Devices
A 1/20-1/23 FDA inspection at Aju Pharm Co. Ltd. in Seongnam-Si, Gyeonggi, South Korea, found Quality System (QS) and Medical Device Reporting (MDR) violations in the company’s manufacturing of the Class 2 Fixone Hybrid Knotless Anchor and the Class 2 Fixone Biocomposite Anchor. A just-
Biologics
FDA has told Capricor Therapeutics that its ongoing BLA review of Deramiocel, the company’s lead cell therapy candidate for treating Duchenne Muscular Dystrophy (DMD)-associated cardiomyopathy, has not necessitated an advisory committee meeting before its user fee review action target date of 8/31. “We remain confident in the
Drugs
CDER acting director Jacqueline Corrigan-Curay has decided to retire and will leave her post next month. After almost nine years at the agency, Corrigan-Curay said in an email to staff that her “incredibly challenging” decision was made more difficult by the fondness she has developed for advancing public
Devices
GE HealthCare is recalling (Class 1 device correction) certain Carestation anesthesia devices due to the risk that they may not provide effective ventilation when used in volume control ventilation mode. “If this issue occurs, it will be apparent to the user through observation and multiple alarms,” a recall notice says.
Drugs
New data from a Phase 2 study on Eli Lilly’s experimental bimagrumab showed that when combined with Novo Nordisk's Wegovy (semaglutide) it led to preservation of muscle mass while achieving significant weight loss. The data were presented 6/23 at an American Diabetes Association scientific session in
Drugs
Medline Industries is recalling (Class 1 device correction) certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to a potential safety risk that could result in serious adverse health outcomes, including stroke or death. The cannulas, a critical component used during heart surgeries involving
Drugs
FDA has released an International Council for Harmonization (ICH) draft guideline entitled “Stability Testing of Drug Substances and Drug Products Q1.” The document outlines stability data expectations for drug substances and drug products, and includes recommendations on how science- and risk-based principles may be applied. It notes that principles
Drugs
A new study is contradicting previous assumptions about the relationship between regulatory scrutiny and drug shortages in the U.S. pharmaceutical supply chain. Researchers from the University of Illinois’ Gies College of Business have found that GMP deficiencies cited in FDA inspections are associated with fewer future drug shortages, not
Drugs
FDA has approved a Daiichi Sankyo BLA for Datroway (datopotamab deruxtecan-dlnk) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy. The drug was granted accelerated approval based on data
Drugs
FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP), which the companies say is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. Approval is based on data from the pivotal ADEPT Phase 2/3 study
Drugs
FDA has approved Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed or refractory follicular lymphoma (FL). Approval is based on data from the inMIND clinical trial, a double-blind, placebo-controlled study involving 548 patients with relapsed or refractory FL, according to
Devices
FDA has cleared a DeepEcho 510(k) for its artificial intelligence (AI)-based fetal ultrasound analysis platform. The device “leverages advanced deep learning algorithms to automate real-time identification of fetal ultrasound views, providing healthcare professionals with enhanced diagnostic accuracy and efficiency,” the company says. The device’s technology is
Drugs
FDA has approved a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU), an ultra-rare genetic metabolic disorder in which patients have a buildup of HGA that leads to osteoarthritis, ochronosis, and complications in the kidneys and heart. Approval
Devices
The issuance by FDA of two Warning Letters to manufacturers of diagnostic products labeled for research use only (RUO) within three months may be a coincidence or may signal a new FDA enforcement emphasis. That’s the view of attorneys Dominick DiSabatino and Audrey Mercer (SheppardMullin) in their firm’s
Biologics
FDA says it is halting and will review new clinical trials that involve sending American citizens’ living cells to “China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients, sometimes without their knowledge or consent.” An agency statement says it took action due to
Biologics
CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol, have been pushed out of the Center and placed on administrative leave in the latest shake-up at FDA. An HHS spokesperson hinted that the move was orchestrated by CBER director Vinay Prasad, telling FDA Webview that
FDA Policy/General
FDA has published a report, Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing, describing the agency’s efforts to address cybersecurity issues affecting medical product manufacturers through the development of a demonstration manufacturing line. “If the cybersecurity of manufacturers or other supply chain participants is compromised, it
Drugs
Bavarian Nordic says it has entered into an agreement with an undisclosed buyer to sell for $160 million a priority review voucher that was awarded for gaining approval of its chikungunya vaccine Vimkunya (see earlier story). Under a license agreement when the company acquired the rights to the vaccine in
Drugs
A Texas federal judge has upheld FDA’s action in removing Novo Nordisk’s Ozempic and Wegovy (both semaglutide) from its drug shortage list. CNBC reports the decision is a blow to compounding pharmacies that had been allowed to produce hundreds of thousands of doses of copies of the obesity
Biologics
Former FDA commissioner Scott Gottlieb expects FDA will reevaluate Sarepta’s approval of Duchenne muscular dystrophy (DMD) gene therapy Elevidys based on two recent patient deaths (see story) and the past controversial nature of former CBER head Peter Marks review interference in 2024 (see earlier story). Marks overrode his then-
FDA Policy/General
FDA Webview is closed and will not be publishing on 6/19 in recognition of the U.S. federal holiday, Juneteenth. We will resume our newsroom activities on 6/20, and our next evening email distribution will go out that evening.
Drugs
FDA is warning that Baxter Healthcare’s antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death. An agency safety alert says that most cases occurred in children 17 years and younger and in adults 60 years and