Drugs
FDA has posted a draft guidance entitled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” The document addresses the agency’s recent requirement that sponsors of an accelerated-approval drug/biologic must have their confirmatory trial underway at the time of approval. The requirement was mandated
Devices
FDA has cleared an Inogen 510(k) for the Simeox 200 Airway Clearance Device, which is intended to promote and improve bronchial drainage by enhancing mobilization of bronchial secretions using high-frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The prescription device is for use in
Drugs
FDA has issued a draft guidance entitled “Considerations for Including Tissue Biopsies in Clinical Trials” that provides considerations for tissue biopsies in adults and children as part of clinical trials that evaluate investigational medical products. “Tissue biopsies in clinical trials are often needed to determine eligibility or to understand the
Drugs
FDA has issued a draft guidance entitled “Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products.” An agency release says FDA has substantial experience in reviewing regulatory submissions with AI components, and they continue to exponentially increase. “AI can be used
Drugs
Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder (MDD) has “disappointing” results. The study did not show a statistically significant improvement regarding the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Week 6 or
Drugs
CDER approved 50 novel products in 2024, which was five (9%) less than the 55 products approved in 2023 and well above the 10-year rolling average of almost 46 approvals. Oncology approvals remained the top therapeutic category last year, with 15 (30%) novel approvals, according to the journal Nature.
Drugs
FDA has given accelerated approval to Array BioPharma’s Braftovi (encorafenib) with cetuximab (Lilly’s Erbitux) and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation as detected by an FDA-approved test. Array is a Pfizer subsidiary. An agency statement says efficacy was evaluated in the
Drugs
FDA says Alcon Laboratories issued a nationwide recall of one lot of its Systane Lubricant Eye Drops Ultra PF Single Vials On-The-Go 25 count, due to fungal contamination. An agency statement says the company evaluated a consumer complaint of foreign material observed inside a single-use vial and
Drugs
FDA has approved Galderma’s Nemluvio (nemolizumab) for a new indication to treat patients aged 12 and older with moderate to severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. In 8/2024, the agency approved
Devices
A 7/22-7/25/2024 FDA inspection at Rontis Hellas SA in Larissa, Thessaloniki, Greece, found Quality System and Medical Device Reporting (MDR) regulation issues in the firm’s manufacturing of the Cronus HP PTA OTW balloon catheter. A recently-released 10/28/2024 Warning Letter says the specific
Drugs
FDA has approved Bristol Myers Squibb’s Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo) indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Bristol Myers Squibb’s Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or carbozantinib (Exelixis’ Cabometyx)
Drugs
FDA has approved Novo Nordisk’s Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients ages 12 and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. An agency statement says Alhemo is
Drugs
FDA has approved a new indication for Lilly’s Zepbound (tirzepatide) to treat moderate to severe obstructive sleep apnea in adults with obesity when used in combination with a reduced-calorie diet and increased physical activity. An agency statement says the approval for this indication was based on results from
Drugs
FDA says Astellas Pharma has recalled one lot of Prograf 0.5 mg (tacrolimus) and one lot of Astagraf XL 0.5 mg (tacrolimus extended-release capsules) because some bottles shipped to the U.S. may contain empty capsules. The company said transplant patients who consume empty Prograf or Astagraf
Drugs
A 7/22-7/26/2024 FDA inspection at the Bhargava Phytolab Private Limited drug manufacturing facility in Bhiwadi, Rajasthan, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and significant deviations from CGMP for active pharmaceutical ingredients (APIs). A 12/18/2024 Warning Letter
Drugs
FDA has published a Federal Register notice to encourage companies to submit sNDAs to modify the labeling statements for buprenorphine-containing transmucosal products indicated to treat opioid dependence (BTODs). An agency statement (contains a link to the Federal Register notice) says the agency has received feedback from multiple interested parties
Drugs
FDA has approved Neurocrine Bioscience’s Crenessity (crinecerfont) to be used with glucocorticoids to control androgen in adults and pediatric patients aged 4 and older with classic congenital adrenal hyperplasia (CAH). An agency statement says the Crenessity approval was based on two trials in 182 adults and 103 children with
Drugs
FDA says Endo USA has recalled all lots within expiry of its Adrenalin Chloride Solution (EPINEPHrine nasal solution) 30mg/30mL. An agency notice says the product pre-dates the 1938 Federal Food, Drug, and Cosmetic Act and was never submitted for FDA approval. Thus, it is legally considered to be
Drugs
FDA has sent Warning Letters to Xcel Peptides, Swisschems, Summit Research, and Prime Peptides for introducing unapproved semaglutide (Nova Nordisk’s Ozempic and Wegovy), tirzepatide (Lilly’s Zepbound), and/or retatrutide (experimental Lilly drug) products into interstate commerce. The agency said its review of the companies’ Web sites and social
Devices
FDA has published an updated guidance, Global Unique Device Identification Database (GUDID), reflecting upcoming changes in the Global Medical Device Nomenclature field in GUDID and other minor clarifications. The document says database enhancements to improve user experience, build in better validation rules, and other changes may continue as the agency
Drugs
FDA has approved Hikma Pharmaceuticals USA’s generic glucagon-like peptide-1 receptor agonist that references Novo Nordisk’s Victoza (liraglutide injection) 18 milligram/3 milliliter. An agency statement says the drug is indicated to improve glycemic control in adults and pediatric patients aged 10 and older with Type 2
Drugs
FDA has approved an expanded indication for Rhythm Pharmaceuticals’ Imcivree (setmelanotide) to include children as young as age 2. A company statement says Imcivree is indicated to reduce excess body weight and Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1)