If they withstand withering legal challenges from the biopharmaceutical industry, hospitals and medical groups, and overcome steep logistic obstacles, rules released by the Trump administration Friday...

Data from NIH’s master protocol trial was the cornerstone for the first FDA approval of a COVID-19 therapy, granted to Gilead’s Veklury Thursday. The approval highlights the critical role of master protocols for generating substantive evidence...

As real-world data continue to take on a more prominent role in clinical development, Gilead’s comparison of severe COVID-19 patients in a clinical trial of remdesivir versus a real-world cohort raises questions of how and...

Demands from President Donald Trump that FDA issue a second Emergency Use Authorization for the use of hydroxychloroquine to treat COVID-19 test agency chief Stephen Hahn’s commitment to public health again, and pose challenges to...

The latest remdesivir data in moderate COVID-19 patients suggest that the therapy’s Emergency Use Authorization should cover only a five-day course of treatment, which would stretch supplies to treat more patients. But the question remains...

Alexis Borisy has launched EQRx to disrupt the biopharma world by developing and launching innovative therapies at “radically lower” prices than commercial competitors. With its first drug expected to hit the market in five years,...

Newly launched Arctos will use CHF8 million in series A money to conduct preclinical work on a vector-delivered technology it believes can restore eyesight in patients whose retinal cells have degenerated, rather than those whose...

No one believes that H.R. 3, the Democratic House leadership’s drug pricing bill, will be enacted into law , but that hasn’t stopped it from precipitating frenzied debates. The bill has become a strawman for advocates...

CMS and the biopharma industry are presenting conflicting explanations for a spike in Medicare Part B premiums and deductibles. CMS says the increases are “largely due to rising spending on physician-administered drugs” (see “Medicare Part...

The lackluster U.S. biosimilars market has led to calls for a new regulatory paradigm that could slash the cost of development. Biosimilars developers and critics of the sector agree on one thing: as it has...