FDA Policy/General
President Donald J. Trump and his HHS secretary, Robert F. Kennedy, Jr., reportedly are considering ways to make it more expensive for drug companies to use direct-to-consumer (DTC) advertising. Bloomberg News reports they are considering not allowing companies to deduct their DTC ads as a business expense. They
Drugs
FDA has approved Gilead’s Yeztugo (lenacapair), an injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis to reduce the risk of sexually acquired HIV in some adults and adolescents. A company statement says Yeztugo is the only twice-yearly option available in the U.S. for people who need
Drugs
FDA has published a guidance, Post-Warning Letter Meetings Under GDUFA, with information on the implementation of the post-Warning Letter meeting process for certain facilities as covered in the GDUFA 3 commitment letter. The document says a post-Warning Letter meeting is a meeting with FDA about the facility’
Biologics
Rep. Frank Pallone (D-NJ), the top Democrat on the House Energy and Commerce Committee, is calling on the committee to open a bipartisan investigation into HHS secretary Robert F. Kennedy, Jr.’s “recent efforts to disrupt and restrict people’s access to vaccines.” In a letter to committee chairman
Biologics
CBER director Vinay Prasad has been given additional duties as FDA’s chief medical and scientific officer, a new combination role for commissioner Marty Makary’s closest advisor. “In this capacity, he will serve as a trusted advisor to the FDA commissioner and other senior officials on cross-cutting and
Drugs
FDA says it is launching the Commissioner’s National Priority Voucher (CNPV) program under which drug developers may redeem vouchers to participate in an agency program that shortens the review time from about 10-12 months to 1-2 months following submission of a final drug application. An FDA notice
Drugs
Aldeyra Therapeutics has resubmitted an NDA for reproxalap to treat the signs and symptoms of dry eye disease. The submission addresses an agency complete response letter sent in April that said the NDA “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry
Drugs
A 1/16-1/24 FDA inspection at Zhejiang Huahai Pharmaceutical Co., Ltd., in Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/6 Warning Letter says the specific violations were: * failure to clean, maintain, and, as appropriate for the nature
Drugs
The HHS Office of Inspector General (OIG) semiannual report covering the period 10/1/2024 to 3/31 says the OIG concluded that FDA’s use of its accelerated approval pathway raised concerns in three of 24 drugs reviewed. The report says OIG identified instances in which FDA (1) approved
Drugs
A ProPublica investigative report cites at least 20 instances in which FDA identified significant problems at drug manufacturing firms in India, imposed import bans on the firm’s products, and then secretly allowed the companies to continue to ship drugs to the U.S. Focusing initially on Sun Pharma, the
Devices
A 10/29-12/20/2024 inspection at Reset Technology Corp. in Irving, TX, identified multiple violations in the firm’s manufacturing of the ResetSmile partial denture device and ResetSmile impression kit device. A 6/9 Warning Letter says specific Quality System Regulation violations were: * failure to ensure that when
Drugs
Sarepta Therapeutics says it has stopped shipping its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to non‑ambulatory Duchenne muscular dystrophy (DMD) patients and paused dosing in a key confirmatory trial after a second recipient died from acute liver failure. Both fatal cases involved non‑ambulatory individuals with DMD, the company
Drugs
A 12/5-12/11/2024 FDA inspection at the Kenil Healthcare Private Limited drug manufacturing facility in Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/12 Warning Letter says the specific violations were: * failure to clean, maintain, and, as appropriate
Drugs
FDA has approved updated labeling on Pfizer’s s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with metastatic castration-resistant prostate cancer (mCRPC). “The FDA approved updated labeling with the inclusion of final overall survival (OS) data for the combination’s existing indication for the treatment of adults
Drugs
Roche says it is moving its Parkinson’s drug prasinezumab into a Phase 3 trial after two mid‑stage trials and their open‑label extensions hinted at a disease‑slowing effect in early‑stage disease. Prasinezumab, a monoclonal antibody, is designed to target aggregated alpha-synuclein. A 2022 Phase 2
Drugs
Milestone Pharmaceuticals has submitted its response to a March-issued FDA complete response letter on the company’s NDA for Cardamyst (etripamil) nasal spray and its use to convert acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. PSVT is described as a sudden, rapid, and irregular
Devices
Zyno Medical has recalled certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps because they were released to customers with incorrect software versions that had not undergone required verification and validation testing. “As a result, these pumps can experience unexpected performance problems, including issues with essential functions
Drugs
Compliance and product testing firm Qalitex Laboratories has issued a warning to dietary supplement and wellness product sellers on Amazon, highlighting a growing overlap between FDA’s enforcement and Amazon’s compliance policies. The industry advisory outlines how Amazon has increasingly aligned its internal compliance standards with FDA regulations — a
Drugs
AbbVie says its Phase 3 VERONA clinical trial evaluating venetoclax in combination with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of extending overall survival. The trial showed a hazard ratio of 0.908 and a p-value of 0.3772, indicating
Drugs
Incyte is reporting the first clinical data from two studies evaluating the safety, tolerability and efficacy of INCA033989, a novel, first-in-class targeted monoclonal antibody in patients with mutant calreticulin (mutCALR)-expressing myeloproliferative neoplasms (MPNs). The studies evaluated the safety and efficacy of INCA033989 in patients with essential thrombocythemia
FDA Policy/General
FDA has granted Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis (MF). Nuvisertib is described as an oral, investigational, highly selective inhibitor of PIM1 kinase. Sumitomo says it has demonstrated clinical activity including symptom and spleen responses correlating with
Devices
Nipro has recalled (Class 1) its MedicaLyte liquid bicarbonate concentrate after receiving reports about “visual irregularities in some product jugs,” according to a recall notice. “Returned units were sent to a third-party laboratory for analysis, where bacterial and fungal particles were identified,” it says, adding that risks associated with