A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda.
Ascentage Pharma Group Corp. Ltd. has priced the first IPO of the year in the U.S. The offering of 7.32 million shares has the Suzhou, China, and Rockville, Md.-based company looking for gross proceeds of about $126.4 million, assuming a price of $17.25 per share.
A pair of investor calls on Jan. 22 added clarity to the rapidly evolving cardiac ablation market with Abbott Laboratories and Johnson & Johnson providing updates on their pulsed field ablation programs. Both outlined challenges in the U.S. market that continue to place them at a disadvantage compared to current market leaders Boston Scientific Corp. and Medtronic plc, though bright spots also shone through.
The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common.
The U.S. FDA approved 19 drugs in December, an increase from 10 in November. In total, 228 FDA approvals were granted in 2024, averaging 19 per month. Seven new molecular entities were approved in December, bringing the year's total to 49.
Neomorph Inc. has signed another billion-dollar deal to develop molecular glue degraders, this time with Abbvie Inc. It’s the third agreement in the past year the five-year-old company has signed with big pharma companies in a space with lots of collaborative deals.
With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.
Beta Bionics Inc. kicked off the new year with plans for an initial public offering of 7.5 million shares “as soon as practicable.” Expected to be priced at $14 to $16 per share, the IPO would gross $105 million to $120 million for the insulin delivery device maker.
In a boon for companies developing brain-computer interface (BCI) technologies, researchers have used a BCI and artificial intelligence to restore touch sensations in a bionic arm.
The backlog of requests for Medicare national coverage analyses is a matter of record, but a new analysis highlights how deep that backlog runs. CMS declared it will review a petition from Impulse Dynamics to consider coverage of cardiac contractility modulation, responding to a request the company filed more than two and a half years ago.
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