Pharma firms are being asked to let the government know how prepared they are in terms of ensuring supplies of investigational medicines and other clinical trial supplies in the event of a no-deal Brexit at the end of October.

Drug pricing reform in Canada could prompt companies to launch elsewhere or see drugs diverted to the US.

Life science companies are uneasy over the government’s latest proposals for emergency medical supplies to the UK if the country leaves the EU without a deal.

The arrest of India's deputy drugs controller creates shock waves and indicates an intent to clamp down on graft at any level, say industry experts.

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.

Divergences between the EU and US agencies in marketing application approval decisions in 2014-2016 were primarily due to differences in the regulators’ conclusions about efficacy based on review of the same data or to differing clinical data submitted to support the application, a study has revealed.

The updated business principles may give pharma companies leverage, or at least talking points, as they continue to engage with the Trump administration on policies like the International Pricing Index and with US lawmakers on drug pricing legislation. J&J's Gorsky heads governing committee of multi-industry business group that revised its principles.

Drug pricing reform in Canada could prompt companies to launch elsewhere or see drugs diverted to the US.

A look at the evolution of litigation, from Amgen's 'bold' at-risk launch of Herceptin and Avastin biosimilars to the jump in settlements, new battles over manufacturing information and an expected petition to the Supreme Court.

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.