BioSpace News Archive

Ascletis’ Ravidasvir Recommended by WHO HCV Guidelines

Ascletis Pharma Inc. (1672.HK) announced today Ravidasvir is recommended by the World Health Organization (WHO) Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection (July 2018) as a future pan-genotypic direct-acting antivirals agent (DAA). Ascletis received the acceptance letter for Ravidasvir new drug application (NDA) from the China Food and Drug Administration (CFDA) on August 1.

August 6, 2018
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1 min read
Business

Can-Fite Signs Multi-Million Dollar Development and Distribution Agreement for Piclidenoson and Namodenoson in China with CMS Medical

Upfront and milestone payments total up to $74.5M plus double-digit royalties

August 6, 2018
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6 min read
Policy

China National Drug Administration Approves Gilead’s Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), a Single Tablet Regimen for the Treatment of HIV-1 Infection

Genvoya is the First TAF-Based Regimen Approved in China for Adults and Adolescents with HIV

August 6, 2018
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9 min read
Business

Regeneron and bluebird bio Announce Collaboration to Discover, Develop and Commercialize New Cell Therapies for Cancer

Regeneron Pharmaceuticals, Inc. and bluebird bio, Inc. announced a collaboration to apply their respective technology platforms to the discovery, development and commercialization of novel immune cell therapies for cancer.

August 6, 2018
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11 min read
Sun Pharma Launches Novel Drug Kapspargo Sprinkle™ in USA

First USFDA approved, extended-release sprinkle formulation of metoprolol succinate indicated for treatment of patients with Hypertension, Angina Pectoris and Heart Failure

August 6, 2018
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9 min read
Drug Development

Final Results from the Protagonist PROPEL Study Support Further Clinical Development of PTG-100 for the Treatment of Ulcerative Colitis

Independent blinded re-read of endoscopies provides signal of clinical efficacy and identifies human error in initial reads provided by contract research organization

August 6, 2018
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8 min read
Business

Casma Therapeutics Expands Executive Team with Appointment of Two Senior Vice Presidents

Jeffrey Saunders, Ph.D., Casma’s new senior vice president of drug discovery, and Daniel Ory, M.D., as senior vice president of translational medicine.

August 6, 2018
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3 min read
Business

Alzheon Appoints Former IVAX President, Neil Flanzraich, JD, as Vice Chairman of Board of Directors

Mr. Flanzraich was an early investor in Alzheon and served in the role of Chief Business Officer of Alzheon as a consultant to the company from February to May 2018.

August 6, 2018
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4 min read
Business

Surmodics Reports Third Quarter Fiscal 2018 Results

Revenue of $22.2 million, up 24.9%

August 6, 2018
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15 min read
Business

AOBiome Therapeutics Announces the Expansion of its Board of Directors

New appointments integrate broad expertise in clinical development, medicine, finance and business management.

August 6, 2018
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5 min read