This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

New vaccines’ journey to market has another stage after FDA approval: CDC and its Advisory Committee on Immunization Practices. In advance of the ACIP’s October meeting, a Pink Sheet infographic follows vaccines approved by the FDA over the last six years through ACIP to the commercially vital recommendation by CDC.

Practicing obstetricians who are maternal fetal-medicine specialists should make up a ‘significant proportion’ of the advisory committee at the forthcoming hearing, Covis says; CDER calls for a more ‘balanced’ panel that includes expertise in biostatistics, neonatology and epidemiology.

Marketing applications for 10 new drugs have been added to the latest list of products under review by the European Medicines Agency.

Leaked documents show that the European Commission has prepared a new proposal on compulsory licensing of coronavirus products to be tabled at the World Trade Organization’s Ministerial Conference next month.

Cyltezo won’t be available until 2023 due to patent settlement with AbbVie. The second-ever interchangeable biosimilar approved by the US FDA also contains a first: published data from a switch trial.

BeNeLuxA, the cross-country medicines access initiative, says it is now the “gold standard” for voluntary collaboration in Europe after a ground-breaking deal was reached with Novartis.

A new study highlights a subset of high-cost drugs in Medicaid for which legal and policy tools may be available to manage spending growth.

Executive director Schwartz suggests Congress may turn its attention to the advisory commission’s proposal to revise Medicaid coverage for drugs approved under the accelerated approval pathway in the next year or two.

The European Medicines Agency is expecting a lively pipeline of advanced therapy medicines over the next few years. It is also making final preparations for the introduction of the new EU clinical trials system from the end of January next year.

The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.

Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.

Drug and medical device company payments to doctors and hospitals for non-research related activities dropped for the first time in 2020 since CMS’s Open Payments database began collecting the information. 

Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull its gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump aministration’s most favored nation reimbursement rule.

Novartis gets some praise for being willing to embrace cost-effective drug prices, but health policy analysts are skeptical the industry would truly adopt the idea for its best-selling drugs, particularly if the appropriate guardrails were put in place to ensure broader budget impact was controlled.  Holes were also poked in the way Novartis determined the total cost of drug utilization management on the US health system. 

Leaked documents show that the European Commission has prepared a new proposal on compulsory licensing of coronavirus products to be tabled at the World Trade Organization’s Ministerial Conference next month.

As discussions continue over the European Commission’s plans to overhaul the EU pharmaceutical legislation, the R&D-based pharma industry body EFPIA says that any new pharma policy framework will need to be stable, fast, effective and globally competitive.

Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.