It's decision time again at the European Medicines Agency and Roche's Polivy and AstraZeneca's Qternmet are among the products up for an opinion on whether they should be approved in the EU.

At just the time when pretty much everything is going digital in China, the nation’s pharma regulatory agency has launched a new mobile application to put itself at your finger tips. And it’s time to give it a test drive.

The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.

The pharmaceutical industry is concerned that too much flexibility may result in a “fragmented and cost intensive implementation” of the EU electronic product information framework.

Pharmaceutical companies will have a better idea of the conditions under which a supplementary protection certificate can be granted after an advocate general of the European court explained how a new legal test established last year should be used. However, lawyers caution that the opinion still leaves some aspects to be clarified.

Canada’s R&D drug industry says it approached the court as a “necessary step,” given the significant impact of the pricing reforms.

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Former US FDA commissioner Scott Gottlieb makes a case for regional or national risk pools to ensure pediatric patients get timely access to gene therapy like the upcoming treatments for sickle cell disease.

It is now a common assertion among insurers that one of the many challenges they face in covering high-priced specialty therapies is that drugs are approved with “less evidence” than used to be the case. That is more myth than reality – but a very dangerous myth if it isn’t corrected by the US FDA and the drug industry.

US FDA agrees to plan to seek approval for ‘off the shelf’ cell therapy with Phase II data showing fewer major mucosal bleeding events in end-stage heart failure patients implanted with mechanical assist devices; confirmatory Phase III is set to begin this year.

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. 

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

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).

After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.

New messaging standard from GS1 would enable industry to sell most returned drugs after November DSCSA deadline without running afoul of the FDA.

FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.