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Labs’ (ABT) Meridia diet pill, the FDA will now ask an advisory panel meeting this Wednesday whether the drug should be withdrawn from the US market.

Doctors must obtain the consent of patients or their families before deciding to turn off or withhold life-preserving treatments, Canada’s largest medical regulator says in a draft new policy that largely reshapes how end-of-life care is decided. The blueprint, to be released officially Thursday, contrasts with the existing advice offered by Ontario’s College of Physicians & Surgeons — that doctors should avoid treatments they believe will be of no benefit or harmful to a gravely ill patient.

(Paxton Holley)

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.

By Smith On Stocks: Investment Opinion and Background

German retail sales bounced back for the second month, but not enough to prevent the aggregate eurozone sales from falling for the eighth consecutive month. Summary of June findings:

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.