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
FDA Policy/General
CDER Office of Prescription Drug Promotion and Fors Marsh researchers say two fictitious television disease awareness and prescription drug promotional communications demonstrated that consumers might be confused about a drug’s benefits and risks. Writing in Health Communication, the researchers say (purchase required) consumers “may incorrectly equate the broadly described
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
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of an Air Products and Chemicals NDA and new animal drug application for medical gas helium because the company says it is no longer marketed and requested their withdrawal. To view the notice, click here.
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
Drugs
A bipartisan group of nine senators led by Sens. Elizabeth Warren (D-MA) and Marco Rubio (R-FL) are asking the Department of Defense (DoD) for an update on its efforts to address risks to the military pharmaceutical supply chain. A statement from Warren (includes a link to a letter
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA efforts to further enhance the adoption of advanced manufacturing technologies (AMTs) in drug manufacturing, including through the implementation of the new AMT designation program. Commenting on an agency draft guidance on the designation program, the association says FDA should:
Drugs
GSK says “statistically significant and clinically meaningful” overall survival and progression-free survival data were observed in its RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial involving Jemperli (dostarlimab) in adult patients with primary advanced or recurrent endometrial cancer. GSK says the data will form the basis of a regulatory
Drugs
A 2/29-completed FDA inspection of Eugia SEZ Private Ltd.’s Telangana, India sterile drug manufacturing facility has resulted in a seven-item Form FDA 483 that cites significant GMP deficiencies. According to the just-posted inspection report, the Eugia facility did not follow procedures that are designed to
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of Bayer’s NDA for relapsed follicular lymphoma drug Aliqopa (copanlisib) after the company requested the action in response to a required postmarketing trial that did not verify the drug’s clinical benefit. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Controlled Correspondence Related to Generic Drug Development .” The document provides information on how generic drug manufacturers submit controlled correspondence requesting information related to their product development. It also describes the agency’s process for providing responses related to the
Biologics
FDA has approved an Orchard Therapeutics BLA for Lenmeldy (atidarsagene autotemcel), a one-time, single-dose gene therapy indicated for treating children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD), a rare genetic disease affecting the brain and nervous system. “It
Drugs
Sleepnet has recalled its CPAP and BIPAP sleep apnea masks with magnets due to potential interference with certain medical devices. “When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or the position of the implant, potentially resulting in serious
Drugs
FDA has completed a pre-license inspection of Abeona’s Cleveland, OH manufacturing facility concerning the company’s BLA for pz-cel (prademagene zamikeracel) for treating recessive dystrophic epidermolysis bullosa (RDEB). The firm was issued a Form 483 that cited observations related to process controls. “During the inspection, the FDA
FDA Policy/General
FDA has posted a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.” The document says that a minimum of three primary batches of drug product should be manufactured under current good manufacturing practice to support application approvals, noting that the batches should be of
FDA Policy/General
Federal Register notice: FDA is correcting a date in a 3/12 notice announcing the availability of a guidance entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” The date on pages 17850 through 17851 is being corrected from “5/13/2024” to “6/10/2024.” To view the notice,
Drugs
FDA has granted Biotronik a beakthrough device designation for the Freesolve below-the-knee (BTK) resorbable magnesium scaffold, intended for use in individuals suffering from chronic limb-threatening ischemia, which the company describes as the most severe form of peripheral arterial disease. The device relies on the design of the
Drugs
FDA has launched a new Web page to highlight how the agency uses inspections to help ensure drug safety and quality. “In order to efficiently share relevant information about inspections for human drugs and make it more accessible, FDA is bringing certain data together on a single public Web page,