Sponsors who fail to meet certain Risk Evaluation and Mitigation Strategy (REMS) requirements won’t face FDA action during the COVID-19 outbreak, the agency announced. Source: Drug Industry Daily
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) wrote up a drug manufacturer in Bangalore, India for data integrity and other serious violations observed during a December 13 inspection.…
In a further blow to Gilead, the U.S. Patent Trial and Appeal Board (PTAB) denied the company’s request to review two HHS patents for the use of Truvada (emtricitabine/tenofovir) for…
The FDA issued a final guidance on online submissions for certain drug product applications, clarifying that some submission types are exempt or may qualify for a waiver. Source: Drug Industry…
The U.S. is bearing the brunt of pharmaceutical research costs because of “free-riding” by foreign countries in the past 15 years, the White House Council of Economic Advisers (CEA) claimed…
The FDA has released a new table listing certain gene-drug interactions backed by scientific evidence that appear on agency-approved drug labeling. Source: Drug Industry Daily
Trinidad-based OTC drug manufacturer CGA drew a warning letter from the FDA for serious GMP lapses including inadequate testing and producing an unapproved drug. Source: Drug Industry Daily
Trials for hematologic malignancies can use measures of minimal residual disease (MRD) as a biomarker, according to a final guidance issued by the FDA that specifies the types and uses…
Gilead fired back at HHS’s patent infringement suit over its HIV drugs Truvada and Descovy, claiming that the patents the department is suing over are invalid. Source: Drug Industry Daily
The Institute for Clinical and Economic Review (ICER) released a draft cost-benefit analysis comparing three sickle cell disease treatments — Novartis’ Adakveo, Global Blood Therapeutics’ Oxbryta and Emmaus Life Sciences’…