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Oct. 1, 2012

Vol. 9 No. 192

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PhRMA Asks Supreme Court to Reverse 3rd Circuit’s ‘Rogue’ Anti-Pay-for-Delay Decision

PhRMA is asking the Supreme Court to take up and overturn the 3rd Circuit Court’s decision that reverse patent settlements between generics and branded drug makers violate antitrust law. Read More

British Drugmaker Cited for cGMP, Misbranding Violations

British drugmaker A Nelson has been cited in an FDA warning letter after an inspection found glass fragments in a batch of the company’s Clikpak drug vials. Read More

Bedford Broadens Recall of Chemotherapy Drug

Ben Venue subsidiary Bedford Laboratories is expanding its voluntary recall of chemotherapy drug leucovorin calcium due to crystalline particulates in a small number of vials. Read More

Bayshore Announces FDA Approval of First ANDA

Bayshore Pharmaceuticals has announced that the FDA has granted final approval for their ANDA for Methscopolamine Bromide tablets (2.5 & 5 mg tablets). Read More

Aurobindo Gets FDA Nod for Provigil Generic

Aurobindo Pharma has received approval from the FDA to manufacture and market modafinil tablets of 100 mg and 200 mg. Read More

Possible Cure for Dementia Found by Taiwan Researchers

A southern Taiwan-based National Cheng Kung University research team has discovered that rapamycin, a drug that acts as an autophagy activator, is a possible treatment to alleviating frontotemporal lobar degeneration, one of the main causes of dementia for which there currently is no effective treatment. Read More

Boehringer Completes Phase III Studies of Nintedanib

Boehringer Ingelheim Pharmaceuticals has completed clinical trial enrollment of two Phase III studies evaluating the safety and efficacy of nintedanib (BIBF 1120). Read More

NovaBay Pharmaceuticals Receives $2.6 Million From Partner Galderma

NovaBay Pharmaceuticals, a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with first-in-class compounds such as its proprietary Aganocides, today announced that it has received $2.6 million from partner Galderma S.A., a global leading pharmaceutical company exclusively focused on dermatology. Read More

UCSD-based Cancer Consortium Receives 5-Year Grant Renewal

An international consortium of scientists studying chronic lymphocytic leukemia, based at the University of California, San Diego School of Medicine, has been awarded a five-year, $20 million grant by the National Cancer Institute, part of the National Institutes of Health. Read More