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.
Bristol-Myers Squibb to acquire Celgene to create a premier innovative biopharma company
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (NASDAQ:CELG) today announced that they have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion.
More Pharma News ...
- Top 20 breaking World Pharma News of 2018
- Lynparza meets primary endpoint in Phase III SOLO-3 trial for the treatment of relapsed BRCA-mutated advanced ovarian cancer
- Merck assigns Chimeric Antigen Receptor T-cell (CAR-T) rights to Intrexon
- Amgen Golden Tickets provide startup companies with free lab space to further advance innovative science and technology
- Bristol-Myers Squibb and Boston Medical Center announce research collaboration to investigate markers of immuno-oncology response and resistance
- Pfizer receives positive CHMP opinion for oncology biosimilar, ZIRABEV™ (bevacizumab)
- Novartis receives European Commission approval for self-administration of Xolair® across all indications