Daiichi Sankyo made a strong case to rebut US FDA’s concners about the “credibility” of a survival benefit reported for its refractory AML therapy quizartinib in front of the US Food & Drug Administration’s Oncologic Drugs Advisory Committee. Then Richard Pazdur spoke.

The BioIndustry Association wants to discuss the importance of close post-Brexit regulatory alignment with the new European Parliament and will also press its message on the next leader of the Conservative Party after prime minister Theresa May steps down.

New call center is designed to help physicians navigate the expanded access pathway for oncology products, but FDA officials are unsure about how much interest it will generate.

A draft resolution on the transparency of medicine prices and R&D costs is being discussed this week by World Health Organization members, but the pharmaceutical industry says some measures will be damaging for medicines access.

Conditions should be attached to the public funding of biomedical R&D in response to escalating prices of drugs developed with public money, a new report says.

CMS has abandoned its plan to give private plans more leverage in the “protected” drug classes in Part D. It will probably be a long time before anyone tries to change the protected classes again.

Conditions should be attached to the public funding of biomedical R&D in response to escalating prices of drugs developed with public money, a new report says.

US FDA dashes hopes for accelerated approval of mirvetuximab soravtansine based on subgroup data, but will work with ImmunoGen to design a new trial focused on highly FRα-positive patients.

Findings being presented at ASCO next month could signify major increase in targets relevant to pediatric oncology, meaning sponsors should prepare for more US FDA-required studies under the RACE for Children legislation.

US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.

Pfizer VP blames rebate strategies of innovators for difficulty in getting biosimilars on formularies while Express Scripts official says it is all about net cost during House hearing on lowering Rx drug prices.

On eve of congressional hearing, the pharmacy benefit manager assures Amgen that Repatha is available to its employees.

A proposal by the European Chemicals Agency that would restrict the use of microplastics in pharmaceuticals in the EU under its REACH regulation has come under attack by the US excipient industry. Officials argue that the proposal is misguided in that it considers all polymers to be microplastics and would unnecessarily restrict the availability of medicines that contain polymers in formulations.

There is growing recognition that the US FDA can use trade agreements to help confront the challenges of globalization and that these agreements can play an increasingly important role in fostering regulatory alignment and improving the quality of imports, agency official says.

The poorest-quality pharmaceuticals consumed in the US are the ones FDA has never reviewed, or are from sites the agency has never inspected, regardless of country of origin; the agency’s inaugural ‘State of Quality’ report contains some surprising findings.