Drugs
Amgen says it will file a BLA supplement by 6/30 for Uplizna (inebilizumab-cdon) to expand its use to treat adults living with generalized myasthenia gravis (gMG). The submission will be based on just-reported data from the Phase 3 MINT trial, demonstrating “durable and sustained efficacy of Uplizna
Drugs
An 8/19-8/21/2024 FDA inspection at Chemspec Chemicals Private Limited in Navi Mumbai, Maharashtra, India, found a deviation from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 2/5 Notice of Violation says the specific deviation was the failure of the
Drugs
FDA says manufacturers are recalling specific lots of seven acne products after agency testing on 95 products containing benzoyl peroxide indicated possible benzene contamination. “More than 90% of products tested had undetectable or extremely low levels of benzene,” an agency notice says. The notice indicates the agency initiated independent testing
Drugs
Merck is announcing “positive results” from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir (DOR/ISL (100mg/0.25mg) in certain adults with HIV-1 infection that is virologically suppressed. It says an NDA will be submitted to FDA by mid-
Drugs
A 9/4-9/12/2024 FDA inspection at the Shree Jaya Laboratories drug manufacturing facility in Yadadri Bhuvanagiri District, Telangana, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 2/28 Warning Letter says the specific deviations were: * failure to clean equipment
Drugs
Pfizer and Arvinas are announcing mixed “positive topline results” from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer. The study is designed to assess patients
Drugs
FDA says it is rejecting all study data from all studies conducted at Mid-Link Technology Testing Co. in Tianjin, China, until the firm demonstrates that the issues described in the agency’s 12/30/2024 general correspondence letter (GCL) have been adequately addressed. The agency announced the move in
Drugs
FDA has sent Warning Letters to six companies responsible for introducing unapproved fat-dissolving injectable drug products into interstate commerce. The letters were sent to Amazon.com, Fox Pharma, Filler Lux USA, Hyaluron Pen Store (Glow Nest Beauty), Julian Naya Beauty, and Vivid Scientific. The companies were told to respond
Drugs
FDA has accepted for review a Sydnexis NDA for SYD-101 (topical low-dose atropine) for treating progression of pediatric myopia. The agency has set a user fee review action date of 10/23. The submission is based on three-year primary and secondary endpoints from the STAR Study, showing
Drugs
CDRH is losing its top science official — chief scientist and deputy Center director Doug Kelly. In a recent Linkedin post announcing his abrupt departure, Kelly said he is departing FDA to write a “new chapter.” He bravely joined FDA in 2020 after taking a break from his 30-year career
Drugs
Mineralys Therapeutics has announced “positive topline data” from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials assessing lorundrostat’s efficacy and safety for treating uncontrolled or resistant hypertension. “Both trials successfully achieved statistical significance and were clinically meaningful in their pre-specified primary efficacy endpoints
Drugs
FDA is clarifying its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Texas that denied a preliminary injunction sought by the Outsourcing Facilities Association to allow continued compounding of the products. Regarding tirzepatide (Lilly’s Zepbound and Mounjaro), the agency
Drugs
It appears that FDA has belatedly inspected India’s Glenmark Pharmaceuticals after a recent ProPublica investigative report found that the agency hadn’t shifted any attention to the firm’s Madhya Pradesh facility despite several recalls for pills that don’t dissolve properly. The report focused on a 5/2024
Drugs
Fresenius Kabi USA has recalled its Ivenix LVP software, embedded in its Ivenix Infusion System, due to anomalies associated with software versions 5.9.2 and earlier. The anomalies have the potential to cause serious patient harm or death, a recall notice says. For example, if during an alarm mode
Drugs
FDA has denied a Vanda Pharmaceuticals request for a hearing on the agency’s proposed refusal to approve the company’s sNDA for Hetlioz (tasimelteon) to treat insomnia characterized by difficulties with sleep initiation. The FDA 2/26 decision, signed by acting commissioner and principal deputy commissioner Sara Brenner, says
Drugs
FDA has approved a scPharmaceuticals supplemental NDA for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patients with chronic kidney disease. Previously, Furoscix was approved for treating edema (i.e., congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure. The company says
Drugs
Participants at a 5/2-5/3/2024 public discussion hosted by FDA and the Center for Research on Complex Generics on “Pathways for Regulatory Acceptance of Dynamic Tools in the New Drug Space” found that model-based approaches like physiologically-based pharmacokinetics and population pharmacokinetics, when validated for their
Drugs
FDA has granted orphan drug designation for Faron Pharmaceuticals’ lead candidate bexmarilimab to treat myelodysplastic syndrome. A company announcement says bexmarilimab is an investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes by targeting myeloid cell function and igniting the immune system. It is said to
Drugs
FDA has approved an ARS Pharmaceuticals supplemental NDA for Neffy (epinephrine nasal spray 1mg) for treating Type I allergic reactions, including anaphylaxis, in children who are aged four years and older and weigh 15 to 30 kg. Previously, the product was approved for adult and pediatric patients who weigh at
Drugs
An 8/26-9/6/2024 FDA inspection at the Granules India Limited drug manufacturing facility in Gagillapur Village, Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/26 Warning Letter says the specific violations were: * failure to establish and follow adequate
Drugs
FDA has accepted for review a Corcept Therapeutics NDA for its selective cortisol modulator relacorilant and its use in treating patients with endogenous hypercortisolism (Cushing’s syndrome). The agency has set a 12/30 user fee review action target date. The submission is based on data from the company’s
Drugs
Lexicon Pharmaceuticals says it will advance pain drug pilavapadin 10mg into a planned Phase 3 trial based on just-announced Phase 2 PROGRESS study results. The oral, non-opioid investigational adaptor-associated kinase 1 inhibitor is being evaluated in adult patients with moderate to severe diabetic peripheral neuropathic pain. “In