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Regulatory
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epitomee capsule

Epitomee swallows FDA clearance for weight loss capsule

Sep. 18, 2024
By Annette Boyle
Epitomee Ltd. happily swallowed the news of U.S. FDA clearance for its capsule for weight management, an ingestible medical device for adults who are overweight or obese. Designed for use along with diet and exercise, the capsule expands in the stomach to create a feeling of fullness that lasts up to six hours.
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Science and medicine icons with head made of computer code

HHS announces LEAP in Health IT awards

Sep. 18, 2024
By Mark McCarty
The U.S. Department of Health and Human Services reported the winners of the Leading Edge Acceleration Projects in Health Information Technology program, with a couple of key areas of interest.
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Cell research illustration
Neurology/psychiatric

PPL-001 gets US orphan drug designation for Friedreich’s ataxia

Sep. 18, 2024
Papillon Therapeutics Inc.’s PPL-001 has been awarded orphan drug designation by the FDA for Friedreich’s ataxia. PPL-001 is an experimental gene-corrected CD34+ hematopoietic stem and progenitor cell (HSPC) therapy.
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China flag and autoinjector pen

Big pharma eyes China ‘at forefront of GLP-1 revolution’

Sep. 17, 2024
By Marian (YoonJee) Chu
Two leading glucagon-like peptide-1 (GLP-1) receptor agonists for obesity and type 2 diabetes – Novo Nordisk A/S’s semaglutide (Wegovy/Ozempic) and Eli Lilly and Co.’s tirzepatide (Mounjaro/Zepbound) – are advancing in China after taking the U.S. market by storm.
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Green plus, red minus, white question mark dice

Senate IRA hearing mix of praise, scathing reviews

Sep. 17, 2024
By Mari Serebrov
Two tales of one law were told Sept. 17 as the U.S. Senate Finance Committee discussed the successes and failures of the health care provisions included in the Inflation Reduction Act (IRA) as members looked toward different sequels.
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FDA clears Senseonic’s Eversense one-year implantable CGM

Sep. 17, 2024
By Annette Boyle
The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc.
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Autoinjectors on pink background

China biotechs rise to challenge Ozempic, Wegovy

Sep. 17, 2024
By Marian (YoonJee) Chu
Chinese pharmaceutical and biotech companies are leading development of glucagon-like peptide-1 receptor agonists as Novo Nordisk A/S and Eli Lilly and Co. edge closer to launching blockbuster therapies in China. At the heart of the GLP-1 boom is a nationwide obesity problem driven by a confluence of factors, including the rise of a modern, sedentary lifestyle, according to Clarivate. Despite the rising prevalence of obesity and type 2 diabetes, the gap in obesity therapeutics is “substantial and leaves a solid market opportunity for weight loss drugs,” Karan Verma, principal analyst of healthcare research & data analytics at Clarivate, said.
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Bio Hong Kong 2024
Bio Hong Kong 2024

Chapter 18A entices biotechs to list on Hong Kong exchange

Sep. 17, 2024
By Marian (YoonJee) Chu
The Stock Exchange of Hong Kong is “all ears” to foster local biotech IPOs, speakers said at the Bio Hong Kong 2024 conference Sept. 11, and more than 60 companies have jumped on board since the introduction of the Chapter 18A listing regime in 2018.
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Cityscape, US flag and virtual lock

US Biosecure Act a step closer to becoming law

Sep. 17, 2024
By Mari Serebrov
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
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Australia’s HTA consultation wraps up with 50 recommendations

Sep. 17, 2024
By Tamra Sami
Australia’s Health Department has released the final report of the Health Technology Assessment (HTA) Review that makes 50 recommendations for improving access to new health technologies while tackling inequity, simplifying HTA processes and making it easier for consumers and clinicians to participate.
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