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Home » Topics » Regulatory

Regulatory
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Laptop displaying FDA logo

Industry afforded more chances to tap into FDA’s TAP

July 5, 2024
By Mark McCarty
The pilot version of the U.S. FDA’s advisory program for breakthrough medical device life cycle management was initially limited to cardiovascular devices, but the agency has announced an expansion into other product areas. Going forward, orthopedic, radiological and ophthalmic devices will be eligible for the FDA’s Total Life Cycle Advisory Program, which will aid applicants in obtaining both faster and more trouble-free market access.
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Kidney, pills, bottle
Nephrology

Eleva’s CPV-104 awarded European orphan drug designation for C3 glomerulopathy

July 4, 2024
Eleva is preparing a first clinical study in this indication, with dosing slated to begin in in the first half of next year.
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Brain with puzzle piece removed

Donanemab approved: Lilly’s Alzheimer’s drug clears FDA hurdle

July 3, 2024
By Jennifer Boggs
Less than a month after the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee handed down a unanimous vote in favor of Eli Lilly and Co.’s Alzheimer’s disease candidate (AD), donanemab, the agency approved the drug as a once-monthly injection for adults with early symptomatic disease. Branded Kisunla, the beta-amyloid antagonist marks the second approved AD drug that has demonstrated in clinical trials an ability to slow cognitive decline, going up against Leqembi (lecanemab) from Biogen Inc. and Eisai Co. Ltd., which won full approval in July 2023, only six months after nabbing an accelerated nod.
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Bar chart, downward arrow

Biosecure Act leaves biopharmas less confident in Chinese partners

July 3, 2024
By Tamra Sami
Confidence in working with Chinese biopharma companies has dropped by 30% to 50% for U.S.-based life sciences companies, with Chinese contract development and manufacturing organizations the hardest hit, according to a recent LEK survey of global life sciences companies on the impact of the pending U.S. Biosecure Act.
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CMS logo and website

MedPAC wary of Medicare software payment in fee-for-service care

July 3, 2024
By Mark McCarty
The problems with U.S. Medicare coverage for medical software are well known, but the Medicare Payment Advisory Commission recently indicated that these problems are largely manageable for services delivered via managed care plans.
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BioHealx device

FDA grants de novo clearance to Signum’s anal fistula device

July 3, 2024
By Shani Alexander
The U.S. FDA granted Signum Surgical Ltd. de novo marketing clearance for its Biohealx technology as a treatment for anal fistula. Biohealx is a single use, bioabsorbable implant, designed to not only to treat the condition in a minimally invasive procedure but also promote healing, prevent fistula recurrence and protect patient continence.
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Antibodies illustration

Tracon quits work on anti-PD-L1 envafolimab after phase III flop

July 2, 2024
By Tamra Sami
Tracon Pharmaceuticals Inc. is shuttering all development of its subcutaneous PD-L1 antibody, envafolimab, after the pivotal trial failed to meet the primary endpoint in soft tissue sarcoma.
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Unwinding of Chevron could bring down HHS, FDA, CMS policies

July 2, 2024
By Mari Serebrov
The U.S. Department of Health and Human Services (HHS) and the FDA already are getting a glimpse of the post-Chevron world and how the Supreme Court’s June 28 unwinding of the 40-year-old Chevron deference could rein in agency policies that defy Congress’ expressed intent.
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Red wooden approved stamp

China approves first cetuximab biosimilar

July 2, 2024
By Tamra Sami
China’s National Medical Products Administration authorized the country’s first cetuximab biosimilar with the approval of Simcere Zaiming’s Enlituo (CMAB-009, cetuximab beta injection) in combination with chemotherapy as first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer. The biosimilar references originator drug Erbitux (cetuximab, Eli Lilly and Co.).
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Drug vials

FDA grants approvals to Stelara, Neupogen, Eylea biosimilars

July 2, 2024
By Marian (YoonJee) Chu
The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
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