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BioWorld - Sunday, April 5, 2026
Home » Topics » North America » U.S.

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US FDA says no, again, to Vanda’s tradipitant in gastroparesis

March 31, 2026
By Mari Serebrov
No Comments
The U.S. path forward is narrowing for Vanda Pharmaceuticals Inc.’s tradipitant as a treatment for gastroparesis, a serious disorder for which there’s been no new treatment in several decades.
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Whoop health and fitness band

Whoop secures $575M, with Abbott a strategic investor

March 31, 2026
By Shani Alexander
No Comments
Whoop Inc. secured $575 million in a series G funding round at a $10.1 billion valuation to advance its AI-powered wearable platform for personalized and preventive health care. Abbott Laboratories joined the round as a strategic investor, backing the company’s push to expand access to its device amid growing demand.
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Handshake icon engraved on metal hexagonal background

Galapagos enters new era as Lakefront after reshaping Gilead alliance

March 31, 2026
By Nuala Moran
No Comments
Galapagos NV is about to bury its recent turbulent past and sail off for the future with its $3 billion cash pile and the new name of Lakefront Biotherapeutics NV. The foundation for the transition was laid earlier this month in an arrangement with Gilead Sciences Inc., holder of 25% of Galapagos’ equity, to “co-parent” the assets of Ouro Medicines LLC, which Gilead is acquiring for up to $2.17 billion.
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Highly complementary Biogen pays $5.6B; who’s jealous of Apellis?

March 31, 2026
By Randy Osborne
No Comments
Biogen Inc. hardly blinked at the competition faced by Apellis Pharmaceuticals Inc. as the two companies sealed a deal whereby the former has agreed to acquire all outstanding shares of the latter for $41 each, or about $5.6 billion.
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Brain with clock hands, day and night background

Lilly shifts from obesity to narcolepsy with $7.8B Centessa buy

March 31, 2026
By Karen Carey
No Comments
Eli Lilly and Co. plans to buy Centessa Pharmaceuticals plc for $6.3 billion in up-front cash and another potential $1.5 billion through contingent value rights, gaining access to a pipeline of orexin receptor 2 agonists for sleep disorders. The Indianapolis-based pharma is re-entering a field that has multibillion-dollar potential and one that could emulate the success seen with its obesity program. Centessa, of Boston and London, has a lead candidate, cleminorexton (formerly ORX-750), with positive phase IIa data in narcolepsy types 1 and 2 and idiopathic hypersomnia.
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Supreme Court shuts the door to three life sciences petitions

March 31, 2026
By Mari Serebrov
No Comments
What do a patent dispute over a CRISPR/Cas system, a rejected whistleblower case involving lab tests and a vaccine injury claim parading as multidistrict tort litigation have in common? All three were denied cert in the U.S. Supreme Court’s latest orders list.
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Brain with handshake and cityscape

Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal

March 30, 2026
By Marian (YoonJee) Chu
No Comments
Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S.
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Oral medication

AAD 2026: Targeted oral therapies challenge injected biologics

March 30, 2026
By Nuala Moran
No Comments
Data presented at the 2026 American Academy of Dermatology (AAD) meeting have put the spotlight on the arrival of target-selective oral therapies that are set to challenge injected biologics in terms of efficacy, while offering greater convenience and improving access to treatment.
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Paper airplanes with red leading

US FDA pondering next steps for CNPV

March 30, 2026
By Mari Serebrov
No Comments
Introduced last year as a pilot program, the U.S. FDA Commissioner’s National Priority Voucher (CNPV) could be here to stay – at least for the duration of Marty Makary’s tenure as FDA commissioner. Since the FDA unveiled the CNPV last June, it has welcomed 18 products from 16 companies into the “game-changer” program for patients, as Makary described it. The goal is to provide an “ultrafast review pathway,” one to two months instead of the standard 10 to 12 months, for drugs and biologics of strategic national importance while maintaining the FDA’s scientific and regulatory standards, according to the agency.
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Boston Scientific - Watchman FLX

Boston Sci boasts Champion-AF data but strokes signal a concern

March 30, 2026
By Shani Alexander
No Comments
Boston Scientific Corp. revealed much-anticipated data from the Champion-AF trial which showed that its Watchman FLX device provides superior protection from bleeding compared to non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). The left atrial appendage closure device also proved noninferior to NOACs in reducing stroke, cardiovascular death, or systemic embolism.
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