The UK drug regulator, the MHRA, has approved its first product under Project Orbis, the US-led international regulatory collaboration scheme it joined four months ago to speed up access to promising cancer medicines.

Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.

The European Commission’s plans for overhauling the EU medicines legislation have elicited a number of proposals from the pharmaceutical industry to improve the regulatory framework, including streamlining the committee system, improving the use of expedited evaluation pathways, and expanding the European Medicines Agency’s role in assessing drug/device combination products.

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

Novartis has failed to reach a reimbursement agreement to keep its first-in-class advanced breast cancer drug on the German market, but it is pressing on with plans to expand market access for the product across Europe. It is also working on securing regulatory approval to use Piqray in a broader patient population that would carve out a more meaningful place in the relevant treatment pathway.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

The UK’s purchase of 60 million extra Pfizer/BioNTech COVID vaccine doses, plus bets on Novavax and Valneva and others gives it a buffer against new variants – so when will it pledge to donate to more needy nations?

Medicare may look to bolster evidence on Biogen’s potential Alzheimer’s treatment, if approved, with a national coverage decision requiring the collection of clinical data in the postmarket setting.

Novartis has failed to reach a reimbursement agreement to keep its first-in-class advanced breast cancer drug on the German market, but it is pressing on with plans to expand market access for the product across Europe. It is also working on securing regulatory approval to use Piqray in a broader patient population that would carve out a more meaningful place in the relevant treatment pathway.

Pfizer disclosed that a Phase III trial for the gene therapy has been unable to start in the US because of questions from the FDA, even while enrollment in 15 sites outside the US is under way.

With elections taking place across the UK on 6 May, the Scottish National Party says it plans to take steps to ensure sustainable medicine supply chains and build up the manufacturing of generics and “specials” within the National Health Service in Scotland.

Phase III trial was statistically significant, but US FDA argues complex study design makes it unclear that ChemoCentryx’s avacopan offers a clinically meaningful benefit, including a safety advantage, for ANCA vasculitis. Agency had tried to direct company to better designed trials earlier in development program.

US FDA will ask advisory committee whether data from the trial supporting full approval of Merck’s Keytruda for second-line setting can be used to confirm clinical benefits for earlier setting of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy following a failed confirmatory study. Genentech’s Tecentriq is also at risk of losing its accelerated approval in that space but it could buy some time as its confirmatory study is not yet complete. New competitor entrant since accelerated approvals also lessens degree of unmet need.

Similarities to AstraZeneca blood clots are clear, but more research needed before any ‘class effect’ conclusions can be drawn.

ICER President Steve Pearson expresses interest in setting drug costs for accelerated approval drugs low with price increases based on confirmatory evidence ahead of upcoming white paper from the group.

Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.

Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It's also not clear whether it’s an ominous sign for other industry battles in the US, including the drug pricing debate.

US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.