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Digital brain and silhouette

​AI Act expected to further exacerbate device flight from EU​

May 22, 2024
By Mark McCarty
The European Council (EC) voted to approve the Artificial Intelligence Act (AI Act), a sweeping horizontal legislative product that affects all sectors of the European Union’s (EU) economy. Regulatory attorney Erik Vollebregt told BioWorld that the horizontal nature of the AI Act is still likely to exacerbate some of the problems already seen with the Medical Device Regulation (MDR) in a way that he said will make the EU market less attractive than is already the case.
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Appeals court: HHS overstepped its 340B role

May 21, 2024
By Mari Serebrov
The Department of Health and Human Services (HHS) has no rulemaking authority over the 340B prescription drug discount program, the U.S. Court of Appeals for the District of Columbia Circuit said May 21 as it handed the government its second big loss in the ongoing debate over whether drug manufacturers have to give unlimited contract pharmacies the steep discounts the program provides to certain health care providers.
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USTR seal

Usual players show up again in US trade report of bad actors

May 21, 2024
By Mari Serebrov
The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.
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Close-up of eye with digital focus

Biocon, Samsung win FDA nods for interchangeable Eylea biosimilars

May 21, 2024
By Marian (YoonJee) Chu
The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).
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Cityscape, US flag and virtual lock

US Biosecure bill advancing through Congress, new tariffs imposed

May 21, 2024
By Mari Serebrov
Shaking up corporate and pipeline structure, San Diego-based cancer developer Erasca Inc. in-licensed two assets from China-based biopharmas in all-cash deals, while laying off 18% of its workforce, primarily in drug discovery. The flurry of announcements made on May 16, which included $160 million raised in private placement, showed that Erasca would scrap three existing pipeline assets – ERAS-007, ERAS-801 and ERAS-4 – and reshape development to a RAS-targeting franchise.
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Report leads to suspension of Ecohealth, NIH rebuke

May 21, 2024
By Mari Serebrov
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
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Joshua Smiley, president and chief operating officer, Zai Lab

Zai Lab exec buys stock as Augtyro, Vyvgart SC advances in China

May 21, 2024
By Marian (YoonJee) Chu
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
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FDA issues CRL on rivoceranib-camrelizumab combo in liver cancer

May 21, 2024
By Marian (YoonJee) Chu
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer.
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3D map of China

Cleveland Clinic clipped for $7.6M for research oversight lapses

May 21, 2024
By Mark McCarty
The Cleveland Clinic Foundation (CCF) has found itself on the wrong end of an enforcement action by a federal attorney’s office, which had alleged that CCF had made false statements to the government regarding three grant awards.
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Medicare puzzle

​Abbott seeks US Medicare national coverage for Cardiomems system​

May 21, 2024
By Mark McCarty
A renewed focus on telehealth and telemedicine may be pumping new life into remote patient monitoring for heart failure, which seems to be the case for the Cardiomems device by Abbott Inc.
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