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Novo Nordisk semaglutide pill

Oral GLP-1 Wegovy chases approval in obesity

May 5, 2025
By Lee Landenberger
No Comments
The U.S. FDA has accepted the NDA for an oral formulation of Novo Nordisk A/S’s Wegovy (semaglutide) in treating obesity. If approved, the daily pill will be the first oral GLP-1 for treating chronic weight management. So far, however, it has been injectables leading the way to approval.
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Magnifying glass over globe, focused on Mexico

Annual US 301 trade report has louder bark

May 5, 2025
By Mari Serebrov
No Comments
Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies.
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3D representation of tumor
Cancer

Nutshell gains IND clearance for p53 Y220C reactivator NTS-071

May 5, 2025
No Comments
Nutshell Therapeutics (Shanghai) Co. Ltd. has received IND clearance from the FDA to initiate a phase I trial in the U.S. with NTS-071 for anticipated use in solid tumors with a p53 Y220C mutation. The trial is expected to begin in the second half of this year.
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U.S. flag on columned building
MDMA annual meeting

Compliance still important under new Department of Justice

May 2, 2025
By Mark McCarty
The U.S. Department of Justice may have dismantled its civil division, but that doesn’t mean companies in the life sciences can let their guard down.
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CMS logo and website
MDMA annual meeting

CMS vows to put more emphasis on MA plans’ prior authorization

May 2, 2025
By Mark McCarty
Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight.
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3D illustration of headache

FDA clears Satsuma’s Atzumi for migraine

May 2, 2025
By Karen Carey
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
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3D heart in chest

Oh them REMS: Cytokinetics heart-hit with FDA delay

May 2, 2025
By Randy Osborne
Wall Street immediately set to weighing the long-term import of Cytokinetics Inc.’s regulatory delay with aficamten, but the short-term impact was evident, as shares (NASDAQ:CYTK) dipped to close May 2 at $37.35, a loss of $5.57 or 13%.
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Immuno-oncology

Obi Pharma gains IND clearance for TROP2-targeting ADC OBI-902

May 2, 2025
No Comments
Obi Pharma Inc. has gained IND clearance from the FDA for OBI-902, a TROP2-targeting cancer therapy for advanced solid tumors.
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U.S. FDA headquarters

FDA’s Tarver says agency open to improvement of third-party reviews

May 1, 2025
By Mark McCarty
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), covered several programmatic areas in a May 1 trade association meeting, such as the CDRH early alert program.
Read More
Device in heart

FDA expands Edwards’ TAVR to asymptomatic severe aortic stenosis

May 1, 2025
By Annette Boyle
In a significant boost to the Edwards Lifesciences Corp. Sapien 3 platform’s market opportunity, the U.S. FDA approved use of the transcatheter aortic valve replacement in patients with asymptomatic aortic stenosis.
Read More
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