news
Enzyme replacement therapy approved for Fabry disease
The European Commission (EC) has given approval to the first PEGylated enzyme replacement therapy to treat Fabry disease.
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Regulation & Legislation
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EMA to review CTIS transparency rules
Public consultation seeks the best methods for balancing transparency with confidentiality in the EU Clinical Trials Information System, says the European Medicines Agency.
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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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European Commission approves CAR T therapy for lymphoma
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.
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FDA releases draft guidance for decentralised clinical trials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on the conduct of remote clinical trial visits are included in new US Food and Drug Administration (FDA) draft guidance.
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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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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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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.
webinar
Mastering regulatory compliance in inventory management: keys for success
25 April 2023 | By Merck KGaA
Watch this webinar where Aurélie Chambon will discuss best practices for inventory control and documentation as well as strategies for managing inventory in a compliant manner.
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European Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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NICE recommends therapy duo for advanced leukaemia
Janssen states Imbruvica® plus venetoclax will provide "a much-needed new treatment option" for chronic lymphocytic leukaemia.
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Pharma within planetary boundaries
Regulatory changes along a drug’s lifecycle should ensure that the health benefits of pharmaceuticals, which have a large ecological footprint, do not cost the environment. Dorothea Baltruks, Research Associate at the Centre for Planetary Health Policy, outlines how forthcoming EU pharmaceutical legislation could pave the way to solutions.
news
FDA approves first new B-cell lymphoma treatment in 20 years
A first-line B-cell lymphoma treatment shown to reduce the risk of disease progression or relapse by 27 percent has been approved by the FDA.
