AbbVie (NYSE: ABBV) announces today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental Biologics License Application (sBLA) concerning epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody. This treatment targets adult patients with relapsed…
Vertex Pharmaceuticals (Nasdaq: VRTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favorable opinion regarding the expansion of the label for KALYDECO® (ivacaftor) to include the treatment…
Bristol Myers Squibb (NYSE: BMY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl® (luspatercept) for the treatment of adult patients with transfusion-dependent anemia due to…
Bristol Myers Squibb (NYSE: BMY) has confirmed the conclusion of its tender offer, initially announced, to acquire all outstanding shares of RayzeBio, Inc. (Nasdaq: RYZB) common stock at a price of $62.50 per share in cash, totaling approximately $4.1 billion.…
The U.S. Food and Drug Administration (FDA) has given priority review status to the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab), marking its sixth potential indication. This review targets its use as an add-on maintenance treatment for specific adult…
AstraZeneca Completes Acquisition of Gracell Biotechnologies Inc., Expanding Cell Therapy Portfolio AstraZeneca has successfully finalized the acquisition of Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL), a prominent global biopharmaceutical company specializing in innovative cell therapies for cancer and autoimmune diseases. This…
Merck (NYSE: MRK), also known as MSD outside of the United States and Canada, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval…
AbbVie Inc. (NYSE: ABBV) and Tentarix Biotherapeutics have unveiled a significant collaboration aimed at pioneering the development of conditionally-active, multi-specific biologics targeting oncology and immunology. This strategic alliance will harness AbbVie’s extensive experience in these fields alongside Tentarix’s groundbreaking Tentacles™…
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical-stage pharmaceutical company specializing in the discovery, development, and commercialization of oral, small molecule protease inhibitors, has announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Innovation Passport…
The COVID-19 pandemic has brought to light the vulnerabilities inherent in global supply chains, especially affecting the access of low- and middle-income countries (LMICs) to crucial medical supplies. The disproportionate concentration of manufacturing capacity in a handful of nations and…
Today, GSK has announced the successful completion of its acquisition of Aiolos Bio (Aiolos), a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions. As previously announced, this acquisition includes AIO-001, a…
CRISPR Therapeutics (Nasdaq: CRSP), a leading biopharmaceutical company dedicated to pioneering transformative gene-based therapies for serious illnesses, has announced a strategic move in securing approximately $280 million through a registered direct offering of its common shares. This offering, set at…