Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug;  FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.

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

As stockpiles of Ebola vaccine are being built up around the world, Médecins sans Frontières has said more action is needed to ensure sufficient numbers of vaccinations are available for use in current and future outbreaks. 

Softening provisions to make EU-wide joint clinical assessments voluntary would make proposed legislation on HTA cooperation redundant, says Eurordis.

Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.

Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.

White House Council of Economic Advisors says US House drug price “negotiation” bill will reduce the number of innovative medicines by 100 over a decade; the Congressional Budget Office says more like 8-15. Both analyses miss the point – but also show that industry is losing a crucial piece of political ground.

As stockpiles of Ebola vaccine are being built up around the world, Médecins sans Frontières has said more action is needed to ensure sufficient numbers of vaccinations are available for use in current and future outbreaks. 

Softening provisions to make EU-wide joint clinical assessments voluntary would make proposed legislation on HTA cooperation redundant, says Eurordis.

White House Council of Economic Advisors says US House drug price “negotiation” bill will reduce the number of innovative medicines by 100 over a decade; the Congressional Budget Office says more like 8-15. Both analyses miss the point – but also show that industry is losing a crucial piece of political ground.

Biogen presented highly anticipated data in Alzheimer’s disease at CTAD for its Phase III EMERGE and ENGAGE studies, but one major question remains unanswered: will the FDA approve the drug? 

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

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.

Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.

Draft recommendation offers path to ICH Q12 regulatory relief.

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.