BioSpace News Archive

Business

Clinigen and Mitsubishi Tanabe initiate European Managed Access Program for edaravone to treat ALS

Clinigen Group plc has partnered with Mitsubishi Tanabe Pharma Corporation (‘MTPC’), to initiate a Managed Access Program (also known as an Early Access Program) in Europe for edaravone, an intravenous treatment for amyotrophic lateral sclerosis (‘ALS’).

May 23, 2018

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2 min read

Drug Development

Webcast Alert: Ionis Pharmaceuticals Provides Corporate Update at 2018 Annual Meeting of Stockholders

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that management will present a general corporate update in conjunction with its 2018 Annual Meeting of Stockholders and Open House on Wednesday, May 23 at 2:10 p.m. Pacific Time (5:10 p.m. Eastern Time) in Carlsbad, CA.

May 23, 2018

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3 min read

Pharm Country

PAVmed Updates Expected Key Dates for Previously Announced Rights Offering

Company had filed a preliminary prospectus as part of a registration statement on Form S-1 with the Securities and Exchange Commission for a rights offering to stockholders of record on Monday, May 21, 2018.

May 23, 2018

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3 min read

FDA

FDA Accepts Supplemental Biologics License Application (BLA) and Grants Priority Review for Prophylactic and Pediatric Use for Bio Products Laboratory’s Coagadex® (Coagulation Factor X, Human) for Treatment of Hereditary Factor X Deficiency

Supplemental BLA based on clinical trial results from the Phase 3 TEN02 Study, a prospective study of Coagadex® for prophylaxis of bleeding episodes in children under 12 years old with moderate to severe hereditary factor X deficiency

May 23, 2018

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6 min read

Business

Dr. Daniel Siegel, Professor of Dermatology and former President of the American Academy of Dermatology joins MedX’s Medical Advisory Board

Dr. Daniel Siegel is a Clinical Professor of Dermatology at SUNY Downstate in Brooklyn, New York, and a former President of the American Academy of Dermatology has joined its Medical Advisory Board.

May 23, 2018

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2 min read

Biotech Bay

RenovoRx Announces $10 Million Financing for Innovative Treatment for Advanced Pancreatic Cancer

Company’s RenovoCath System Has Received Orphan Drug Designation from the FDA for its Innovative Approach

May 23, 2018

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3 min read

FDA

FDA Grants Breakthrough Therapy Designation for Tafamidis for the Treatment of Patients with Transthyretin Cardiomyopathy

Transthyretin cardiomyopathy is a rare, fatal, and underdiagnosed condition associated with progressive heart failure

May 23, 2018

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8 min read

Drug Development

SCYNEXIS to Participate in a Panel at the 2018 BIO International Convention

SCYNEXIS, Inc. today announced that Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS, will participate in a panel at the 2018 BIO International Conference at the Boston Convention and Exhibition Center on Wednesday, June 6, 2018 from 4:15 - 5:15 p.m. ET.

May 23, 2018

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1 min read

Business

Astero Bio Acquires Key Technologies for the Management of Cryopreserved Biologics from BroadOak Capital Partners

In conjunction with the acquisition, Astero will receive growth capital investment from BroadOak.

May 23, 2018

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3 min read

FDA

Newest Generation of Leading Heart Stent is Now Approved in the U.S. for People with Coronary Artery Disease

Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for XIENCE SierraTM, the newest generation of the company’s gold-standard XIENCE everolimus-eluting coronary stent system.

May 23, 2018

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4 min read