Food and Drug Administration decisions of note last week included approval of AcelRx’ opioid analgesic Dsuvia but rejection of Trevena’s Olinovo (oliceridine) and also approval of Pfizer’s Lorbrena, which puts the company all along the continuum for ALK-positive lung cancer. On the political front, US mid-term elections resulted in a split Congress, which has implications for the pharma industry. Among deal-making news, it seems that Nektar has convinced another big pharma – Pfizer –on the promise of its cancer immunotherapy NKTR-214.
US regulator sails into treacherous opioid waters
Rarely does a US drug approval elicit a detailed public explanation from the FDA Commissioner himself. Then again, if the drug in question is, like Acelrx’ Dsuvia, an opioid analgesic the agency’s apologia can be seen as a rational way of limiting another public outcry, commented Jacob Plieth on Vantage, the editorial arm of the Evaluate group.
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