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The FDA’s latest annual report on the postmarket performance of drug and biologics firms, which covers the fiscal year Oct. 2, 2019, to Sept. 30, 2020, says 75 percent of the 816 unique postmarket requirements (PMRs) and postmarket commitments (PMCs) in the FDA’s system were on schedule. But the agency said many of the studies failed to file timely reports. Read More
The FDA’s Oncologic Drugs Advisory Committee voted nearly unanimously (16 for and one abstaining) to require makers of phosphatidylinositol 3-kinase (PI3K) inhibitors in blood cancers to complete randomized phase 3 trials with active comparators before they submit applications for approval. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) released a final guidance yesterday on drugs and biologics that contain nanomaterials, noting that the agency has not yet established regulatory definitions of nanomaterials and nanotechnology. Read More
U.S. spending on drugs shot up by 12 percent in 2021 — climbing to $407 billion — due to increased use of COVID-19 vaccines and therapeutics, says a new analysis from healthcare analytics firm IQVIA. Read More
More than 25 percent of the adverse event reports in 2021 discussed by the agency’s Pharmacovigilance Risk Assessment Committee were related to COVID-19 vaccines, the agency said. Read More
For the vast majority of Americans, the most practical COVID-19 vaccination program would be a primary series of two doses plus a booster and an extra booster given every fall, with the goal of preventing serious illness, hospitalization and death, according to CDC’s Advisory Committee on Immunization Practices (ACIP). Read More
The FDA’s Oncologic Drugs Advisory Committee is meeting today and tomorrow to discuss the now controversial phosphatidylinositol 3-kinase (PI3K) inhibitor class of drugs in blood cancers, but based on the agency’s briefing document, the fate of the class, which may be decided at this two-day meeting, seems in doubt. Read More
FDA Commissioner Robert Califf said yesterday that the FDA is taking new steps to address the ongoing opioid crisis, but emphasized that there’s only so much the agency can accomplish without laws changing. Read More
The FDA has sent both Teva Pharmaceuticals and France-based MedinCell a Complete Response Letter regarding their joint new drug application (NDA) for TV-46000/mdc-IRM, their extended-release formulation of risperidone for the treatment of patients with schizophrenia. Read More
The Regenerative Stem Cell Institute — a Chicago company with eight branches — may need to secure a biologics license to continue treating patients with adipose cell-derived stem cells, the FDA has said in an untitled letter. Read More
Johnson & Johnson (J&J), Endo Pharmaceutical and drug distributor McKesson have agreed to pay approximately $276 million to settle allegations that they contributed to the opioid epidemic in Alabama. Read More