Drugs
A 3/8-3/23 FDA inspection at Adamson Analytical Laboratories, Corona, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals in the company’s work as a contract testing laboratory for prescription and over-the-counter finished drug products and active pharmaceutical ingredients. A
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A cross-sectional study by researchers at Yale University and other institutions raises questions about the use of the FDA accelerated approval program for certain therapeutic agents, especially if post-approval trials neither consistently evaluate clinical outcomes nor are much longer than pivotal trials using surrogate endpoints. As reported in
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Congressional interest in FDA’s consulting contracts with McKinsey & Co. continues to grow as the House Oversight and Reform Committee has requested details about the company’s role in advising opioid maker Purdue while also advising FDA on its regulatory actions involving opioids. The committee’s probe mirrors an
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FDA acting commissioner Janet Woodcock says there continues to be enormous opportunities for growth in the generic and biosimilar space. Addressing the virtual Association for Accessible Medicines generics and biosimilars conference 11/8, Woodcock said the agency’s goal is to “apply cutting edge science and maximize scientific and regulatory
Drugs
FDA has approved an Eton Pharmaceuticals and Azurity Pharmaceuticals NDA for Eprontia (topiramate) oral solution, 25mg/mL, indicated as a monotherapy for treating partial-onset or primary generalized tonic-clonic seizures in patients two years of age and older. It is also indicated as an adjunctive therapy for treating partial-
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FDA has issued a seven-item Form FDA-483 to ACRX Specialty (Las Vegas, NV) after inspecting the firm in July and finding GMP issues. For example, FDA said the firm’s ISO 5-classified aseptic processing areas had visibly dirty equipment or surface areas. It also found non-microbial
Drugs
Pfizer plans to soon submit to FDA data as part of its ongoing rolling submission seeking an Emergency Use Authorization for the Covid-19 oral antiviral candidate, Paxlovid (PF-07321332; ritonavir), after new data showed it significantly reduced hospitalization and death. An interim analysis of 1,200 patients in the
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee 11/5 voted 12 to 1 that a Levo Therapeutics NDA for carbetocin nasal spray and its use for treating Prader-Willi syndrome (PWS) did not show significant evidence of effectiveness. The submission is seeking approval for the drug to treat PWS-related hyperphagia,
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FDA has approved a Tris Pharma NDA for Dyanavel XR (amphetamine), extended release once-daily tablets for treating attention-deficit hyperactivity disorder (ADHD) in patients six years and older. Approval was based on data showing that DyanaveL XR extended-release tablets were bioequivalent to the company’s Dyanavel XR extended-
Drugs
FDA has granted orphan drug designation for Menarini Group’s SEL24/MEN1703 to treat acute myeloid leukemia (AML). The drug is described as a first-in-class orally available dual PIM/FLT3 inhibitor that is being investigated in the DIAMOND-01 trial as a single agent for treating patients with
Drugs
FDA says that as of 10/13, all manufacturers and labelers of isoxsuprine hydrochloride drug products agreed to cease distribution of the unapproved drugs. An agency online statement says that FDA announced on 7/15/20 a final decision of the commissioner that Vasodilan containing isoxsuprine HCl lacked substantial evidence,
Drugs
FDA has released the FDA-483 issued following a 5/3-5/21 inspection at Atlas Pharmaceuticals, a Phoenix, AZ, outsourcing facility. The three inspection observations were: * failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * determinations of conformance to
Drugs
Covid-19 has led to an unprecedented number of new product submissions to FDA to help combat it. To date, there are more than 660 drug development programs in the planning stages and the agency has reviewed more than 470 trials of potential therapies, according to acting commissioner Janet Woodcock.
Drugs
A lengthy Reuters series on the U.S. battle against diabetes says the treatment goal to lower A1c below 7% pushed by makers of diabetes drugs is leading to cases of hypoglycemia that have significant adverse effects and can lead to death. “Pharmaceutical giants launched years-long marketing campaigns for
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FDA says it is evaluating a DC federal court 9/2021 action remanding to the agency the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products to either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis. The
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CDER says it will start issuing electronic Certificates of Pharmaceutical Product (eCPPs) 12/3 and will no longer issue or mail paper CPPs. “The change from paper to electronic certificates will improve efficiency in issuing CPPs, reducing delivery time for export certificates and decreasing impact on the environment,” CDER says
Drugs
FDA has granted fast track designation to TransThera Science’s Phase 2 product TT-00420 for treating patients with cholangiocarcinoma (CCA) who have no standard treatment options. The company says TT-00420 is a spectrum selective kinase inhibitor that is found to show high potency to a variety of clinically
Drugs
An FDA inspection in May led to a 10-item Form FDA-483 issued to Innoveix Pharmaceuticals (Addison, TX) that took issue with the firm’s GMPs for sterile drug products. For example, the agency said the firm failed to conduct media fills that closely simulate aseptic production operations under
Drugs
FDA has approved an ANI Pharmaceuticals supplemental NDA for purified cortrophin gel (repository corticotropin) for treating certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due to nephrotic syndrome. Cortrophin gel is an adrenocorticotropic hormone, also known as purified corticotropin,
Drugs
FDA has extended to 2/28/22 the PDUFA action date for Legend Biotech and Janssen’s BLA for ciltacabtagene autoleucel (cilta-cel). The companies say cilta-cel is a B-cell maturation antigen CAR-T therapy that is being investigated for treating adults with relapsed and/or refractory multiple
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FDA has approved Novartis’ Scemblix (asciminib) for treating chronic myeloid leukemia (CML) in two distinct indications. The company says it received accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs), based on major molecular response rate
Drugs
Amylyx Pharmaceuticals has submitted an NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), indicated for treating amyotrophic lateral sclerosis (ALS). The submission is based on data from the CENTAUR trial, a placebo-controlled study evaluating 137 people with ALS. In this study, participants receiving AMX0035 had “statistically significant slowing of functional