Drugs
SpringWorks Therapeutics says it will file an NDA in the first half of 2024 for mirdametinib, an investigational MEK inhibitor, indicated for use in pediatric and adult patients with neurofibromatosis Type 1-associated plexiform neurofibromas. The company says its move follows just-announced “positive topline results” from the pivotal Phase
Drugs
After 37 years at FDA, second-in-command and principal deputy commissioner Janet Woodcock is retiring early next year. In confirming her departure, FDA commissioner Robert Califf called her a legend for making an “indelible mark on so many of us, and on public health.” Califf said that while no
Devices
A Mitre Corp. report, “Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks,” prepared under a contract with FDA, makes recommendations for protecting legacy medical devices that “cannot be reasonably protected against current cybersecurity threats.” The report says that because of the long lifetimes of medical devices and the lack
Drugs
FDA has approved a Bristol Myers Squibb NDA for Augtyro (repotrectinib) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. The tyrosine kinase inhibitor (TKI) works by targeting ROS1 oncogenic fusions, according to the company. The approval is based on data from the
Drugs
FDA has launched a Web page devoted to its efforts to research and promote alternative methods for product testing. The page says alternative methods “have the potential to provide more timely and more predictive information to assess certain aspects of FDA-regulated products while also replacing, reducing, and/or refining
Drugs
FDA says its review of records submitted by Saruhan Kimya Va Temizlik Urunieri Sanayi Ticaret Anonim Sirketi Corlu Subesi, an over-the-counter drug manufacturer in Tekirdag, Turkey, in response to three FDA requests, found significant violations of current good manufacturing practice (CGMP) regulations. An 11/6 Warning Letter says
Drugs
FDA has granted SIRPant Immunotherapeutics an orphan drug designation for SIRPant-M, an autologous macrophage therapy for treating T-cell lymphoma. “Unlike B-cell lymphomas and classical Hodgkin Lymphoma, many T-cell lymphoma subtypes do not have a suitable drug target, and approved cellular immuno-therapy is currently unavailable in
Drugs
FDA reviewers say that making an assessment on the clinical meaning of “complicated” data presentations in a Merck NDA resubmission for chronic cough medicine gefapixant is a challenge and will be submitted to an 11/17 Pulmonary-Allergy Drugs Advisory Committee meeting for discussion. An earlier NDA was issued an
Drugs
FDA has approved CorMedix’s Defencath (taurolidine and heparin) catheter lock drug to reduce catheter-related bloodstream infections in adult patients with kidney failure who are receiving chronic hemodialysis through a central venous catheter. The agency says it is the third drug approved under the Limited Population Pathway for Antibacterial
Drugs
FDA commissioner Robert Califf says “the time is right” to address the post-market evidence generation recommendations in a new Reagan-Udall Foundation report. In the prepared text of a speech to be given to an unidentified group, Califf says the post-market questions “stretch beyond the direct purview of
Devices
Baxter Healthcare has recalled (Class 1) its Novum IQ Syringe Infusion Pump because the device may indicate an infusion is complete when it is not. The problem has been identified as a software error that may “miscalculate volume after the pump detects a blockage (occlusion),” according to a recall notice.
Drugs
FDA says the Arizona federal court has entered a consent decree of permanent injunction ordering Smart Women’s Choice and its CEO, Jennifer Richard, to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic Act and meets other requirements in the decree. According to a
Devices
Israel’s IceCure Medical says it is appealing FDA’s denial of the company’s de novo classification request for its ProSense system to treat patients with early-stage, low-risk breast cancer. A company statement says the ProSense is a minimally invasive cryoablation technology that destroys tumors by freezing
Drugs
Ascendis Pharma has resubmitted an NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism. In May, FDA issued a complete response letter on the original NDA, citing manufacturing control strategy concerns related to the variability of the delivered dose in the drug/device combination product, according to the company.
Devices
A 3/6-3/10 FDA inspection at Ming Fai Industrial Co in Guangdong Sheng, China, found Quality System regulation violations in the firm’s manufacturing of ultrasound gel and probe cover products. A just-released 6/1 Warning Letter says the specific violations were: * failing to adequately ensure that
Drugs
A 2/20-3/2 FDA inspection at Global Pharma Healthcare in Tamil Nadu, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/19 Warning Letter says the firm’s drug products are adulterated because they were “prepared, packed, or held
Drugs
Bayer is withdrawing its NDA for Aliqopa (copanlisib) for adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. The decision follows discussions with FDA about a failed confirmatory study that was required to confirm the therapy’s clinical benefit, according to the company. Aliqopa
FDA Policy/General
Federal Register notice: FDA is renewing the Nonprescription Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 8/27/2025. To view the notice, click here.
Devices
Former Becton Dickinson (BD) medical director Hooman Noorchashm has petitioned FDA to warn patients about the “unknown and inadequately studied effect” of FDA-regulated mesh products being implanted off-label in cosmetic mastopexy operations on the sensitivity of standard surveillance mammography and ultrasound for detection of breast cancer. Cardiac surgeon
Drugs
FDA is asking the Oncologic Drugs Advisory Committee (ODAC) to consider at its 11/16 meeting the lengthy delays Acrotech Biopharma is experiencing in completing confirmatory post-marketing requirement trials for its Folotyn (pralatrexate) and Beleodaq (belinostat). An agency briefing document circulated before the meeting says the drugs were granted
Devices
Cardinal Health is recalling its latest version (6/2023) of its Monoject syringes branded as “Cardinal Health Monoject syringes” because their dimensions differ from the previously branded syringes and they may be incompatible with syringe infusion pumps. “The dimensional changes made to the affected Cardinal Health Monoject syringes when used
Biologics
Pharmaceutical Research and Manufacturers of America says it backs the overall aim of an FDA draft guidance to support a “lifecycle approach” to management and reporting of manufacturing changes for human cellular and gene therapy (CGT) products. The trade association’s comment letter gives its perspective on CGT lifecycle management