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.

Eisai wins on appeal: Leqembi recommended in Europe

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. Patients who are homozygous for ApoE4 are at highest risk of amyloid-related imaging abnormalities, a serious side effect that involves edema and potentially, hemorrhage in the brain. 

Trump nominates Robert F. Kennedy Jr. as HHS head

President-elect Donald Trump’s nomination of vaccine skeptic Robert F. Kennedy Jr. as U.S. Secretary of Health and Human Services sent ripples through the biopharma sector, but whether Kennedy can claim the seat remains to be seen. Four Republican senators’ “no” votes could block the appointment. Other strategies might be deployed by Trump, however, including a “recess appointment.” Article II, section II of the Constitution says the president has “power to fill up all vacancies that may happen during the recess of the Senate, by granting commissions which shall expire at the end of their next session.”

Merck licenses Lanova’s PD-1/VEGF bispecific in $2.7B+ deal

Merck & Co 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.

Vitalli terminates $477M Daewoong deal, retains $941M option

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. Disclosed on the Korea Exchange Nov. 15, Daewoong said Vitalli had notified the former of the termination on Nov. 14, which will become finalized after a sixty-day negotiation period. Seoul, South Korea-based Daewoong said it has no obligation to return the $11 million (₩14.73 billion) received in an up-front payment. Vitalli’s rationale for the termination was not disclosed.

Celltrion to acquire Iqone Healthcare Switzerland for ₩30B

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. “While we have successfully built direct sales networks, we are now leveraging acquisitions to accelerate our European expansion.” Versoix, Switzerland-based Iqone, a specialty pharma distribution and sales company, will become a wholly owned subsidiary of Budapest, Hungary-based Celltrion Healthcare Hungary Kft by year’s end. Parent company Celltrion is based in Incheon, South Korea.

BioWorld Insider podcast: Modifi gets creative on the rocky road to a multibillion-dollar buyout

For a small company, Modifi Biosciences has come a long way very quickly. In the newest episode of the BioWorld Insider podcast, 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.

Also in the news

3B, AC Immune, Adial, Alloy, Artbio, Beigene, Calidi, Curium, Eli Lilly, Eupraxia, Flashpoint, Gilead, Giostar, GSK, Humacyte, Idrx, Immunic, ImmunoCure, Immutep, Inovio, Khondrion, Lanova Medicines, Leo, Mediprint Ophthalmics, Merck, Microbion, Nobias, Nurexone, Nuvectis, Opthea, PTC, Sparian, Syncona, X4