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.

Pink Sheet infographic breaks down the breakthrough therapy designations made by the US FDA, with statistics on what’s been approved, rescinded, and everything in between.

The vast majority of meeting requests eligible for the in-person/virtual format were not requested as such, according to Center for Drug Evaluation and Research data.

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.

The move expands access to the Pharmacopoeial Discussion Group’s quality standards to the Indian pharmaceutical industry.

Vigorous regulatory scrutiny is a given, but opinions vary about how much the companies’ respective PBM businesses present a major antitrust risk.

Pink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies, the agency’s policy for using background music in direct-to-consumer advertising, and the FDA’s new incoming principal deputy commissioner.

A second public consultation on the review of the HTA system will be held in January to February 2024 after more than 100 stakeholder responses were received during the first consultation earlier this year.

The pharmaceutical legislation overhaul offers some solutions to the problem of immature applications.

The European Parliament has adopted changes to the proposed European Health Data Space that would protect the intellectual property of pharma companies, but trade body EFPIA says the rules should be made clearer and warned the proposed system could cause “bottlenecks”.

Japan has announced the latest evaluation results under its cost effectiveness assessment scheme. But how does it work and how much have prices been revised so far under the four-year-old program following discussions between pharma firms and authorities?

Instead of asking why confirmatory trials take so long, the FDA commissioner suggests insurance companies ask what they can do to help answer those questions.

The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.

Low- and middle-income countries need to have the know-how, capability and capacity to produce mRNA vaccines, from concept, design and testing through to manufacturing and registration, a conference heard this week.

The number of conditional marketing authorization non-renewals could increase.

MSD and Kyowa Kirin have separately criticized England’s HTA body, NICE, for assessing their respective rare disease medicines Welireg and Crysvita using its standard appraisal pathway. Both medicines were provisionally rejected for reimbursement.

The developers of survodutide and elsunersen will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.