New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
April 19, 2014
18:32 EDTTEVASupreme Court denies Teva stay in generic Copaxone case
Teva Pharmaceutical Industries announced that while the Chief Justice of the United States found that Teva had demonstrated “a fair prospect of success on the merits” in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808, he denied the company’s application to stay the Federal Circuit's decision due to the potential for the company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis, RRMS, product, Copaxone 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone. Teva previously prevailed in the District Court, which upheld the validity of nine Copaxone patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE patents that expire in May, while invalidating the ‘808 patent that is the subject of Teva’s now-granted certiorari petition. Any purported generic version of Copaxone would be required to obtain the approval of the FDA prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints in RRMS patients. The company is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.
News For TEVA From The Last 14 Days
Check below for free stories on TEVA the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
July 24, 2014
07:27 EDTTEVASome of Teva's biggest investors to vote against re-electing directors, WSJ says
Subscribe for More Information
06:45 EDTTEVATeva price target raised to $70 from $65 at Barclays
Subscribe for More Information
July 23, 2014
10:02 EDTTEVAOn The Fly: Analyst Initiation Summary
Subscribe for More Information
08:10 EDTTEVADeutsche Bank hosts an analyst Specialty Pharma/Industry conference call
Subscribe for More Information
July 22, 2014
16:08 EDTTEVATeva initiated with a Buy at Deutsche Bank
Subscribe for More Information
July 21, 2014
08:11 EDTTEVAArena Pharma' subsidiary enters into agreement for Belviq with Teva subsidiary
Subscribe for More Information
08:01 EDTTEVATeva completes acquisition of Labrys
Subscribe for More Information
July 16, 2014
08:48 EDTTEVATeva says ISS supports company's nominees, shareholders' meeting proposals
Subscribe for More Information
July 15, 2014
11:13 EDTTEVAPerrigo retreats after analyst sees limited potential buyers
Subscribe for More Information
06:28 EDTTEVAActivist shareholder says Teva to appoint new chairman, Reuters says
Subscribe for More Information
July 14, 2014
08:04 EDTTEVATeva announces FDA acceptance of NDA filing for albuterol MDPI
Teva Pharmaceuticals Industries announced that the U.S. Food and Drug Administration has accepted for review the company’s new drug application for albuterol multi-dose dry-powder inhaler, an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents with asthma and exercise-induced bronchospasm. The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.

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