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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
The Federal Trade Commission reached an agreement with Endo to settle claims that the company blocked the market entry of Opana ER and Lidoderm generics, and then refiled a lawsuit against Allergan and its former subsidiary Watson Laboratories with identical charges. Read More
The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing a drug shortage. Read More
The FDA has served drug manufacturer Eisai Inc. with a Form 483 after an investigation revealed laboratory control issues and incomplete records. Read More
Mylan has not reached a settlement with the Justice Department to resolve allegations that it misclassified its allergy therapy the EpiPen for a Medicaid program, and as a result, underpaid state rebates, the Centers of Medicare and Medicaid said. Read More