Pink Sheet reporters discuss the proposed opioid lawsuit settlement, Public Citizen's opioid citizen petition denial, and the upcoming FDA public meeting on opioid standards, as well as a proposal to better outline agency flexibility with rare disease drugs.

The European Pharmacopoeia, which has been updated to reflect regulatory and scientific advances, contains 114 new monographs including substances of “high therapeutic interest.” Holders of CEPs have been advised to update their certificates in line with the new monographs.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

New medicines under evaluation at the European Medicines Agency.

Petition was consumer advocacy group's first request for halt to approval of an entire drug class; Public Citizen has gotten full and partial approval of other recent petitions.

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.

NICE has recommended BioMarin’s Brineura for use in the National Health Service in England after a managed access deal and product pricing were agreed between BioMarin and NHS England. Final details of the deal are expected next month.

The most important thing to know about a draft version of the House Democratic leadership’s proposed drug price negotiation plan is that it is still just a draft – not the draft – much less a bill that could pass the Democratic controlled House, to say nothing of the GOP controlled Senate.

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. 

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).

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.

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.