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FDA Commissioner Scott Gottlieb announced Wednesday that the agency is hiring the National Academies of Sciences, Engineering and Medicine to help develop guidelines for opioid analgesic prescribing. Read More
The FDA is asking stakeholders to suggest structural endpoints for use in trials of medical products aimed at treating the root cause of osteoarthritis. Read More
The approval “represents a significant regulatory shift, with the approval received under unprecedented timelines,” said Sandra Horning, Roche’s chief medical officer and head of global product development. Read More
Under a voluntary initiative set to take effect this month, Oklahoma will introduce value-based drug purchasing for Medicaid, only fully compensating manufacturers of drugs that deliver the promised results. Read More
CVS and Rite Aid filed an antitrust suit accusing AbbVie of mounting “sham” patent lawsuits against two generic manufacacturers to protect its testosterone replacement drug AndroGel from competition. Read More
In the first 100 days since the Trump administration issued its American Patients First blueprint, 15 drug companies have cut list prices, reversed planned price hikes or called for price freezes for the rest of the year, HHS says in a report released Tuesday. Read More