Drugs
CDER director Patrizia Cavazzoni says areas of agency flexibility developed during the Covid-19 pandemic do not include changes to how the balance between a drug’s risks and benefits is determined. Responding to a question during a wide-ranging WebMD video interview, she said CDER continues to ensure that
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Drug company representatives say their experience with the FDA MIDD (Model-Informed Drug Development) paired meeting program has been strongly favorable. “The companies have recognized savings in resources, achieved alignment with FDA on developmental strategies, and gained clarity on important aspects of programs and product characteristics,” an open-source report
Drugs
FDA has authorized another vaccine drug substance batch (15 million doses) that was manufactured at troubled Emergent BioSolutions’ Baltimore facility for use in Janssen’s Covid-19 vaccine. The authorization follows last week’s sign-off on two other batches (10 million doses) from the same plant (see earlier story)
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The FDA regulatory system is “grievously and horribly broken” and there is no signal that it is getting better any time soon. That’s the perspective of University of California San Francisco associate professor of medicine Vinay Prasad. Writing in a hard-hitting online Medpage Today essay, Prasad says the
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FDA has issued a drug safety alert for alcohol-based hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying them. “These symptoms are likely to have occurred because of vapors from the hand sanitizer, potentially from exposure in enclosed spaces or places with poor
Drugs
Biogen says it has halted development of gosuranemab (BIIB092), an investigational anti-tau antibody that was being evaluated as a potential treatment for Alzheimer’s disease. Topline results from its Phase 2 TANGO study show gosuranemab did not meet its primary efficacy endpoint of change from baseline at week 78
Drugs
FDA has cleared a Neo Medical 510(k) for the use of its Pedicle Screw System in late stage tumor indications in combination with Osartis’ BonOs Inject cement. The clearance applies to the screws used at spinal levels where the structural integrity of the spine is not severely compromised, the
Drugs
FDA has started a five-year project with ConcertAI to evaluate real-world outcomes and safety in cancer treatment. The agreement is with CDER’s Office of Clinical Pharmacology and Office of Translational Science. An announcement says the collaboration builds on FDA’s program intended to explore the use of
Drugs
CDER Office of Generic Drugs (OGD) Office of Research and Standards director Robert Lionberger says OGD has taken many steps to encourage the development of complex generic drugs (drugs that have complex active ingredients, dosage forms, routes of administration, or drug-device combinations). In an online post, Lionberger outlines the
Drugs
In a complete response letter for Sanofi’s sNDA for Aubagio (teriflunomide) for children and adolescents 10 to 17 years old with relapsing forms of multiple sclerosis, FDA said the data submitted were not sufficient to obtain approval of an indication in the pediatric population at this time. Sanofi says
Drugs
FDA has extended for three months to 9/25 the PDUFA review action date for the Ascendis Pharma BLA for lonapegsomatropin to treat pediatric growth hormone deficiency. The agency determined that information submitted by the company for FDA review constituted a major amendment, necessitating the additional review time. Company officials
Drugs
The Department of Justice says a Florida grand jury charged five additional defendants for their roles in an alleged scheme to purchase and distribute millions of dollars in diverted prescription drugs. A department statement says 14 people have now been charged in the scheme. The 6/10 indictment charged the
Drugs
FDA says its review of a Web site at www.pharmacygeoff.md determined that the site is offering drug products for sale in the U.S. intended to mitigate, treat, prevent, diagnose, or cure Covid-19 and several other diseases such as lupus, rheumatoid arthritis, malaria, HIV, and hepatitis C.
Drugs
FDA has granted Cerevel Therapeutics a fast track designation for CVL-871, a selective dopamine D1/D5 partial agonist in development for treating dementia-related apathy. The company says that apathy is a “strong predictor of dementia progression and can lead to decreased quality of life, increased morbidity and mortality,
Drugs
Viona Pharmaceuticals has recalled two lots of diabetes drug metformin HCl 750mg because the product was found to contain levels of human carcinogen nitrosodimethylamine (NDMA) impurities above acceptable daily limits. The product was manufactured by Cadila Healthcare (Ahmedabad, India) for U.S. distribution by Viona Pharmaceuticals, according to a recall
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Generic drug manufacturer KVK-Tech (Newtown, PA) and executives Murty Vepuri (defacto owner) and Ashvin Panchal (head of quality assurance) have been indicted on charges of defrauding FDA based on their alleged distribution of unapproved drugs as well as alleged efforts to mislead the agency and conceal information which could
Drugs
FDA has issued Avenue Therapeutics a second complete response letter on its NDA for an intravenous formulation of tramadol, indicated for treating patients in acute pain who require an opioid. The letter said that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as
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A third advisory committee member — Harvard medical school professor Aaron Kesselheim — has resigned in the wake of FDA’s 6/7 decision to grant accelerated approval for Biogen’s Alzheimer’s therapy. Earlier this week, Mayo Clinic (Rochester, MN) professor David Knopman and Washington University School of Medicine professor Joel
Drugs
An Eli Lilly investigation into whether a company executive altered manufacturing documents required by FDA found no wrongdoing, according to a Reuters report. Law firm Covington & Burling spearheaded the probe of an internal Lilly complaint that alleged a Branchburg, New Jersey factory executive changed technical documents required by regulators
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FDA has just released the FDA-483s issued following 2019 inspections of two trial investigators at the Hennepin County Medical Center Department of Emergency Medicine in Minneapolis, MN. A 4/10-4/26/19 investigation of Jon Cole, clinical investigator, found these observations: * failing to submit an IND to FDA
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[Report by David McFarland and Jim Dickinson] In the wake of FDA’s controversial decision to approve Biogen’s Alzheimer’s drug, two members of the advisory committee that reviewed data and voted against approving the therapy have resigned in protest. Mayo Clinic (Rochester, MN) professor David Knopman and Washington
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FDA has released the FDA-483 issued following a 3/1-1/11 inspection at BSO, a Lakewood, CO, outsourcing facility. The form’s four inspection observations were: * written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up; * procedures for the cleaning and maintenance