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MHRA granted almost £1m to advance digital and data regulation
Almost £1m awarded to MHRA will advance projects to innovate AI and microbiome regulation and develop synthetic clinical trial data.
List view / Grid view
Therapeutics
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Psychedelic research: evaluating the fast-evolving regulatory roadmap
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
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Drug Delivery In-Depth Focus 2022
Articles explore the potential of tryptamines in treatment-resistant depression and drug delivery options for mRNA therapeutics.
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World’s first approval of an allogeneic T-cell immunotherapy
Ebvallo™ is the first authorised allogeneic T-cell immunotherapy and has been approved for EU patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease.
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CHMP recommends fenfluramine for LGS-associated seizures
Positive Phase III study data has prompted the CHMP to recommend FINTEPLA ®▼ (fenfluramine) for seizures associated with Lennox-Gastaut syndrome (LGS).
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Converging knowledge and technology to transform neuromuscular disease treatment
With the emergence of innovative therapeutic technologies and progress in the genetic understanding of diseases, Biogen’s Toby Ferguson explains why it is a promising time for the development of therapies for neuromuscular conditions such as amyotrophic lateral sclerosis (ALS).
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Could ketamine-assisted therapy help treat alcoholism?
The largest clinical trial of its kind will investigate if ketamine-assisted therapy can reduce harmful drinking in people with severe alcohol use disorder.
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FDA approves first gene therapy for high-risk early bladder cancer
The first gene therapy for high-risk non-muscle-invasive bladder cancer has been approved by The US Food and Drug Administration (FDA).
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CHMP meeting highlights – December 2022
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
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Alzheimer’s therapeutics market to reach $6.8 billion by 2032
A large patient population and limited treatment options are expected to expand the Alzheimer’s therapeutics market at a CAGR of 9.3 percent, suggested a report.
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WHO updates guidelines for treating drug-resistant tuberculosis
A historic change to guidelines for treating drug-resistant tuberculosis has been published by the World Health Organization.
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CHMP adopts positive opinion for haemophilia B gene therapy
Gene therapy etranacogene dezaparvovec has been granted a positive opinion by the CHMP as a haemophilia B treatment for adults in Europe.
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First targeted delivery of siRNA into muscle
A Phase I/II trial demonstrated the first successful targeted delivery of siRNA into muscle, using monoclonal antibody AOC 1001.
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Lilly and EVA Pharma to aid affordable insulin access in Africa
Insulin for at least one million diabetics in low- and middle-income countries, mainly in Africa, is the aim of Eli Lilly and EVA Pharmaceutical's new collaboration.
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European Commission approves first medicine for prurigo nodularis
Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.
