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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A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
Here, Jason Fontenot, Chief Scientific Officer of Sangamo Therapeutics, discusses with EPR’s Hannah Balfour how the industry is developing chimeric antigen receptor (CAR) T regulatory cells (Tregs) as a potentially paradigm-shifting therapeutic option for conditions driven by the immune system, such as autoimmunity and transplant rejection.
Sanofi’s Japan-based manufacturing site near Tokyo will be sold to a European contract development and manufacturing organisation.
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
Study highlights benefit of initiating high-efficacy therapies early for relapsing multiple sclerosis (RMS) patients, as opposed to changing from lower efficacy therapies later.
Work is underway to create a collaborative virtual research institute (VRI) to support the fundamental research and subsequent clinical translation of precision medicine in Abu Dhabi, as well as the United Arab Emirates more broadly. Here, European Pharmaceutical Review’s Hannah Balfour discusses the project with the Head of the new…
Pipe-307 demonstrated linear pharmacokinetic (PK) data consistent with pre-clinical modelling and was generally well tolerated at all doses in 70 healthy adult volunteers.
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
Zeposia® (ozanimod) also demonstrated a low annualised relapse rate (ARR) of 0.103 in the five-year Phase III DAYBREAK study.
In this article, Included’s Raafi-Karim Alidina explores biases in product design, outlining how they impact pharmaceuticals as well as technologies, and practical steps to enhance diversity and ensure inclusion.
The European Commission has approved once daily oral Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis in adult patients.
In its March meeting the EMA’s human medicines committee recommended five medicines for approval and concluded its review of regdanvimab as a treatment for COVID-19.
The European medical cannabis market lacks a common regulatory framework; Peter Kohut charts a route through the complexity and highlights opportunities for the taking.
The Scottish Medicines Consortium has approved Zeposia® (ozanimod) for use in relapsing remitting multiple sclerosis patients.