The Janssen Pharmaceutical (a Johnson & Johnson company) medicine Invokana (canagliflozin) has a list of safety warnings, including ketoacidosis, a severe complication of diabetes that is potentially life-threatening. According to an investigation conducted by Reuters, J&J knew of the risk of ketoacidosis, but covered it up.
Janssen Pharmaceutical and Amgen received another regulatory win for Darzalex Faspro (daratumumab and hyaluronidase-fihj) as the U.S. Food and Drug Administration approved the drug in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
Johnson & Johnson expects to file for approval of 14 new drugs by 2025, and projected average peak sales of $4 billion a year for each, a top J&J scientist said ahead of a strategy review of the company’s pharmaceuticals unit on November 18.
The U.S. Food and Drug Administration extended Legend Biotech Corporation’s Prescription Drug User Fee Act (PDUFA) target date for the drug cilta-cel that the company is developing with partner Janssen Biotech to treat relapsed and/or refractory multiple myeloma.
F-star Therapeutics announced a new partnership with Janssen Biotech on Oct. 20, only one month after presenting an optimistic trial-in-progress update to the public on the clinical-stage biopharma company’s tetravalent dual T-cell agonist FS120 at the European Society for Medical Oncology 2021 Conference.
Janssen Pharmaceutical’s experimental vaccine for a respiratory syncytial virus (RSV) demonstrated an 80 percent efficacy level in adults over the age of 65 years.
Companies presented very promising data for treating lung cancer at European Society of Medical Oncology (ESMO) Congress 2021.
The U.S. Food and Drug Administration greenlit Janssen’s long-acting, twice-per-year schizophrenia drug Invega Hafyera (paliperidone palmitate six-month).
Johnson & Johnson announced that the company’s Imbokodo Phase IIb trial in HIV failed to hit the primary endpoint. The study evaluated J&J’s investigational HIV vaccine regimen in young women in sub-Saharan Africa at high risk of acquiring HIV.
The U.S. Food and Drug Administration approved an expanded peripheral artery disease indication for Janssen’s Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization due to symptomatic PAD.
