Press Releases

Revance Therapeutics, Inc. and Mylan N.V. announced Mylan’s decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA), the market-leading neuromodulator. Feedback obtained from the U.S. Food and Drug Administration (FDA) during a Biosimilar Initial Advisory Meeting (BIAM) held in February 2019 indicated that the 351(k) regulatory pathway for an onabotulinumtoxinA product is via

Vivet Therapeutics announced that the Food and Drug Administration (FDA) and the European Commission (EC) have assigned the designation orphan drug (ODD) for their second gene therapy product, VTX-803 developed for the treatment of familial progressive intrahepatic cholestasis type 3 (PFIC3). PFIC3 is a rare, life-threatening, disabling chronic condition due to severe progressive liver dysfunction, accompanied by jaundice, portal hypertension, hepatosplenomegaly and stunting. Symptoms of the

AgeX Therapeutics, Inc., a biotechnology company developing therapeutics for human aging and regeneration, and Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-stage regenerative medicine therapeutics company, announced today a research collaboration where Sernova will utilize AgeX’s UniverCyteTM gene technology to generate immune-protected universal therapeutic cells for use in combination with Sernova’s Cell PouchTM for the treatment of type I diabetes and hemophilia

Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. known as MSD outside the United States and Canada, today announced that results from two trials evaluating LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., will be presented at the American Society of Clinical Oncology (ASCO20 Virtual Scientific Program) from May 29 to 31, 2020. The two trials, Study 1

Using Department of Defense supercomputers, Southwest Research Institute is virtually screening millions of drug compounds to search for and test possible treatment options for the novel coronavirus 2019. The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc. (HJF) has awarded SwRI a $1.9 million, one-year contract to support these efforts to identify potential COVID-19 treatments. HJF supports COVID-19 countermeasure development at the Walter Reed Army Institute of Res

Theraly Fibrosis, a preclinical-stage biotechnology company focused on development and commercialization of drugs for various fibrotic diseases today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to TLY012 for the treatment of systemic sclerosis. The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. In 2019, the FDA granted OD

Advent Srl, an IRBM company and global leader in viral vector manufacturing, announces it has manufactured 13,000 doses of the novel Covid-19 vaccine candidate, ChAdOx1 nCoV-19 (now known as AZD1222). The first 4,000 doses have been delivered for use in the Phase 2/3 clinical trial  COV002 by the University of Oxford, England. Following a long history of partnership, including the announcement on 7 February of an agreement between The Jenner Institute and IRBM’s Advent to

Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced today that the company has entered into a strategic collaboration with Genmab for the process development and manufacture of bispecific antibodies generated with Genmab’s DuoBody® technology platform. This partnership uses an innovative business model which fits well with the expansion plans for Rentschler Biopharma’s U.S. site in Milford, MA.

Leading Asia-Pacific biotech specialist CRO Novotech will collaborate with Endpoints, the independent biotech news platform, for a series of webinars on the advantages of conducting clinical trials in the Asia-Pacific. "Clinical Trial Continuity in Asia-Pacific during the COVID-19 Pandemic" will be broadcast on 8 June, 2020, to open the series. To register please visit Endpoints at : https://tinyurl.com/y9j9szuf. Endpoints Founder & CEO Arsalan Arif will mode

Sorrento Therapeutics, Inc. announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for STI-6129, a CD38-targeting antibody drug conjugate (ADC). STI-6129 utilizes several technology platforms that are under development by Sorrento Therapeutics, including a CD38 specific antibody identified from its fully human G-MAB™ antibody library, its proprietary drug payload Duostatin 5 and its site-specific C-LOCK con