Akero Therapeutics Inc.’s phase IIb data with FGF21 analogue efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) kept interest alive in the face-off between the company and 89bio Inc. with pegozafermin, another FGF21 drug targeting MASH, for which a phase III study is planned. Read More
Vivoryon Therapeutics NV said it will conduct an in-depth analysis after reporting top-line data showing the phase IIb European Viviad study testing its oral small molecule, varoglutamstat, in patients with early Alzheimer’s disease missed statistical significance on the primary endpoint measuring changes in cognition over time. Investors, however, opted for a more immediate reaction, sending company shares (Euronext Amsterdam:VVY) plunging 90% March 4, to close at €0.80 (US87 cents) Read More
While preparing a follow-on phase III study of its Cardiamp cell therapy, Biocardia Inc. has mined positive interim data at a mean 20-month follow-up of all patients in the original Cardiamp HF Trial. Read More
With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration. Read More
A new spinout from Monash University in Melbourne, Australia, is tackling biology to better understand immune cell function and to find targets that were thought to be undruggable. Read More
With valuations heading higher, pharmaceutical companies are looking to make deals. “The M&A environment has kind of woken up a little bit,” Jay Stamatis, vice president and head of business development and acquisitions at Abbvie Inc., told the audience at Biocom California’s Global Life Science Partnering & Investor Conference. Read More
The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer. Read More
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer. Read More
Discover a wealth of industry insights with BioWorld’s extensive collection of infographics, covering the latest trends and developments in both biopharma and med-tech. Our weekly infographics are curated to provide concise summaries of key topics: financings (IPOs, private financings, public/other and follow-on offerings), deals and M&As (top deals, and monthly value and volume), regulatory (including U.S. FDA and worldwide approvals), clinical trials and more. In addition, you’ll find access to BioWorld’s year-in-review reports, as well as special infographics about obesity, pain and addiction, biosimilars and the aging space. Read More
New hires and promotions in the biopharma industry, including: Anagenex, Apollomics, Aruna, Elevation Oncology, Eyepoint, Shattuck Labs, Sitryx, Skye, Tome, Verona, Y-mabs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Beigene, Biovie, Bone Biologics, Cardiff Oncology, Innovent, Maat, Oncopeptides, Sellas, Sonnet. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antibe, Bayer, Biocon, Biomunex, Bridgebio, C4 Therapeutics, Coherus, Genesis Pharma, Janssen, Kinnate, Merck KGaA, Nuance, Pierre Fabre, Regeneron Ireland, Sandoz, SQZ, Stemcell. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4SC, Atara, Carsgen, Cullinan, Jacobio, Mallinckrodt. Read More
