“It all comes down to outcomes,” said Michael Davidson, CEO of Newamsterdam Pharma Co. NV, which hailed “robust” and “consistent” data from its phase III study testing a fixed-dose combination of CETP inhibitor obicetrapib plus established anti-cholesterol drug ezetimibe, even as investors focused on a couple of findings that turned up lower than expected, sending shares of the company (NASDAQ:NAMS) down 15.5% to close Nov. 20 at $20.01. Read More
While women with “big hearts” play well in popular culture, cardiologists see a very different picture – with significant implications for women’s health and medical care. Women have smaller hearts and narrower blood vessels than men and their cardiovascular systems respond to disease and treatment in very different ways. Growing evidence that failure to reflect women’s distinct anatomy in cardiac care leads to deadly disparities in outcomes has recently stimulated development of new diagnostics and increased focus on inclusion of women in medical device trials. Read More
The U.S. FDA added hidradenitis suppurativa to the label for UCB SA’s Bimzelx (bimekizumab-bkzx), throwing renewed light on the indication, a chronic disease that causes painful, boil-like lumps that appear under the skin. Regulators cleared the humanized IL-17A and IL-17F antagonist for adults with moderate to severe HS, marking the drug’s fifth approval. Read More
The bad news keeps piling up for Sage Therapeutics Inc. Having absorbed other study stumbles in the past few months, the company now has halted development of dalzanemdor in treating Huntington’s disease after top-line phase II data showed it missed a statistically significant difference compared to placebo on the primary endpoint. Read More
Radiopharmaceutical company Telix Pharmaceuticals Ltd. has inked a deal worth up to AU$264 million (US$171 million) to license and develop next-generation radiopharma imaging and therapy technology targeting fibroblast activation proteins found in a wide range of cancers. Read More
For a small company, Modifi Biosciences has come a long way very quickly. Founder Ranjit Bindra talks about how his company went from tiny to nearly extinct at least twice until it was acquired by Merck for $30 million up front. Read More
New hires and promotions in the biopharma industry, including: Avenzo, C4, Conduit, Eikon, Eli Lilly, Flagship Pioneering, Hutchmed, Metaphore, Pfizer, Rondo, Seaport, Thryv, Unnatural Products. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Appili, Bayer, Beigene, Biolojic, Bristol Myers, Cytokinetics, Intas, Lindis, MSN Pharmaceuticals, Neurogene, Pharmanovia, SK Biopharmaceuticals, Telix, Xbrane. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Leo, Pharmather, Ractigen, Siren, Tris, Vir. Read More
