ViGuard Health called on the FDA to declare pyridoxamine to be a dietary supplement and no longer authorized for investigation as a new drug. Source: Drug Industry Daily

The FDA issued a warning letter to Chinese drugmaker Guangdong Zhanjiang Jimin Pharmaceutical following a May inspection of its Guangdong Province facility. Source: Drug Industry Daily

The Federal Circuit upheld two Sanofi patents for its antiarrhythmic drug Multaq (dronedarone) — agreeing with Sanofi’s argument that the drug’s label, which is required to be similar for any…

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended ten medicines for approval, including two orphan medicines and a new treatment for multiple sclerosis. Source: Drug Industry…

Senate Republicans released a competing tax reform plan that — in comparison to the House side’s proposed repeal — merely shrinks the size of the orphan drug research tax credit.…

The FDA published an ICH-developed revision to its industry guideline on the detection of reproductive risks in new drugs. Source: Drug Industry Daily

The FDA published guidance assisting sponsors in evaluating the effects of psychoactive drugs on the ability to operate a motor vehicle, saying reducing the incidence of accidents is a public…

The PTO’s Patent Trial and Appeal Board ruled against a Purdue Pharma patent on OxyContin, agreeing with Amneal Pharmaceuticals on the patent’s obviousness. Source: Drug Industry Daily

Under a new category of generic ANDAs eligible for priority review, the FDA will prioritize applications likely to be ready for approval shortly after the six months of marketing exclusivity…

Danish drug regulators have moved to shut down a drug importer and repackager due to its inadequate quality control systems, the Danish Medicines Agency said. Source: Drug Industry Daily