After US FDA authorization for additional COVID vaccine shots, the focus now shifts to CDC’s advisory committee, which may be concerned about variations in eligible populations, timing and dosing when it comes to giving a booster different from the primary vaccination series.

Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’

Entasis is seeking a pathogen-specific approval for its antibiotic/beta lactamase inhibitor candidate rather than an indication specific the site of an infection. Achaogen’s earlier failure to do the same may have helped set a path.

The European Medicines Agency has OKd new manufacturing sites and a ready-to-use formulation for Comirnaty, while Australia has provisionally approved Ronapreve for treatment and post-exposure prophylaxis.

The news that the Biden Administration is considering asking Robert Califf to return as Commissioner of the US FDA is the latest twist in a most unusual transition process at the agency. But one message seems abundantly clear: the White House is perfectly happy with FDA as it is.

The International Council for Harmonisation has delivered the first of a two-part project to modernize the international good clinical practice framework by finalizing changes to its primary efficacy guideline. 

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.

The news that the Biden Administration is considering asking Robert Califf to return as Commissioner of the US FDA is the latest twist in a most unusual transition process at the agency. But one message seems abundantly clear: the White House is perfectly happy with FDA as it is.

Agency’s apparent ‘intellectual exercise’ in treating pre-Hatch-Waxman ANDAs as NDAs could expose biosimilars to liability, Teva deputy general counsel notes at FDLI conference.

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. 

Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’

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.