Archive for July 2022

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. Source: Drug Industry Daily

Massachusetts-based Editas Medicine announced that the FDA has removed a partial clinical hold on its trial of EDIT-301 (AsCas12a), its experimental gene treatment for severe sickle cell disease. Source: Drug Industry Daily

Bristol Myers Squibb’s (BMS) combination treatment for renal cell cancer missed its primary endpoint of disease-free survival in the phase 3 CheckMate-914 trial, Part A, the company reported. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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). Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily