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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
The FDA has sent New Jersey-based Bi-Coastal Pharma International a warning letter, insisting that the company complete a complaint investigation rather than passing the buck to its now-defunct supplier. Read More
Avadel Pharmaceuticals has sued the FDA and HHS for holding up review and approval of its Lumryz narcolepsy drug after making administrative errors in the approval process, including delaying the review 10 months beyond the legal limit and requiring an unneeded patent certification. Read More
Sandoz’s biosimilar of Biogen’s blockbuster multiple sclerosis drug Tysabri (natalizumab) has gained new regulatory footholds with both the FDA and the European Medicines Agency (EMA). Read More
Teva Pharmaceuticals has agreed to a proposed $4.25 billion settlement to resolve lawsuits brought by more than 2,500 U.S. cities, counties, states and Native American tribes over the company’s alleged role in the opioid crisis. Read More