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.
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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.
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).
Sanofi licenses Innate Pharma’s NK cell platform with €25m upfront payment
Innate Pharma will receive a €25m upfront payment from Sanofi to license its B7H3 ANKETTM platform, which is creating a new class of molecules to induce synthetic cancer immunity.
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.
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).
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.
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.
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.
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.
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.
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.
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.
Takeda’s $4 billion acquisition to address autoimmune diseases
Takeda will acquire Nimbus Therapeutics for $4 billion and gain rights to its allosteric TYK2 Inhibitor to address multiple immune-mediated diseases.
New collaboration could advance small molecule epilepsy therapy
UCB and Praxis Precision Medicines, Inc. will collaborate to advance Praxis’ PRAX-020 small molecule programme for KCNT1 related epilepsies.
