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Regulatory
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Woman scratching hives on shoulder

Dupixent bounces back in treating hives with FDA approval

April 21, 2025
By Lee Landenberger
The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.
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4-17-intuitive-da-vinci.png

NICE OKs conditional coverage of robotic surgery

April 17, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) gave the nod to a total of 11 robotic surgical systems for use in the U.K.’s trusts, but this is no free pass as the agency expects the manufacturers of these systems to gather data under this conditional coverage framework.
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Puzzle pieces missing from $100 bill

Budget woes ahead for US life sciences sector?

April 17, 2025
By Mari Serebrov
The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS.
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Gloved hand holding petri dish containing world map
Immune

WHO member states outline pandemic plan

April 17, 2025
By Lee Landenberger
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
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U.S. FDA headquarters

Regulatory attorney says CDRH reviewers easier to work with

April 16, 2025
By Mark McCarty
The recent staff cuts at the U.S. FDA’s device center caught the attention of outsiders but also caught the attention of those who work on premarket applications for 510(k) and PMA filings.
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China’s NMPA accepts Innocare’s zurletrectinib NDA for solid tumors

April 16, 2025
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted Innocare Pharma Ltd.’s NDA for its second-generation pan-tropomyosin receptor kinase inhibitor, zurletrectinib (ICP-723), for treating adults and adolescents with advanced solid tumors harboring neurotrophic tyrosine receptor kinase gene fusions.
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Doctor, female patient, stethoscope

AMA panel eyes CPT code for cardiac contractility modulation

April 16, 2025
By Mark McCarty
The American Medical Association’s CPT editorial panel will meet May 1-3 to consider codes for several devices and services, but the most important of these might be the code for cardiac contractility modulation.
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WHO member states outline pandemic plan

April 16, 2025
By Lee Landenberger
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
Read More
Pills, bottle on $100 bills

New Trump order zeroes in on drug prices

April 16, 2025
By Mari Serebrov
In a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate efforts of his first administration to drive down prescription drug prices. “My first term included numerous significant actions, including some of the most aggressive in recent history, to deliver lower prescription drug prices to American patients,” Trump noted in the order, which builds on many of those actions, including increased competition, re-importation, price transparency and a mandate to pass discounts through to patients.
Read More
Induced pluripotent stem cells
Neurology/psychiatric

Xellsmart announces US IND clearances for iPSC-derived cell therapies for Parkinson’s disease and ALS

April 16, 2025
Xellsmart Biopharmaceutical (Suzhou) Co. Ltd. has announced IND clearances by the FDA for its XS-411 and XS-228 cell therapies, for Parkinson’s disease and amyotrophic lateral sclerosis (ALS), respectively.
Read More
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