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Astrazeneca China HQ at Shanghai Zhangjiang Hi-Tech Park

Astrazeneca’s China president under investigation in China

Nov. 5, 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.
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Illustration showing layers of the meninges between the skull and brain

FDA clears fourth Qiagen test in 2024

Nov. 5, 2024
By Annette Boyle
Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.
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Medicare puzzle

US CMS lauded, blasted for physician fee final rule for 2025

Nov. 5, 2024
By Mark McCarty
Medicare coverage of digital mental health therapies has traditionally been lacking, but the final Medicare physician fee schedule for 2025 added three new codes to deal with the coverage gap.
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US-capital-washington-congress-government.png

Congress poised to revisit site-neutral payment

Nov. 5, 2024
By Mark McCarty
While the inpatient and outpatient final rules for 2025 are baked into the U.S. Medicare payment system, there are indications that Congress will consider legislation that would flatten rates across sites of service.
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Monoclonal antibody illustration
Inflammatory

Hifibio Therapeutics’ BTLA agonist antibody gains US IND clearance

Nov. 5, 2024
Hifibio Therapeutics Inc. has gained IND clearance from the FDA for HFB-200604, a potentially best-in-class BTLA agonist monoclonal antibody for inflammatory and immunology diseases.
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Neurology/psychiatric

Damona’s α5-GABAAR-targeting PAM gains IND clearance to treat cognitive deficits in brain disorders

Nov. 5, 2024
Damona Pharmaceuticals Inc. has obtained IND clearance from the FDA for DPX-101 for the treatment of cognitive deficits in brain disorders, including major depressive disorder.
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Liver and lungs
Endocrine/metabolic

Korro Bio files in Australia to begin first-in-human study of KRRO-110 for AATD

Nov. 5, 2024
Korro Bio Inc. has announced a submission to the Australian Bellberry Human Research Ethics Committee (HREC) for a phase I/II study of KRRO-110 for α-1 antitrypsin deficiency (AATD).
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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.
Read More
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