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4:14 PM, Sep 20, 2018  |  BC Extra | Company News

Celenex takeout first of several planned gene therapy deals for Amicus

Just weeks after gaining its first FDA approval, Amicus Therapeutics Inc. (NASDAQ:FOLD) has announced its entrance into the gene therapy space with the acquisition of Nationwide Children's Hospital spinout Celenex (Columbus, Ohio) for $100 million...
4:13 PM, Sep 20, 2018  |  BC Extra | Company News

Opiant gets BARDA grant for intranasal opioid antagonist

HHS partnered with Opiant Pharmaceuticals Inc. (NASDAQ:OPNT) to accelerate development of the company's OPNT003, an intranasal formulation of opioid receptor antagonist nalmefene. Under a one-year contract with HHS's Biomedical Advanced Research and Development Authority, Opiant...
3:35 PM, Sep 20, 2018  |  BC Extra | Company News

Management tracks: Garland to lead Portola; Gallagher joining Abingworth

Hematology company Portola Pharmaceuticals Inc. (NASDAQ:PTLA) hired Scott Garland as president and CEO. He replaces CEO Bill Lis, who retired Aug. 1. Interim Co-Presidents John Curnutte, the company’s head of R&D, and Mardi Dier, its...
2:08 PM, Sep 20, 2018  |  BC Extra | Politics & Policy

FDA may crack down on clinical trial reporting

FDA is signaling that it may start fining clinical trial sponsors if they fail to meet legal requirements to publicly register trials and report results at ClinicalTrials.gov, or if they report false or misleading information. In...
1:36 PM, Sep 20, 2018  |  BC Extra | Company News

FDA: No new safety concerns for Acadia's PD psychosis drug

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) rose $4.01 (27%) to $19.11 on Thursday, adding more than $500 million in market cap, after an FDA safety review of the company's Nuplazid pimavanserin found postmarketing safety data were consistent...
12:52 PM, Sep 20, 2018  |  BC Extra | Clinical News

Roxadustat meets in Phase III for CKD patients with anemia not on dialysis

Astellas Pharma Inc. (Tokyo:4503) said roxadustat (ASP1517, FG-4592) met both primary endpoints in the Phase III ALPS trial to treat anemia in patients with chronic kidney disease who were not receiving dialysis. On the primary endpoint...
11:00 AM, Sep 20, 2018  |  BC Extra | Politics & Policy

Ex-FDA Chief Hamburg says AAAS will take on harassment

The scientific community urgently needs systemic changes that address sexual and gender-based harassment, Margaret Hamburg wrote in a Science editorial. Hamburg, president of the American Association for the Advancement of Science and former FDA commissioner, told...
6:56 AM, Sep 20, 2018  |  BC Extra | Preclinical News

RNA-modifying enzyme loops mRNA to increase oncogene translation

Boston Children's Hospital researchers showed interaction between a translation factor and RNA-modifying enzyme could enhance oncogene translation by circularizing mRNA, suggesting that disrupting the protein-protein interaction could help treat cancer. At least two companies -- Storm...
6:46 AM, Sep 20, 2018  |  BC Extra | Financial News

DePinho's STAT3 company Tvardi raises $9M series A

Tvardi Therapeutics Inc. (Houston, Texas) raised $9 million in a series A round from Alexandria Venture Investments and other undisclosed institutional and private investors. Tvardi is developing inhibitors of signal transducer and activator of transcription 3...
4:07 PM, Sep 19, 2018  |  BC Extra | Company News

Management tracks: GSK adds Corsico, Enzmann to chair CHMP

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) hired Chris Corsico, CMO of Boehringer Ingelheim GmbH (Ingelheim, Germany), to lead all development activities for the pharma. As SVP development, Corsico will be based at GSK’s R&D hub in Stevenage,...

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