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The Justice Department filed a motion to intervene in a multistate antitrust lawsuit accusing six generics makers of colluding to raise the prices of the antibiotic doxycycline hyclate and the diabetes drug glyburide. Read More
Sen. Chuck Grassley (R-Iowa) is planning to examine the FDA’s orphan drug programs to find out if companies are using the designation to justify higher prices for common drugs. Read More
Tom Price was confirmed by the Senate as the next Secretary of HHS in a late-night Thursday vote and swiftly sworn in Friday morning by Vice President Mike Pence. Read More
The FDA issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls. 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
A federal appeals court temporarily suspended a permanent injunction that bars Sanofi and Regeneron from selling their cholesterol drug Praluent, pending a final ruling on an appeal. Read More
A group of 31 Democratic senators have asked Kaléo to provide details on pricing of the company’s opioid overdose treatment Evzio, requesting documents on production costs and donation programs. Read More