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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. Read More
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 mRNA-1287, a vaccine candidate that will target four endemic human coronaviruses (HCoVs). Read More
The settlement “will further support public health efforts to respond to the challenges brought on by this epidemic,” said Rhode Island Attorney General Peter F. Neronha. Read More
Belcher Pharmaceuticals received a Form 483 from the FDA for several deficiencies observed during a Nov. 1- 15, 2021, inspection of its drug manufacturing facility in Largo, Fla. Read More
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. Read More
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. Read More
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 much better. Read More
In its complaint, Acuitas argues that Arbutus and Genevant had nothing to do with the vaccine’s success and only sued after the Pfizer/BioNTech COVID-19 vaccine achieved “worldwide commercial success.” Read More