The new EU commissioner for health has been given a number of high-priority tasks, including medicines supply and tackling antimicrobial resistance. These topics will be taken up by the European Commission’s advisory body, the Pharmaceutical Committee, in its new work plan.

Plans for EU-wide Joint Clinical assessments will come under scrutiny at an EU council meeting next week.

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Merck Sharp & Dohme's Ebola vaccine, Ervebo. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

Stephen Hahn will have over 100 stocks to divest upon becoming FDA commissioner.

The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate ­– Hylton Joffe – will be serving as acting OND deputy director.

Health and Human Services Department Deputy Secretary Eric Hargan invites biopharma companies to submit proposals on how to modify or create safe harbors that would be suitable for innovative reimbursement contracts involving prescription drugs.

Plans for EU-wide Joint Clinical assessments will come under scrutiny at an EU council meeting next week.

Walgreen and other retailers allege no-authorized generic patent settlement for extended-release metformin allowed Santarus (Valeant) to block generic entry for four years while raising the price more than 750%.

Medicines For Europe has called on EU leaders to take action on the issue of medicine shortages, urging the new European Commission to prioritize prevention measures in its first 100 days.

Final guidance provides more details on clinical trial designs that use Bayesian adaptive features; says monitoring committee recommendations may deviate from the anticipated algorithm.

Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows.

An inquiry by the EU Ombudsman has prompted the European Medicines Agency to introduce changes to ensure that its experts, who advise companies in the premarket phase, are not appointed to evaluate marketing applications for the same drugs.

Other NASH registration trails have targeted fibrosis, but Galectin's mostly-resolved discussions with US FDA will allow the belapectin program to focus of signs and symptoms of the disease.

Sanofi spends 70% of vaccine production on quality control, Sanofi Pasteur exec VP David Loew tells the Pink Sheet; company is working on next generation flu vaccines that may provide greater efficacy.

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 new EU commissioner for health has been given a number of high-priority tasks, including medicines supply and tackling antimicrobial resistance. These topics will be taken up by the European Commission’s advisory body, the Pharmaceutical Committee, in its new work plan.

Proposal could yield a bounty of new options for innovative drug delivery systems.

Accelerating post-approval change oversight by focusing on ‘established conditions’ means trusting pharmaceutical quality management systems. But how?