FDAnews Drug Daily Bulletin

Generic-drug makers must submit self-identification information to the FDA by Dec. 3 to comply with the recently passed Generic Drug User Fee Amendments of 2012.

Brioschi Pharmaceuticals, a maker of antacid products, was handed a Form 483 for lax investigations into out-of-specification lots released to market and complaints of odiferous drugs.

The FDA is in the last stages of finalizing a June 2011 guidance on classification of combination products, a senior FDA employee said Sept. 20.

The Supreme Court has been asked to review the validity of patents on isolated human genes associated with breast and ovarian cancer, which campaigners and medical groups said stifle research and hamper women’s access to care.

Janssen Research & Development announced that use of the investigational medicine canagliflozin substantially lowered blood glucose levels when used as add-on therapy in patients on insulin therapy for Type 2 diabetes and who are considered to be at greater risk for cardiovascular disease.

With added, positive Phase III breast cancer data from a trial called EMILIA for the antibody-drug conjugate T-DM1, Roche AG subsidiary Genentech and partner ImmunoGen uplifted — but didn’t overly surprise — investors, who are waiting to see whether the first label permits front-line use in metastatic disease.

Celgene said its unit Celgene International Sàrl announced results of its Phase III, randomized, international study of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in chemotherapy-naïve patients with metastatic melanoma.

Danish drugmaker Lundbeck and Japanese partner Takeda Pharmaceutical have submitted a new antidepressant for regulatory approval in the United States.

Astex Pharmaceuticals announced that it has initiated a Phase II, open label, randomized, multi-center, controlled clinical trial, evaluating SGI-110 in combination with carboplatin in platinum-resistant recurrent ovarian cancer patients.