Mylan

KINECT 4 Phase III Study Demonstrating INGREZZA® Improves Tardive Dyskinesia Symptoms Neurocrine Biosciences, Inc. announced new long-term data from the KINECT 4 Phase III open-label study demonstrate that once-daily INGREZZA® (valbenazine) capsules, the first FDA approved treatment for adults with tardive dyskinesi...

Gilead faces revived lawsuit claiming it sidestepped FDA with HIV drug imports Gilead Sciences thought it had prevailed in a whistleblower lawsuit alleging it circumvented FDA rules to use a China-made active ingredient in three top HIV meds, rather than a higher-priced version from South Korea that the agency had a...

Shadowed by nearly $30B in debt, Valeant's $50M guidance raise looks pretty paltry Faced with a crippling pile of debt, Valeant on Tuesday slightly increased its 2017 earnings guidance, one small positive development as it works to rebound from its noted downfall. The Canadian drugmaker reported first-quarter reven...

Malaysia calls for phase 4 Dengvaxia study before considering full approval Already struggling to meet initial expectations, Sanofi Pasteur's dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia before the endemic country agrees to sign off on a full approval. Malaysia’s National Pharmaceutical ...

Biogen triumphs in latest Tecfidera patent dispute Biogen has prevailed in a patent squabble with Denmark’s Forward Pharma over multiple sclerosis med Tecfidera—but the decision may not actually help the Big Biotech steer clear of generic rivals. The Patent Trial and Appeal Board (PTAB) ruled Friday that Forward cou...

Mylan closing Illinois plant, cutting 90 jobs as part of slim-down after Meda buyout Mylan has been in the midst of cutting about 3,500 jobs to decrease costs and refocus after its $7 billion buyout last year of Meda Pharmaceuticals. About 90 of those cuts will come with the closure of a plant in Illinois.The drugma...

NPPA slams pharma giants for overcharging The price regulator in the pharmaceutical industry, National Pharmaceutical Price Authority (NPPA) has discovered that the leading Pharma companies are overcharging customers for abundantly prevalent drugs in the market. NPPA has alleged that the listed 634 drugs are being s...

For Inflectra launch, Pfizer uses 'hybrid model' to home in on HCPs Pfizer hit the market with Inflectra, a biosimilar of Johnson & Johnson's Remicade. And with the launch came not only the beginning of a new class of copycats, but a new way to go to market. Each biosimilar, even versions of the same biologic—wh...

Novartis eyes $8B Amneal buy Novartis is weighing a deal for the generics maker Amneal Pharmaceuticals to expand its already-hefty Sandoz unit, at a time when two of its biggest rivals in the field are integrating big buyouts of their own. The Amneal buy could be worth up to $8 billion. Joerg Reinhardt, chairman of ...

Fresenius Kabi introduced Bivalirudin for Injection Fresenius Kabi announced that it has introduced Bivalirudin for Injection in the United States, which is an anticoagulant, and a generic alternative to Angiomax. Fresenius Kabi’s Bivalirudin was approved by the U.S. Food and Drug Administration in October. The U.S....