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FDA releases draft guidance for decentralised clinical trials
Recommendations on the conduct of remote clinical trial visits are included in new US Food and Drug Administration (FDA) draft guidance.
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R&D
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Astellas to accelerate ocular disease treatments with $5.9 billion acquisition
A $5.9 billion acquisition of biotech Iveric Bio by Astellas is set to accelerate development of treatments for blinding retinal diseases.
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Why R&D innovation holds the key to greater patient impact
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.
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Bristol Myers Squibb boosts CAR T therapy manufacturing capabilities
Securing in-house viral vector production capabilities in the US is set to help Bristol Myers Squibb manufacture its two CAR T-cell therapies.
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Global research consortium to help address antimicrobial resistance
Researchers in the UK, South Africa, Uganda and Brazil have formed the Centres for Antimicrobial Optimisation Network (CAMO-Net) to optimise antimicrobial use globally.
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Application note: Enhancing microbial monitoring with an online bioburden analyser
A data-driven approach to optimise sanitisation and improve process control of the microbial parameter in a water system.
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Pharma responds to proposed EU pharmaceutical legislation reform
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.
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Innovating pharma at the edge
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.
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Bristol Myers Squibb appoints new CEO
Bristol Myers Squibb’s leadership team is set to reshuffle, with Christopher Boerner becoming it’s new CEO in late 2023.
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Biologic could be first new hidradenitis suppurativa treatment in a decade
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).
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Immunotherapy to become standard treatment for infants with ALL
First-line immunotherapy blinatumomab significantly improved survival in babies with acute lymphoblastic leukaemia in an international trial.
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Novartis releases data for potentially “practice-changing” PNH medicine
Iptacopan achieved "improvement of anaemia never seen before with anti-C5s” in paroxysmal nocturnal haemoglobinuria, showed Novartis data presented at 2023 EBMT.
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Pioneering malaria vaccine gains regulatory clearance
University of Oxford-developed R21/Matrix-M malaria vaccine has secured approval in two African countries.
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Monoclonal antibody combination treatment given NICE approval
Shown to increase myeloma remission times by more than two years, a combination treatment that uses a monoclonal antibody has been approved by NICE.
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Boehringer Ingelheim invests €350m in new biotech R&D facility
The new €350 million biotechnology R&D centre is Boehringer Ingelheim’s largest single investment in Germany to date.
