Following a discussion that focused more on a new personalized trial strategy rather than the proposed therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 April 30 that Astrazeneca plc’s camizestrant demonstrated a clinically meaningful benefit in treating patients with HR+/HER2- metastatic breast cancer. Read More
The memory of Merck & Co. Inc.’s $10 billion takeover last year of inhaled respiratory drug specialist Verona Pharma plc may not have been far from the minds of Wall Street speculators as Avalyn Pharma Inc. priced its IPO, selling about 16.6 million shares at the high end of the targeted range, or $18 each, to reap about $300 million. The stock (NASDAQ:AVLN) came out of the gate strong on the first day of trading and closed April 30 at $29.49, up $11.49, or 64%. Read More
Dermatology specialist Leo Pharma A/S is moving into gene therapy with the $50 million acquisition of Replay Holdings LLC, a seed-stage company that is developing high capacity herpes simplex virus vectors to treat rare inherited diseases. Read More
Beone Medicines Ltd. gained an exclusive option to develop cancer immunotherapy HH-160 worldwide in a deal potentially worth more than $2 billion for Huahui Health Ltd., the developer of the trispecific antibody. Read More
A new molecule combines the action of two incretins, GLP-1 and GIP, hormones that regulate glucose and appetite, with lanifibranor, a triple agonist of peroxisome proliferator activated receptors (PPAR α/γ/δ). GLP-1-GIP-Lani enables targeted delivery of the PPAR agonist to cells that express incretin receptors, enhancing weight loss, improving glucose control and reducing inflammation in obese mice. In these models, it surpassed the effects of GLP-1 receptor agonists such as semaglutide and GLP-1-GIP co-agonists such as tirzepatide in reducing body weight, improving glycemic control and enhancing metabolic outcomes during active treatment. Read More
The European Medicines Agency (EMA) has launched a pilot program to fast track breakthrough medical devices in the EU and get lifesaving technologies to patients sooner. The program will allow for companies to obtain scientific advice from the expert panels intended to support evidence generation and clinical development of their devices. Read More
After a standout 2025, the BioWorld Cancer Index (BCI) started 2026 on more measured footing. Early volatility this year saw the BCI drop 11.51% by the end of January before recovering to post a modest 1.39% gain for the first quarter (Q1). Read More
The U.S. SEC filed a settlement April 29 that it reached with Anthony Cataldo regarding allegations that the former chairman and CEO of a clinical-stage biopharma company misappropriated about $3.2 million from the company and then concealed the misconduct from the company’s auditors. Read More
The U.S. Department of Health and Human Services (HHS) has appealed a recent federal ruling that put on hold several changes to the childhood vaccine schedule and the Advisory Committee on Immunization Practices as reconstituted by HHS Secretary Robert Kennedy. Read More
Biopharma and med-tech companies raising money in public or private financings, including: AB Science, GH Research, Axoft, Hypervision Surgical, Intellia, Neurosense, Oruka, Tacalyx, Vivacta. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Candel, Circular, Emalex, Eversana, Greywolf, Infinite, Pfizer, Psyga, Teva, XTL. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: 3D Systems, Agitated Solutions, Beone, Chest Wall, CMR, Dr. Reddy, Earflo, Expression, Gilead, Henlius, Hutchmed, Immunome, Norgine, Olympus, Prelude, Ray. Read More
