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GVK Biosciences

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FDA issues final guidances for clinical cancer trials

The FDA is working to address inequities, target the right treatments to the right patients and speed progress against the most deadly and rare cancers

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Janssen and Legend Biotech’s Carvykti receives FDA approval for patients with relapsed or refractory multiple myeloma

In the study, 98% of patients with relapsed or refractory multiple myeloma responded to a one-off treatment of the drug

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Sanofi and Regeneron announce positive phase 3 trial results for Dupixent

The trial involved patients with eosinophilic oesophagitis, an inflammatory disease that damages the oesophagus and makes eating and drinking painful

Biomarin

FDA keeps BioMarin’s gene therapy for phenylketonuria on hold

The decision follows data suggesting BioMarin’s experimental gene therapies may have the potential to progress cancers

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Sandoz launches generic oncology treatment in Europe

Lenalidomide can be used to treat patients with haemato-onocology conditions, following recommendations from recent European Society for Medical Oncology (ESMO) guidelines

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Eli Lilly’s Omicron drug treatment gets emergency use authorisation from FDA

The drug can be used to treat adults with mild-to-moderate COVID-19, and children aged 12 or older, in specific emergency cases in non-hospital settings

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FDA accepts Priority Review for Dupixent in children with moderate-to-severe atopic dermatitis

If approved, Dupixent would be the first biologic treatment available in the US for children aged six months to five years with the skin condition

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FDA issues approval for Sanofi’s Enjaymo treatment for patients with CAD

The treatment is the first-of-its-kind for patients living with cold agglutinin disease, a rare blood disorder

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Sanofi unveils new corporate brand and logo

Sanofi Pasteur and Sanofi Genzyme will unite under the new brand image

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FDA issues approval for Janssen’s HIV drug Cabenuva

The injectable treatment for adults with HIV can be administered every two months

- PMLiVE

New Omicron subvariant appears more transmissible but no more severe than original Omicron strain

The new subvariant is already emerging as a dominant strain in Denmark, the Philippines, Nepal, Qatar and India

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Janssen submits marketing authorisation to EMA for teclistamab

The drug has been developed to treat patients with relapsed or refractory multiple myeloma, an incurable blood cancer

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