Drugs
FDA has denied a hearing request and permanently debarred former Aegerion Pharmaceuticals sales representative Mark Moffett for his role in persuading physicians to prescribe Juxtapid for statin intolerant patients who had not been diagnosed with homozygous familial hypercholesterolemia (HoFH), which is the drug’s approved indication. Moffett schemed to increase
Drugs
Cancer researchers from FDA and several academic medical centers say clinical trials for myelodysplastic syndromes (MDS) treatments should be designed from the outset to allow the practicable application of new therapies in the high-needs population, with drugs that can be administered and tolerated in community settings, and with endpoints
Drugs
FDA has lifted its 11/2022 full clinical hold on the clinical trial of Inhibikase Therapeutics’ Phase 2a IkT 148-009 trial in Parkinson’s disease. The company’s multiple systems atrophy program using 148-009 remains under a hold. The company says IkT-148009 is a c-Abl tyrosine
Drugs
FDA has published a request for comment on its research roadmap for a BsUFA 3 (Biosimilar User Fee Act) regulatory research pilot program. The request for comment says the BsUFA 3 commitment letter between FDA and industry representatives that led to the reauthorization of the user fee program included a
Drugs
The FDA Oncology Center of Excellence will have a five-year collaboration with Aetion to advance research using novel oncology real-world data (RWD) sources through platform analytics on the Aetion Evidence Platform. Aetion says it and the agency will use the evidence platform to identify and analyze fit-for-
Drugs
Mifepristone manufacturer GenBioPro has sued the state of West Virginia in federal court to overturn state law that effectively bans the use of the drug for medical abortions. The company argues that FDA regulation of drugs including mifepristone preempts the state law, CNBC reports. The report notes that since the
Drugs
Merck says it is terminating a Phase 3 trial of its Keytruda (pembrolizumab) combined with enzalutamide (Astellas’ Xtandi) and androgen deprivation therapy to treat patients with metastatic hormone-sensitive prostate cancer. The company says the decision to end the trial follows the recommendation of an independent data monitoring committee that
Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 14 to 1 to recommend that a Cidara Therapeutics NDA for rezafungin demonstrated a favorable benefit-risk profile for a limited use indication in treating candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options. The submission has
Drugs
The American Pharmacists Association (APhA) is urging pharmacies to join them in calling for FDA to postpone the upcoming Drug Supply Chain Security Act (DSCSA) — known as the “track-and-trace” law —requirements for small business dispensers to allow for more time to comply with the requirements, which go into
Drugs
Former FDA Oncologic Drugs Advisory Committee (ODAC) chairman Mikkael Sekeres, a professor of medicine at the University of Miami Sylvester Cancer Center, says he has seen repeated instances of missteps, clumsy excuses, and faulty logic in sponsor presentations to ODAC. In an online Cancer Letter guest editorial, Sekeres says the
Drugs
FDA has announced a 3/22 Peripheral and Central Nervous System Drugs Advisory Committee to review an NDA for Biogen’s tofersen, an investigational new drug intended to treat superoxide dismutase 1 amyotrophic lateral sclerosis, known as Lou Gehrig’s Disease. Late last year, the agency extended its review by
Drugs
Verrica Pharmaceuticals has resubmitted an NDA resubmission for VP-102 to treat molluscum contagiosum, described by the Centers for Disease Control as an infection caused by the molluscum contagiosum virus. The result of the infection is usually a benign, mild skin disease characterized by lesions that may appear anywhere on
Drugs
Researchers at Harvard, Yale, and Dartmouth say their analysis of the therapeutic value (whether they represent advances over existing treatments) of drugs subject to the most direct-to-consumer advertising from 2015 to 2021 found that fewer than one-third of the most common drugs featured in DTC ads were
Drugs
An 11/12-11/19/22 FDA inspection at the Larkin Community Hospital institutional review board (IRB) in South Miami, FL, conducted as part of the FDA Bioresearch Monitoring Program, determined that the IRB did not adhere to applicable statutory requirements or FDA regulations governing the protection of human subjects
Drugs
FDA has accepted for review a Fabre-Kramer Pharmaceuticals NDA resubmission for Exxua (gepirone HCl) extended-release tablets, novel serotonin (5HT) single receptor (1A) agonist that has demonstrated effectiveness and a favorable safety profile in clinical trials as monotherapy for major depressive disorder. This is the fourth attempt to get
Drugs
Despite an appeals court decision suggesting FDA was wrong to base previous orphan drug exclusivity decisions on the uses or indications for which a drug is approved instead of all uses or indications within an orphan-designated disease or condition, a just-posted agency notice says it has considered the
Drugs
Johnson & Johnson’s DePuy Synthes medical device unit has agreed to pay $9.75 million to resolve allegations it violated the False Claims Act by paying kickbacks to an orthopedic surgeon in Massachusetts to induce his use of DePuy products. The qui tam or whistleblower suit was originally filed
Drugs
A 1/20 citizen petition submitted by the law firm Hyman, Phelps & McNamara on behalf of Curium U.S. LLC asks FDA to refuse to approve any NDA seeking approval of a conventional Technetium-99m (Tc-99m) generator or Tc-99m product that relies on neutron capture technology given
Drugs
FDA has accepted for review a Blueprint Medicines supplemental NDA for Ayvakit (avapritinib) for treating adults with indolent systemic mastocytosis (SM). The agency set a user fee review action date of 5/22. Ayvakit is a kinase inhibitor currently approved for treating adults with advanced SM, including aggressive SM, SM
Drugs
In a move to help curb product shortages, FDA has issued an immediately-in-effect guidance on compounding certain ibuprofen products. The document describes regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for use in hospitals and health systems. An FDA notice
Drugs
Covis Pharma’s Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in certain women should be withdrawn from the market because the drug does not have a favorable benefit-risk profile, says an FDA recommendation memo to FDA commissioner Robert Califf and chief scientist Namandjé Bumpus. The
Drugs
FDA has accepted for review an Intercept Pharmaceuticals NDA resubmission for obeticholic acid (OCA) for use in treating patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). In 2020, FDA issued a complete response letter on the company’s NDA that was seeking accelerated approval. The letter indicated