Pink Sheet infographic breaks down the mix of patient advocacy groups, individual patients and clinicians offering input to CMS on the first 10 drugs facing Medicare price negotiation.

Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.

While a decline in complete response letters in FY 2023 is good, the continued drop in ANDA submissions could be a bad sign for the industry’s long-term health, a former FDA official worries.

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.

Regulators from Canada, the UK and Australia discuss their experiences of working together under both the ACCESS Consortium, an international regulatory worksharing coalition, and Project Orbis, a parallel review process designed to speed up access to oncology medicines.

The UK joined Project Orbis in 2021 with the aim of speeding up the regulatory process for promising cancer drugs, but fewer than half of the drugs licensed under this pathway are available on the NHS in England.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

The pressure of having to reach agreement on a global pandemic treaty by May 2024 could mean countries end up opting for a less far-reaching version than originally planned. A group of European parliamentarians has called on the EU to take a stronger stance.

Christine Baeder’s departure from Teva means transition at the Association for Accessible Medicines’ board of directors as well; Sandoz’s Keren Haruvi becomes chair. The group also started looking for a new permanent CEO to replace Dan Leonard, who left AAM in December 2022.

Medicare payment for higher quality drugs would help abate shortages, experts with the Brookings Institution, Civica Rx and University of California say. Brookings’ Wosińska explains how hospitals could identify quality generic injectable drug manufacturers without waiting for FDA quality ratings.

Beremagene geperpavec, Krystal Biotech’s topical, redosable gene therapy for treating dystrophic epidermolysis bullosa, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Up to $1bn in incentive and milestone payments is to be offered to manufacturers over a 10-year period, focusing on priority antigens and diseases.

Biden administration’s new framework will consider whether a product’s price is reasonable in deciding whether to exercise march-in rights. Numerous other factors could limit provision’s impact, but industry is concerned it will discourage firms from licensing government-funded inventions.

Findings could provide a basis for future policy interventions, the department says. Speeding generics and biosimilars would seem a natural outshoot of the conclusions, but the report does not contain any recommendations.

Former NCI Director Monica Bertagnolli, who now is head of the NIH, said FDA, NCI and National Clinical Trials Network officials are working on potential clinical trial system innovations.

In meta-analyses of biosimilar switching studies, FDA researchers found ‘zero difference in the risk of death, serious adverse events, and treatment discontinuations between participants who switched between biosimilars and reference products and participants who did not switch.’

Earlier dialogues would mean faster access to new medicines.

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.