The Philippines regulator has issued more guidance for companies that want to use its registration pathways for products that are already approved in other countries.

After issuing guidance and making public statements saying the first updated COVID-19 vaccines would require clinical trial data, agency picks new vaccine composition that will make obtaining such data highly unlikely before a planned fall booster campaign. 

Court restricts EPA’s ability to regulate greenhouse gas emissions saying agency must have “clear congressional authorization” to address “major questions.” Decision is not likely to pose a problem for the FDA unless it were to regulate something new, attorneys say.

A new industry report has painted a sobering picture of the UK life sciences sector, which is facing challenges on a number of fronts including clinical research, market access and manufacturing. On the bright side, the report says that implementing the measures in the government’s Life Sciences Vision could make the UK a “world-leading” hub for drug discovery and development.

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.

Many VRBPAC committee members said they were impressed with Novavax’s booster data, including with its prototype vaccine, raising questions about whether non-mRNA vaccine platforms may be preferable to address COVID long-term.

In their latest charm offensive, Chinese regulators issue policies clearly designed to encourage the import of innovative drugs from overseas and better serve foreign drug makers already operating in the country.

A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.

In the report accompanying FY 2023 HHS appropriations legislation, the House committee also addresses biosimilar uptake in Part D, Medicare dispensing fees for oral COVID-19 drugs and NIH grants for expanded access to investigational ALS drugs.

The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.

Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.

The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.

Publisher’s Spotlight: Citeline, the publisher of Pink Sheet, is to merge with fellow pharmaceutical solutions provider Norstella.

Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of a regulatory sound, “NSURE.” The proposed rule also detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.

News and views from day four of the BIO annual meeting include a fireside chat with FDA commissioner Robert Califf, gene therapy insights, and pharma efforts to provide cancer medicines in lower income countries.

Poor inspection history was dropped as a criteria for unannounced inspections, OIG says in an audit report, even as support grows for surprise inspections of poor quality sites. An exhaustive review of foreign for-cause inspections shows the FDA reorganization has sped up a process that must go faster still. Meanwhile, whatever happened to experienced investigators’ training records?

A new industry report has painted a sobering picture of the UK life sciences sector, which is facing challenges on a number of fronts including clinical research, market access and manufacturing. On the bright side, the report says that implementing the measures in the government’s Life Sciences Vision could make the UK a “world-leading” hub for drug discovery and development.

If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.