Feb 23, 2009 (Datamonitor via COMTEX) –
— Medtronic, a medical technology company, has received approval from the FDA for a humanitarian device exemption for its Reclaim deep brain stimulation therapy for chronic, severe obsessive-compulsive disorder.
The company also announced the first enrollment in its multi-center, randomized clinical trial of deep brain stimulation (DBS) for treatment-resistant depression.
Medtronic is proceeding with Read the rest of this entry »

WASHINGTON (AP) — A division of Johnson & Johnson has asked federal regulators to grant full approval to an HIV drug designed to treat patients who have stopped responding to other treatments.
The Food and Drug Administration gave Intelence preliminary approval in January under its accelerated approval program, which allowed J&J to market the drug. In order to gain full approval, FDA required the company to submit follow-up data on the drug’s Read the rest of this entry »

KING OF PRUSSIA, Pa.
,
Jan. 5
/PRNewswire/ — Prism Pharmaceuticals
announced today that the U.S. Food & Drug Administration (FDA) has approved
the new drug application (NDA) for NEXTERONE(R) (amiodarone HCl) Injection, a
novel, patent-protected, cosolvent free formulation of the antiarrhythmic
agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone(R)
Intravenous. NEXTERONE is indicated for the treatment and prophylaxis Read the rest of this entry »

The FDA approval is based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of atrial fibrillation (AFib). In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug therapy for the treatment of drug refractory recurrent symptomatic paroxysmal AFib.
The approval by the FDA also includes the EZ Steer Thermocool navigational catheter, which is a bi-directional Read the rest of this entry »

Dec 23, 2008 (Datamonitor via COMTEX) –
— Novartis has announced that its Gleevec tablets have received approval from the FDA for the post-surgery treatment of adult patients following complete surgical removal of Kit-positive gastrointestinal stromal tumors.
According to the company, Gleevec is now the only post-surgery treatment indicated to delay the return of this highly aggressive cancer, filling a major need for gastrointestinal stromal Read the rest of this entry »

KANSAS CITY, Missouri (Reuters) – Monsanto Co said Wednesday it filed for U.S. regulatory approval for what could be the world’s first drought-tolerant corn, a product that agricultural companies around the globe are racing to roll out amid fears of global warming and the needs of a growing population.
Monsanto said it submitted its product to the U.S. Food and Drug Administration for regulatory clearance. It is working with German-based BASF on Read the rest of this entry »

Prism intends to submit a supplemental new drug application (NDA) for the premixed configurations which will form the focus of the commercial launch of Nexterone as a complete product line.
Prism is currently implementing a full scale manufacturing development program with the medication delivery business of Baxter Healthcare, a developer of premix technologies.
The FDA approval of Nexterone triggers a second $10 million milestone payment from Read the rest of this entry »

The Food and Drug Administration approved Watson Pharmaceuticals Inc.’s generic version of the nicotine gum Nicorette, the company said Wednesday, and Watson plans to start selling the mint-flavored gum in early January.
Watson said the FDA approved its over-the-counter nicotine polacrilex gum in 2 mg and 4 mg strengths. Nicorette is made by British drug maker GlaxoSmithKline PLC, and sold by Johnson & Johnson Healthcare. The FDA approved Nicorette Read the rest of this entry »

has received approval from the Food and Drug Administration to begin a clinical trial of a product candidate to treat Pelizaeus-Merzbacher Disease (PMD), a fatal brain disorder that affects mainly young children.
Palo Alto-based StemCells (NASDAQ: STEM) designed the Phase 1 trial to evaluate the safety and efficacy of its HuCNS-SC product candidate cells as a treatment for PMD. Currently, there are no approved treatments for this disease, the company Read the rest of this entry »

(Adds analysts’ comments, updates stock movement)
Dec 9 (Reuters) – Targanta Therapeutics Corp said U.S. health regulators declined the approval of its antibiotic and raised questions about the safety of the drug, triggering a 63 percent drop in its shares.
The U.S. Food and Drug Administration asked the company to perform an additional clinical study to show efficacy and safety of the drug, oritavancin, for treating complicated skin and skin Read the rest of this entry »