In the wake of a Congressional Research Service (CRS) report calling for tweaks to the Hatch-Waxman Act to maintain a balance between innovative drugs and generics, the Generic Pharmaceutical Association (GPhA) released a new study touting the savings the act has produced.

The FDA has lifted a five-year clinical hold on the development of Allergy Therapeutics plc's Monophosphoryl Lipid A (MPL)-adjuvanted grass pollen allergy vaccine (Grass MATA MPL/ Pollinex Quattro Grass 0.5ml) and has cleared a Phase III protocol for determining the product's efficacy.

Sponsors of biosimilars must demonstrate similarity, not safety and efficacy, FDA officials reiterated as they discussed ways to do that at an advisory committee meeting.

The U.S. Department of Defense has stopped work on Ebola contracts.