Sanofi and Google to develop new healthcare Innovation Lab
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- Category: Sanofi
Sanofi and Google will establish a new virtual Innovation Lab with the ambition to radically transform how future medicines and health services are delivered by tapping into the power of emerging data technologies. The collaboration aims to change how Sanofi develops new treatments and will focus on three key objectives:
Bristol-Myers Squibb provides update on pending merger with Celgene
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE: BMY) today provided an update on the approval process and timeline for the Company’s pending merger with Celgene Corporation (NASDAQ: CELG). The Company remains actively engaged in discussions with the U.S. Federal Trade Commission ("FTC") on the FTC's continued review of the proposed transaction.
Regorafenib to be tested in brain cancer patients in multi-arm cooperation trial
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- Category: Bayer
Bayer announced that the regorafenib arm of the platform trial "GBM AGILE" (Glioblastoma Adaptive Global Innovative Learning Environment) opened for enrollment in the US for patients with newly diagnosed and recurrent glioblastoma, the most aggressive and common form of primary brain cancer. This marks the start of an international, innovative study with a seamless Phase II/III design set up to rapidly identify effective therapies for patients with GBM;
Breztri Aerosphere (PT010) approved in Japan for patients with chronic obstructive pulmonary disease
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- Category: AstraZeneca
AstraZeneca announced that Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD). This is the first global regulatory approval for Breztri Aerosphere and is the first approval by
Japan becomes the first country to approve Roche's personalised medicine Rozlytrek
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours.
FDA approves Amgen and Allergan's KANJINTITM (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab)
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- Category: Amgen
Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTITM (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA grants Roche's Polivy accelerated approval for people with previously treated aggressive lymphoma
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies.
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