FDA halts uniQure’s plans for Huntington’s disease gene therapy
The path to approval for uniQure’s gene therapy candidate for Huntington’s disease is in doubt as the US Food and …
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Tidmarsh’s FDA exit marks latest high-profile jockeying at US agencies
George Tidmarsh has resigned from the US Food and Drug Administration (FDA), becoming the latest in a long line of …
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Top 20 biopharma companies Q3 2025 market cap up 4% despite headwinds
The top 20 global biopharmaceutical companies experienced mixed performances in their individual market capitalisations in the third quarter (Q3) of …
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ViiV Healthcare launches ‘Risk to Reasons’ initiative in the UK to empower women to take control of their HIV prevention choices
While surveillance data from 2024 shows an encouraging reduction in HIV transmissions1, more needs to be done to meet the …
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Kimberly-Clark buys troubled Tylenol-maker Kenvue for $48.7bn
Kimberly-Clark has agreed to acquire Johnson & Johnson (J&J) consumer health spinout Kenvue for $48.7bn. One of America’s largest consumer health …
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FDA approves UCB’s Kygevvi for genetic mitochondrial disease
The US Food and Drug Administration (FDA) has approved UCB’s Kygevvi (doxecitine and doxribtimine) to treat genetic mitochondrial disease, thymidine …
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Eli Lilly to invest $3bn in new Dutch manufacturing facility
Eli Lilly and Company has outlined plans to develop a $3bn manufacturing facility in Katwijk, situated in the Leiden Bio …
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AI breakthrough promises earlier prostate cancer diagnosis
According to Cancer Research UK, prostate cancer is the most common cancer among men in the UK, representing 28% of …
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Alvotech faces FDA setback for its Simponi biosimilar AVT05
Alvotech’s inflammation-targeting biosimilar AVT05 has been rejected by the U.S. Food and Drug Administration (FDA) because of issues with the …
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Pfizer hits Novo Nordisk and Metsera with lawsuit amid bidding war
Pfizer has followed through on its threats, filing a lawsuit against both Metsera and Novo Nordisk during a M&A bidding …
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ESMO 2025: Sichuan-Kelun moves in breast cancer ADC space
18 October 2025 marked the presentation of the highly anticipated OptiTROP-Breast02 trial at the 2025 European Society for Medical Oncology …
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ESMO 2025: Bayer and BI neck and neck in first line HER2+ NSCLC
On 18 October 2025 at the European Society of Medical Oncology, held in Berlin, Germany, from 17 to 21 October, …
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IntoCell and Xcellon Biologics to advance ADC development
South Korean biotechnology company IntoCell has announced a memorandum of understanding (MoU) with US-based contract development and manufacturing organisation (CDMO) …
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4DMT and Otsuka to advance eye disease treatment in APAC
4D Molecular Therapeutics (4DMT) has announced an exclusive licence agreement with Otsuka Pharmaceutical to develop and market 4D-150, a treatment …
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Sensei to ditch its lead candidate and cut workforce amidst strategic review
Sensei Biotherapeutics is set to abandon its sole clinical-stage asset solnerstotug as it prepares to cut its workforce and consider …
