As part of its efforts to preserve patient access to medicines amid the COVID-19 pandemic, Russia is planning to cap drug prices if increases of more than 30% are detected. It will also allow online sales of non-prescription drugs and may also tighten the rules on fake and substandard products. 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include two new products, including Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

France is exploring the use of hydroxychloroquine and lopinavir/ritonavir in COVID-19, but only in hospitalized patients and in clinical trials, and has banned all exports of the products to avoid possible shortages. 

Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.

In addition to our daily in-depth coverage of key events relating to the coronavirus pandemic, we’re bringing you a periodic round-up of other significant developments. 

FTC and DoJ issue guidance for businesses working together to tackle coronavirus pandemic; BIO is 'pleased' they intend to help facilitate critical partnerships.

Stephen Hahn’s low visibility period as the newly installed FDA commissioner comes to an abrupt end. Trump offers generous praise amid COVID-19 response – but how quickly might that change to blame?

The health technology assessment institute is taking a virtual approach to meetings and has said that it can provide free fast-track advice for companies developing novel diagnostics or therapeutics for the coronavirus.

Health-system pharmacist organization assesses the evidence behind off-label use of existing drugs for COVID-19, along with top investigational prospects like Gilead’s remdesivir. 

Efforts are under way in the UK on many fronts to develop new treatments and vaccines for coronavirus infection, including researching new uses of existing products and clinical trials of new vaccines.

Around the world, government agencies, academic and other researchers and the biopharmaceutical industry have rushed to see what drugs could help treat COVID-19 and the symptoms it causes, and accelerate a vaccine that could help limit the spread of the pandemic. This chart will be updated daily as additional research gets underway. 

DTC spending had shown an uptick in 2020 compared with 2019. Many advertisers are not, however, providing clear drug pricing information in their TV spots, despite some voluntary commitments to do so.

A joint meeting of the US FDA and the FTC on biosimilar competition may have delivered a symbolic message about the need for a ‘level playing field’ in the biologics market – but it did not deliver much in the way of an actionable agenda for antitrust regulators.

Aimmune CEO Jayson Dallas tells the Pink Sheet how physicians and patients are being certified to use Palforzia and how the product's food-based manufacturing process is actually an advantage. 

The US FDA has added hydroxychloroquine sulfate to the list of drugs outsourcing facilities can compound as pharmacy group calls for more such approvals with COVID-19 driving demand for additional prescription and over-the-counter drugs.

Quality experts with AstraZeneca and Thermo Fisher describe how their companies are responding to the COVID-19 pandemic – but urge industry not to lose focus on monitoring unrelated drug products.

Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.