FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Horizon Therapeutics’ Tepezza (teprotumumab-trbw), indicated for treating thyroid eye disease. The review period is 2,958 days, of which 2,760 days occurred during the testing phase and 198 days occurred during the approval
Biologics
FDA has told Covid-19 vaccine manufacturers seeking to update their vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component (bivalent) booster vaccine. This follows advice from the agency’s Vaccines and
Drugs
Janssen says a plan by the CDER Office of Prescription Drug Promotion to study how patients and doctors value different aspects of medical product labels “is invaluable in improving clinical care by assessing both what patients and physicians value when considering medical products and how these values may lead to
FDA Policy/General
FDA commissioner Robert Califf has announced that former Johns Hopkins School of Medicine professor Namandjé N. Bumpus has joined the agency as its new chief scientist, and former White House Covid Response Team member Hilary D. Marston has been named chief medical officer. As chair of Johns Hopkins’ Department of
Devices
Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) are putting pressure on FDA to finalize a proposed rule on making certain hearing aids available over the counter. In a 6/29 letter to FDA commissioner Robert Califf, the lawmakers highlight findings from a Senate staff investigation on leading
Biologics
FDA has extended by three months the review of a Provention Bio BLA for teplizumab, indicated for delaying progression to Stage 3 clinical Type 1 diabetes in at-risk individuals. The extended user fee review action goal date is 11/7. The agency recently told the company that its response
Drugs
FDA has granted breakthrough therapy designation for Janssen’s talquetamab to treat adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The company describes talquetamab as an investigational,
Biologics
FDA has published a draft guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, the third in a series of four methodological patient-focused drug development guidances that describe how stakeholders such as patients, caregivers, researchers, medical product developers, and others, can collect and
FDA Policy/General
Federal Register notice: FDA has determined for patent restoration purposes the regulatory review period for ViiV Healthcare’s Rukobia (fostemsavir tromethamine), indicated in combination with other antiretrovirals for treating HIV–1 infection in heavily treatment-experienced adults. The review period is 5,322 days, of which 5,110 days occurred
FDA Policy/General
Federal Register notice: FDA has determined for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics’ Danyelza (naxitamab-gqgk), indicated for use in combination with granulocyte-macrophage colony-stimulating factor for treating pediatric patients one year of age and older and adult patients with relapsed or refractory
Drugs
FDA has accepted for review a Regeneron sBLA for Eylea (aflibercept) injection for an every 16-week 2 mg dosing regimen, after an initial monthly dose, in patients with diabetic retinopathy. The target date for a review decision is 2/28/23. Regeneron says Eylea was approved in 2019 to
FDA Policy/General
A Duane Morris Legal Alert says a Department of Justice (DoJ) Statement of Interest filed in a Florida federal court in a Trividia Health whistleblower case makes clear the department’s decision to reawaken a theory of liability thought to be dead. The alert says the fraud-on-FDA theory
Drugs
The HHS Office of Inspector General (OIG) is recommending that FDA “identify and implement additional ways to improve the timeliness of its foreign for-cause drug inspection program.” In an audit report, the OIG says its audit objective was to determine whether FDA’s foreign drug inspection process has improved
Devices
FDA has cleared an Invictus Sterilization 510(k) for the Aura Storm ultraviolet medical air purifier. The free standing device uses ultraviolet light and a multi-stage filtration system to inactivate bacteria and viruses (e.g., coronavirus, monkeypox, and hospital-acquired infections) in hospitals and other medical facilities, according to
Drugs
Santhera Pharmaceuticals says that a planned NDA submission for vamorolone in Duchenne muscular dystrophy (DMD) has been postponed by four to six months after a third-party contract manufacturing organization (CMO) communicated a delay in reaching FDA-inspection readiness. The completed rolling NDA is now expected sometime in the fourth
Drugs
Some 100 members of the House and Senate, led by Sen. Elizabeth Warren (D-MA) and Rep. Lloyd Doggett (D-TX) are calling on HHS secretary Xavier Becerra to “swiftly act and use his existing authorities to lower prices on critical prescription drugs.” A release (includes the text of a
Drugs
University of Colorado researchers say two FDA-approved drugs — imipramine and olanzapine — block apolipoprotein E4 (apoE4)-catalyzed polymerization of amyloid-beta, making them potentially useful in preventing Alzheimer’s disease. Writing in the open-access journal Alzheimer’s Research and Therapy, the researchers say the two drugs also show evidence
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment.” The document is intended to aid sponsors developing drugs and biologics for the adjuvant treatment of muscle-invasive bladder cancer. It provides recommendations on eligibility criteria, choice of comparator, follow-
FDA Policy/General
Federal Register notice: FDA has announced the approval of a product that redeemed a priority review voucher — AstraZenca’s sBLA for Ultomiris (ravulizumab-cwvz) that was approved 4/27 for treating adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor (AChR) antibody-positive, which represents 80% of people
Devices
FDA says the GE Healthcare 4/18 recall of its Carescape R 860 ventilator backup batteries and replacement backup batteries manufactured on or after 4/1/19 is Class 1. An agency announcement says GE recalled 4,222 units distributed between 4/2/19 and 4/18/22 because the
Drugs
FDA has released the FDA-483 issued following a 2/23-3/4 inspection at Expert Compounding Pharmacy, a Lake Balboa, CA, producer of non-sterile drugs. The six inspection observations were: * producing hazardous drugs without providing adequate cleaning of utensils to prevent cross-contamination; * non-microbial contamination was observed
Devices
FDA has issued an update of activities in the Digital Health Center of Excellence “that promote awareness and consistent application of digital health regulatory policies to foster equity in health care, pioneer the development and enhancement of digital health regulatory paradigms, and cultivate digital health-focused collaborations.” The update says