Tezepelumab granted Breakthrough Therapy Designation by US FDA
- Details
- Category: AstraZeneca
AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.
Novartis to divest the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo
- Details
- Category: Novartis
Novartis today announced it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids portfolio, to Aurobindo Pharma USA Inc., for USD 0.9 billion of cash plus USD 0.1 billion of potential earn-outs.
Pfizer terminates domagrozumab (PF-06252616) clinical studies for the treatment of Duchenne muscular dystrophy
- Details
- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that it is terminating two ongoing clinical studies evaluating domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy (DMD): a Phase 2 safety and efficacy study (B5161002) and an open-label extension study (B5161004).
New tablet production facility in Ingelheim: Centerpiece for global launches
- Details
- Category: Boehringer Ingelheim
Boehringer Ingelheim held a groundbreaking ceremony for the construction of a new production facility for innovative drugs. This new Solids Launch facility will focus on development activities for drugs in tablet form and manufacture them for worldwide market launches.
Shire completes sale of oncology franchise
- Details
- Category: Shire
Shire plc (LSE: SHP, NASDAQ: SHPG) announces today that it has completed the sale of its Oncology franchise to Servier S.A.S. for $2.4 billion. The franchise includes the global rights to ONCASPAR® and ex-US and ex-Taiwan rights to ONIVYDE®, as well as Oncology pipeline assets. David Lee, who was previously the head of Shire's Global Genetic Diseases and Oncology franchises, will continue with Servier as CEO of its new US commercial subsidiary, Servier Pharmaceuticals.
Bayer accelerates six new startups
- Details
- Category: Bayer
Changing the experience of health: that's the focus of the six startups which the Bayer G4A team has included in the Accelerator program this year. The young companies from Canada, Germany, Israel, Spain, the United Kingdom and the United States came out ahead of more than 1,800 competitors from 100 countries. They now have 100 days in which to intensively drive the further development of their products and solutions with expertise and investment from Bayer.
Pfizer and Astellas amend clinical research protocols for two phase 3 trials of enzalutamide in patients with hormone-sensitive prostate cancer
- Details
- Category: Pfizer
Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI® (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC). These amendments accelerate timelines for the anticipated primary completion dates of both trials.
More Pharma News ...
- Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)
- SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation
- China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer
- Bristol-Myers Squibb - Pfizer Alliance ACROPOLIS™ real-world data program grows to sample size of nearly one million lives worldwide
- Novo Nordisk acquires Ziylo Ltd to accelerate its development of glucose responsive insulins
- Merck awarded Australian CRISPR nickase patent for foundational genome-editing technology
- Selumetinib granted orphan designation in Europe for neurofibromatosis type 1