The future of high-potency APIs: Strategies for manufacturing challenges
The growing friction between the US and China has serious consequences for the supplies of high-potency active pharmaceutical ingredients (HPAPIs), …
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ADCs: A Primer for the Pharmaceutical Industry
ADCs are precision medicines that hitch a cell-killing drug (the “payload”) to an antibody via a chemical “linker”. The antibody …
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Galapagos to shutter cell and gene therapy unit
Galapagos NV is winding down its cell and gene therapy (CGT) division after an unsuccessful attempt to sell the unit, …
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ESMO 2025: Hengrui’s immunotherapy combo shows perioperative benefit in HCC
On Saturday 19 October 2025, at the European Society for Medical Oncology (ESMO), held in Berlin, Germany, Hengrui presented results …
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Novo Nordisk sees board shakeup amid member exodus
Novo Nordisk has announced that seven members of its board of directors will stand down from their roles. This includes board …
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ICH E6(R3) in effect: transforming quality management for cell and gene therapy trials
This long-awaited guideline will revolutionise clinical trial management across life sciences, giving CGT developers a regulatory framework that finally matches …
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Ventus and Genentech partner for small-molecule medicine discovery
Ventus Therapeutics has entered a multi-year partnership with Roche’s Genentech for the discovery and optimisation of new small-molecule medicines, utilising …
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Oximio welcomes Canada’s Bay Area Research Logistics to expand global reach and services
Oximio, a global leader in supply chain solutions for the clinical research industry, was delighted to welcome Bay Area Research …
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Health Canada conditionally approves Gilead Sciences’ Lyvdelzi for PBC
Health Canada has granted conditional approval for Gilead Sciences’ Lyvdelzi (seladelpar) for adults with primary biliary cholangitis (PBC) who have …
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Gibson, Dunn & Crutcher, White & Case top MEA legal advisers in Q1-Q3 2025
Gibson, Dunn & Crutcher and White & Case have emerged as the foremost legal advisers for mergers and acquisitions (M&A) …
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ESMO 2025: Merck KGaA’s ADC leapfrogs to Phase III in colorectal cancer
Merck KGaA's antibody-drug conjugate (ADC), precemtabart tocentecan (Precem-TcT), has shown promising efficacy during an early-stage trial in heavily pre-treated colorectal …
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From the experts: How to successfully implement Annex 1 regulations
Annex 1 regulations refer to a set of guidelines from the European Medicines Agency (EMA) for the manufacture of sterile …
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AAO 2025: EYP-1901 continues to show promise in DME and wAMD
At the 129th Annual Meeting of the American Academy of Ophthalmology (AAO) 2025 in Orlando, Florida, EyePoint Pharmaceuticals presented updates …
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MSD initiates construction on $3bn Virginia drug manufacturing site
Merck & Co (MSD) has broken ground on its new pharmaceutical manufacturing Centre of Excellence in Virginia, US, amid looming …
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Lundbeck and Contera partner for oligonucleotide-based medicines
H Lundbeck and Contera Pharma have announced a research partnership aimed at expediting the discovery as well as development of …
