Pharmaceutical Technology

NOVEMBER 9, 2022

In the EU however, two years later, the European Commission awarded a conditional marketing authorisation for Roctavian. BioMarin previously said that the treatment’s European price would likely be around EUR1.5 million price tag. The post Can gene therapies for haemophilia defend their high price tags?

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FDA 111

pharmaphorum

AUGUST 25, 2022

Tecvayli (teclistamab) has been approved by the European Commission for adults with the blood cancer whose disease has progressed have after at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, said J&J.

FDA 98

FDA Immunization 98

pharmaphorum

APRIL 5, 2022

Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based on T cell receptor (TCR) technology – after getting a green light from the European Commission. The European population is meanwhile estimated at several thousand patients, across all stages, according to registry data.

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Labelling Chemotherapy Immunization 52

pharmaphorum

JUNE 2, 2022

This is why the action by the US in 1983 and subsequently the European Commission Regulation No. While in 2021, orphan drugs made up over half of all the US FDA’s approvals, with the figures in European being similarly high – 19 out of 54 approved new active substances. It is estimated that between 3.5 Raising questions.

Compounding 52

Compounding Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

JUNE 21, 2023

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Despite the limited market, the price tags of haemophilia make it potentially lucrative. Haemophilia B is a rare condition.

FDA 98

FDA 98

pharmaphorum

AUGUST 26, 2022

The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII. million spread over five years.

FDA 111

FDA 111