Weekly roundup: Approvals, patents and pricing: healthcare regulation heats up
PDUFA action date for Hansa Biopharma’s imlifidase BLA set for December 19, 2026
Hansa Biopharma announced that the Food and Drug Administration (FDA) has notified the company that the previously accepted Biologics License Application (BLA) for imlifidase has been assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.
📺Optimum TV
Don’t miss the brand-new episode of our Thought Leaders series featuring John Murphy and Aude Gerspacher from Bloomberg Intelligence.
As the infamous pharma patent cliff looms ever close, listen to their insights on the key findings from their recent report on Merck’s global patent portfolio for its cancer drug Keytruda.
Watch the full episode below.
🔥Hot topic
As England and Wales’s drugs cost regulator, NICE, prepares to raise the price it deems acceptable for the NHS to pay for new drugs, this week’s hot topic asks why the ‘QALY’ threshold is being raised now – and its likely impact.
Read the full article below.
Prefer to catch the highlights? Watch Stephen Adams explain the top line ⬇️
👥Industry events
LSX World Congress Europe
From 24th – 26th March, LSX World Congress Europe arrives in Lisbon. A leading life science fundraising and investment event, bringing early-stage innovators and investors together through strategic 1:1 meetings and targeted networking.
Be sure to connect with Optimum’s CEO Mary Clark, as she will be taking to the stage to present ‘The Art of the Pitch: Communicating Commercial Potential to Investors’.
When booking your partnering pass to LSX Europe, you are eligible to an exclusive 50% discount on your BIO-Europe Spring ticket as part of Spring Innovation Week. Combine this with Optimum’s 15% F&F discount for LSX Europe events, reach out to the team for more information, or register today at informaconnect.com/lsx-world-congress/register
Anglonordic Life Sciences Conference XXII
Are you an early-stage Life Science company looking for investment? Do you want to meet with Europe’s leading life science investors?
If the answer is YES, then the Anglonordic Life Science Conference is a must attend event for your diary! Sponsorship & exhibition opportunities are still available. Anglonordic is the ideal platform to promote your services, engage others with your brand and grow your network.
Register today at anglonordiclifescience.com/page/registration
That’s all folks! To stay in the know – subscribe to Optimum’s weekly wrap-up today!
