Pharmaceutical Technology

APRIL 13, 2023

While Vertex and CRISPR submitted the Biologics License Application (BLA) for exa-cel earlier this April, bluebird has yet to do so for lovo-cel. ICER uses quality-adjusted life year (QALY), a cost effectiveness metric to measure the value of a healthcare intervention. The treatments would have to cost $1.92

Gene Therapy 147

Gene Therapy Gene FDA Approval Licensing 147

pharmaphorum

APRIL 20, 2021

Kesimpta was one of the first medicines to be review under the new Medicines and Healthcare products Regulatory Agency (MHRA) authorisation process following the UK’s departure from the EU at the start of the year. GlobalData thinks Ocrevus will remain the most widely-used option, hitting $7.6 billion by 2028. billion in sales in 2028.

Sales 109

Sales Medicine Drugs Marketing 109

Worldwide Clinical Trials

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. According to GlobalData, as of November 16, 2023, over 175 trials have been initiated for gene editing products, trialing nearly 150 different novel treatments around the world. In June 2023, the U.S.

Gene Editing 168

Gene Editing Gene Gene Therapy In-Vivo 168

XTalks

MAY 2, 2024

The Prescription Drug User Fee Act (PDUFA) date is the deadline that the FDA sets for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. Alexion, AstraZeneca Rare Disease is serving as a licensing partner of BridgeBio’s affiliate, Eidos Therapeutics, Inc.,

Drugs 52

Drugs FDA Approval Sales Vaccination 52

Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). GlobalData is the parent company of Pharmaceutical Technology.

Gene Therapy 246

Gene Therapy Gene Protein Sales 246

Pharmaceutical Technology

AUGUST 12, 2022

According to a 2021 GlobalData survey, Brexit is expected to have a worse impact on the UK’s healthcare sector than the Covid-19 pandemic. That’s not to mention the running costs (£127m-£171m) and licensing costs (£6.2m) – or the possibility that these additional costs could lead to products being discontinued.

Medicine 290

Medicine Production Generic Drugs Regulation 290

Pharmaceutical Technology

APRIL 4, 2023

million) in the latest extension round, which was led by Pontifax Venture Capital, and existing investors Novo Holdings and Ysios Capital, along with RA Capital Management, HealthCap and Gilde Healthcare. GlobalData is the parent company of Pharmaceutical Technology. Adcendo then went on to raise the additional €31 million ($33.9

Development 130

Development Licensing Licensing Antibody 130