Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

BIO, PhRMA, Novartis, Amgen, and Genentech suggest revisions to guidance on hot-button issue of subject matter patent eligiblity; patent owners group says 'best approach' is to enact legislation to restore patent eligibility law.

NICE has given the green light to Akcea Therapeutics’ ultra-rare disease treatment Tegsedi (inotersen) after the company offered a better “commercial arrangement.”

The Pink Sheet takes a closer look at recent clinical announcements showing how rare disease therapy sponsors are already increasingly reliant on natural history studies to guide drug development.

Janssen, Krystal Biotech and Takeda are the latest companies to win a place on the European Medicines Agency’s popular priority medicines scheme for getting drugs for unmet medical needs through the review process faster.

In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.

Bernstein Research analysts said CMS could charge pharmaceutical manufactures a fee to offset increases in insurance premiums anticipated from the elimination of rebates in a "win-win" move.

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

A recent survey shows that pharmaceutical manufacturers are increasingly interested in adopting continuous manufacturing. Most respondents say they plan to use this mode of manufacturing for their new drugs.

The organization that works to harmonize drug review requirements across a growing number of regulatory authorities aims to partner with non-profit groups to train regulatory authorities and industry on its guidelines, starting with guidelines on stability testing, good clinical practice and good manufacturing practices for active pharmaceutical ingredients.

Jury convicts Pharmakon CEO of conspiracy to defraud the FDA and nine counts of adulterating drugs. The firm allegedly ignored and tried to cover up dangerously out-of-specification potency testing results for morphine and other compounded drugs. In one case, providers resorted to naloxone to rescue an overdosed infant.