FDA Grants Fast Track Designation to ERAS-0015 for Metastatic Pancreatic Cancer
Summary:
ERAS-0015 earns FDA Fast Track designation after early responses in KRAS-mutant pancreatic cancer, advancing a broader pan-RAS strategy toward pivotal testing.
Regeneron to challenge Ipsen as FDA clears bone disease drug
Summary:
Regeneron’s Pasatru wins FDA approval for ultra-rare FOP, offering a potent new approach to preventing abnormal bone formation and challenging Ipsen’s incumbent therapy.
BioMarin bulks up bone unit with $275M Alesta buyout to challenge AstraZeneca
Summary:
BioMarin acquires Alesta for $275 million, adding an oral HPP therapy that could challenge AstraZeneca’s enzyme replacement treatment and expand access for adult patients.
Merck and Sarah Cannon team up to boost oncology trial efficiency
Summary:
Merck partners with Sarah Cannon to streamline community oncology trials, aiming to accelerate site activation, improve enrollment and bring cancer studies closer to patients.
The use of AI in biotechnology is changing faster than the rules governing either technology
Summary:
AI is blurring the boundaries between computation and biology, outpacing regulations and forcing policymakers to rethink how emerging biotechnologies are governed.
