listing rules within a 180-day period that ended Jan. 3. NASDAQ [...]

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Category : News

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