Drugs
FDA has issued a complete response letter (CRL) to ARS Pharmaceuticals for its NDA for neffy (epinephrine nasal spray) to treat Type 1 allergic reactions, including anaphylaxis, in adults and some children. The company says it will submit a formal dispute resolution request to appeal the CRL. In the letter,
Drugs
FDA has published a guidance, Considerations for the Conduct of Clinical Trials of Medical Procedures During Major Disruptions Due to Disasters and Public Health Emergencies, to assist sponsors, institutional review boards, and clinical investigators in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks
Drugs
FDA commissioner Robert Califf says drug manufacturers have fought agency efforts to encourage companies to ramp up production when a shortage occurs in another company. “People don’t like to be regulated,” he said during an appearance on a Healthcare Unfiltered podcast. “But we need it for the public health.
Drugs
FDA medical reviewers have reiterated their concerns about Intarcia Therapeutics’ implantable ITCA 650 (exenatide in DUROS device) in a briefing document released in advance of a 9/21 meeting of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee that will consider the company’s NDA. The document says the
Drugs
Writing in a Washington Legal Foundation Legal Opinion Letter, attorneys Philip Goldberg and Christopher Gramling (Shook, Hardy & Bacon) discuss court cases that demonstrate, they say, that while the preemption defense in state failure-to-warn cases is demanding, it is attainable. “District judges have issued thoughtful and thorough analyses
Drugs
FDA has granted Disc Medicine a fast-track designation for MWTX-003 and its use for treating patients with polycythemia vera (PV). The investigational, anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibody is designed to increase hepcidin production and suppress serum iron, according to the
Drugs
Relmada Therapeutics says data from the Phase 3 REL-1017-310 Major Depressive Disorder (MDD) study shows that patients treated daily with REL-1017 for up to one year “experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment.” It says REL-1017 was well-tolerated
Drugs
UCB says its BLA for bimekizumab, indicated for treating adults with moderate to severe plaque psoriasis, is facing another FDA review extension. While the company says FDA is continuing its review following an April pre-licensure inspection at its Belgium manufacturing facility, the agency has not yet communicated the timelines
Drugs
A 7/11-7/22/2022 FDA inspection at Kimera Labs in Miramar, FL, determined that the company manufactures and distributes two exosome products and an amniotic fluid product for allogeneic use. A 9/1 Warning Letter says the products have been distributed to practitioners and medical facilities throughout the
Drugs
Byron A. Marshall of Houston, TX has been sentenced to 300 months in federal prison for his role in leading a counterfeit drug trafficking scheme. According to the indictment, from 4/2014 to 8/2021, Marshall conspired with 10 others including Adam P. Runsdorf, the owner and president of Woodfield
Drugs
Vanda Pharmaceuticals says FDA commissioner Robert Califf should strike a 9/8 CDER proposed order as being unlawful for several reasons and should then set a prompt deadline for issuing a final decision on whether to grant summary judgment approving a Vanda sNDA for a new Hetlioz (tasimelteon) indication to
Drugs
An 11/17-11/22/2022 FDA inspection at the PureChemPros drug manufacturing facility in Tempe, AZ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, and other violations. A 9/1 Warning Letter says the firm’s 35% food-grade hydrogen peroxide and 3% food-
Drugs
FDA has accepted for review a Verona Pharma NDA for ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The agency has set a user fee review action target date of 6/26/2024, and it is not currently planning to hold an advisory committee meeting
Drugs
FDA has released a draft guidance entitled “Regulatory Considerations for Prescription Drug Use-Related Software.” The document describes the agency’s application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a
Drugs
FDA has released a draft guidance entitled “Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence.” The document is intended to provide more context than previous guidances on meeting the substantial evidence standard based on one adequate and well-controlled clinical trial.
Drugs
FDA has denied a 4/2020 Belcher Pharmaceuticals citizen petition that sought a requirement that generic drug makers of pre-12/2012-approved tacrolimus oral capsules conduct product testing pursuant to a rigorous 2012 draft product-specific guidance. This would demand both fasting and fed bioequivalence studies designed as single-
Drugs
FDA has reportedly issued Novo Nordisk a Form FDA-483 that cites GMP deficiencies at its Clayton, NC, manufacturing plant, which is a key facility for making its diabetes and weight-loss drug semaglutide (trade names Ozembic and Wegovy). The agency action was reported by Marketwire News and picked up
Drugs
FDA has approved a GlaxoSmithKline NDA for Ojjaara (momelotinib) for treating intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anemia. Ojjaara is described as a once-a-day, oral JAK1/JAK2 and activin A receptor type 1
Biologics
FDA has published a guidance, Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989, to give information to applicants that are required to report annually on the status of postmarketing studies and clinical trials for human drug and biological products
Drugs
FDA has made exploring how artificial intelligence (AI) can play a role in its regulatory operations a top strategic goal of its just-released four-year information technology strategic plan. It calls for the agency to “(d)rive exploration and address impacts of emerging technologies and trends such as AI
Drugs
The Federal Trade Commission has issued a policy statement, which is supported by FDA, warning brand-name pharmaceutical companies that they could face legal action if they improperly list patents in FDA’s Orange Book. “Improperly listing patents in the Orange Book may harm competition from less expensive generic alternatives
Drugs
FDA has approved updated labeling for Merck’s Temodar (temozolomide) under Project Renewal, an Oncology Center of Excellence program to update labeling information for older oncology drugs to ensure the information is clinically meaningful and scientifically up-to-date. An agency statement says it is the second drug to receive