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BioWorld - Wednesday, March 4, 2026
Home » Topics » Regulatory, BioWorld

Regulatory, BioWorld
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Vanda scores hearing to review Hetlioz in jet lag disorder

March 3, 2026
No Comments
Vanda Pharmaceuticals Inc. will get to take its argument for twice-rejected jet lag disorder drug Hetlioz (tasimelteon) before the U.S. FDA in a formal evidentiary public hearing, a rare move by the agency that the firm claims underscores the “gravity of the legal and scientific issues” it has raised.
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Red and white roadblock

Experts: Regulatory roadblocks stalling rare disease therapies

March 3, 2026
By Mari Serebrov
No Comments
A lot of distance lies between talking regulatory flexibility and actually being flexible. That message was driven home again after Uniqure NV disclosed in its latest earnings report March 2 that the U.S. FDA wants a sham-controlled study before it will consider approval of the company’s gene therapy AMT-130 in Huntington’s, a rare disease currently affecting about 41,000 people in the U.S.
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Woman applying skin cream to elbow

Adquey finds hatchway, still more in PDE4

March 2, 2026
By Randy Osborne
No Comments
The U.S. FDA clearance Feb. 20 of East Windsor, N.J.-based Acrotech Biopharma Inc.’s PDE4 inhibitor Adquey (difamilast ointment 1%) for mild to moderate atopic dermatitis brought renewed focus on the mechanism, where other drugs are already approved and more are stocking developers’ pipelines across indications.
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ACIP grows by two ahead of next meeting

March 2, 2026
By Mari Serebrov
No Comments
The U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) has two new members, bringing its total membership to 15. As he has done since dismissing the entire ACIP panel last June, Health and Human Services Secretary Robert Kennedy named the new members, Angelina Farella and Sean Downing, barely two weeks before the next ACIP meeting, March 18-19.
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Tablets form silhouette of world map

Changing US FDA trial default a global matter

Feb. 27, 2026
By Mari Serebrov
No Comments
The U.S. FDA’s expectations that its new default position of basing marketing authorization of novel drugs on one adequate, well-controlled trial may be overstated. In explaining the policy in a recent article in The New England Journal of Medicine, FDA Commissioner Marty Makary and CBER Director Vinay Prasad said they expect the initiative will create a “surge in drug development,” substantially reduce development costs and will speed drugs to market. While the initiative could reduce the time to the U.S. market, those expectations don’t take into consideration global norms and payer expectations.
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US taking a closer look at China biotech subsidies

Feb. 26, 2026
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U.S. scrutiny of China’s trade practices, especially in the biotech sector, continues to escalate as the U.S. International Trade Commission launches two factfinding investigations Congress mandated in the fiscal 2026 appropriations.
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Ninth Circuit agrees with Lilly in royalty dispute

Feb. 26, 2026
By Mari Serebrov
No Comments
Eli Lilly and Co. got a breather when the U.S. Ninth Circuit Court of Appeals agreed that the company doesn’t owe Research Corporation Technologies Inc. (RCT) royalties on its diabetes drugs under a licensing agreement Lilly had made with Phillips Petroleum Co. in 1990 and that Phillips later sold to RCT.
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Jiuyuan seeks approval of Wegovy biosimilar in China

Feb. 26, 2026
By Marian (YoonJee) Chu
No Comments
China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
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Allurion swallowable gastric balloon

FDA approves Allurion’s gastric balloon system

Feb. 26, 2026
By Shani Alexander
No Comments
The U.S. FDA approved Allurion Technologies Inc.’s premarket application for its swallowable gastric balloon system, which features its Smart Capsule, for weight loss. The clearance is boon for the company as GLP-1 agonists gets increasingly adopted to treat obesity. The approval also brings to the market a new non-invasive option to patients looking for alternative ways to lose weight.
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Another lawsuit challenges changes to ACIP, US vaccine schedule

Feb. 25, 2026
By Mari Serebrov
No Comments
U.S. Health and Human Services Secretary Robert Kennedy is facing a second lawsuit challenging his replacement of all the members of the Advisory Committee on Immunization Practices (ACIP) and seeking to undo the CDC’s Jan. 5 revision of its childhood immunization schedule.
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