A.P. Pharma: Side Effect Issue With Competitive Drug Is A Huge Positive

By Andrew McDonald:AP Pharma (APPA.PK) intends to resubmit the New Drug Application (NDA) for APF530 in 1H12 after working quietly and diligently on addressing all the issues raised in a March 2010 complete response letter (CRL), which the FDA issued in response to the original NDA filing (May 2009).

Pharmalot submits: Eight months after their European counterparts told doctors to stop prescribing Abbott Labs’ (ABT) Meridia diet pill, the FDA will now ask an advisory panel meeting this Wednesday whether the drug should be withdrawn from the US market.

By Trefis: Johnson & Johnson's (NYSE:JNJ) received a major boost as its blockbuster potential type 2 diabetes drug, Invokana (commonly known as Canagliflozin), was granted FDA approval. [1] The approval marks JNJ's first entry into the huge diabetes market.

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A heart drug by French pharmaceutical giant Sanofi-Aventis has been linked to liver damage in some patients, two of whom had to receive transplants, the US Food and Drug Administration said Friday.Dronedarone, marketed as Multaq, was approved in 2009 and has been prescribed at least 492,000 times to people in the United States for treating abnormal heart rhythm.The FDA issued its warning to the public and to health professionals, saying labels to the medication would be changed to advise of possible liver dangers.

A young runner who collapsed and died during the London marathon had "significant" levels of a banned amphetamine-like fatburning supplement in her system, an inquest has heard. Claire Squires, 30, suffered a cardiac arrest outside Buckingham Palace, where she was treated in a medical tent before being rushed to hospital.

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Pharmalot submits: When the FDA issued a complete response letter last month for the Arena Pharmaceutical (ARNA) diet pill, the agency cited a few reasons: pending results of a trial in 604 patients with diabetes, concerns that the pill may cause tumors in rats and efficacy was marginal (look here).