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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
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
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
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
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
The defendants are barred from seeking or accepting reimbursement for any Gilead medication dispensed to individuals enrolled in the programs. Read More
A three-judge panel has rejected Pfizer’s plan to help Medicare patients pay for one of its most expensive drugs, citing the federal anti-kickback statute. Read More