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The rationing scheme allegedly led to the death of one patient in 2010, and injured the health of four others, who were co-plaintiffs in the case. Read More
Chinese pharmaceutical company Sichuan Deebio Pharmaceutical has suspended manufacture of at least one active pharmaceutical ingredient bound for the U.S. marketplace and may be banned from importation altogether if it doesn’t correct multiple deficiencies cited in a scathing 483 inspection report, according to a warning letter issued earlier this month. Read More
This edition of Quick Notes looks at significant drug approvals, including the first cellular therapy for patients with unresectable or metastatic melanoma, a drug to reduce accidental food allergy reactions, Tagrisso with chemotherapy for patients with EGFR-mutated advance lung cancer and a dosage reduction for patients with relapsed or refractory multiple myeloma. Read More
Enhanced access to real world data (RWD) sources critical to regulators, pharma companies and researchers is the objective for the two electronic catalogues launched last week by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). Read More
This edition of Quick Notes looks at consequential new drug approvals, including a first drug for frostbite, a first of its kind gene therapy authorization for sickle cell disease and transfusion-dependent beta thalassemia, supplemental approvals for pancreatic and non-small cell lung cancer and a treatment for an inflammatory esophageal condition. Read More
Judges from the U.S. Court of Appeals for the First Circuit have revived a nearly 12-year-old lawsuit that charged Sanofi with damaging the health of patients with a rare liver disease by selling virally contaminated Fabrazyme (agalsidase beta) the only medication approved for the condition — and then rationing it at drastically reduced doses. Read More
Wayne Pines, Senior Director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the FDA’s recent actions related to marketing of drug products both to healthcare professionals and to consumers. Read More
The historic 2023 approval of OTC naloxone was a highlight of the FDA’s efforts to combat the opioid overdose crisis, according to CDER’s year-end report on drug safety actions. Read More
Despite its denial of any wrongdoing, Pfizer has agreed to a settlement payment of $93 million to finally erase 12 years of antitrust litigation with drug distributors involving Lipitor, the pharma giant’s cholesterol drug. Read More
Senate Majority Whip Dick Durbin (D-Ill.) and Senator Mike Braun (R-Ind.) have urged the FDA to take “swift” action to update its enforcement tools to address the alarming proliferation of dangerous and misleading social media content promoting prescription drugs. Read More