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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
The FDA first approved Enhertu in 2019 for patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. Read More
Plastikon Healthcare’s drug manufacturing facility in Lawrence, Kan., drew an 11-observation Form 483 following an FDA inspection in late October-early November that identified several testing and documentation failures. Read More
Three FDA investigators observed multiple quality lapses during a more than two-week inspection of Noven Pharmaceuticals’ transdermal drug manufacturing plant in Miami, Fla in November 2021. Read More
Johnson & Johnson (J&J) has agreed to pay $99 million to settle allegations that its Janssen subsidiary helped facilitate the opioid epidemic in West Virginia, just weeks after a trial got under way in the state. Read More