European Commission approves Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE: BMY) announced that the European Commission has approved the combination of Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg ("low-dose") for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
US FDA accepts regulatory submissions for review of tafamidis to treat transthyretin amyloid cardiomyopathy
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company's New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid.
EVENITY™ (romosozumab) receives approval in Japan for the treatment of osteoporosis in patients at high risk of fracture
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- Category: Amgen
Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) announced that the Japanese Ministry of Health, Labor and Welfare has granted a marketing authorization for EVENITY™ (romosozumab) for the treatment of osteoporosis in patients at high risk of fracture.(1) Amgen and UCB are co-developing EVENITY worldwide, with development in Japan being led by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo.
Boehringer Ingelheim initiates a collaborative partnership with Science 37 to accelerate patient centricity in the development of novel therapies
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- Category: Boehringer Ingelheim
Science 37, an industry leader in virtual clinical trials, and Boehringer Ingelheim announced a technology enterprise collaboration agreement that will support Boehringer Ingelheim in running remote clinical trials. Science 37 is licensing access to its proprietary software platform, NORA® (Network Oriented Research Assistant), which leverages mobile technology and telemedicine capabilities, enabling patients to
Sandoz and Pear Therapeutics announce US launch of reSET-OTM to help treat Opioid Use Disorder
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- Category: Novartis
Sandoz Inc., a Novartis division, and Pear Therapeutics, Inc., announced today the US commercial launch of reSET-O(TM) for patients with Opioid Use Disorder (OUD). reSET-O*, cleared by the US Food and Drug Administration (FDA) in December, is immediately available.
AstraZeneca announces organisational changes
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- Category: AstraZeneca
AstraZeneca is today announcing organisational changes to support continued scientific innovation and commercial success in the main therapy areas as the Company enters a new phase in its strategic development. Included in the changes will be the arrival at AstraZeneca of the world-renowned oncology scientist, José Baselga, as well as the creation of:
Pfizer initiates phase 2b/3 clinical trial for PF-06651600, an oral JAK3 inhibitor, for the treatment of patients with moderate to severe alopecia areata
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced the initiation of a Phase 2b/3 clinical trial for its oral JAK3 inhibitor, PF-06651600, for the treatment of patients with moderate to severe alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body, and currently has no approved therapies.
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