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Bayer’s BAY94-9027 Biologics License Application accepted by U.S. FDA

Oct 31, 2017
The U.S. Food and Drug Administration (FDA) has accepted Bayer's Biologics License Application (BLA) filing for BAY94-9027, an extended half-life site-specifically PEGylated recombinant…
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Daiichi Sankyo’s ENLIVEN Phase 3 Study of Pexidartinib Met Primary Endpoint in TGCT

Oct 31, 2017
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the pivotal phase 3 placebo-controlled ENLIVEN (NCT02371369) study of pexidartinib met its primary…
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Novartis submits application to FDA for Kymriah (tisagenlecleucel)

Oct 31, 2017
Novartis announced that the company has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah™ (tisagenlecleucel)…
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Saudi FDA approves Sobi’s Alprolix for the treatment of haemophilia B

Oct 31, 2017
Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Alprolix (eftrenonacog alfa), for the…
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AbbVie receives FDA Priority Review for elagolix

Oct 31, 2017
AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH)…
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Charles River Announces Expansion of In Vitro Oncology Services

Oct 31, 2017
Charles River Laboratories International, Inc. announced its partnership with InSphero AG, a leading supplier of 3D solutions for in vitro drug discovery and development. Through…
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Zydus receives final approval from the USFDA for Tamoxifen Citrate Tablets USP

Oct 31, 2017
Zydus Cadila has received the final approval from the USFDA to market Tamoxifen Citrate Tablets USP in the strengths of 10 mg (base) and 20 mg (base). The drug is indicated to treat…
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Lannett and Celgene enter into settlement and License Agreement related to Thalomid

Oct 31, 2017
Lannett Company, Inc. announced that it has entered into a settlement and license agreement with Celgene Corporation that resolves patent infringement litigation in the U.S. related to…
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Xynomic Pharma Acquires Global Rights of Boehringer Ingelheim’s BI 882370

Oct 31, 2017
Xynomic Pharma announced that it has acquired exclusive global rights to develop, manufacture and commercialize BI 882370, a 2nd-generation RAF inhibitor, from Boehringer Ingelheim, a…
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New to 2018: The Role of Artificial Intelligence in Drug Discovery

Oct 30, 2017
SMi Reports: SMi’s 2nd annual Drug Discovery conference,taking place in London on 21st and 22nd March 2018, will discuss the role of artificial intelligence in drug discovery ‘The…
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