An arm of the private equity firm pledged up to $750 million in funding for Moderna’s flu shot development, in exchange for milestones and royalties.
The failure of a medicine known as TUDCA is yet another disappointment for ALS patients, as it comes just after Amylyx’s therapy Relyvrio proved unsuccessful in confirmatory testing.
Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.
The biotech is trying to develop a Spinraza-like drug for the condition, a form of genetic epilepsy. Fresh data appear supportive of a high dose’s effectiveness.
The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.
“We look forward to helping hospital care teams more easily get patients to the right specialist at the right time,” said Stacey Churchwell, vice president and general manager, Cardiovascular ...
The high court's treatment of the case, which centers on a conservative challenge to FDA decisions expanding abortion pill access, is seen as potentially consequential for the drug agency.
The results are from a small Phase 1 study, but suggest Viking’s oral GLP-1 drug may not come with high rates of gastrointestinal side effects.
Despite the late-stage victory, shares of the New York-based biotech dipped more than 3%. One analyst argued that Axsome’s drug has “largely been falling under investor radars.” ...
As precision medicine expands into a growing number of therapeutic areas, the “one size fits all” approach to drug development is becoming less common.
Leveraging real-world data (RWD) transforms global clinical trials, enhancing patient engagement and improving regulatory decision-making.
After his first biotech startup was sold off in parts, Sharei is applying the lessons he’s learned to a new company with a different business model.