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Red arrow pointing downward on a stock market ticker

Some unshod by Prasad nod as CBER change socks stocks

May 7, 2025
By Randy Osborne
No Comments
The appointment May 6 of Vinay Prasad as the head of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) “bodes poorly” for Sarepta Therapeutics Inc.’s development-stage pipeline, said Wainwright analyst Mitchell Kapoor – and Wall Street reflected as much, as the stock (NASDAQ:SRPT) ended that day down 26.6% vs. an XBI drop of 6.6% – this ahead of the after-hours earnings disclosure that pushed the Cambridge, Mass.-based firm down even farther by more than another 20%, with the XBI unchanged.
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Illustration of stent angioplasty balloon in artery

UK’s NICE seeks to apply price pressures on drug-eluting stents

May 6, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) opened a late-stage assessment for drug-eluting stents (DES) with an eye toward costs, advising clinicians that they should implant the least expensive DES unit that is clinically appropriate for that patient while the assessment is underway.
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US flag, gavel, book

Q’apel’s withdrawal of Hippo ends patent lawsuit with Route 92

May 6, 2025
By Mark McCarty
Q’apel Medical Inc., of Fremont, Calif., might have thought the company’s withdrawal of the Hippo catheter was nothing but a loss, but Route 92 Medical Inc. managed to shine a positive light on the withdrawal by dropping a patent lawsuit against Q’apel because of the Hippo device.
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Approved stamp

South Korea approves record number of biosimilars in 2024

May 6, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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Australia map, flag

Australia follows Canadian lead; Labor win a sharp rebuke to Trump

May 6, 2025
By Tamra Sami
No Comments
Australian biopharma stakeholders welcomed the reelection of Prime Minister Anthony Albanese, who promised to expand Medicare and to invest more in Australian research.
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Magnifying glass over globe, focused on Mexico

Annual US 301 trade report has louder bark

May 6, 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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FDA clears Satsuma’s Atzumi for migraine

May 6, 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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Pharmaceutical manufacturing

EO offers US onshoring relief, FDA steps up foreign inspections

May 6, 2025
By Mari Serebrov
No Comments
In an ongoing effort to onshore more of the biopharma supply chain, U.S. President Donald Trump signed an executive order (EO) late May 5 to shorten the time involved in bringing a new manufacturing plant or expansion online and to remove some of the incentives for foreign production of finished drugs and active pharmaceutical ingredients.
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Gavel and scales

US states seek to undo HHS reorg, terminations

May 6, 2025
By Mari Serebrov
No Comments
Claiming that they’re suffering the consequences of a March 27 directive ordering a mass reduction in force and reorganization throughout the U.S. Department of Health and Human Services (HHS), 19 states and the District of Columbia took their grievances to court.
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More stringency expected under new CBER head

May 6, 2025
By Mari Serebrov
No Comments
U.S. FDA Commissioner Marty Makary is starting to fill the vacancies at the agency that’s seen its senior leadership ravaged by retirements and terminations. Makary’s first pick is Vinay Prasad as the new head of the FDA’s Center for Biologics Evaluation & Research (CBER), the center that oversees vaccines, blood products, allergenics and cellular, tissue and gene therapies.
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