FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101)
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- Category: Novartis
Novartis today announced the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) and has granted Priority Review for its investigational sickle cell medicine crizanlizumab (SEG101). If FDA-approved, crizanlizumab is expected to represent the first monoclonal antibody targeting the P-selectin mediated multi-cellular adhesion in sickle cell disease.
Boehringer Ingelheim acquires AMAL Therapeutics, significantly enriching its cancer immunology portfolio with novel cancer vaccines platform
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- Category: Boehringer Ingelheim
Boehringer Ingelheim today announced its acquisition of all shares of AMAL Therapeutics SA, a private Swiss biotechnology company focused on cancer immunotherapy and advancing first-in-class therapeutic cancer vaccines derived from its technology platform KISIMA. AMAL's lead vaccine ATP128 is currently developed for stage IV colorectal cancer and is slated to begin first-in-human trials later this month.
Novartis, Amgen and Banner Alzheimer's Institute discontinue clinical program with BACE inhibitor CNP520 for Alzheimer's prevention
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- Category: Novartis
Novartis, Amgen and Banner Alzheimer's Institute today announced the decision to discontinue investigation of the BACE1 inhibitor CNP520 (umibecestat) in two pivotal Phase II/III studies in the Alzheimer's Prevention Initiative Generation Program. An assessment of unblinded data during a regular pre-planned review identified worsening in some measures of cognitive function.
FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
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- Category: Sanofi
The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The target action date for the FDA decision is April 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.
Pfizer completes acquisition of Therachon
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced the successful completion of its acquisition of the privately held clinical-stage biotechnology company Therachon Holding AG. Under the terms of the transaction, Pfizer acquired Therachon for $340 million with an additional $470 million in additional payments contingent on the achievement of key milestones in the development and commercialization of TA-46.
LEO Pharma completes the acquisition of Bayer’s prescription dermatology business
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- Category: Bayer
LEO Pharma and Bayer announced today the achievement of the relevant closing conditions to allow the transfer of Bayer’s global prescription dermatology business to LEO Pharma. The companies first announced the proposed transaction on July 31, 2018 and completed the first step of the acquisition with the closing in the United States on September 4, 2018.
Novartis successfully completes acquisition of Xiidra®, bolstering ophthalmic portfolio
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- Category: Novartis
Novartis today announced that it has completed its acquisition of Xiidra® (lifitegrast ophthalmic solution) 5%, the first and only prescription treatment approved to treat both signs and symptoms of dry eye by inhibiting inflammation caused by the disease[1].
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