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Mallinckrodt Submits INDA For Synacthen Depot
Company will pursue an indication for the drug in treatment of Duchenne Muscular Dystrophy.Mallinckrodt plc a leading global specialty biopharmaceutical company, announced it has submitted an Investigational New Drug (IND) application for Synacthen® Depot to the U.S. Food and...
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Pfizer Announces Final Results From Inotuzumab Ozogamicin Pivotal Phase 3 Study With Refractory Acute Lymphoblastic Leukemia
Pfizer Inc announced the publication of findings from the Phase 3 INO-VATE ALL study in the online issue of The New England Journal of Medicine. The study, also known as Study 1022, is an open-label, randomized,...
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Ironwood and Allergan Announce New Drug Application for 72 mcg Linaclotide Has Been Accepted for FDA Review
Ironwood Pharmaceuticals, Inc.and Allergan plc announced that the U.S. FDA has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation (CIC)....
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Merck Expands its Investment Fund Merck Ventures
• Existing biopharma venture fund renamed and expanded to all Merck business sectors• Newly established teams will focus on each of the three existing Merck business sectors as well as new businesses• Total fund size doubled to up to...
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Ultragenyx Pharmaceutical Inc and Takeda Pharmaceutical Company enter into a Collaboration to Develop Rare Genetic Diseases
Ultragenyx Pharmaceutical Inc. a biopharmaceutical company focused on the development of novel productsfor rare and ultra-rare genetic diseases, and Takeda Pharmaceutical Company Limited announced a strategic partnership to develop and commercialize therapies to treat rare genetic diseases. ...
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Novartis data show more than 50 percent of eligible Ph+ CML patients maintain Treatment-free Remission after stopping Tasigna
In ENESTfreedom, 51.6% of eligible first-line Tasigna patients maintained TFR for 48 weeks after stopping treatment; study did not meet its statistical primary endpoint, specifically the > 50% lower limit of the 95% confidence interval ENESTop...
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AbbVie and Eisai Subsidiary EA Pharma Commence Co-promotion of Fully Human Anti-TNF-a Monoclonal Antibody HUMIRA® in the Field of Gastrointestinal Disease
AbbVie GK announced that EA Pharma and AbbVie will commence the co-promotion of fully human anti-TNF-α monoclonal antibody HUMIRA® for indications in the field of gastrointestinal disease. Established in April 2016 through the integration of Eisai's...
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