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.

Advisory committee members say clinical data proves the second shot should be considered part of the primary series, while Janssen wants it called a single-shot vaccine with a booster.

EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.

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.

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

Pilot program offers Part D beneficiaries an alternative to manufacturer assistance in the form of copay coupons, which are prohibited in government-sponsored health plans. New program also available to commercial insurance and cash-paying patients.

Congress is considering legislation that would reverse some of the Trump administration's friendly corporate tax policies, presenting another challenge to the biopharmaceutical industry.

Value assessments of COVID-19 monoclonal antibodies should inform pricing decisions, says cross country coalition.

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.