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A former study coordinator at Unlimited Medical Research, which helped conduct a clinical trial on behalf of GlaxoSmithKline (GSK), has been indicted by the Department of Justice (DOJ) for allegedly falsifying data. Read More
India’s surging COVID-19 cases threaten to derail the global drug supply as the world’s largest producer of generic drugs is unable to secure critical raw materials. Read More
In the latest round of Generic Drug User Fee Act (GDUFA) negotiations, the FDA and industry representatives discussed criteria for issuing Complete Response Letters (CRLs) to facilities that cannot be inspected due to a public health emergency or travel restrictions, among other topics. Read More
The temporary pause was not prompted by drug-related adverse events in either the low- or high-dose adult arms of the phase 1 study, the company said. Read More
The Center for Drug Evaluation and Research’s Office of Surveillance and Epidemiology (OSE) said it aims to prioritize Risk Evaluation and Mitigation Strategy (REMS) assessments and the use of new technologies to evaluate adverse event reports, among other priority activities highlighted in its first-ever annual report released yesterday. Read More
On Capitol Hill in recent days, Republicans have challenged the Biden’s administration’s support of a World Trade Organization (WTO) proposal to temporarily waive patents for COVID-19 vaccines. Read More
Iceland-based biosimilar developer Alvotech has sued AbbVie in a U.S. federal court, seeking to have AbbVie’s patents for its blockbuster arthritis drug Humira (adalimumab) declared invalid. Read More
Attorneys representing more than 70,000 plaintiffs in multi-district litigation against Sanofi have accused the company of “widespread destruction” of company emails associated with a 2019 recall of its Zantac (ranitidine) heartburn medication and asked a federal court to allow more time to gather evidence. Read More
The Institute for Clinical and Economic Review (ICER) has assessed the clinical effectiveness and value of three new treatments targeting the B-cell maturation antigen for heavily pre-treated patients with triple-class refractory multiple myeloma who have completed many previous lines of therapy. Read More
A group of 10 moderate House Democrats have written to Speaker Nancy Pelosi (D-Calif.) urging her to embrace bipartisan drug pricing legislation, signaling a cooperative effort as a more realistic way to get a drug pricing bill to the Oval Office. Read More
The FDA has finalized guidance on qualified infectious disease product (QIDP) designations, drug designations that are meant to encourage the development of certain antibacterial and antifungal products for serious or life-threatening infections. Read More