Despite government efforts to prop up biopharma and med-tech research toward creating women’s health products, companies must eventually reach out to the private markets to bring their inventions to the next stage of development. Anna Zornosa-Heymann, a women’s health investor, serves as a part-time contractor with the U.S. NIH’s SEED (Small business Education & Entrepreneurial Development) office, where she helps companies move from government to external funding. Government funds are “excellent to pay for research … but those funds don’t allow you to build a first-class team and to develop a sales apparatus,” she told BioWorld. Read More
The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file. Read More
President-elect Donald Trump’s nomination of Robert F. Kennedy Jr. as U.S. Secretary of Health and Human Services (HHS) grabbed headlines globally, but the political jostling to come will determine whether Kennedy can secure the seat. Read More
Merck & Co. Inc. has in-licensed Lanova Medicines Ltd.’s PD-1/VEGF bispecific antibody LM-299 in a deal worth up to $2.7 billion in a move to bolster its Keytruda (pembrolizumab) fortress. Under terms of the deal, Merck (known as MSD outside the U.S.) gains an exclusive global license to develop, manufacture and commercialize LM-299 in exchange for an up-front payment of $588 million. Shanghai-based Lanova is eligible to receive up to $2.7 billion in milestone payments associated with the technology transfer, development, regulatory approval and commercialization of LM-299 across multiple indications. Read More
Vitalli Bio Inc. terminated a potential $477 million licensing deal for autoimmune disease drug, DWP-213388, signed a year ago with Daewoong Pharmaceutical Co. Ltd., although Vitalli still retains option rights to two more dual inhibitor candidates that could fetch up to $941 million. Read More
Celltrion Inc. said it would acquire Iqone Healthcare Switzerland SA in the fourth quarter of 2024 for about ₩30 billion (US$21.34 million) to expand its European business. “This move represents a strategic shift in our growth strategy,” Taehun Ha, Celltrion vice president and Europe head, said in a statement Nov. 15. 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
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Curium, Eli Lilly, Eupraxia, Gilead, GSK, Idrx, Immunic, ImmunoCure, Immutep, Inovio, Nuvectis, Sparian, AC Immune, Mediprint, Microbion, Nobias, X4. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3B, Alloy, Artbio, Beigene, Beone, Flashpoint, Slingshot, Syncona. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Global Institute of Stem Cell Therapy, Kondrion, Leo Pharma, Nurexone, PTC. Read More
