Drugs
FDA has issued Camurus a complete response letter (CRL) on its NDA for CAM2029 (octreotide) extended-release injection and its use in treating patients with acromegaly. The agency letter cited “facility-related deficiencies identified during a current good manufacturing practices inspection of a third-party manufacturer completed in September,” the
Drugs
FDA has published a draft guidance, Drug Interaction Information in Human Prescription Drug and Biological Product Labeling, to assist applicants in determining the appropriate placement and content of drug interaction information in labeling as described in the regulations for the content and format of labeling for human prescription drug and
Drugs
Comments from three biosimilar industry stakeholders are rejecting the idea of FDA developing product-specific guidances (PSGs) for biosimilars. In its response, Sandoz says that PSGs are ill-suited to biosimilars. “Biosimilar development is a complex process that does not follow a rigid one-size-fits-all model and the
Drugs
FDA has accepted for review a Lenz Therapeutics NDA for LNZ100 (aceclidine), an eyedrop medication for treating presbyopia (farsightedness). The agency set a user fee review action target date of 8/8/2025. The submission is based on Phase 3 data from CLARITY 1 and 2 trials which showed that
Drugs
Novo Nordisk says it will seek an expanded label for its diabetes drug Rybelsus (semaglutide) based on data from the SOUL cardiovascular outcomes trial. The double-blind, randomized trial compared oral semaglutide to placebo as an adjunct to standard of care for preventing major adverse cardiovascular events (MACE), according to
Drugs
FDA has accepted an Elevar Therapeutics NDA resubmission for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic liver cancer. The agency has set a user fee review action target date of 3/
Drugs
A coalition of 18 attorneys general have filed an amicus brief in support of a district court decision finding that North Carolina “cannot impose unnecessary and burdensome restrictions” to access the abortion drug mifepristone that were rejected by FDA. The attorneys general filed the Fourth Circuit brief in Bryant v.
Drugs
FDA has placed a partial clinical hold on a BioNTech and OncoC4, Phase 3 trial (PRESERVE-003) that is assessing BNT316/ONC-392 (gotistobart) in non-small cell lung cancer (NSCLC). The hold is due to varying results between the squamous and non-squamous NSCLC patient populations, according to the
Drugs
FDA has posted a guidance entitled “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA.” The document is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an ANDA. It explains how FDA is using a
Drugs
Gilead Sciences says it is withdrawing the accelerated approval for a Trodelvy (sacituzumab govitecan-hziy) indication for treating adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1)
Drugs
FDA has approved an Avadel Pharmaceuticals supplemental NDA for Lumryz (sodium oxybate) for treating cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. The drug was originally approved 5/2023 for the same indication but in adult patients. Approval for the pediatric indication
Biologics
FDA has published a guidance, Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development, with a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful to support a determination of the safety of a drug, biological product, or
Drugs
FDA has informed Intercept Pharmaceuticals that the agency is continuing to review the company’s sNDA for full approval of Ocaliva (obeticholic acid, OCA) to treat indicated patients with primary biliary cholangitis. A company statement said FDA indicated that the original PDUFA action date of 10/15 has been delayed
Drugs
FDA has approved an AbbVie NDA for Vyalev (foscarbidopa and foslevodopa), which is described as the first subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in adults with advanced Parkinson's disease. In June, the agency had issued a second complete response letter (CRL) on
Drugs
FDA has released a draft guidance entitled “Postoperative Nausea and Vomiting: Developing Drugs for Prevention.” The document provides recommendations regarding the design of clinical trials for such drugs, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments. The agency notes that the guidance does not address
Drugs
FDA is asking users of the NDA integrated review format that the agency started using several years ago to provide feedback on questions involving its usefulness. Attorney Deborah Livornese (Hyman, Phelps & McNamara) writes in a Pharmaceutical Online guest column that there are upsides and downsides to producing a leaner
Drugs
Staska Pharmaceuticals has recalled (Class 1) one lot of ascorbic acid solution for injection (500mg/mL, 50mL vials) due to the presence of glass particulates in some vials. The product is used as a vitamin supplement. “The administration of an injectable product containing particulate matter may result in local irritation
Drugs
FDA has published a guidance, Core Patient-Reported Outcomes in Cancer Clinical Trials, with recommendations to sponsors for the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. The document says some of the recommendations may
Drugs
FDA has published a guidance, Requests for Reconsideration at the Division Level Under GDUFA, with recommendations on the procedures for ANDA applicants that want to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. The document says such reconsideration requests should concern
Drugs
FDA has approved a Novocure PMA for Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for treating adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen. The portable device is designed to produce alternating electric
Drugs
The DC federal court has granted summary judgment to FDA and MSN Pharmaceuticals, the defendants in a suit filed by Novartis claiming the agency violated the Administrative Procedure Act, the Federal Food, Drug, and Cosmetic Act, and its implementing regulations by approving an MSN application to market a generic form
Drugs
FDA has accepted for priority review a GSK NDA for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for treating female adults and adolescents with uncomplicated urinary tract infections (uUTIs). The company says new treatments are needed as uUTIs caused by drug-resistant bacteria