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The company believes the drug will inhibit C5 in patients with certain complement-mediated diseases. There is currently no cure for myasthenia gravis. Read More
Aarkish Pharmaceuticals received a nine-observation Form 483 for missing records and other quality lapses observed during an inspection of its Fairfield, N.J., facility. Read More
A federal appeals court sided with AbbVie’s Pharmacyclics and Johnson & Johnson’s Janssen Biotech this week, affirming that a generic version of the blockbuster cancer drug Imbruvica (ibrutinib) infringes their patents. Read More
Sellas Life Sciences is amending the statistical analysis in an ongoing phase 3 trial for acute myeloid leukemia after a preliminary data review found that patients enrolled were living twice as long as originally projected. Read More
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