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.

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

As final decision looms, initial move to hold off on DRG but increase payment for CAR-T therapies shows CMS taking a slow and steady approach to paying for the products.

Health technology appraisal mechanisms like discounts do nothing to address a lack of clinical evidence and simply transfer the uncertainty to patients, NICE’s recent annual conference heard.

It has taken 17 months of negotiations but soon 600-1,200 people in the UK may be able to get Biogen's spinal muscular atrophy therapy now that an access agreement has been inked.

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 add microplastics to the list of banned chemicals 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 polymers as 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.