New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 4, 2014
08:13 EDTACTActavis files ANDA to market Bendamustine Hydrochloride for injection
Actavis confirmed that it has filed an Abbreviated New Drug Application, or ANDA, with the FDA seeking approval to market Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial. Actavis' ANDA product is a generic version of Cephalon's Treanda, a treatment for chronic lymphocytic leukemia and non-Hodgkin's lymphoma. Cephalon filed suit against Actavis on January 31 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
News For ACT From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
January 27, 2015
17:04 EDTACTShire granted petitiion by U.S. Supreme Court
Subscribe for More Information
January 26, 2015
17:34 EDTACTActavis registration statement for Allergan acquisition declared effective
Subscribe for More Information
07:34 EDTACTActavis to acquire Auden Mckenzie for GBP306M accretive in FY15
Subscribe for More Information
January 22, 2015
05:57 EDTACTActavis, Valeant raise prospects of more healthcare deals, Financial Times says
Subscribe for More Information
January 21, 2015
12:30 EDTACTGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
Subscribe for More Information
07:22 EDTACTActavis price target raised to $330 from $280 at Deutsche Bank
Subscribe for More Information
January 20, 2015
05:34 EDTACTActavis reports positive Phase III results for cariprazine
Gedeon Richter and Actavis announced positive results from a Phase III trial evaluating the efficacy and safety of cariprazine in the prevention of relapse in patients with schizophrenia. There were 101 patients randomized to cariprazine 3 to 9 mg per day and 99 randomized to placebo. The primary efficacy measure was time to first relapse during the double-blind period. There were 25 relapses in the cariprazine group versus 47 relapses in the placebo group. Treatment with cariprazine was associated with a 55% reduction in risk of relapse versus placebo.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use