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An FDA advisory committee voted 9-4 yesterday in favor of Ardelyx’s Xphozah (tenapanor) for adults with chronic kidney disease (CKD) who are on dialysis, despite some concerns over the drug’s efficacy. Read More
Richmond, Va.-based Indivior, maker of the opioid treatment Suboxone (buprenorphine-naloxone), has announced plans to purchase Opiant Pharmaceuticals, a Santa Monica, Calif., producer of the opioid overdose nasal spray Narcan (naloxone), in a deal valued at $145 million. Read More
The settlement, if approved, will resolve the defendants’ alleged abuse of the generic pharmaceutical approval process under the Hatch-Waxman Act. Read More
Elahere (mirvetuximab soravtansine-gynx), ImmunoGen’s antibody-drug conjugate for ovarian cancer, has received FDA accelerated approval — and the company has already completed enrollment for a confirmatory trial with topline results expected in early 2023. Read More
Pfizer has picked up three allies in its legal battle to continue a financial support program that provides cash to help patients buy its extremely expensive heart medication, tafamidis. Read More
The Biden administration has asked a federal judge to dismiss claims that the FDA has intentionally delayed rendering a decision on a Florida proposal to import prescription drugs from Canada. Read More
The decision follows an FDA review of the final overall survival analysis of the phase 3 trial for the drug, which showed no risk reduction compared to the control treatment. Read More
The FDA issued a nine-observation Form 483 to ImprimisRx’s Ledgewood, N.J., facility for unsanitary conditions and other deficiencies observed during a July 11 to Aug. 5 inspection. Read More