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
Biologics
Taysha Gene Therapies says it is discontinuing the development of its gene therapy TSHA-120 program as a treatment for giant axonal neuropathy (GAN) after receiving FDA feedback in a recent Type C meeting. The company says its decision is “due to challenges related to the feasibility of the study
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
Devices
Medline Industries is recalling (Class 1) its Hudson RCI Addipak unit dose vial, 0.9% full normal saline solution (Lot 3B085) due to sterility concerns. The affected lot passed sterility testing, but another lot within the same cleaning cycle (Lot 3B087) failed the testing, exposing the affected lot to potential
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
Devices
FDA has issued a draft Center for Devices and Radiological Health (CDRH) International Harmonization Strategic Plan. A CDRH statement (contains a link to the draft plan) says the plan “includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on the
Devices
Three Ropes & Gray attorneys say FDA likely has more significant reforms in mind than the recent three draft guidances to modernize and update the 510(k) medical device approval pathway. Writing in an online post, the attorneys analyze the three draft guidances, while suggesting that the agency is considering
Devices
FDA says that as of 9/19, its medical device Accreditation Scheme for Conformity Assessment (ASCA) program is converting from a pilot to a permanent program. The notice says the program will continue to be implemented through its final guidance document. ASCA is described as an accreditation scheme that capitalizes
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
Biologics
Atara Biotherapeutics says it expects to file by 7/2024 a BLA for tabelecleucel, an allogeneic, Epstein-Barr virus (EBV)-specific T-cell immunotherapy that targets and eliminates EBV-infected cells in a human leucocyte antigen-restricted manner. The company says it recently achieved agreement with FDA on the company’
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-
Devices
FDA has granted InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as an adjunctive therapy for treating Parkinson’s disease. “The InBrain system harnesses the power of graphene, a two-dimensional material made of a lattice of carbon atoms only one atom thick,
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
Biologics
[Report by Jim Dickinson] Data cited by FDA and CDC to support vaccinating everyone over age six months against the latest Covid-19 variants are “quite incredible … it’s almost as if the CDC were arithmetically challenged,” according to retired English doctor John L. Campbell in a scathing 15-minute
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-