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BioWorld - Sunday, June 14, 2026
Home » Topics » Regulatory

Regulatory
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Compounded weight-loss drugs hit on every side

Feb. 9, 2026
By Mari Serebrov
No Comments
True to its word, Novo Nordisk A/S filed a patent infringement lawsuit in U.S. district court against Hims & Hers Health Inc. over compounded versions of Novo’s semaglutide products.
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Vaccine vial and syringe
Immune

Delonix gains clinical trial clearances for MenB vaccine DX-104

Feb. 9, 2026
No Comments
Delonix Bioworks Ltd. has obtained IND clearance from China’s National Medical Products Administration (NMPA) for its group B meningococcal (MenB) vaccine candidate, DX-104. This follows the successful completion last month of clinical trial notification (CTN) procedures and ethics committee approval in Australia.
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Art concept for molecular glue degradation
Immune

Innocare’s VAV1 degrader ICP-538 cleared for clinic in China

Feb. 9, 2026
No Comments
Beijing Innocare Pharma Tech Co. Ltd. has gained IND clearance in China to conduct clinical trials of ICP-538, an orally administered molecular glue degrader targeting VAV1, which is a key protein downstream of T-cell and B-cell receptors. ICP-538 is being studied for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus and multiple sclerosis.
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Medtronic to pay Applied Medical $382M in antitrust ruling

Feb. 6, 2026
By Shani Alexander
No Comments
A jury in a U.S. District Court unanimously found that Medtronic plc violated federal and state antitrust laws relating to its blood sealing surgical devices and must pay $382 million in damages to Applied Medical Resources Corp.
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Trumprx screenshot

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

Feb. 6, 2026
By Randy Osborne and Mari Serebrov
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.
Read More
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