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An FDA task force Tuesday recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More
Tofacitinib is part of a new class of medicines being studied in patients with moderate-to-severe plaque psoriasis, according to the drugmaker. Read More
The UK’s Health Research Authority is helping drugmakers do a better job justifying their trial designs and protocol assumptions early on to avoid trial failures due to insufficient information. Read More
Drugmakers and distributors are asking the FDA to delay strict enforcement of federal track-and-trace requirements, since most companies won’t be able to meet the first deadlines for exchanging transaction data. Read More
The FDA Monday approved Eli Lilly’s Cyramza to treat advanced gastric cancer — a shot in the arm for Lilly, which is attempting to recover from expiring patents on two blockbuster products. Read More
Emergent BioSolutions has received an orphan drug designation for an expanded indication for BioThrax, its anthrax vaccine already in wide use by the U.S. military. Read More
Indian Cabinet Secretary Ajit Seth and other top Indian officials today are laying a framework to begin discussions about intellectual property rights with U.S. drugmakers, a number of whom have lost patent protection in India in recent months. Read More
U.S. Supreme Court Chief Justice John Roberts on Friday denied Teva’s attempt to recall and stay a lower court’s ruling that invalidated a patent on Copaxone, opening the gate for generic versions of the blockbuster multiple sclerosis drug to reach the market as early as next month. Read More
The European Medicines Agency said late last week that additional drugs have been diverted in a still unfolding case of product tampering that began with stolen vials of the cancer drug Herceptin (trastuzumab). Read More