The federal government issued a subpoena to Biogen requesting information on prices, rebates and co-assistance programs for four of its therapies, according to an SEC filing by the company. Source:…
Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said. Source: Drug Industry Daily
Spain’s medicines and medical devices agency suspended manufacturing at Euro Far Alergi’s Madrid facility citing serious GMP violations. Source: Drug Industry Daily
The FDA will no longer redact the CVs of its advisory committee members, in response to a Freedom of Information Act lawsuit filed by Public Citizen last year. Source: Drug…
The Office of Management and Budget on Friday clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over…
The European Medicines Agency for the first time published data on its clinical data website from a withdrawn application, while adding clinical study reports for two generics. Source: Drug Industry…
The FDA’s civil monetary penalties are increasing to adjust for inflation at under 2 percent. Source: Drug Industry Daily
Japan’s largest drugmaker, Takeda Pharmaceuticals, said it will maintain its existing pricing model in the U.S., despite President Donald Trump’s call for drug companies to lower their prices. Source: Drug…
The FDA came down on Softech Pharma, handing them a Form 483 after an inspection of their India facility revealed 12 issues. Source: Drug Industry Daily
The European Parliament’s committee on Environment, Public Health and Food Safety voted Tuesday to approve a draft report that includes dozens of recommendations for improving how the EU promotes access…