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The FDA has issued a third Complete Response Letter (CRL) to Mallinckrodt for the company’s investigational drug terlipressin for the treatment of adults with hepatorenal syndrome (HRS), a life-threatening syndrome involving rapid reduction in kidney function. Read More
Boise, Idaho-based Smart Surgical, which does business as Burst Biologics, failed to ensure that its blood products were free of the threat of infection and contamination, the FDA said in a warning letter to the company. Read More
AstraZeneca and Daiichi Sankyo have released promising results from a phase 3 study of Enhertu (trastuzumab deruxtecan), saying the drug significantly improved both progression-free and overall survival in patients with HER2-low metastatic breast cancer. Read More
Kodiak Sciences’ antibody designed to treat age-related macular degeneration with eye injections every three to five months was no better than Regeneron Pharmaceutical’s Eylea (aflibercept), the currently approved drug for the condition, injected every two months, Kodiak reported. Read More
An FDA remote inspection can carry major drawbacks, including that they may last longer than an in-person visit and that the FDA doesn’t consider them to be a full substitute for an on-site inspection. Read More
The move follows a December injunction temporarily halting pay-for-delay agreements between branded drug manufacturers and makers of generics in the state. Read More
The FDA’s Office of Pharmaceutical Quality (OPQ) used alternative tools because of the ongoing pandemic that reduced the number of facilities needing pre-approval inspections by more than 50 percent in fiscal 2021, OPQ said in its annual report released yesterday. Read More
Takeda Pharmaceuticals and Code Biotherapeutics are teaming up to develop gene therapies for treatment of rare diseases in a deal that is potentially worth up to $2 billion to Hatfield, Pa.-based Code Bio. Read More