Drugs
FDA has issued Alnylam Pharmaceuticals a complete response letter on a supplemental NDA for Onpattro (patisiran) for treating cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. Onpattro was approved in 2018 to treat hereditary ATTR amyloidosis polyneuropathy, and the sNDA rejection has no affect on the original approval, according to the company.
Drugs
FDA has issued Biocon Biologics a complete response letter on its BLA for insulin aspart. While the letter did not identify any outstanding scientific issues with the product, the company did say it references a requirement for a “satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our
Devices
FDA has granted ZKR Orthopedics a breakthrough device designation for its Lift implant technology, which is designed to decrease pain, improve function, and delay or eliminate the need for knee replacement. If granted marketing authorization, the company says Lift will “expand the continuum of care for patients suffering from later
FDA Policy/General
Federal Register notice: FDA is withdrawing 11 ANDAs from Dr. Reddy’s Laboratories after the company requested the actions because the products are no longer marketed. To view the notice, click here.
Devices
FDA has granted HistoSonics a de novo marketing authorization for the Edison System, which the company says uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue, including tumors, at sub-cellular levels. Authorization was based on data from the #HOPE4LIVER Trials in
Drugs
AstraZeneca is asking FDA to provide more detailed guidance or recommendations on how early in the drug development process sponsors should start to collect data/information on diverse representative populations. In just-released comments on the agency’s draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of two Monkeypox-related Emergency Use Authorizations after the authorization holders requested they be revoked because the products are no longer being offered for sale. The affected products are Life Technologies’ TaqPath Monkeypox/Orthopox Virus DNA Kit, and Becton, Dickinson’s Viasure
FDA Policy/General
Federal Register notice: FDA is correcting a 9/19 notice entitled “Food and Drug Administration Information Technology Strategy; Request for Comments.” The document was published with an incorrect set of fiscal year information and this notice corrects this. To view the notice, click here.
Drugs
FDA has approved Novartis’ intravenous (IV) Cosentyx (secukinumab) formulation for treating adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The non-tumor necrosis factor alpha IV formulation offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring, the company
Devices
Sen. Richard Blumenthal (D-CT) is calling on the Justice Department to take action against Philips Respironics after a recent investigation by ProPublica and the Pittsburgh Post-Gazette revealed the company kept secret more than 3,700 complaints about its faulty CPAP breathing devices over the course of 11 years
Drugs
FDA has approved an Arcutis Biotherapeutics supplemental NDA to expand the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, in children aged six to 11 years. Previously, Zoryve was approved for the same indication in people aged 12 years and older.
Drugs
Syndax Pharmaceuticals says new positive data warrants stopping the pivotal AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute myeloid leukemia and acute lymphoid leukemia. The decision to stop the trial is based on a recommendation from
Drugs
Amplifying the Reagan-Udall Foundation’s just-released report on misinformation, FDA commissioner Robert Califf has outlined a daunting task the agency faces to combat misinformation that is proliferating due to the “power of the Internet, the digitization of our world, and the preponderance of what is commonly referred to
Devices
FDA has cleared a Sanguina 510(k) for the AnemoCheck Home, a home-use hemoglobin test kit. The prescription-only test is designed for individuals with anemia due to nutritional deficiency (iron deficiency anemia, vitamin B12 deficiency anemia, and folate deficiency anemia), sickle cell disease, and thalassemia to monitor their
Drugs
FDA has accepted for review a Sun Pharmaceutical Industries NDA for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2 for treating adults with moderate to severe alopecia areata. The submission is based on data from two pivotal Phase 3 trials (THRIVE-AA1 and THRIVE-AA2), which
Drugs
FDA’s Oncologic Drugs Advisory Committee 10/5 voted 10 to 2 that the CodeBreak 200 confirmatory study, with its progression-free survival primary endpoint, cannot be reliably interpreted as the basis for Amgen’s request to have Lumakras’s (sotorasib) 5/28/21 accelerated approval converted to a full
Drugs
FDA has placed a partial clinical hold on the Innate Pharma lacutamab IND, leading to a pause in patient enrollment in the company’s Phase 2 TELLOMAK and Phase 1b PTCL trials in cutaneous and peripheral T-cell lymphoma. A company statement says the hold follows one fatal case of
Devices
As part of Cybersecurity Awareness Month, CDRH is marking the 10th anniversary of its cybersecurity program with an online post highlighting ways in which the program has contributed to patient safety in the last decade. CDRH Office of Strategic Partnerships and Technology Innovation director Suzanne Schwartz says the activities were:
Devices
Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) say FDA’s recent action in issuing a proposed rule on laboratory-developed tests “recognizes the need for action in this space.” In a statement, the two say the way to ultimately ensure the analytical and clinical validity of tests
Drugs
FDA has granted Invitae a de novo market authorization for its Common Hereditary Cancers Panel for identifying germline variants associated with hereditary cancer. The in vitro diagnostic test focuses on 47 genes already known to contain tens of thousands of genetic variants that increase risk of developing certain cancers, the
FDA Policy/General
Federal Register notice: FDA is announcing an 11/7 Radiological Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the proposed classification of blood irradiator devices for preventing metastasis, which are currently unclassified pre-amendments devices, to Class 3 (general
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of 11 Covid-related Emergency Use Authorizations after the authorization holders requested they be revoked because the products are no longer being offered for sale. To view the notice, click here.