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Drugmakers should include information for all uses of a product — including off-label uses — when preparing periodic benefit-risk evaluation reports, the International Council on Harmonisation says in new Q&A guidance. Read More
GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
U.S. Supreme Court Chief Justice John Roberts on April 18 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 FDA has produced final recommendations for how manufacturers can prove “sameness” when they develop generic versions of monoclonal antibody (mAb) products approved under the Orphan Drug Program. Read More
The drug industry isn’t happy with the FDA’s decision to use actual direct-to-consumer (DTC) ads as part of a study looking at whether companies present too much risk information in prescription drug ads. Read More
Pfizer Monday reached an agreement to settle a class action lawsuit, alleging the drugmaker attempted to improperly delay generics of its epilepsy drug Neurontin from reaching the market. Read More
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