Biologics
FDA has granted full approval to Amgen’s previously accelerated-approved BLA for Blincyto (blinatumomab) for treating adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
Drugs
FDA has approved Boehringer Ingelheim’s Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as treatments, in addition to diet and exercise, for improving blood sugar control in children 10 years and older with Type 2 diabetes. Empagliflozin works by increasing glucose excretion in the urine, according to an FDA
Drugs
Twenty-five bipartisan House representatives are urging FDA to create patient-centered policies on compounded hormones that maintain patients’ access to care and treatment options. In a 6/20 letter to FDA commissioner Robert Califf, the lawmakers said they were concerned that recommendations in a 2020 National Academies of Sciences,
Drugs
FDA has launched a voluntary pilot program to help cut risks in using laboratory-developed tests (LDTs) to identify cancer biomarkers. An online statement says the agency has become increasingly concerned that some tests made by laboratories and not authorized by FDA may not provide accurate and reliable test results
Drugs
FDA has issued F2G Ltd. a complete response letter on its NDA for olorofim, an antifungal for invasive fungal infections in patients who have limited or no treatment options. The letter requested additional data and analyses before it can approve the submission, according to the company. “The FDA encouraged the
Devices
A 1/24-1/31 FDA inspection at Vitang Technology in Tustin, CA, determined that the firm is marketing the misbranded and adulterated UniSmile Clear Aligner, a Class 2 dental aligner that was cleared under a 510(k). A 6/12 Warning Letter says the medical device is misbranded because
Drugs
FDA has placed a clinical hold on Arcellx’s CART-ddBCMA, an investigational drug for treating patients with relapsed or refractory multiple myeloma, following a recent patient death. The company believes “limitations on bridging therapy are a contributing factor and is working with FDA to amend the protocol to expand
FDA Policy/General
Federal Register notice: FDA has announced a meeting of the Medical Devices Advisory Committee’s Circulatory System Devices Panel on 8/22/23. On 8/22, members will discuss and vote on a ReCor PMA for its Paradise Ultrasound Renal Denervation System, indicated for reducing blood pressure in adult patients
Drugs
University of Pennsylvania Perelman School of Medicine professor of medicine, medical ethics and health policy, and neurology Jason Karlawish says FDA should require a Risk Evaluation and Mitigation Strategy (REMS) for new Alzheimer’s disease drugs to mitigate the concern of Alzheimer’s clinicians that some patients will be needlessly
Drugs
FDA has granted in part and denied in part a 10/17/2012 Boehringer Ingelheim (BI) petition asking that the agency adopt certain requirements for proposed generic and follow-on versions of Boehringer’s Spiriva Handihaler or any other BI orally inhaled product containing the active ingredient tiotropium bromide. The
Drugs
The International Council for Harmonization (ICH) Assembly approved three new topics for harmonization at its 6/12-6/13 meeting in Vancouver, Canada. The topics are general considerations for patient preference studies, nonclinical safety studies for oligonucleotide-based therapeutics, and bioequivalence for modified-release products. An ICH statement says the
Drugs
FDA has extended by three months an ARS Pharmaceuticals NDA for neffy (intranasal epinephrine) for treating allergic reactions (Type 1), including anaphylaxis, for adults and children. The revised user fee review action target date is 9/19. Shortly after a favorable 5/11 vote (see story) by FDA’s Pulmonary-
Devices
FDA has approved Surmodics’ SurVeil drug-coated balloon (DCB) and its use in percutaneous transluminal angioplasty. The device is intended to be used for treating de novo or restenotic lesions (less than 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm to 7
Drugs
FDA says the number of surveillance inspections of human drug manufacturing sites tripled from FY 2021 to FY 2022. The agency’s FY 2022 Report on the State of Pharmaceutical Quality says CDER’s site catalog lists over 4,800 manufacturing sites, with over 40% in the U.S. While
Drugs
Senators Gary Peters (D-MI) and Joni Ernst (R-IA) have introduced bipartisan legislation to ensure the government is better prepared to address the national security threat posed by overreliance on foreign sources for critical medications. The legislation responds to two reports released by Peters in 2019 and2023 that identified
Drugs
FDA has approved a Pfizer NDA for Talzenna (talazoparib) with Astellas’ Xtandi (enzalutamide) for treating homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). Approval was based on data from the TALAPRO-2 (NCT03395197) 399-patient study whose major efficacy outcome measure was radiographic progression-free survival
FDA Policy/General
FDA has posted a CVM guidance entitled “#171 Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media.” The document discusses how CVM intends to evaluate requests for waiving the requirement for performing in vivo
Biologics
FDA has granted Genentech accelerated approval for its BLA for Columvi (glofitamab-gxbm) and its use in treating adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of
Drugs
FDA has approved a Bristol Myers Squibb supplemental NDA to add positive data from its Phase 3 VALOR-HCM study to the U.S. prescribing information for Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules). Data added to the label showed that Camzyos significantly reduced the
Biologics
One day after an FDA advisory committee voted 21 to 0 (see story) to recommend that the Covid-19 vaccination program for the 2023-2024 season should contain a monovalent vaccine comprising the XBB-lineage variant, the agency posted a notice that adhered to the panel recommendation. The 6/16
Drugs
The Harvard Drug Group is recalling a single lot of dronabinol capsules (2.5 mg) and ziprasidone hydrochloride capsules (20 mg) after receiving a customer complaint from a distributor suggesting that some unit dose cartons labeled as ziprasidone were found to contain blister packages labeled as and containing dronabinol. Patients
Drugs
FDA has extended by three months its review of a GSK NDA for momelotinib, indicated for treating myelofibrosis patients with anemia, to allow more time to review recently submitted data. The revised user fee review action target date is 9/16. GSK says momelotinib has a novel mechanism of action,