Drugs
Responding to an FDA request for information on biosimilar product development guidances, Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the agency issuing cross-cutting guidances for a class of biosimilar products rather than product-specific guidances (PSGs). The PhRMA comment letter says the trade group is concerned
Drugs
Citing New York Times 10/23 reporting that participants in two Alzheimer’s drug trials were not told if their genetic profiles indicated a higher risk of brain injuries from the drug, Public Citizen is calling on FDA and the HHS Office for Human Research Protection (OHRP) to look into
Drugs
Researchers from Case Western Reserve University School of Medicine have found that semaglutide, a popular diabetes and weight-loss drug, may reduce the risk of Alzheimer's disease in people with Type 2 diabetes (T2D). The findings, published in the latest issue of Alzheimer’s & Dementia: The Journal
Drugs
The American Society of Health-System Pharmacists (ASHP) says that as of September, the number of active drug shortages as tracked by the University of Utah Drug Information Service was 277, down from an all-time high of 323. ASHP reports that 50% of active shortages have persisted for two
Drugs
FDA has accepted for priority review a Telix NDA for Pixclara (18F-floretyrosine), a positron emission tomography agent for glioma imaging. The agency has set a user fee review action target date of 4/26/2025. The therapy is intended for use to provide a characterization of progressive or recurrent
Drugs
Alto Neuroscience says a Phase 2b study of ALTO-100 in patients with major depressive disorder (MDD) did not meet its primary endpoint, assessed by a change from baseline in a depression rating scale compared to placebo. The company expects to complete its analysis of the full data set before
Drugs
Novo Nordisk is petitioning FDA to add its semaglutide products (Ozempic and Wegovy) to the Demonstrable Difficulties for Compounding (DDC) lists. The firm’s nominating petition says the products belong on the lists “due to the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes,
Drugs
A California man operating a company called Warrior Labz SARMs has pleaded guilty to selling unapproved drugs. According to the Justice Department, Jeremy Brown sold selective androgen receptor modulators, unapproved versions of erectile-dysfunction drugs Viagra and Cialis; and unapproved versions of weight-loss drugs Ozempic, Wegovy, and Rybelsus from
Drugs
FDA has granted U.P. Oncolytics an orphan drug designation for its oncolytic virus-based therapy to treat malignant gliomas. Last month, the company was awarded a $500,000 from NIH as part of a Phase 1-2 fast-track grant that will fund the company’s proposed in vitro
Drugs
An FDA 6/12-6/23/2023 Bioresearch Monitoring inspection at a clinical trial site maintained by Dr. Namita Goyal, an Orange, CA, neurologist, found that she violated regulations governing the proper conduct of clinical studies involving investigational products. A 10/10 Warning Letter says specific violations were: * failure to
Biologics
An 8/15-/29/2022 FDA inspection at Amnio Technology in Phoenix, AZ, documented that the firm manufactures an amniotic membrane and fluid product and an amniotic fluid-derived product that have been distributed to third-party distributors, hospitals, and medical clinics in the U.S. A 10/1 Warning
Drugs
Otsuka Pharmaceutical is reporting “positive topline interim data” from an ongoing Phase 3 clinical trial of sibeprenlimab and its use for treating immunoglobulin A nephropathy (IgA nephropathy) in adults. The investigational anti-APRIL (a proliferation-inducing ligand) monoclonal antibody works by blocking a “key initiating step in the immune pathogenic
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)