Drug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
The newly authorised formulation of the anti-CD20 therapy provides certain multiple sclerosis patients with another treatment option comparable to intravenous infusion.
EU approval for Roche’s subcutaneous OCREVUS is anticipated mid-2024, depending on acceptance of regulatory submission.
At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
Positive findings from a first-in-human trial means that an advanced cell therapy for progressive multiple sclerosis will be evaluated in Phase II.
OCREVUS subcutaneous injection was comparable to intravenous (IV) infusion in providing near-complete suppression of multiple sclerosis brain lesions over 24 weeks, Phase III study data shows.
Sandoz’s monoclonal antibody Tyruko® has been approved for all indications of reference medicine, as the first biosimilar to treat relapsing forms of multiple sclerosis (MS) in Europe.
Sandoz’s Tyruko (natalizumab-sztn) is now the first US Food and Drug Administration (FDA)-approved biosimilar to Tysabri (natalizumab) injection for relapsing forms of multiple sclerosis.
A Phase III trial for the only therapy approved for both relapsing and primary progressive multiple sclerosis (MS) met its clinical endpoints, Genentech has announced.
In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.
COVID-19 and multiple sclerosis patients experienced reduced inflammation when given the first nasal monoclonal antibody in a pilot trial.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a UK manufacturing facility good manufacturing practice (GMP) registration for its cannabis API.
Study suggests stem cell transplants may delay disability longer than some other medications in patients with active secondary progressive multiple sclerosis.
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.