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Prominent industry figures have praised the FDA’s recent draft guidance on using electronic health records (EHRs) and medical claims data in trials, but they hope it will acknowledge issues inherent to real-world data (RWD), offer clarity in certain areas and be flexible as sponsors adjust to the new recommendations. Read More
Immunocore’s Kimmtrak (tebentafusp-tebn) has won FDA approval for treating inoperable or metastatic uveal melanoma, a rare adult eye cancer with poor prognosis. Read More
Researchers from the University of Minnesota and 46brooklyn Research have shown in a new analysis that prices of entecavir, a generic drug that’s one of the first-line treatments used to treat chronic hepatitis B (CHB), from 2014 to 2018 stayed artificially high despite a dramatic increase in generic competition. Read More
Rhode Island’s settlement with the distributors was negotiated separately from a $21 billion global settlement being proposed for other states. Read More
Fiscal 2022 is already setting a dismal pace for generic drug approvals, which sunk to a record low last year under the full brunt of COVID-19 supply-chain and clinical trial interruptions. Read More
Sierra Oncology has announced that its experimental blood cancer treatment has reached all primary and key secondary endpoints in a phase 3 study, including maintaining platelet counts. Read More
The FDA, as part of its Drug Competition Action Plan, has released final guidance for companies preparing to submit abbreviated new drug applications (ANDAs) to the agency for generic products. Read More
The FDA issued a warning letter to Aurobindo Pharmaceutical after an inspection of the company’s active pharmaceutical ingredient (API) facility in Hyderabad, India. Read More