Sponsors of a raft of new products will find out this week if the European Medicines Agency’s medicines evaluation committee, the CHMP, is convinced the therapies are ready for marketing.

US FDA advisory committee will weigh fate of the injectable antibiotic, which can cause renal failure and is only approved for treatment of pediatric pneumonia. However, its real-world use is almost entirely in the surgical setting for irrigation and prophylaxis. Xellia, one of five companies that markets the generic drug, said the risk/benefit profile for on-label use remains positive and evidence on off-label use warrants further exploration.

KEI vows to continue battle over Bayh-Doyle restrictions after US Commerce Department suggests it may issue regulations to exclude pricing as a basis for requiring companies to license their patents.

Change would increase maximum new technology add-on payments from 50% to 65% of costs.

Sherman, who left the No. 2 post at FDA in January, is working part-time at Duke-Margolis and serving as a consultant to Medidata Solutions.

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. 

The US FDA reports that particulate contamination was the second leading cause of recalls for injectable drugs over a 10-year period. Yet the good news is that the recalls attributed to visible particle contamination has actually gone down. FDA official says it may be premature to celebrate, more work is needed to bring these recalls down and improve the quality of injectable products.

Final guidance recently issued by the European Medicines Agency explains how to show assessors that new drugs, along with the drug substances, excipients and final containers, have been adequately sterilized.

Some ingredient risks to consider: IV castor oil hypersensitivity; oral liquid bioburden; elm in the coconut.