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The approval provides another treatment option for pediatric patients, who were previously given non-selective immunosuppressants and corticosteroids, the company said. Read More
The FDA issued a warning letter to Jost Chemical Co. — an active pharmaceutical ingredient (API) manufacturer based in Saint Louis, Mo. — for what the agency said was an inadequate investigation into a quality-related complaint and out-of-specification results. Read More
Vertex Pharmaceuticals has doubled down on its patent fight against Lupin over the company’s plan to market a generic version of Vertex’s cystic fibrosis treatment Kalydeco (ivacaftor). Read More
Armed with a re-analysis of a previously negative trial and some FDA encouragement, German biotech InflaRx intends to seek Emergency Use Authorization (EUA) for its first-in-class anti-C5a monoclonal antibody vilobelimab for critically ill, ventilated COVID-19 patients. Read More
Seagen and Astellas Pharma are touting positive topline data from an early study of Padcev (enfortumab vedotin-ejfv) plus Merck’s Keytruda as a treatment for patients with unresectable locally advanced or metastatic urothelial cancer who can’t receive cisplatin treatment. Read More
Following Teva’s $4.25 billion opioid settlement earlier this week, AbbVie subsidiary Allergan has agreed to pay $2 billion to settle about 3,000 lawsuits against the company for alleged deceptive marketing of its Kadian (morphine sulfate extended release) painkiller. Read More
The combination drug is authorized for treatment of mild-to-moderate COVID-19 adult and pediatric patients 12 years and older who weigh at least 88 pounds. Read More
Kelun-Biotech will receive an upfront payment of $35 million and is eligible to receive future milestone payments totaling up to $901 million. Read More