A number of new drugs have taken a major step towards being approved for use in the EU after receiving the nod from the European Medicines Agency’s human medicines committee, the CHMP. Meanwhile, the marketing applications for three drugs have been withdrawn.

Bimervax is the first bivalent recombinant protein COVID-19 vaccine to be authorized in the EU, says Spanish company HIPRA.

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

Pink Sheet reporters and editors discuss the FDA’s upcoming advisory committee meeting for the controversial ALS cell therapy NurOwn, a proposal to batch test all drugs coming into the US amid problems conducting foreign inspections, and the FDA’s return to in-person meetings with industry.

Open public hearings can include both emotional patient testimony and angry, anti-industry proclamations. During the isotretinoin REMS panel, the OPH was particularly effective in making a case for easing patient access despite the risks. Will it get FDA on board?

Panel favors elimination of 19-day lockout after missed prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.

US Solicitor General urges the Supreme Court to grant Teva's petition, arguing that the Federal Circuit was wrong in ruling that Teva's carved-out labeling for generic carvedilol induced infringement of GlaxoSmithKine's brand product.

Canadian rare disease drugs strategy is expected to improve access to treatments and the collection and use of real-world evidence.

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Early parent involvement in drug development and clinical trial design could improve recruitment and outcomes, stakeholders argue.

Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.

 Obamacare’s affordable access to HIV pre-exposure prophylaxis is jeopardized by court order. Access to vaccines, contraception may also be at risk as the case continues to play out in higher courts. 

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Novo Nordisk has been given a two-year suspension from membership of the Association of the British Pharmaceutical Industry for breaching the association’s code of practice.

Pink Sheet reporters and editors discuss the FDA’s upcoming advisory committee meeting for the controversial ALS cell therapy NurOwn, a proposal to batch test all drugs coming into the US amid problems conducting foreign inspections, and the FDA’s return to in-person meetings with industry.

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

While food oversight dominated lawmakers' attention, Republicans and Democrats were united on need to onshore more drug manufacturing to the US as FDA Commissioner Robert Califf testified about the agency’s fiscal year 2024 budget request.