pharmaphorum

JULY 25, 2022

The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer.

Antibody 52

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pharmaphorum

AUGUST 25, 2022

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

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Antibody Marketing Drugs Medicine 98

XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. As such, unresectable or metastatic uveal melanoma usually has a poor prognosis and until the approval of Kimmtrak, there was no approved treatment. The median treatment time is about 23 weeks (or 5.3

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pharmaphorum

NOVEMBER 16, 2021

“We look forward to the full technology appraisal guidance (TAG) which is due to be published in early December 2021,” he added. Cenobamate was originally developed by South Korean biotech SK Biopharmaceuticals, and was approved as Xcopri in the US in 2019. The drug made almost $17 million in US sales in the third quarter.

Drugs 98

Drugs Medicine Clinical Trials Clinical Trials 98

XTalks

OCTOBER 26, 2021

This latest data may have finally won over NICE to reverse its decision and grant approval to the drug. Givlaari was approved by the European Medicines Agency (EMA) in March 2020 and by the US Food and Drug Administration ( FDA ) in 2019.

Gene Silencing 98

Gene Silencing Gene Clinical Trials Clinical Trials 98

XTalks

FEBRUARY 27, 2024

The US Food and Drug Administration (FDA) has approved a number of new rare disease drugs in recent years, including gene therapies. In 2020, 31 out of 53 novel drug approvals were for rare or orphan diseases​​. Both therapies were awarded their approvals on the same day in December 2023.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

pharmaphorum

MARCH 27, 2022

Johnson & Johnson is in course for approval of its multiple myeloma CAR-T therapy Carvykti in the EU the next few weeks, after getting a green light from the EMA’s human medicines committee. In the US, Abecma has a list price of around $420,00, while J&J has set its therapy a little higher at $465,000.

Antibody 98

Antibody Clinical Trials Clinical Trials Sales 98