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BioWorld - Wednesday, January 7, 2026
Home » Topics » North America » U.S.

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U.S. flag, stethoscope

Industry supportive of CMS move to tighten MA plans’ coverage

Feb. 5, 2025
By Mark McCarty
Medicare Advantage plans have drawn criticism for deviating somewhat from Medicare coverage policies, a question CMS took up in a recent draft rule. In comments to the docket, the Medical Device Manufacturers Association said it sees a need to throw a lasso around such practices, alleging that they may result in beneficiaries receiving more limited coverage than they would in fee-for-service care.
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Farawave system

Boston Sci’s Farapulse tops $1B in 2024, bright prospects for 2025

Feb. 5, 2025
By Annette Boyle
As pulsed field ablation transformed the electrophysiology market over the last year, Boston Scientific Corp. emerged as the biggest winner by far. In its fourth quarter earnings call on Wednesday, the company quantified just how successful its Farapulse PFA system has been.
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More China ADCs: Arrivent gets GI cancer drug in $1.2B Lepu deal

Feb. 4, 2025
By Marian (YoonJee) Chu
A year after its $175 million IPO in 2024, Arrivent Biopharma Inc. picked up rights to develop and commercialize Lepu Biopharma Co. Ltd.’s antibody-drug conjugate (ADC) candidate, MRG-007, worldwide excluding the greater China region.
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Ascentage prices first US IPO of the year

Feb. 4, 2025
By Lee Landenberger
Ascentage Pharma Group Corp. Ltd. has priced the first IPO of the year in the U.S. The offering of 7.32 million shares has the Suzhou, China, and Rockville, Md.-based company looking for gross proceeds of about $126.4 million, assuming a price of $17.25 per share.
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Central nervous system

Alterity’s ATH-434 looks to be disease modifying in multiple system atrophy

Feb. 4, 2025
By Tamra Sami
Alterity Therapeutics Ltd. reported positive top-line phase II results for lead candidate ATH-434 for treating multiple system atrophy, a rare neurological disorder similar to Parkinson's disease.
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Updated Maia phase II data nudges its stock higher

Feb. 4, 2025
By Lee Landenberger
New and positive data for Maia Biotechnology Inc.’s lead candidate for a particularly deadly and advanced lung cancer propelled the stock modestly higher on Feb. 4. The pivotal phase II THIO-101 study of Thio, a telomere-targeting agent sequenced with Regeneron Inc.’s immune checkpoint inhibitor, Libtayo (cemiplimab), as a third-line treatment for advanced non-small-cell lung cancer (NSCLC) showed median overall survival of 16.9 months for the 22 NSCLC patients who received at least one dose of Thio in parts A and B.
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Sen. Raphael Warnock at RFK confirmation hearing

Kennedy advances toward confirmation as HHS secretary

Feb. 4, 2025
By Mari Serebrov
Robert F. Kennedy Jr. moved a step closer Feb. 4 to becoming the next secretary of the U.S. Department of Health and Human Services (HHS). The Senate Finance Committee voted 14-13 along party lines to send Kennedy’s nomination to the Senate floor for confirmation. While “no” votes were expected from the 13 Democrats serving on the committee, a big question mark had hung over which way Sen. Bill Cassidy, R-La., would vote, given the comments he made at two committee hearings on the nomination. In the end, Cassidy voted along with his 13 Republican colleagues, offering no comment on his vote at the meeting.
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Illumina sign, building

China blacklists Illumina as part of US tariffs counter

Feb. 4, 2025
By Marian (YoonJee) Chu
The Chinese government blacklisted several American companies, including gene sequencing-focused biotechnology firm Illumina Inc. and fashion brand PVH Corp., citing threats to China’s “national sovereignty, security and development interests.”
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Hourglass on glowing circuit board, symbolizing time and technology

California AG advisory tightens down on AI in health care

Feb. 4, 2025
By Mark McCarty
U.S. federal law is still lacking where AI is concerned, but California’s attorney general issued a bulletin that elevates the legal hazards of AI in medical use. The bulletin says that AI tools may not supplant a physician’s decision-making, a provision that would seem to render some FDA-cleared products illegal there.
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Silhouette made of gears

A blood test could identify postpartum depression risk

Feb. 4, 2025
By Annette Boyle
Curently the only available blood test to tell which women are at risk of postpartum depression (PPD) is the one that confirms their pregnancy – and a one in seven chance of developing the condition which can have long-term implications for both mother and child. Research out of the University of Virginia and Weill Cornell Medicine could soon change that by identifying biomarkers in the third trimester of pregnancy that indicate which women have the greatest risk of developing PPD.
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