Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”

More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.

Reduction in the risk of hypoglycemia level 2 and 3 events, along with either a reduction or maintenance of an acceptable hemoglobin A1C, is a clinically relevant efficacy endpoint for drug development in Types 1 and 2 diabetes, FDA states in new draft guidance.

Pink Sheet reporters and editors discuss CMS’s latest coverage announcement for Alzheimer’s drugs and the VA’s approach to the issue, the FDA’s new one-page patient medication information document, international convergence on COVID-19 vaccine strain selection and Novavax’s place in the vaccine toolbox going forward.

The three major EU institutions are all calling for urgent action to tackle antimicrobial resistance, with the emphasis very much on incentives for the development of novel medicines and a reduction in overall consumption of antibiotics.

With talks on the next UK voluntary pricing scheme now well under way, the Pink Sheet looks at the industry and government negotiators who will be thrashing out the details in the coming months.

House Energy and Commerce Committee cleared a PBM bill that seems to contain more transparency loopholes and makes more limited policy tweaks to the drug supply chain middleman than the Senate HELP Committee’s bill, but the House-side legislation would pull back the curtain on specialty-drug reimbursement in a way the Senate version does not.

Health policy experts discuss ways Medicare coverage policy may evolve in the coming years and how efforts to smooth the transition between accelerated drug approvals and Medicare reimbursement decisions could play out.

Bristol Myers Squibb and Pfizer both asked the health technology assessment body NICE to evaluate their respective drugs, Camzyos and Vydura, for use in indications that are narrower than those for which they are – or will potentially be – approved.

Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”

The three major EU institutions are all calling for urgent action to tackle antimicrobial resistance, with the emphasis very much on incentives for the development of novel medicines and a reduction in overall consumption of antibiotics.

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.

US Department of Veterans Affairs' head for pharmacy benefits management says her agency’s coverage of Leqembi and Aduhelm is actually closely aligned with that provided by Medicare, in contrast to the initial characterization of the VA taking a different stance on the drugs.

The company has been found in breach of the UK code once again for its work with pharmacists,  although this time Novo Nordisk has escaped the heaviest censure.

Academic expert provides insight into the economic and quality challenges behind generic drug shortages, and what to do about it.

The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.

Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.