First RSV vaccine approved for older adults
The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.
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The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.
CD19-directed CAR T-cell therapy Breyanzi has been approved by the European Commission (EC) based on significant results from a lymphoma Phase III trial.
A novel ultrasound technique opened the blood-brain barrier to successfully deliver chemotherapy to glioblastoma patients in a first-in-human trial.
Recommendations on the conduct of remote clinical trial visits are included in new US Food and Drug Administration (FDA) draft guidance.
A $5.9 billion acquisition of biotech Iveric Bio by Astellas is set to accelerate development of treatments for blinding retinal diseases.
How can innovation in clinical trials drive greater patient impact? BeiGene’s Dr Nils Eckardt and Dr Mieke Borgs highlight how novel systems and ways of working can support the delivery of high-quality medicines faster and more efficiently, helping to deliver greater and faster patient access in Europe.
Securing in-house viral vector production capabilities in the US is set to help Bristol Myers Squibb manufacture its two CAR T-cell therapies.
Researchers in the UK, South Africa, Uganda and Brazil have formed the Centres for Antimicrobial Optimisation Network (CAMO-Net) to optimise antimicrobial use globally.
A data-driven approach to optimise sanitisation and improve process control of the microbial parameter in a water system.
Industry bodies EPFIA and the Alliance for Regenerative Medicine and law firm Pinsent Masons have responded to the recent proposed revision of the EU pharmaceutical legislation.
Solving the sector-specific challenges of life sciences while enabling innovation requires data integrity, with data collected and analysed at the source in real time, explains Greg Hookings, Industry Director, Stratus Technologies.
Bristol Myers Squibb’s leadership team is set to reshuffle, with Christopher Boerner becoming it’s new CEO in late 2023.
The first and only fully human biologic that directly inhibits interleukin-17A has been granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).
First-line immunotherapy blinatumomab significantly improved survival in babies with acute lymphoblastic leukaemia in an international trial.
Iptacopan achieved "improvement of anaemia never seen before with anti-C5s” in paroxysmal nocturnal haemoglobinuria, showed Novartis data presented at 2023 EBMT.