Japanese health ministry makes changes around the allowance of drug generic names and study codes in information provided by pharma companies on their websites for clinical studies, with the aims of improving transparency and facilitating patient participation.

Novel agents targeting similar indications suggest potential commercial struggles across the therapeutic landscape, with battlegrounds taking shape between RSV vaccines, new mechanisms in major depression, and bispecifics for large B-cell lymphoma.

The upcoming year could see a rebound approvals if the bigger-than-usual queue of novel agents with 2023 user fee goal dates pans out.

Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.

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

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 EU, and updates on EU marketing authorization changes recommended by the CHMP.

With price controls in Medicare looming nine years after approval, launch strategies such as ‘bridge’ programs that build initial volume with free drug may have to be adjusted.

The ABPI, which represents the R&D-based pharmaceutical industry in the UK, says the proposed increase in the statutory scheme rebate sends "the worst possible signal" to global investors and boardrooms.

Packaging for such products reflects ‘unique circumstances’ that should exempt them from the rebates on discarded drugs otherwise required by the policy, stakeholders tell CMS at a ‘town hall’ forum.

US biopharma companies are warning of significant changes in drug development priorities as they prepare for the implementation of new Medicare pricing measures enacted in 2022. Those changes will have ripple effects on the FDA, which may spark some responses.

Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.

While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.

First Humira biosimilar launches raise worries about holes in US health system that may let the brand product continue to dominate. If Humira biosimilars can’t get a strong foothold, reform to biosimilar policy for medicines reimbursed through the pharmacy benefit may be necessary if the US wants to rely on these products to bring down the cost of brand biologics.

Industry leaders are concerned about the outlook for small molecule drugs in particular, but execs at the J.P. Morgan Healthcare Conference were also optimistic there could be chances to shape the implementation of certain policies.

However, similar claim in materials directed at health care providers need not be discontinued, National Advertising Division says in challenge brought by Lilly; NAD decisions in Rx promotion disputes are rare, but voluntary resolution process could become more appealing to pharma firms.

Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages. 

A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.

The omnibus spending bill included dozens of reform provisions related to the US FDA. One seemingly minor change to FDA’s inspection authorities could end up being a big help to the challenges ahead in catching up after the COVID-19 pandemic.