Search Results

Despite the PDUFA date being extended by three months for Merus’ zenocutuzumab, Truist Securities analyst Asthika Goonewardene in a Tuesday note to investors said the delay is not a cause for concern with an approval expected.

Spago Nanomedical Spago Nanomedical AB announced the appointment of Birgitta Rembratt Svensson as Head of CMC & Supply.

Tonix Pharmaceuticals Holding Corp. today announced receipt of the formal minutes from a recent pre-New Drug Application (NDA) Type-B Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ for the management of fibromyalgia.

BrainStorm Cell Therapeutics Inc. ment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm’s Phase 3b clinical trial for NurOwn.

SELLAS Life Sciences Group, Inc. today announced that it recently concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Company’s Chemistry, Manufacturing, and Controls (CMC) sections in a potential biologics license application (“BLA”) for SELLAS’ lead product candidate, galinpepimut-S (GPS).

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd., a clinical-stage biotechnology company committed to advancing oligonucleotide therapies, with a primary focus on achieving a functional cure for chronic hepatitis B infection, announced that Dr. Will Wei has joined the company as Head of CMC, SVP.

Charles River Laboratories International, Inc. (NYSE: CRL) today announced a strategic agreement with Wheeler Bio, Inc., an antibody contract development and manufacturing organization (CDMO) focused on preclinical and early clinical supply of recombinant proteins, providing clients access to Wheeler’s Portable CMC® (Chemistry, Manufacturing and Controls) platform.