Preliminary performance data suggests only a handful of applications receiving US FDA action by the end of FY 2018 actually missed their review goals.

A month after being asked to attend an oral explanation meeting with the European Medicines Agency, Paratek Pharmaceuticals has decided to withdraw the EU marketing application for its broad spectrum antibiotic, Nuzyra. The company is one of two drug sponsors that has withdrawn an EU marketing application in October.

Shionogi's cUTI drug clears US FDA advisory committee by 14-2, though a black box warning is possible after one of the clinical studies showed a potential mortality imbalance disfavoring cefiderocol in other diseases.

The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.

Amarin’s cardiovascular risk reducing drug, Vascepa, is among four new products being considered for accelerated assessment by the European Medicines Agency.

A new bill giving the UK regulator more powers after Brexit has been welcomed by the life sciences industry. However, observers have warned that it needs fleshing out with detail, and that the government would be wise to proceed carefully if it considers relaxing clinical trial regulations.

A draft decree in Italy aims to put added therapeutic value at the centre of reimbursement decisions.

NIH Director Francis Collins describes evolution of existing collaborations and how the two agencies might facilitate development of gene therapy, such as by having a common template for regulatory review.

Senate Majority Leader McConnell is the one constant keeping drug price controls from gaining any legislative traction.

A new tool from the European Network For Health Technology Assessment to evaluate the quality of registries is now being piloted.

Only two of seven applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical need to patients faster were successful last month.

Final guidance documents for bacterial vaginosis, vulvovaginal candidiasis, and uncomplicated urinary tract infections contain few changes from draft.

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).

Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.

Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.

Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.