Devices
The U.S. Justice Department has charged 12 dental practices and alleged accomplices in the Eastern Pennsylvania federal court with defrauding FDA, Medicaid, U.S. Immigration authorities, and the IRS, as well as laundering the fraud proceeds. Three of the defendants allegedly conspired to place adulterated and misbranded dental devices
Drugs
FDA has told Torrent Pharmaceuticals that a 9/2022 inspection of the company’s India (Indrad, Gujarat) facility has been classified as “Official Action Indicated.” The company says the classification will not have impact on existing supplies or revenues from the facility. “Torrent Pharma continues to cooperate with the USFDA
Drugs
FDA says there is no evidence at this time that contaminated cough syrup products that have killed more than 300 children in Asia and Africa have entered the U.S. supply. CBS News reports the agency gave the assessment while saying it is joining the World Health Organization (WHO) and
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee 1/26 unanimously voted (21 to 0) to recommend that Covid-19 vaccine composition be “harmonized” so that one vaccine composition can cover the primary series in newly vaccinated and booster doses in those already vaccinated. For example, if FDA moves
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
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document describes the agency’s regulatory and enforcement priorities for outsourcing facilities to compound certain ibuprofen oral suspension products for administration
Devices
Datascope/Getinge has recalled its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) due to the risk of blood entering the pumps through a damaged balloon catheter. According to a recall notice, blood entering the pump could cause an unexpected shutdown, which could lead to organ damage or death.
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
Biologics
New emails released by FDA provide a glimpse of a frustrated senior FDA vaccine official arguing why her office could not “compress” its review activities any more to further expedite the 8/23/2021 approval of Pfizer-BioNTech’s Covid-19 vaccine Comirnaty for use in individuals 16 years of
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
Devices
AdvaMed says it appreciates a proposed update to the EPA emissions standards for facilities using ethylene oxide (EtO) to sterilize medical devices and offers points for the Biden Administration to consider as it finalizes the regulation. In a letter to President Joseph Biden, AdvaMed asks the administration to: * consider the
Devices
Intense lobbying on behalf of laboratory-developed test (LDT) makers, professional associations, and academic medical centers led Congress to reject the inclusion of the VALID (Verifying Accurate Leading-edge IVCT Development) Act in the omnibus spending bill that was approved at the end of 2022, according to a ProPublica analysis.
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