BioSpace News Archive

The U.S. Food and Drug Administration issued a Complete Response Letter to Merck & Co. for its New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough.

Oncopeptides has discontinued the marketing of Pepaxto drug in the US. But, in a recent turnaround, they decided to withdraw this decision of stopping the production.

ERYTECH Pharma announced presentation of results of two trials evaluating eryaspasein advanced pancreatic cancerat the American Society of Clinical Oncology Gastrointestinal Cancers Symposium on January 21, 2022.

MaxCyte, Inc., a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, provides a preliminary update on revenue results for the fourth quarter and full year 2021.

BeiGene announced positive findings from the global Phase 3 RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Magnesium Development Company (MDC) has received the FDA’s Breakthrough Device designation, having exceeded the criteria required for participation in the Breakthrough Device Program.

The journal Nature Medicine recently published a study in which researchers developed a novel receptor to enhance recognition of tumors by engineered T cells, addressing an underlying cause for relapsed tumors in patients after chimeric antigen receptor therapy.

Greenwich LifeSciences, Inc. announced that its Board of Directors has authorized the Company’s management to implement a stock repurchase program for up to $10 million of the Company’s common stock at any time.

Bio-Thera Solutions, Ltd. announced that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6021, a monoclonal antibody with enhanced ADCC targeting TIGIT in cancer cells.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced the U.S. commercial availability of Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) 80 U/mL.