As research advances into the biological underpinnings of diseases such as cancer, the FDA is expecting to see more drugs providing more data demonstrating survival benefit earlier in product development,…
The FDA warned a Korean manufacturer over significant GMP violations observed during an inspection in March, including its failure to test incoming components. Source: Drug Industry Daily
A class of indirect purchasers filed an antitrust suit against Allergan over the transfer of its Restasis patents to the St. Regis Mohawk tribe and other anticompetitive practices that inflated…
Pfizer reached a $94 million settlement with a class of direct purchasers over claims it used fraudulent patents to keep generic competition off the market for its anti-inflammatory drug Celebrex.…
President Trump’s nominee for the next secretary of HHS, former Eli Lilly executive Alex Azar, told the Senate’s health committee Wednesday he agrees prescription drug prices are too high, and…
Medicare and its beneficiaries would face significantly lower costs for drugs if the Centers for Medicare and Medicaid Services excluded noncovered versions of drugs while setting Part B drug payments,…
The UK government announced a long-term strategy for the nation’s industries, including a multi-billion pound initiative to boost investment in the life sciences sector. Source: Drug Industry Daily
The European Medicines Agency published new, practical guidance for marketing authorization holders in navigating the UK’s 2019 departure from the European Union — including the procedures for classifying any Brexit-related…
The FDA is working to develop and finalize a handful of new guidances on bringing complex generics to market — including complicated medicines that may require alternate methods of establishing…
The FDA flagged Horizon Pharmaceuticals for failure to follow sanitation procedures, insufficient investigations into customer complaints and inadequate reviews of product discrepancies, among other issues. Source: Drug Industry Daily