Drugs
FDA has accepted for priority review an Applied Therapeutics NDA for AT-007 (govorestat) for treating classic Galactosemia. Govorestat is described as a central nervous system penetrant aldose reductase inhibitor. The agency has set a user fee review action target date of 8/28. Galactosemia is a rare genetic metabolic
Drugs
An 8/7-8/15/2023 FDA inspection at the Amman Pharmaceutical Industries drug manufacturing facility in Amman, Jordan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/14 Warning Letter says specific violations were: * failing to perform operations within specifically defined areas of
Drugs
FDA says its testing of samples of LightEyez MSM eye drugs obtained through the company’s Web site found that the product is adulterated because “it consists in whole or in part of any filthy, putrid, or decomposed substance.” A 2/15 Warning Letter says the company is headquartered in
Drugs
FDA says it inspected Delsam Pharma in Mamaroneck, NY, and EzriCare in Lakewood, NJ, after an agency inspection revealed violative conditions at Global Pharma Healthcare Private Limited, a contract manufacturing organization used to manufacture ophthalmic drugs for Delsam and EzriCare. FDA issued 2/13 Warning Letters to Delsam and EzriCare
Drugs
FDA has denied a 12/2/2020 Boehringer Ingelheim petition asking that the agency: * interpret the term “strength” in a section of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) relating to parenteral solutions to mean the total drug content in the relevant container; and * revise applicable guidance
Drugs
FDA has released a final guidance entitled “Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.” The document is intended to assist registrants of drug establishments in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by
Drugs
FDA country director (India) Sarah McMullen says the agency will increase the number of inspections at Indian drug manufacturing facilities in 2024. Speaking with Reuters, McMullen said there were more than 200 inspections in the country in 2023, up from a lull in unannounced inspections during the pandemic. “We are
Drugs
Viking Therapeutics says its Phase 2 clinical trial of VK2735, a dual agonist of glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptor for treating obesity, met its primary endpoint and all secondary endpoints. Patients treated with VK2735 had significant reductions in body weight compared with placebo, the company
Drugs
An FDA analysis of the first decade of the rare pediatric disease priority review voucher program establishes that a wide range of diseases have seen development, from rare pediatric cancers to rare genetic disorders. “Continued support of product development for children with rare diseases is needed to find treatments for
Drugs
FDA has issued Minerva Neurosciences a complete response letter on its NDA for roluperidone, indicated for treating negative symptoms in patients with schizophrenia, recommending another clinical study to demonstrate the drug’s safety and effectiveness. The company says the agency letter cited the submission’s study (MIN-101C03) as being
Drugs
Milestone Pharmaceuticals says it will resubmit an NDA in the second quarter for etripamil nasal spray, a novel calcium channel blocker for treating paroxysmal supraventricular tachycardia (PSVT). The filing will address issues raised in a 12/2023 FDA refuse-to-file action that found the NDA was not sufficiently complete
Drugs
Boehringer Ingelheim says data from its recent Phase 2 survodutide study showed that up to 83.0% of adults treated with the drug achieved a statistically significant improvement of the chronic liver disease metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%). “The trial met its primary endpoint with survodutide
Drugs
FDA has created a new CARES Act Amount Information Reporting application for drug establishments (or their authorized agents) to use when submitting annual reports of the amount of listed drugs and biological products produced. If establishments have already submitted their required report for calendar year 2023 using the previous version
Drugs
FDA has denied an Oncopeptides appeal seeking to stop a CBER request for the company to voluntarily withdraw its accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide). This looks to be one of the first tests of the modified authority FDA was granted in 2022 under the Food and Drug
Drugs
New York attorney general Letitia James is urging FDA to take further safety actions to address the “dangers” of Merck’s asthma and allergic rhinitis drug Singilair (montelukast) and generics, particularly for minor children. Despite FDA four years ago approving a new Boxed Warning for Singulair (see story), “the prevalence
Drugs
BrainStorm Cell Therapeutics has submitted a Special Protocol Assessment request for a Phase 3b study of NurOwn, its investigational treatment for amyotrophic lateral sclerosis (ALS). The submission follows an in-person meeting that BrainStorm held with the FDA in December after the company withdrew its BLA for NurOwn, a move
Drugs
FDA has accepted for priority review a Sanofi and Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The agency has set a 6/27 user fee review action target date. The companies say the submission
Drugs
FDA has issued Venatorx Pharmaceuticals and Melinta Therapeutics a complete response letter on their NDA for cefepime-taniborbactam, a beta-lactam/beta-lactamase inhibitor for treating adult patients with complicated urinary tract infections, including acute pyelonephritis caused by susceptible gram-negative microorganisms. The companies say the letter requested additional “chemistry,
Drugs
The CDER Office of Generic Drugs (OGD) approved or tentatively approved 956 generic drug applications in 2023. The OGD 2023 Annual Report says there were 90 first generic medicines approved. It notes that first generics “provide access where no generic competition previously existed [and] because of their importance to public
Drugs
Hogan Lovells attorneys Lowell Zeta and Blake Wilson say actions that FDA will and will not take this year will vary in part because this is a presidential election year. Zeta and Wilson were joined by Greenleaf Health executive vice president for regulatory compliance Kalah Auchicloss and executive vice president
Drugs
FDA has granted a Universities Allied for Essential Medicines 2/27/23 petition request that the agency consider a different enforcement framework in its approach to registration of applicable clinical trials at ClinicalTrials.gov. “We believe that … the agency’s current enforcement policy … has been effective,” the FDA response says.
Drugs
FDA has accepted for review a Daiichi Sankyo and AstraZeneca BLA for datopotamab deruxtecan (Dato-DXd) for treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The agency has set a user fee review action target date of