Hansa Biopharma To Be Transformed By Idefirix Approval In EU

Launch In Selected Markets In The Fourth Quarter

27 Aug 2020

• By John Davis

With the first approval in the bag for its lead product, Idefirix, from the European Commission, Sweden’s Hansa Biopharma is planning to launch the product in Europe using its own medical and commercial organization in core markets.

Sweden’s Hansa Biopharma AB will be transformed by the EU Commission’s conditional approval of the company’s first product, Idefirix (imlifidase), which will bring the biotech into the commercial arena, with first launches in Europe pencilled in for the fourth quarter of 2020.

The indication conditionally approved by the European Commission is for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The approval was based on four completed Phase II studies in which the product met all primary and secondary endpoints

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Strong Showing For Bayer’s Pharma Business In Uncertain Times

13 May 2025

• By Kevin Grogan

As CEO Anderson backs high prices for innovative drugs in Europe

Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

12 May 2025

• By Andrew McConaghie

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

09 May 2025

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Verastem Wins Approval For Novel Drug Combo In Rare Ovarian Cancer

08 May 2025

• By Jessica Merrill

The novel RAF/MEK inhibitor and FAK inhibitor are the first treatment approved specifically for KRAS-mutated recurrent low-grade serious ovarian cancer (LGSOC).

Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

15 May 2025

• By Cathy Kelly

Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.