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Irish contract research organization ICON has retained its position as the most active CRO worldwide in the first quarter of 2025, according to a new analysis by GlobalData. 16 May 2025
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A biopharma company utilising small interfering RNAs (siRNAs) to improve and expand the reach of RNAi-based medicines.
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Biotechnology
Canadian clinical-stage biotech Zymeworks today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). 30 May 2025
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending Forxiga (dapagliflozin) as an option to treat chronic kidney disease in adults, AstraZeneca announced today. 30 May 2025
Biotechnology
Japanese drugmaker Astellas Pharma today announced an exclusive license agreement with China’s Evopoint Biosciences for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2. 30 May 2025
Pharmaceutical
Swiss pharma giant Roche today announced new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. 30 May 2025
Biotechnology
Shares in US biotech Intellia Therapeutics slid by a quarter on Thursday following a safety update from its late-stage trial of a CRISPR-based treatment for a rare heart disease. 30 May 2025
Biotechnology
US biotech Regeneron and French drugmaker Sanofi are reviewing next steps for their experimental COPD therapy itepekimab following contrasting outcomes from two Phase III studies. The companies plan to discuss the results with regulatory agencies before determining the future of the interleukin (IL)-33 inhibitor. 30 May 2025
Biotechnology
Vima Therapeutics, a Cambridge, USA-based clinical-stage biotechnology company focused on oral therapies for movement disorders, has launched with a $60 million Series A financing. 30 May 2025
Pharmaceutical
Swiss eye care specialist Alcon yesterday revealed the US Food and Drug Administration (FDA) has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512.The new pushed the firm’s shares up 2.5% to 72.32 francs this morning. 30 May 2025
Generics
Japanese drugmaker Eisai said yesterday that it has received a favorable decision regarding the lawsuit filed in the US District Court for the District of New Jersey in November 2019 against generic drug manufacturer Shilpa Medicare, which submitted an Abbreviated New Drug Application (ANDA) for a generic version of Lenvima (lenvatinib), for infringement of US Patent No 11,186,547. 30 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has identified a potential path forward for elamipretide for the treatment of Barth syndrome, Stealth BioTherapeutics revealed today. 29 May 2025
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Biosimilars
At its May meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted positive opinions for three biosimilar medicines: 23 May 2025
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Germany-based mental health specialist atai Life Sciences is to buy privately-held UK psychedelic drug developer Beckley Psytech in an all-share transaction subject to pre-agreed BPL-003 (mebufotenin benzoate) Phase IIb success criteria. 3 June 2025
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