After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

Plus deals involving Santen/Harrow/Visiox, Aurobindo/BioFactura, AFT/Crossject, Imugene/RenovoRx, Biotheus/BioNTech, GeneQuantum/InxMed, ObsEva/Yuyuan, Monopar/National University of Singapore and Doer Biologics/BioNTech.

New supplies of Shionogi's antiviral Xofluza will be used to boost Japan's national stocks of flu therapeutics, along with others including Tamiflu and Relenza, to increase preparedness for new viral strains. While resistance concerns for Xofluza appear to be reducing, local experts supported the decision on condition use is limited to those under 12 years of age.

Teva’s counsel notes a key factor in the jury's finding that Gilead’s patent settlement with Teva did not include a reverse payment to delay entry of Truvada and Atripla generics. A second trial will proceed on claims a collaboration agreement between Gilead and Janssen was anticompetitive.