Novartis unit AveXis is one of several companies seeking extra time to address questions the European Medicines Agency has regarding their marketing applications. The company says it could get a decision on whether the product should be approved in the EU by year-end.

Following a report that identified several shortcomings of the European Medicines Agency fee system, the European Commission has suggested various options to make it sustainable and future-proof.

As the Brexit clock continues to tick, industry says it is not impressed by government reassurances that all is well where the continued supply of medicines is concerned.

Database is expected standardize natural history and other data collection, but won't help streamline drug development in the space for a while yet.

The projects could help streamline rare disease drug development, along with the Rare Disease Cures Accelerator.

Industry speakers offer series of suggestions for ways to incentivize development of pain and addiction products at US FDA public meeting on the opioid crisis.

UK members of parliament have called on pharmaceutical companies to be more transparent in their pricing process and to improve the way they gather and present data for health technology appraisals. They also say that industry rebates should be ring fenced to fund new medicines.

Absent any legislative remedy, an administrative fix could provide manufacturers with confidence that value-based arrangements won’t trigger a new best price, Duke Margolis policy experts propose.

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.

The projects could help streamline rare disease drug development, along with the Rare Disease Cures Accelerator.

Industry speakers offer series of suggestions for ways to incentivize development of pain and addiction products at US FDA public meeting on the opioid crisis.

Agency recommends an anchor-based approach to statistical analyses of drug effects on core signs and symptoms.

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).

Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.

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.