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Regulatory
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Black umbrella open against blue sky with clouds

Disc over the moon as FDA urges Apollo bid with bitopertin in EPP

Nov. 4, 2024
By Randy Osborne
Disc Medicine Inc. found itself after an end-of-phase II meeting with the U.S. FDA in what Wainwright analyst Douglas Tsao called a “best-case scenario” regarding the path forward for bitopertin in erythropoietic protoporphyria (EPP).
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Australia reimburses Vazkepa a decade after US approval

Nov. 4, 2024
By Tamra Sami
For the first time, Australians have access to CSL Inc.’s Vazkepa (icosapent ethyl/Vascepa) for managing cardiovascular disease more than a decade after the drug was first approved in the U.S.
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Product recall concept image

Smiths Medical announces recall of tracheostomy tubes

Nov. 4, 2024
By Mark McCarty
The U.S. FDA reported a class I recall of tracheostomy tube kits by Minneapolis-based Smiths Medical Inc., because of the risk of separation of the tube’s pilot balloon and inflation line.
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CMS logo and website

CMS opts for separate pass-through categories for renal denervation

Nov. 4, 2024
By Mark McCarty
The U.S. Medicare outpatient final rule affirms several new devices for the new technology pass-through program, but one of the more significant findings is that CMS will use separate payment mechanisms for two renal nerve denervation devices, following the blueprint the agency employed for this question in the inpatient final rule.
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Digital pills on a circuit board

EFPIA calls for EMA to oversee AI in drug development

Nov. 1, 2024
By Nuala Moran
Just ahead of the EMA setting out its latest thinking on regulation in the new era of artificial intelligence (AI), the industry has put forward its position on how to ensure AI rules enable, rather than hinder, the drug development and approval process.
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Hand holding ballot over box, US flag backdrop

Change is the constant in wake of US elections

Nov. 1, 2024
By Mari Serebrov
The drug and device industries have a lot hinging on the results of the Nov. 5 U.S. presidential and congressional elections. Tax policies. The reach of the FTC. Legislation aimed at drug prices, competition, pharmacy benefit managers and lab-developed tests. Cabinet and agency appointments that could reshape Medicare drug negotiations, the 340B program, FDA Orange Book device patent listings, regulatory flexibility and Bayh-Dole march-ins. And that’s just the top of the list.
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DNA in drug capsules

BioFuture 2024: FDA eases the way for cell and gene therapy companies

Oct. 31, 2024
By Lee Landenberger
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.
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Lexicon diabetes drug didn’t get much love from FDA adcom

Oct. 31, 2024
By Mari Serebrov
The second time around wasn’t lovelier for Lexicon Pharmaceuticals Inc. as it once again made its case before the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista (sotagliflozin) as an adjunct to insulin to improve glycemic control in people with type 1 diabetes and mild to moderate chronic kidney disease.
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Astrazeneca China HQ at Shanghai Zhangjiang Hi-Tech Park

Astrazeneca’s China president under investigation in China

Oct. 31, 2024
By Tamra Sami
Astrazeneca plc’s China president, Leon Wang, is under investigation in mainland China, the company said in an Oct. 30 statement. Although details are scant, Astrazeneca said Wang is “cooperating with an ongoing investigation by Chinese authorities,” and the company’s China operations will continue under the leadership of the current general manager of Astrazeneca China.
Read More
Blood cells and bacteria

Abionic’s test enters increasingly competitive sepsis fray

Oct. 31, 2024
By Annette Boyle
Abionic SA received U.S. FDA 510(k) clearance for its in vitro diagnostic Capsule pancreatic stone protein (PSP) sepsis test. Produced by the pancreas and immune cells, PSP provides an early biomarker for sepsis that could push back detection of deadly condition by 24 to 48 hours.
Read More
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