Edwards Lifesciences Corp. said it is scrapping plans to acquire Jenavalve Technology Inc. for $945 million after a federal court ruled against the company in a case brought by the U.S. Federal Trade Commission (FTC) to block the deal.
With rumors regarding a couple of potential mega-mergers making the rounds, the week of the annual J.P. Morgan Healthcare Conference kicked off with the official disclosure of some billion-dollar collaborations, leading with Abbvie Inc.’s exclusive licensing deal with Remegen Co. Ltd. for PD-1/VEGF-targeted bispecific antibody RC-148.
And another firm has reached a most-favored nation (MFN) pricing deal with the White House. Johnson & Johnson announced Jan. 8 a voluntary agreement with the Trump administration aimed at improving access and lowering prices for medications in the U.S., in exchange for exempting the pharma firm’s products from tariffs.
Radiopharma-focused Aktis Oncology Inc. priced its recently upsized IPO, selling 17.65 million shares at $18 apiece, the high end of its pricing range, raising gross proceeds of $318 million, a hopeful sign that 2026 might signal an opening of the IPO window for biopharma.
Jun Chen, a tenured associate professor of bioengineering at the Samueli School of Engineering at the University of California Los Angeles (UCLA), leads a team developing a speech-sensing wearable patch. The technology translates the intricate muscle movements of the larynx into discernible speech.
Haemonetics Corp. acquired Vivasure Medical Ltd. for €100 million (US$116 million) cash plus up to an additional €85 million (US$99 million) in contingent payments based on sales and other milestones. The deal continues nearly four years of increasing investment in Vivasure by Haemonetics in support of its latest version of the Perqseal vessel closure device.
Generative AI has largely escaped the U.S. FDA’s regulatory purview up to now, but OpenAI seems poised to create a new source of regulatory angst for the agency. The company unveiled its ChatGPT Health Jan. 7, a large language model that when used professionally could land the company in the FDA’s regulatory crosshairs.
The U.S. FDA signaled during a Type B meeting that existing data could support a BLA filing for Moonlake Immunotherapeutics AG’s sonelokimab to treat the skin disease hidradenitis suppurativa (HS), despite one of two pivotal phase III trials missing the mark.
Debate over Vanda Pharmaceuticals Inc.’s Hetlioz (tasimelteon) for use in jet lag disorder looks to continue after the U.S. FDA rejected the latest supplemental NDA submission, with the agency’s Center for Drug Evaluation and Research concluding the application cannot be approved in its current form.
Takeda Pharmaceuticals Co. Ltd.’s oral tyrosine kinase 2 inhibitor, zasocitinib (TAK-279), met the co-primary endpoints and all ranked secondary endpoints in two pivotal phase III studies in patients with moderate to severe plaque psoriasis.
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