Daily Top News – September 28, 2020

September 28, 2020

Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Heron Therapeutics Receives European Commission Authorization for ZYNRELEF (HTX-011) for the Treatment of Postoperative Pain (PRNewswire) – Sep 28, 2020 – “Heron Therapeutics, Inc….today announced that the European Commission has granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency’s (EMA) positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2020. Heron currently expects to make ZYNRELEF available to patients in the European Union (EU) during 2021.”


troriluzole (BHV-4157) / Portage; Nurtec ODT (rimegepant ODT) / Portage
BioShin, Biohaven’s Asia-Pacific Subsidiary, Raises $60M in Series A Funding to Advance Neuroscience Pipeline in Asia-Pacific Region (PRNewswire) – Sep 28, 2020 – “Biohaven Pharmaceutical Holding Company Ltd….announced today that BioShin Limited…has closed a $60M Series A investment round. The financing was led by OrbiMed, with participation from Cormorant Asset Management LLC….The Series A funds will be used to build out BioShin in China and advance the Biohaven clinical portfolio in the Asia-Pacific region, including the imminent start of the NURTEC™ ODT (rimegepant) Phase 3 study for the acute treatment of migraine in China and Korea. BioShin also plans to initiate sites in China to participate in the global registrational trial of troriluzole in Spinocerebellar Ataxia (SCA). BioShin expects to begin both Asia-Pacific studies in the fourth quarter of 2020.”


Epidaza (chidamide) / Chipscreen, Meiji Seika, Eisai, HUYA Bioscience, GNT Biotech
HUYA Bioscience International Announces Orphan Drug Designation for HBI-8000 Monotherapy Adult T-cell Leukemia-Lymphoma ATL in Japan (PRNewswire) – Sep 28, 2020 – “HUYA Bioscience…announced today the Ministry of Health, Labour and Welfare (MHLW) granted HBI-8000 orphan drug designation (ODD) in Japan as monotherapy for relapsed or refractory Adult T-cell Leukemia-Lymphoma or (ATL)…We are now preparing an application to the PMDA for approval of HBI-8000 as monotherapy for the treatment for R/R ATL.”

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