Medivation and Astellas Pharma on Wednesday announced that the Food and Drug Administration approved a new use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer.
Sanofi Pasteur announced that the Food and Drug Administration approved the use of Menactra [meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine] as a booster vaccination against meningococcal disease in people ages 15 years through 55 years.
Teva Pharmaceutical Industries on Monday announced that its acquistion of Labrys has been completed. The acquisition brings to Teva LBR-101, which is currently in phase-2b clinical trials for prevention of chronic and episodic migraines.
Roche on Wednesday announced that Genentech, a member of the Roche Group, has entered into a definitive agreement to acquire Seragon Pharmaceuticals, a privately held biotechnology company based in San Diego.
Upsher-Smith Laboratories on Wednesday announced the launch of testosterone gel (1%), the generic of Vogelxo (testosterone) gel 1%, for topical use. Newly approved by the Food and Drug Administration, it is the first and only available generic testosterone replacement therapy available in three configurations, the company stated.
Upsher-Smith Laboratories on Wednesday announced that it has received final approval from the Food and Drug Administration for its new drug application for Vogelxo (testosterone) gel for topical use CIII.
Teva Pharmaceutical and Labrys Biologics, a privately-held development stage biotechnology company focused on treatments for chronic migraine and episodic migraine, on Tuesday announced that Teva has entered into a definitive agreement to acquire Labrys in a deal for $200 million in upfront payment in cash at closing as well as up to $625 million in contingent payments upon achievement of certain pre-launch milestones.
Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.
Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.