Seven new products, including the world’s first ever Ebola vaccine, are on track to receive EU-wide approval. Meanwhile, two drugs have failed to make the grade.

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

Following on from moves to push price transparency on to the global agenda, Italy is poised to pass a decree that would oblige companies to disclose public R&D funding.

Efforts to ensure that supplies of medicines continue to flow if the UK leaves the EU without a deal have been stepped up with the announcement of three contracts to provide an express delivery service for urgently needed products.

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 The company is one of two drug sponsors that has withdrawn an EU marketing application in October.

Following on from moves to push price transparency on to the global agenda, Italy is poised to pass a decree that would oblige companies to disclose public R&D funding.

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.

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).

An upcoming PDA technical report is expected to build on the concepts of an earlier report on laboratory systems and propose a risk-based approach for protecting data integrity using a nine-box grid for assessing data integrity risks.

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.