18:32 , Aug 10, 2018 |  BC Week In Review  |  Company News

FDA reviewers say data are lacking on TIRF drug use

FDA reviewers pointed to significant data gaps for evaluating the REMS program for transmucosal immediate-release fentanyl (TIRF) drugs at a joint advisory committee meeting Aug. 3. Participants gave "important feedback" that insufficient data exists to...
19:35 , Jan 19, 2018 |  BC Week In Review  |  Clinical News

FDA approves Teva's Trisenox for newly diagnosed APL

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said FDA approved Trisenox arsenic trioxide plus tretinoin to treat adults with newly diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or...
07:00 , Jun 20, 2016 |  BC Week In Review  |  Company News

Mesoblast, Teva deal

Teva returned rights to Mesoblast’s mesenchymal precursor cell (MPC) technology for cardiovascular indications, including lead program MPC-150-IM . According to Mesoblast, Teva’s decision was based on “strategic reasons aligned to their core therapeutic areas of...
00:32 , Jun 11, 2016 |  BC Extra  |  Company News

Eagle soars after bendamustine patent ruling

A judge in the U.S. District Court for the District of Delaware upheld most claims of a patent from the Cephalon Inc. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) covering cancer drug Treanda bendamustine. Eagle...
00:58 , Mar 24, 2016 |  BC Extra  |  Company News

FDA approves Teva's Cinqair for asthma

FDA approved Cinqair reslizumab from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) as an add-on maintenance treatment of severe asthma in adults with an eosinophilic phenotype. Teva said it plans to launch the humanized mAb against IL-5...
02:35 , Dec 10, 2015 |  BC Extra  |  Company News

FDA panel backs Teva's reslizumab for adults

FDA's Pulmonary- Allergy Drugs Advisory Committee voted 11-3 that efficacy and safety data support approval of reslizumab from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to treat asthma in adults. The committee voted 14-0 against approval for...
00:55 , Sep 19, 2015 |  BC Extra  |  Company News

FDA committee to discuss Teva's asthma biologic

FDA's Pulmonary-Allergy Drugs Advisory Committee will meet Dec. 9 to discuss a BLA for reslizumab from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to reduce exacerbation, relieve symptoms and improve lung function in asthma patients. Teva gained...
07:00 , Jul 27, 2015 |  BC Week In Review  |  Company News

AstraZeneca, Biogen, Teva pharmaceuticals news

The companies will pay $55.5 million to settle a law suit filed by whistleblower Ronald Streck, who alleged that the companies defrauded the government by under-reporting Medicare rebates. Specifically, AstraZeneca will pay $46.5 million, Teva’s...
07:00 , Jun 22, 2015 |  BC Week In Review  |  Clinical News

Reslizumab regulatory update

FDA accepted for review a BLA from Teva for IV reslizumab to treat inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. Teva expects a decision from...
07:00 , Jun 1, 2015 |  BC Week In Review  |  Company News

Teva neurology news

Teva will pay $1.2 billion to settle a 2008 Federal Trade Commission antitrust suit alleging that Cephalon Inc. , which Teva acquired in 2011, paid generic drug manufacturers more than $200 million to drop challenges...