CSL Paid $355 Million and Gave Up 45% of the Profits to Win a Claudin-1 Antibody
No development milestones and no royalty: CSL funds every trial through Phase 3 and gives Alentis 45% of the profits.
Orphan Drug Designation
NICE Backs Tryngolza for FCS, Giving Sobi a Monthly Successor to Its Own Waylivra
Sobi is moving its FCS franchise to a less frequent, better-tolerated drug, on broader NICE terms than the one it replaces.
EU Pharma Package Sets Nine Years’ Default Protection and Rewards Comparative Trials With a Tenth
The default gets shorter, and the route back to the maximum runs through comparative trials and filing early in Europe.
The MHRA Authorised Two Obesity Drugs in Two Days. Neither Is on the NHS.
Two MHRA authorisations in two days. One drug is too common to fund, the other too rare to prioritise. Neither is on the NHS.
LifeScience Weekly Digest: Key Industry Updates (6th – 10th January)
In early 2025, significant developments across the biopharmaceutical and medical device sectors shaped the healthcare landscape. Stryker’s $4.9 billion acquisition of Inari Medical, Transcarent’s $621 million deal for Accolade, and several FDA designations for investigational treatments, such as Johnson & Johnson’s nipocalimab, highlight industry advancements. Medicare’s rescinding of coverage for certain cancer genetic tests and … Read more
Regulatory Roundup: Weekly Insights on Pharma and MedTech—Key Updates from Leading Agencies (December 30th to January 3rd)
Welcome to this week’s Regulatory Insights from Synopulse, featuring the latest updates from the FDA, EMA, and other global regulatory authorities. From groundbreaking drug approvals to critical recalls and new designations, we cover the most significant events driving the pharmaceutical sector. This comprehensive report offers a concise view of the regulatory milestones shaping the pharma, … Read more