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BioWorld - Sunday, February 8, 2026
Home » Topics » Regulatory

Regulatory
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Scientist holding semaglutide pill

Novo’s semaglutide fails in phase III Alzheimer’s trials

Nov. 24, 2025
By Nuala Moran
No Comments
Novo Nordisk A/S’ wild card bet that its GLP-1 receptor agonist semaglutide could be used to treat Alzheimer’s disease has not paid off, with the company reporting two phase III trials have shown no effect on slowing disease progression.
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Freestyle Libre 3 sensor with smartphone app

Abbott mum on malfunction behind Freestyle Libre 3 recall

Nov. 24, 2025
By Mark McCarty
Abbott Laboratories announced a recall of Freestyle Libre 3 and Libre 3 Plus sensors used in continuous glucose monitors after receiving reports of more than 700 injuries and seven fatalities that may be associated with the sensor malfunction. The company did not describe the nature of the malfunction let alone a root cause, but said the affected product comes from only one of three production lines, and thus it expects no shortages associated with the recall.
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CMS logo and website

CMS finalizes plan to do away with inpatient-only list

Nov. 24, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services released the 1657-page final rule for inpatient payment for calendar year 2026, a document chock full of important policy decisions including a renewed call for elimination of the inpatient-only list.
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CDC logo on website
Neurology/psychiatric

RFK skirts promise as CDC alters vaccine-autism webpage

Nov. 24, 2025
By Karen Carey
One Comment
Changes to a U.S. CDC website regarding autism and vaccines has sparked a backlash from numerous scientific and other groups, placing HHS Secretary Robert F. Kennedy Jr. (RFK) in the spotlight once again for appearing to break promises made earlier this year to secure his nomination.
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Concept art for "unlocking the secrets of the mind"
Neurology/psychiatric

CSPC’s SYH-2056 cleared to enter clinic in China for depression

Nov. 24, 2025
No Comments
CSPC Pharmaceutical Group Ltd. has obtained approval from China’s National Medical Products Administration (NMPA) to initiate clinical trials with the company’s selective 5-HT2A receptor agonist, SYH-2056 tablets, for the treatment of depression.
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Female doctor and patient
FT Global Pharma and Biotech Summit

Could restricting diversity efforts stall women’s health research?

Nov. 21, 2025
By Nuala Moran
No Comments
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12.
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FDA Approved seal
Biopharma regulatory actions and approvals October 2025

Jascayd for idiopathic pulmonary fibrosis among 20 October US nods

Nov. 21, 2025
By Amanda Lanier
No Comments
The U.S. FDA cleared 20 drugs in October 2025, up from 17 in September, 18 in August and 17 in July, bringing the year’s total to 181 approvals through the first 10 months. Two new molecular entities (NMEs) gained U.S. approval in October: Boehringer Ingelheim GmbH’s Jascayd and Bayer AG’s Lynkuet.
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CDC logo on website

RFK skirts promise as CDC alters vaccine-autism webpage

Nov. 21, 2025
By Karen Carey
No Comments
Changes to a U.S. CDC website regarding autism and vaccines has sparked a backlash from numerous scientific and other groups, placing HHS Secretary Robert F. Kennedy Jr. (RFK) in the spotlight once again for appearing to break promises made earlier this year to secure his nomination.
Read More
Flag of Scotland against blue sky

Scotland sets out 10-year plan to double its life sciences sector

Nov. 21, 2025
By Nuala Moran
No Comments
The Scottish government has published a strategy setting out a roadmap to more than double the size of Scotland’s life sciences sector over the next 10 years. The most recent data show the sector currently contributes £10.5 billion (US$13.8 billion) in turnover to the economy, supporting 46,000 jobs. The aim of the strategy is to increase this to £25 billion by 2035.
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In virtro fertilization

Overture Life receives CE mark for Davitri platform

Nov. 21, 2025
By Shani Alexander
Overture Life SLU secured CE mark certification for its Davitri system that automates the vitrification and thawing of oocytes and embryos, making the processes more efficient, consistent and cost-efficient. Davitri has the potential to transform IVF, giving women and families more control over their fertility timelines and ensuring every egg and embryo has the best possible chance of survival.
Read More
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