New tablet production facility in Ingelheim: Centerpiece for global launches
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- 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
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- 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
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- 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
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- 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.
Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)
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- Category: Novartis
Novartis today announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation
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- Category: Novartis
Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS). SOLAR-1 is evaluating BYL719 in combination with fulvestrant compared to fulvestrant alone in postmenopausal women and men with hormone-receptor positive,
China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa® (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).
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