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BioWorld - Sunday, February 8, 2026
Home » Topics » Regulatory

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Trumprx screenshot

Hims in trouble, Novo says no-go as Trumprx.gov debuts

Feb. 6, 2026
By Mari Serebrov and Randy Osborne
No Comments
Trumprx.gov launched with much fanfare late Feb. 5, and the online tool brings promise for the “world’s lowest prices” on prescription drugs. Alongside the website hoopla came word from Hims & Hers Health of its own steep discounts on what’s to be the compounded version of a Trumprx-featured therapy: oral Wegovy (semaglutide) for obesity. Novo Nordisk A/S, Wegovy’s originator, vowed to fight.
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Abbott Laboratories’ Cardiomems HF system

UK’s NICE recommends Abbott’s Cardiomems heart failure system

Feb. 5, 2026
By Shani Alexander
No Comments
The U.K.’s National Institute for Health and Care Excellence (NICE) has recommended the use of Abbott Laboratories’ Cardiomems HF system, giving people living with heart failure an option to monitor their condition daily from home. The implantable wireless sensor could transform care for individuals with the chronic condition as it will enable them to catch early warning signs before they escalate to medical emergencies.
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NIH Biomedical Research Center

Unburdening the past, HELPing NIH advance the future

Feb. 5, 2026
By Mari Serebrov
No Comments
In keeping with the congressional practice of passing major NIH reform legislation every 10 years, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee took the first step in looking at what can be for the NIH while unburdening it from what has been over the past few years.
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Heart scientific overlay
Cardiovascular

FDA clears IND for Affinia’s AFTX-201 for BAG3-DCM

Feb. 5, 2026
No Comments
Affinia Therapeutics Inc. has obtained IND clearance from the FDA for AFTX-201, an investigational genetic medicine for the treatment of BAG3-associated dilated cardiomyopathy (DCM). The phase I/II UPBEAT trial will begin in the first half of this year.
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Infection

BARDA offers $100M in prize money for antiviral development

Feb. 4, 2026
No Comments
Looking to fill a treatment gap, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is launching the first stage of a $100 million prize competition to support development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families.
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BARDA offers $100M in prize money for antiviral development

Feb. 4, 2026
No Comments
Looking to fill a treatment gap, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is launching the first stage of a $100 million prize competition to support development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families.
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Gavel and block with Chinese flag

China amends drug rules to enforce lifecycle accountability

Feb. 4, 2026
By Tamra Sami
No Comments
China’s State Council updated its Drug Administration Law, and the changes mark a substantive evolution in the country’s drug regulatory framework.
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Rare pediatric PRV extended to 2029

Feb. 4, 2026
By Jennifer Boggs
No Comments
Reauthorization of the rare pediatric disease priority review voucher (PRV) was included in the spending package signed into law Feb. 3 by U.S. President Donald Trump, removing at least one aspect of uncertainty facing rare disease companies, many of which have relied on the PRV’s transferrable option as a lucrative source of funding.
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Amgen headquarters

Amgen thumbs-down on FDA’s ask, Tavneos sales continue

Feb. 4, 2026
By Randy Osborne
No Comments
Amgen Inc.’s head of R&D James Bradner said his firm was “surprised” by the request from the U.S. FDA Jan. 16 to take Tavneos (avacopan) off the market – and the company said no. “We're in discussions with FDA, and we'll answer questions as we talk with them,” he added.
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FTC consent order beefs up PBM reforms in spending bill

Feb. 4, 2026
By Mari Serebrov
No Comments
In a one-two-punch to pharmacy benefit managers (PBMs), the U.S. FTC announced Feb. 4 what it’s calling a “landmark settlement” with the Cigna Group’s Express Scripts Inc. and its affiliates that will require fundamental changes to the company’s business practices.
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