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Recognizing that a lack of standard methods is the primary challenge to widespread manufacturing of cell and gene therapies, two groups are aiming to lower the barrier by bringing best practices to this branch of the life sciences industry. Read More
This two-part series hones in on the specifics of the House and Senate user fee bills, their differences and what the final law, the Food and Drug Administration Safety and Landmark Advancements (FDASLA), may look like when it gets to President Biden’s desk.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
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