Rethinking Clinical Trials

JULY 6, 2023

The European Medicines Agency (EMA) released a separate guidance around DCTs in December 2022. While similar to the FDA draft guidance, the EMA guidance differs slightly in its emphasis and lack of certain topics. The EMA guidance also features an extensive discussion on the need for investigator oversight.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

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

Antibody Medicine Drugs Trials 52

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. An opinion from the Scottish Medicine Consortium (SMC) on the use of the drug by NHS Scotland is expected to be published early in 2022.

Drugs 97

Drugs Medicine Clinical Trials Clinical Trials 97

pharmaphorum

AUGUST 25, 2022

Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA. A marketing application for teclistamab is also under review at the FDA, with a decision expected later this month or in early September.

Antibody 98

Antibody Marketing Drugs Medicine 98

XTalks

JANUARY 28, 2022

The company is expecting approval from the European Medicines Agency (EMA) soon as it prepares for a European launch in the second quarter of this year. Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose. The median treatment time is about 23 weeks (or 5.3

FDA Approval 98

FDA Approval Development Licensing Licensing 98

XTalks

OCTOBER 26, 2021

Givlaari was approved by the European Medicines Agency (EMA) in March 2020 and by the US Food and Drug Administration ( FDA ) in 2019. The treatment came with an initial price tag of $39,000 per vial, which amounts to a total of $575,00 each year.

Gene Silencing 98

Gene Silencing Gene Clinical Trials Clinical Trials 98

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

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Production Pharma Production Pharma Companies Drugs 264