AstraZeneca’s checkpoint inhibitor Imfinzi (durvalumab) didn’t meet its primary endpoint of improving progression-free survival when compared with chemoradiotherapy (CRT) alone in the treatment of patients with locally advanced cervical cancer,…
The FDA has issued a Form 483 to a drug manufacturer and repackager in Saint Paul, Minn., for multiple deficiencies observed during a Nov. 1-18, 2021 inspection of its facility,…
Pfizer’s investigational once-a-day oral drug, etrasimod, has shown significant efficacy in a phase 3 study for the treatment of patients with ulcerative colitis. Source: Drug Industry Daily
Moderna says that it’s expanding its messenger RNA (mRNA) vaccine pipeline to include mRNA-1230, a triple-combination respiratory vaccine candidate to protect against COVID-19, influenza and respiratory syncytial virus (RSV), and…
India currently makes the lion’s share of active pharmaceutical ingredients (APIs), the raw materials used to create prescription drugs, for the U.S. Source: Drug Industry Daily
Argenx has released positive results from a late-stage trial of Vyvgart (efgartigimod alfa-fcab) for the subcutaneous treatment of patients with generalized myasthenia gravis. Source: Drug Industry Daily
ECI Pharmaceuticals said a warning letter it received from the FDA for listing an incorrect active pharmaceutical ingredient for its drug products was the result of a “clerical error.” Source:…
The FDA’s communications with the biosimilars industry around inspection delays have been “poor,” and its interaction with that sector of the industry around application-level communications and regulatory science hasn’t been…
Johnson & Johnson (J&J) is further curtailing its participation in the controversial 30-year-old 340B Drug Discount Program, which was designed to serve low-income patient populations in the U.S. Source: Drug…
The FDA has reclassified ophthalmic drugs packaged with eye cups, eye droppers or other dispensers as “drug-led combination products” rather than just drugs, the agency said in a final guidance.…