BioSpace News Archive

Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted a Biologics License Application from Genentech, a member of the Roche Group, for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous administration using Halozyme’s ENHANZE® drug delivery technology in combination with intravenous chemotherapy for the treatment of eligible patients with HER2-positive breast cancer..

Lysogene announced that the U.S. Food and Drug Administration has granted Fast Track Designation to its LYS-SAF302 program for the treatment of mucopolysaccharidosis Type IIIA.

RedHill to receive $30 million following closing to support its commercial operations, including the planned launch of Talicia® this quarter and the ongoing promotion of Aemcolo®

RedHill Biopharma Ltd., a specialty biopharmaceutical company primarily focused on the commercialization and development of proprietary drugs for the treatment of gastrointestinal diseases, announced that it is acquiring the global rights to Movantik® 1, excluding Europe, Canada and Israel, from AstraZeneca.

Arecor Ltd announces that it has achieved an important second, contractual milestone with one of its pharmaceutical partners.

HUNT VALLEY, Md. , Feb. 25, 2020 /PRNewswire/ -- Pharmaceutics International, Inc. (Pii), a pharmaceutical contract development and manufacturing organization (CDMO), announces the expansion of its aseptic filling capacity and capabilities with the addition of a new, fully robotic filling line. Pii has installed a GENiSYS ® R fillin

LONDON, Feb. 25, 2020 (GLOBE NEWSWIRE) -- Further to its announcement dated January 31, 2020, Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announced that its final results for the year ended December 31, 2019 will be released on Tuesday, March 3, 2020. The time has been revised to 12:00 noon Greenwich Mean Time (GMT) / 7:00 am Eastern Standard Time (EST) / 8:00 pm Hong Kong Time (HKT). Due to travel restrictions resulting from the novel coronavirus outbreak, Chi-Med managem

STOCKHOLM , Feb. 25, 2020 /PRNewswire/ -- InDex Pharmaceuticals Holding AB (publ) today announced the publication of scientific data on the mechanism of action of cobitolimod, the company’s lead drug candidate in development for the treatment of moderate to severe ulcerative colitis. The paper, published in the peer-reviewed Journal of Crohns and Colitis (JCC) , shows that t

Hansa Biopharma has been invited to participate in two global biotech and healthcare conferences during March including Cowen Annual Health Care Conference in Boston and Carnegie Nordic Healthcare Seminar in Stockholm

HELSINKI , Feb. 25, 2020 /PRNewswire/ -- Topline analysis confirms positive safety and tolerability of CDNF in advanced-stage Parkinson’s disease patients, with encouraging biological responses as measured by PET imaging in some patients. Results from the second part of trial, in which all patients will receive CDNF for an additional six months, are expected in Q3 2020. H