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BioWorld - Monday, December 29, 2025
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Ozempic pen and packaging

EMA warns Ozempic linked to ‘very rare’ side effect

June 6, 2025
By Nuala Moran
No Comments
The EMA’s safety committee has issued a warning that the GLP-1 receptor agonist Ozempic (semaglutide, Novo Nordisk A/S) can cause an acute eye condition in which the optic nerve is damaged by a sudden loss of blood supply. After reviewing several large epidemiological studies, clinical trial and in-market data, EMA’s Pharmacovigilance Risk Assessment Committee has concluded non-anterior ischemic optic neuropathy is a “very rare” side effect of Ozempic, that “may affect up to one in 10,000 people taking semaglutide.
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ETH Zurich Menstruai

Menstrual blood-based device detects disease biomarkers

June 5, 2025
By Shani Alexander
Researchers at ETH Zürich developed Menstruai, a device that detects in menstruation blood biomarkers associated with certain diseases. Menstruai uses a sensor built into a sanitary pad and changes color if certain biomarkers are present. The first of its kind technology has the potential to enable the early detection of diseases and transform women’s health care.
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Pregnant woman

EMA: New clinical guideline includes pregnant, breastfeeding patients

June 5, 2025
By Nuala Moran
No Comments
The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.
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Flag of South Korea with skyscrapers in the background

Korea pharma exports rise to quarterly high of $2.5B in Q1

June 4, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
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Pill with British pound sign

Pharma execs speak out: UK pricing rebates scare investors

June 4, 2025
By Nuala Moran
No Comments
The row between pharma companies and the U.K. government over rebates has intensified, with the Association of the British Pharmaceutical Industry calling up its members to speak on the record, as it ramps up the campaign against paying back over 23% on sales of branded drugs.
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Amber Implants VCFix Spinal System

Amber Vcfix spinal system shows promising data

June 3, 2025
By Shani Alexander
Amber Implants BV reported no device-related adverse events were seen in any of the patients fitted with its Vcfix spinal system, which treats vertebral compression fractures, at one-year. Data from the first-in-human trial of the device also showed patients experienced a significant reduction in their pain levels.
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Stethoscope, hand, health care icons

NICE says new tech may no longer be required to save on costs

June 3, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence reported it will streamline its health technology assessment, but the bigger news might be that the agency will no longer require new technologies prove to be cost saving to win an endorsement from the agency.
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Amanda Feilding, late co-founder of Beckley Psytech

Atai in $370M merger deal with psychedelic drug specialist Beckley

June 3, 2025
By Nuala Moran
No Comments
Privately held Beckley Psytech Ltd. is to be taken over by Atai Life Sciences in an all-share deal that values the U.K. psychedelic drug specialist at $370 million. After making a $50 million investment in January 2024, Berlin-based Atai already owns 36% of Beckley. It will now issue 105 million new shares to its fellow Beckley investors, giving them 34% ownership of the merged company.
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Boston Scientific Corp overstitch

Rising obesity levels spur endoscopic sleeve uptick

June 2, 2025
By Shani Alexander
While GLP-1 receptor agonists continue to grab the headlines as a treatment option for obesity, another therapy, endoscopic sleeve gastroplasty (ESG), is seeing a steady rise in demand.
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Sanofi-signage on office facade in Edinburgh, U.K.

Sanofi buying Blueprint and its TKI BLU-808 for $9.5B

June 2, 2025
By Nuala Moran
No Comments
Sanofi SA is to acquire Blueprint Medicines Inc. in a $9.5 billion deal that will give the French pharma ownership of a marketed rare disease immunotherapy heading toward blockbuster status, a follow-on product in phase II/III, and a phase II clinical program relevant to a number of autoimmune diseases.
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