More than 150 industry organizations and drugmakers have submitted a letter to Congressional leaders urging passage of the Pasteur Act, a languishing bill first introduced in 2020 to incentivize development…
Lupin has again run afoul of the FDA, drawing a Form 483 over deficiencies observed at its injectable drug manufacturing plant in Nagpur, Maharashtra, India, following a pre-approval inspection conducted…
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…
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. Source: Drug Industry Daily
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…
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…
The FDA is considering whether some versions of the overdose reversal drug naloxone may be approvable for nonprescription use. Source: Drug Industry Daily
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. Source:…
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…
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.…