Drugs
FDA has granted Invivyd an emergency use authorization for Pemgarda (pemivibart) and its use for pre-exposure prophylaxis of Covid-19 in certain adults and adolescents. Pemgarda is authorized for those who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to
Drugs
FDA has agreed to settle a lawsuit brought by three physicians who objected to the agency’s messaging during the Covid-19 pandemic that consumers should stop taking ivermectin because it was for treating horses. A court had earlier ruled (see earlier story) that when the agency issued its “You
Drugs
FDA’s new draft guidance on “Real-World Evidence (RWE): Considerations Regarding Non-Interventional Studies for Drug and Biological Products” provides “additional clarity” on the agency’s focus when analyzing a RWE program’s adequacy, according to an online post from attorneys at Hogan Lovells. “Notably, unlike previous guidances on
Drugs
Organon is asking FDA to impose requirements on any ANDAs that cite its Nexplanon (etonogestrel implant) as the reference-listed drug. The company’s 3/1 petition asks that the agency specifically: * require that an ANDA applicant establish bioequivalence (BE) of the generic drug through (1) an in vivo BE
Drugs
FDA has released the form FDA-483 issued following a 5/15-5/26/2023 inspection at Medi-Fare, a Blacksburg, SC, outsourcing facility. The four inspection observations were: * reports of analysis from component suppliers are accepted instead of testing each component for conformity with all appropriate written specifications, without
Drugs
FDA has granted in part and denied in part a 2016 petition from the Center for Responsible Science asking that the agency issue a guidance communicating broadly that it will accept in vitro primary skin and eye irritation data and that in vivo rabbit ocular and skin irritation tests (Draize)
Drugs
FDA has approved safety labeling changes for fluorouracil injection drug products. An online post says the Office of Generic Drugs and Oncology Center of Excellence collaborated on the revisions. Fluorouracil injection was first approved in 1962, the post says. FDA became aware of additional safety information on the risk of
Drugs
Merck says its Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with maintenance Lynparza (olaparib), a PARP inhibitor, did not meet its primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic
Drugs
Abiomed is recalling (Class 1) its Impella Left Sided Blood Pumps because the pump catheter may slice the heart’s left ventricle wall during operations. “The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood
Drugs
A 4/25/2023 virtual public meeting sponsored by FDA on “Long Covid” focused on several key themes raised by patients, their caregivers, and other patient representatives. A 3/2024 meeting report says some 3,200 people attended the meeting whose discussion focused on: * health effects and daily impacts of
Drugs
Attorneys Dominick DiSabatino and Arushi Pandya (SheppardMullin) say FDA’s publication of a draft guidance on key information and facilitating understanding in informed consent may mean the agency will soon finalize its 9/28/2022 proposed rule that will harmonize FDA regulations with the HHS common rule on the protection
Drugs
FDA has published a draft guidance, Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products, with recommendations for sponsors and investigators who are considering submitting a non-interventional study to the agency to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of
Drugs
FDA has approved an Idorsia NDA for Tryvio (aprocitentan) for treating hypertension in combination with other antihypertensive drugs in adult patients who are not adequately controlled on other drugs. Aprocitentan is described as an endothelin receptor antagonist that inhibits the binding of endothelin (ET)-1 to ETA and ETB receptors.
Drugs
FDA has approved Johnson & Johnson’s Edurant PED (rilpivirine) for treating HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children at least two years of age and weighing at least 14 kg and less than 25 kg. The approval is based on data from the
Drugs
FDA has issued Warning Letters (see below) to Jiangsu Shenli Medical Production Co. Ltd, a China-based plastic syringe manufacturer, and Medline Industries and Sol-Millennium Medical, two firms marketing and distributing in the U.S. plastic syringes made in China. “All three Warning Letters describe violations related to the
Drugs
FDA has approved an Optinose NDA for Xhance (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. The drug-device combination product combines a widely used nasal steroid with the Opinose’s Exhalation Delivery System, an “innovative delivery
Drugs
FDA is seeking applicants for a funding opportunity to explore the role of digital health technologies (DHTs) such as actigraphy, photography, and environmental sensors, in evaluating new drugs. An agency announcement says projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups, and other stakeholders. The project
Drugs
FDA is proposing to establish criteria to use in evaluating drugs or categories of drugs that present demonstrable difficulties for compounding (lists of DDC drugs). A Federal Register notice says the agency also proposes to identify three categories of drug products on two DDC lists, with the possibility of adding
Drugs
U.S. Representatives Abigail Spanberger (D-VA) and Don Bacon (R-NE) have reintroduced a bipartisan bill to create an emergency supply of active pharmaceutical ingredients (APIs) used in essential generic medicines and “incentivize domestic manufacturing of these ingredients.” The measure is intended to reduce the U.S.’s reliance
Drugs
FDA has published a guidance, Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing, to assist sponsors in designing and analyzing studies assessing the influence of impaired renal function on the pharmacokinetics (PK) and/or pharmacodynamics of an investigational drug. The document also provides
Drugs
FDA has granted Takeda Pharmaceutical accelerated approval for Iclusig (ponatinib) for use with chemotherapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The approval was based on data from the PhALLCON (NCT03589326) study of 245 adult patients with newly diagnosed Ph+ ALL. Efficacy was
Drugs
FDA has accepted for review a Citius Pharmaceuticals BLA resubmission for Lymphir (denileukin diftitox), an interleukin-2-based immunotherapy for treating patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy. The resubmission addresses issues raised in a 7/28/2023 FDA complete response