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Artificial intelligence has edged past the pilot phase in clinical development. Once a niche add-on, AI is now helping biopharma companies design, recruit, and run trials faster, cheaper, and—crucially—more inclusively. And regulators are starting to pay serious attention. 17 July 2025
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South Korea’s Samsung Bioepis today announced it has entered into a license, development and commercialization agreement (DCA) with Harrow, for Samsung Bioepis’ ophthalmology portfolio. 17 July 2025
Biotechnology
Swiss pharma giant Roche has won approval from the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for its combination treatment of Columvi (glofitamab) alongside gemcitabine and oxaliplatin (GemOx) for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant. 17 July 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Kisqali (ribociclib) as an adjuvant treatment for all eligible populations of HR+/HER2- early breast cancer patients. 17 July 2025
Pharmaceutical
Artificial intelligence has edged past the pilot phase in clinical development. Once a niche add-on, AI is now helping biopharma companies design, recruit, and run trials faster, cheaper, and—crucially—more inclusively. And regulators are starting to pay serious attention. 17 July 2025
Biotechnology
US rare disease meds developer Sarepta Therapeutics late yesterday announced a strategic restructuring plan designed to prioritize high-value, high impact programs, meet its 2027 financial obligations, and support its long-term financial viability. 17 July 2025
Pharmaceutical
Swiss pharma giant Novartis this morning reported second quarter 2025 financial results, showing that net sales were $14.1 billion (+12%, +11% cc), with volume contributing 12 percentage points to growth. This was slightly better than the consensus estimate of $14.02 billion. 17 July 2025
Pharmaceutical
Bayer is giving chief executive Bill Anderson more time to deliver on his ambitious efforts to reshape the German group, extending his contract by three years to March 2029. The move signals strong support from the company’s supervisory board, which voted unanimously in favor of the renewal. 17 July 2025
Biotechnology
UK pharma major GSK has gained US regulatory approval for a new prefilled syringe presentation of its shingles vaccine, Shingrix (zoster vaccine), a move aimed at streamlining administration and boosting immunization coverage. 17 July 2025
Pharmaceutical
Shares in US healthcare conglomerate Johnson & Johnson rose by 6% during Wednesday morning’s trading after the presentation of its second-quarter financial results and latest guidance for 2025. 16 July 2025
Biotechnology
UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications. 16 July 2025
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Biotechnology
US biotech Nanoscope Therapeutics has begun a rolling submission to the American medicines regulator for MCO-010, the first gene-agnostic therapy seeking approval for retinitis pigmentosa (RP). 15 July 2025
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