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The FDA has released final guidance for industry on the agency’s approach for overseeing requests for the importation of unapproved finished dosage form drugs by applicants preparing medicines for market launch of a pending new drug application (NDA), an abbreviated new drug application (ANDA) or biologics licensing applications (BLA) regulated by the agency’s Center for Drug Evaluation and Research (CDER). Read More
Carvykti, a new CAR-T cell therapy developed by Legend Biotech and Janssen, is now approved for patients with relapsed or refractory multiple myeloma who have already received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. Read More
The Cambridge, Mass., drugmaker earned $18.5 billion in total revenue for 2021, almost all of which was from sales of its coronavirus vaccine. Read More
FDA clinical holds saw a sharp increase in 2021, propelled in large part by holds on cell and gene therapy trials, according to an analysis by investment banking firm Jefferies that evaluated holds over the past 12 years. Read More
The FDA has issued a complete response letter (CRL) to Reata Pharmaceuticals, rejecting the company’s new drug application (NDA) for bardoxolone methyl for treatment of patients with Alport syndrome-related chronic kidney disease. Read More
Amryt Pharma received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Oleogel-S10 for treating a rare genetic skin ailment — epidermolysis bullosa (EB). Read More
Sanofi and Regeneron added another brick to their joint Dupixent franchise with more phase 3 data confirming the antibody’s benefit in eosinophilic esophagitis, a chronic inflammatory disorder that can increase the risk of esophageal cancer. Read More
Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay generic competition to its EpiPen allergy treatment, used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More
A biologics-focused subsidiary of Bangalore, India-based Biocon is buying the biosimilars portfolio of Pittsburgh, Pa.-based Viatris for up to $3.3 billion. Read More