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BioWorld - Thursday, January 15, 2026
Home » Topics » North America » U.S.

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Flags of US and UK on negotiation table

UK/US deal fixes import tariff on drugs at 0% for next 3 years

Dec. 2, 2025
By Nuala Moran
No Comments
The U.K. government has secured a deal guaranteeing there will be no tariffs on the £6.6 billion (US$8.7 billion) of pharmaceutical products exported annually to the U.S., as part of a package of measures under which the U.K. will pay more for patented drugs.
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Last-minute changes made ahead of ACIP meeting

Dec. 2, 2025
By Mari Serebrov
No Comments
U.S. Health and Human Services Secretary Robert Kennedy continued his last-minute musical chairs ahead of the Dec. 4-5 meeting of the Advisory Committee for Immunization Practices (ACIP) when he named Kirk Milhoan as the new chair of the panel that advises the CDC on vaccine schedules.
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Jasper solves Beacon CSU sneak-throughs, wins in asthma phase Ib

Dec. 2, 2025
By Randy Osborne
No Comments
Wall Street was sorting through two batches of news from Jasper Therapeutics Inc., which made public positive data from the phase Ib study called Etesian with KIT-targeting briquilimab in adults with allergic asthma, while making known the outcome of a probe into the phase Ib/II Beacon study with the same drug in chronic spontaneous urticaria.
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3-30-fractyl-revita.png

Fractyl procedure sustains weight loss after GLP-1s

Dec. 2, 2025
By Annette Boyle
Glucagon-like peptide-1 (GLP-1) receptor agonists clearly help patients shed pounds, but many regain all - or more - of the weight once they discontinue the medications. Fractyl Health Inc. could offer an enduring solution with its Revita procedure. Six-month results from its open-label REVEAL-1 cohort of individuals with obesity who lost 15% or more of their total body weight on a GLP-1 therapy maintained that loss after discontinuing the drugs and undergoing the Revita procedure.
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Medicare puzzle

Medicare’s competitive bidding program draws opposition

Dec. 2, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services has posted the home health final rule for calendar year 2026 and has established a framework for competitive bidding for products such as continuous glucose monitors, a move that is struggling to find support among stakeholders.
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SS Innovations International Inc. SSi Mantra 3 robotic surgical system

SS Innovations SSi Mantra surgical robot sees increasing demand

Dec. 2, 2025
By Shani Alexander
SS Innovations International Inc. is experiencing rapid growth and rising demand for its SSi Mantra 3 surgical robotic system. Its revenues are increasing, and so are installations and procedures driven by the design features and affordability of the SSi Mantra, said Sudhir Srivastava, chairman of the board and CEO of SS Innovations. “The system that we have created is, in my personal opinion, better than anything that exists out there because of its various differentiating features and cost effectiveness,” he told BioWorld.
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Kidneys

Otsuka’s IgAN therapy gets a thumbs-up from the FDA

Dec. 2, 2025
By Lee Landenberger
No Comments
The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA.
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US vaccine path under (re)construction

Dec. 1, 2025
By Mari Serebrov
No Comments
Both the FDA and the CDC’s Advisory Committee for Immunization Practices are on the threshold of revising how vaccines are approved and used in the U.S., but whether that opens to a precipice or a new era of stronger evidence and safer use is in the telling of the beholder.
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Protego secures $130M in series B for its AL amyloidosis program

Dec. 1, 2025
By Brian Orelli
No Comments
Protego Biopharma Inc. closed an oversubscribed $130 million series B financing that will be used to advance PROT-001, the company’s treatment for amyloid light (AL) chain amyloidosis. a plasma cell disorder where the cells produce abnormal, misfolded immunoglobulin light chain proteins.
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Kidney disease illustration

Q32 sells rare kidney disease drug to Akebia for $12M up front

Dec. 1, 2025
By Jennifer Boggs
No Comments
Q32 Bio Inc. handed off rights to phase II-stage complement inhibitor ADX-097 in a deal with Akebia Therapeutics Inc. that helps the former extend its cash runway to focus on lead candidate bempikibart in alopecia areata and bolsters the latter’s efforts to build a rare kidney disease pipeline.
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