The US FDA is proposing a novel pathway to permit OTC drugs to be marketed with some additional controls to assure appropriate use, more than a decade after floating the idea. The pathway has a new name (“ACNU” not “NSURE”) and very different commercial dynamics.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add five new products, including VLA2001, Valneva’s vaccine for COVID-19.

The unblinding process began months before a third dose was added to the study in the 6 months-4 years group. Consequently, only about one-third of vaccine recipients in each age cohort received three doses of BNT162b2.

The decision to maintain or revoke breakthrough therapy status when trial results do not appear to support the original designation will depend on the facts specific to a development program, the US FDA says in new draft guidance. Since 2012, the agency has granted 475 breakthrough therapy designation requests and rescinded 35 designations.

A new EU guideline outlines the steps that notified bodies can take to facilitate the European Medicines Agency’s assessment of the appropriateness of a companion diagnostic’s use with a drug.

European payers have called for fast-track approval pathways and only limited use of conditional approvals in the upcoming reform of the EU’s pharmaceutical legislation. They also want to see data and market protection periods reduced to boost competition.

Progress on appropriations follows passage of legislation in the House formally authorizing the new agency dedicated to advancing cutting edge research.

The Court denies a petition for review of American Axle and Manufacturing v. Neapco despite requests from the US government, BIO and former PTO director Kappos that it take up the case to  provide greater clarity on the types of inventions that may be patented.

Project Site Selector will allow FDA Oncology Center of Excellence staff to discuss site selection process with industry and potentially help improve clinical trial diversity efforts.

Progress on appropriations follows passage of legislation in the House formally authorizing the new agency dedicated to advancing cutting edge research.

Project Site Selector will allow FDA Oncology Center of Excellence staff to discuss site selection process with industry and potentially help improve clinical trial diversity efforts.

Neurodegenerative and cardiovascular diseases, along with cancer and early feasibility studies, are among the topics to be addressed by consortia interested in taking part in the EU’s latest research partnership.

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.