New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.

Australian patients with phototoxicity due to the rare condition EPP will now have their first treatment option – provided the drug's developer, Clinuvel, secures reimbursement under the Pharmaceutical Benefits Scheme.

European Commission proposals for strengthening intellectual property protections in the EU, particularly the supplementary protection certificate (SPC) system, have been broadly welcomed by the European pharmaceutical industry federation EFPIA. But the medical NGO, MSF, says the SPC proposals run counter to the commission’s own efforts to improve access to medicines.

The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.

Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.

The EU has published an action plan that is intended to upgrade the bloc’s intellectual property framework while ensuring that goods such as medicines and vaccines are made as widely available as possible. The initiative is part of wide-ranging plans to support member states’ recovery from the pandemic crisis and help ensure the EU’s resilience to future health threats.

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.

Rushed final rule seeking to impose draconian cuts on drug reimbursement rates in the Medicare Part B program is certain to face legal and political obstacles. But the data included on international price benchmarks will still have an impact.

Highlighting progress it has made over the past few years, Japan’s regulatory agency says it wants to raise even further the number of “Japan-first” approvals, as part of its stated mission to get safe and effective new drugs to patients more quickly.

Russia says it will make the first deliveries of its $10-per-dose Sputnik V vaccine in January, while international regulators say vaccine trials should continue for as long as possible to generate longer-term evidence on their benefits and risks. A UK research body has stressed that drugs repurposed for COVID-19 also need to undergo thorough safety and efficacy testing as reports suggest the UK regulator could approve a vaccine within days.

Incoming US President may be wise to up government investment in COVID-19 therapeutics, including both research and manufacturing, experts say. Additional government funding should target a larger variety of treatment types and prioritize better study designs.

Strengthening regulatory partnerships and being ready to support the translation of disruptive innovations into the treatments of tomorrow are on the to-do list of incoming European Medicines Agency chief Emer Cooke.

Given its ever-growing role as a critical component of the global biopharma industry, you can’t afford not to be up to speed on Asia. This biweekly selection of insights from our experienced on-the-ground team will help.

The price of the antibody monotherapy for COVID-19 will be $1,250 per vial for wealthy countries. CEO David Ricks outlined the company's guidelines for pricing and distributing a limited supply.

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.

Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.

The EU pharmaceutical strategy published on 25 November will be the first step in a “complete overhaul” of the medicines legislative framework to be proposed in about two years’ time, says the European Commission.