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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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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
Biotechnology
Japan’s Daiichi Sankyo and partner Merck & Co today revealed that the Biologics License Application (BLA) seeking accelerated approval in the USA for patritumab deruxtecan (HER3-DXd) has been withdrawn. 29 May 2025
Biotechnology
US biotech Moderna has reported encouraging early-stage results from a trial of its experimental vaccine for avian influenza, just as a significant federal funding agreement was unexpectedly withdrawn. 29 May 2025
Biotechnology
Sino-American biotech BeiGene has now effected its previously announced transition, becoming BeOne Medicines and redomiciling to Switzerland, marking a significant milestone in the company’s evolution. 29 May 2025
Pharmaceutical
Germany’s Merck KGaA today announced the presentation of detailed positive results from Part 1 of the global Phase III MANEUVER trial evaluating pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics, in the treatment of patients with tenosynovial giant cell tumor (TGCT). 28 May 2025
Biotechnology
Texas, USA-based clinical-stage biopharma Savara on Tuesday announced that the company received a refuse to file (RTF) letter from the US Food and Drug Administration (FDA) for the biologics license application (BLA) of Molbreevi (molgramostim) as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (PAP), with the news sending its shares plunging 32% to $1.94. 28 May 2025
Pharmaceutical
US biotech GRIN Therapeutics has secured $140 million in Series D funding and signed a licensing deal with Italy's Angelini Pharma that could bring in more than $500 million in future payments tied to its lead investigational therapy, radiprodil. 28 May 2025
Biotechnology
In a policy shift that breaks with the previous administration's broad vaccination campaign, US health authorities have removed the COVID-19 vaccine from the routine immunization schedule for healthy children and healthy pregnant women. 28 May 2025
Pharmaceutical
New York-based neurosciences company Gilgamesh Pharmaceuticals yesterday announced Phase IIa results for GM-2505, a novel, rapid-acting 5-HT2A receptor agonist and 5-HT releaser in development for the treatment of patients with moderate-to-severe major depressive disorder (MDD). 28 May 2025
Biotechnology
US biotech Lexeo Therapeutics has secured $80 million from a private placement, giving the company enough capital to push ahead with its cardiac gene therapy pipeline and fund operations into 2028. 28 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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German biotech TQ Therapeutics today announced the acquisition of Juno Therapeutics GmbH, a cell therapy company, through a share purchase agreement. Financial terms of the agreement were not disclosed. 28 May 2025
16 May 2025
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