A fresh attempt to bring more pharmaceutical manufacturing back to US soil has put the sector on alert, as a new executive order from Donald Trump seeks to overhaul how American medicines are made and regulated. But a research note from GlobalData suggests the move could raise as many questions as it tries to answer. 10 June 2025
Oxford, UK-based biotech SynaptixBio, which is developing a therapy for a rare, deadly, and currently incurable rare disease (H-ABC), says it has identified the drug it will take forward into clinical trials. 10 June 2025
UK privately-held T-regulatory (Treg) cell therapies developer Quell Therapeutics today revealed that pharma major AstraZeneca has selected a lead Treg cell therapy candidate to progress from the inflammatory bowel disease (IBD) program. 10 June 2025
Privately-owned German biotech XL-protein GmbH today announced that it has entered into a worldwide license, development and commercialization agreement with Spanish plasma-derived medicines specialist Grifols for a novel, long-acting biopharmaceutical product. 10 June 2025
June 10, 2025
The US Food and Drug Administration (FDA) has approved Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season, US pharma giant Merck & Co revealed yesterday. 10 June 2025
Specialty immunotherapy company Tevogen Bio Holdings has announced the execution of a lease agreement to expand its corporate headquarters in Warren, New Jersey, more than doubling its footprint. 10 June 2025
Dutch late-stage biotech NewAmsterdam Pharma late yesterday announced positive top-line data from prespecified Alzheimer’s disease (AD) biomarker analyses in the Phase III BROADWAY clinical trial (NCT05142722). The firm’s US-traded shares were up 4.1% at $20.99 in pre-market activity this morning. 10 June 2025
Shares of USA-based Elevation Oncology leapt more than 20% to $0.38, on the news that it has accepted a takeover bid from Concentra Biosciences, a vehicle controlled by hedge fund Tang Capital Partners, an investment firm focused on buying struggling biotechs and shutting them down. 10 June 2025
US Health Secretary Robert F. Kennedy Jr has removed all 17 members of a key vaccine advisory committee, a move officials say is aimed at rebuilding public trust in the country’s immunization policies. 10 June 2025
Following global reports of serious adverse events in older people, the government’s independent expert advisory body, the UK’s Commission on Human Medicines (CHM), has temporarily restricted use of a chikungunya vaccine called Ixchiq in people aged 65 and over until a further safety review has been concluded. 10 June 2025
Africa is grappling with a worsening mpox crisis, with a critical shortfall of vaccine doses threatening to derail containment efforts. Public health leaders are warning that the scarcity is exacerbating the spread of the virus, even as the World Health Organization (WHO) maintains that mpox remains a public health emergency of international concern. 10 June 2025
German science and technology firm Merck KGaA has moved a step closer to introducing a new therapy for tenosynovial giant cell tumor (TGCT) in China, with regulators accepting its marketing application and initiating a priority review for pimicotinib. 10 June 2025
US ophthalmic gene therapy company Beacon Therapeutics, which is focused on restoring the vision of patients with blinding retinal diseases, has appointed Daniel Chung as chief medical officer (CMO). 9 June 2025
France-based SparingVision, a genomic medicine company focused on the treatment of retinal disease, has announced the appointment of Kalliopi ‘Kali’ Stasi, as chief medical officer, effective immediately. 9 June 2025
Privately-held Italian pharma company Italfarmaco today revealed that the European Commission (EC) has granted conditional marketing authorization for Duvyzat (givinostat), a novel histone deacetylase (HDAC) inhibitor. 9 June 2025
Shares of Avidity Biosciences were up almost 5% at $38.00 pre-market today, as it announced the accelerated approval regulatory pathway in the USA is open for delpacibart braxlosiran (del-brax) in the treatment of facioscapulohumeral muscular dystrophy (FSHD). 9 June 2025
A fresh attempt to bring more pharmaceutical manufacturing back to US soil has put the sector on alert, as a new executive order from Donald Trump seeks to overhaul how American medicines are made and regulated. But a research note from GlobalData suggests the move could raise as many questions as it tries to answer. 10 June 2025
Oxford, UK-based biotech SynaptixBio, which is developing a therapy for a rare, deadly, and currently incurable rare disease (H-ABC), says it has identified the drug it will take forward into clinical trials. 10 June 2025
UK privately-held T-regulatory (Treg) cell therapies developer Quell Therapeutics today revealed that pharma major AstraZeneca has selected a lead Treg cell therapy candidate to progress from the inflammatory bowel disease (IBD) program. 10 June 2025
Privately-owned German biotech XL-protein GmbH today announced that it has entered into a worldwide license, development and commercialization agreement with Spanish plasma-derived medicines specialist Grifols for a novel, long-acting biopharmaceutical product. 10 June 2025
June 10, 2025
The US Food and Drug Administration (FDA) has approved Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season, US pharma giant Merck & Co revealed yesterday. 10 June 2025
Specialty immunotherapy company Tevogen Bio Holdings has announced the execution of a lease agreement to expand its corporate headquarters in Warren, New Jersey, more than doubling its footprint. 10 June 2025
Dutch late-stage biotech NewAmsterdam Pharma late yesterday announced positive top-line data from prespecified Alzheimer’s disease (AD) biomarker analyses in the Phase III BROADWAY clinical trial (NCT05142722). The firm’s US-traded shares were up 4.1% at $20.99 in pre-market activity this morning. 10 June 2025
Shares of USA-based Elevation Oncology leapt more than 20% to $0.38, on the news that it has accepted a takeover bid from Concentra Biosciences, a vehicle controlled by hedge fund Tang Capital Partners, an investment firm focused on buying struggling biotechs and shutting them down. 10 June 2025
US Health Secretary Robert F. Kennedy Jr has removed all 17 members of a key vaccine advisory committee, a move officials say is aimed at rebuilding public trust in the country’s immunization policies. 10 June 2025
Following global reports of serious adverse events in older people, the government’s independent expert advisory body, the UK’s Commission on Human Medicines (CHM), has temporarily restricted use of a chikungunya vaccine called Ixchiq in people aged 65 and over until a further safety review has been concluded. 10 June 2025
Africa is grappling with a worsening mpox crisis, with a critical shortfall of vaccine doses threatening to derail containment efforts. Public health leaders are warning that the scarcity is exacerbating the spread of the virus, even as the World Health Organization (WHO) maintains that mpox remains a public health emergency of international concern. 10 June 2025
German science and technology firm Merck KGaA has moved a step closer to introducing a new therapy for tenosynovial giant cell tumor (TGCT) in China, with regulators accepting its marketing application and initiating a priority review for pimicotinib. 10 June 2025
US ophthalmic gene therapy company Beacon Therapeutics, which is focused on restoring the vision of patients with blinding retinal diseases, has appointed Daniel Chung as chief medical officer (CMO). 9 June 2025
France-based SparingVision, a genomic medicine company focused on the treatment of retinal disease, has announced the appointment of Kalliopi ‘Kali’ Stasi, as chief medical officer, effective immediately. 9 June 2025
Privately-held Italian pharma company Italfarmaco today revealed that the European Commission (EC) has granted conditional marketing authorization for Duvyzat (givinostat), a novel histone deacetylase (HDAC) inhibitor. 9 June 2025
Shares of Avidity Biosciences were up almost 5% at $38.00 pre-market today, as it announced the accelerated approval regulatory pathway in the USA is open for delpacibart braxlosiran (del-brax) in the treatment of facioscapulohumeral muscular dystrophy (FSHD). 9 June 2025