In what could be a blow to some aspiring developers eyeing the nascent but growing biosimilars market in China, new rules lay out when extrapolation of approved indications of reference biologics will be allowed, meaning this will not be automatic.

Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.

The individual contribution of the three mABs in Regeneron’s Ebola treatment could not be clinically tested due to the highly lethal nature of the disease and the potential for development of resistance; instead, the FDA accepted nonclinical data demonstrating the mechanism of action for each component.

Chronicle of the development and review of Regeneron’s REGN-EB3, a triple mAB combination treatment for Ebola infection.

Chronicle of the development and review of Ridgeback Biotherapeutics’ ansuvimab-zykl for treatment of Ebola infection.

As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.

Policymakers should instead focus on increasing efficiencies in drug development, distribution and reimbursement, National Academies report says, while also seeking broad policies like HHS direct negotiation for drug prices in Medicare.

Executive order calls for short-term and long-term study, broad consultation, coordination with allies.

Senate Finance confirmation hearing concluded without a vote on Xavier Becerra’s nomination as Health and Human Services Department secretary. Republicans continued to express concerns with his background and views. But he is expected to win enough votes to clear the committee.

Janssen-Cilag has asked for a WHO Emergency Use Listing for its vaccine candidate, while azelastine and carrageenan are both showing promise as potential treatments for COVID-19.

COVID treatments have not advanced as rapidly or as publicly as vaccines. That may trigger some issues for the US FDA as Congress digs into the next phase of the COVID response – and starts to assess agency performance and leadership after the crisis.

Acting CDER Director Cavazzoni says it is ‘a very active time’ as many clinical trials for COVID-19-related products are expected to read out soon.

AstraZeneca's CEO and other leaders from COVID-19 vaccine companies will face some tough questions in Brussels, but the European Commission wants to put differences behind it and solve the vaccine supply problem as soon as possible.

Of the two main contenders to lead FDA, Josh Sharfstein is seen as much more likely to open up review decisions to public scrutiny, while Janet Woodcock might be a vote for the status quo and more deferential to industry concerns.

Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says ‘politics with a capital P is not my thing.’

Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.

Executive order calls for short-term and long-term study, broad consultation, coordination with allies.

Regulators in the EU have decided on specific arrangements they plan to employ if sponsors detect and report nitrosamine impurities in their products being sold on the market.