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The FDA Philadelphia district office has issued a warning letter to a compounding pharmacy in Allentown, PA over misbranded drugs and sterility issues. Read More
British Prime Minister Theresa May is working toward a deal with the UK’s life sciences industry to increase the sector’s productivity and maximize the country’s investment in research and development. Read More
Pressed for details by a Senate committee Tuesday, Rep. Tom Price (R-Ga.) — President Donald Trump’s pick to lead HHS — refused to confirm whether or not he would push for the power to negotiate Medicare drug prices, but said he was open to ideas. Read More
The European Medicines Agency said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago. Read More
On the administration’s first full workday yesterday, President Donald Trump froze federal hiring for most agencies, leaving the FDA with about 500 job vacancies out of its workforce of 15,000. Read More
The International Council on Harmonization is proposing to expand guidance concerning data quality, medication errors and product issues by developing a more detailed companion document that would include Q&A sections and more examples. Read More
Merck has agreed to pay Bristol Myers Squibb and Ono Pharmaceutical $625 million, plus royalties on global Keytruda sales, to resolve patent-infringement allegations involving an antibody designed to treat cancer by reactivating the body’s anti-tumor immune response. Read More