Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.

US FDA approved expanded label for male breast cancer based on a supplement that included only non-traditional data sets. But agency is making clear that the “substantial” evidence for efficacy still came from the traditional pivotal trials – in women.

The latest drug development news and highlights from our US FDA Performance Tracker. 

Pink Sheet reporters review Novartis' latest response to Zolgensma data manipulation, discuss ICER reviews of Sarepta's Duchenne muscular dystrophy treatments, and recap the FDA's latest antibiotic approval.

A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns. 

EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that will kick in soon for integral drug-device combination products.

Primary sponsors of the 21st Century Cures Act are trying to get the band back together. Is there hope to recapture a bipartisan, pro-innovation spirit in the current US Congress?

Legislation redirecting manufacturer rebates on prescription drugs to the point of sale could face an uphill battle following report’s description of the way rebates lower costs in Medicare Part D.

Amid fierce jostling among Asian countries to attract clinical research, South Korea unveils a five-year road map to accelerate trial activities and improve global competitiveness, focusing on expansion of opportunities for rare and intractable diseases, protection of subjects' rights and enhancement of new drug development capabilities.

Primary sponsors of the 21st Century Cures Act are trying to get the band back together. Is there hope to recapture a bipartisan, pro-innovation spirit in the current US Congress?

A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns. 

Roche's Richard Peck says adoption of outcomes-based pricing in the US could be powerful incentive to study precision dosing, although he also calls on drugmakers to put out scientific examples.

Novartis is pioneering the new “living drugs” model. But its present financial performance benefits from regulatory problems that have beset generic competitors to a franchise written off for dead: the antihypertensive brand Diovan (valsartan).

Amgen and Allergan launched the first US biosimilar for Roche's Herceptin – and the Swiss pharma's Avastin – at a 15% discount to the brand-name products' list prices. Infographic reviews Herceptin's past and its future competitors.

Spark signaled in an SEC filing that its merger with Roche could be delayed into 2020, fueling more speculation that FTC is increasing scrutiny over biopharma mergers.

Lantech’s solvent recovery operations expected to meet US drug GMP requirements due to risk of carcinogens in blood pressure medications.

A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns.