Drugs
FDA has lifted an Immunome clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19. The hold was placed in early January, when the agency requested further information on the preparation and administration of IMM-BCP-01 at clinical sites. IMM-BCP-01 is a three-antibody
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Venatorx Pharmaceuticals says it is planning an NDA submission in the fourth quarter after reporting “positive results” from its pivotal Phase 3 study evaluating cefepime-taniborbactam as a potential treatment for adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. The company says that if approved the combination
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FDA has set 8/4 as the PDUFA target action date for an Acadia Pharmaceuticals resubmitted sNDA for a new indication for its Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. The company says it was told by the CDER Division of Psychiatry that it
Drugs
Sen. Charles Grassley (R-IA) has called on the Federal Trade Commission to find a way to overcome a 2/17 deadlocked vote on initiating a study into the business practices of pharmacy benefit managers (PBMs). In a 3/9 letter to FTC chair Lina Khan, Grassley says PBMs “operate
Drugs
FDA has issued Zydus Lifesciences (formerly known as Cadila Healthcare) a three-item Form FDA-483 after inspecting the firm’s Jarod, Gujarat (India) injectable facility between 2/24 and 3/10. Without disclosing the cited observations, the company says it is confident they will be addressed and corrected to
Drugs
FDA has released the FDA-483 issued following an 11/8-12/2/21 inspection at Valgene Incorporated, doing business as Cape Drugs, an Annapolis, MD, producer of sterile and non-sterile drug products. The four inspection observations were: * disinfectant contact time (dwell time) and coverage of the item being
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AbbVie says that based on the results of the Phase 3 PROGRESS trial it will submit an sNDA to FDA to expand the indication for its Qulipta (atogepant) for the preventive treatment of chronic migraine. The company says Qulipta met its primary endpoint of statistically significant reduction from baseline in
Drugs
Two Morrison Foerster attorneys say the 2/10 meeting of the Oncologic Drugs Advisory Committee (ODAC) to consider a sintilimab application based on the ORIENT-11 trial conducted only in China sends a message to sponsors to engage early and formally with FDA if they want its approval for their
Drugs
The House Energy and Commerce Committee Health Subcommittee has announced a 3/17 hearing entitled “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight.” The hearing will discuss various draft legislative proposals to revamp FDA’s approval and oversight of medical products, among other issues. For example, the
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FDA has published a draft guidance, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, to provide clarity about existing requirements to facilitate the tracing and verification of certain prescription drug products through the U.S. pharmaceutical distribution supply chain. The document describes the agency’s
Drugs
FDA has released a 26-page FDA-483 with 12 observations from a 9/21-11/4/21 inspection at SterRx, a Plattsburgh, NY, 503B outsourcing facility. The inspection observations were: * aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under pressure;
Drugs
FDA says that as a precautionary measure, specified lots of immune globulin intravenous and immune globulin subcutaneous have been voluntarily withdrawn by several manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant. An agency online notice includes a list of the
Drugs
A Trinity Life Sciences online white paper says that while most of its recommendations for increasing the diversity of participants in clinical trials involve patients and drug companies, “diversity in clinical trials cannot be accomplished without coordinated efforts of clinical trial sites and overseeing regulatory bodies or sponsors.” The paper
Drugs
FDA is stepping up its review of phosphatidylinositol-3-kinase (PI3K) inhibitor safety concerns by convening a 4/21-22 Oncologic Drugs Advisory Committee meeting to review the issue. Recent concerns stem from a safety alert last month on a possible increased risk of death with TG Therapeutics’ PI3K inhibitor
Drugs
Sanofi and partner Swedish Orphan Biovitrum (Sobi) have announced what they call positive topline results from the pivotal XTEND-1 Phase 3 study evaluating efanesoctocog alfa (BIVV001) in previously treated patients 12 years of age and older with severe hemophilia A. The companies say the data will support regulatory submissions
Drugs
The National Academies Committee on Security of America’s Medical Product Supply Chain makes seven recommendations for FDA, other government agencies, and other stakeholders to take to increase the resilience of the medical product supply chain. In a report (purchase or free PDF download) mandated by the 2020 CARES Act,
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CDER has released its FY 2021 GDUFA Science and Research Report that updates stakeholders on the development of innovative methodologies and more efficient tools to help establish drug equivalence standards to support generic drug development. Much of the research is focused on complex products, which often have few generics or
Drugs
FDA is soliciting comments on specific aspects of changes it is proposing to the drug quality metrics reporting program. The changes arise from two pilot programs with industry that were first announced in 2018, a Federal Register notice says. The notice says FDA believes that a change in the entities
Drugs
An Illinois federal court has ordered Salud Natural Entrepreneur, Waukegan, IL, to stop distributing dietary supplements that violate the Federal Food, Drug, and Cosmetic Act (FFDCA). A Department of Justice statement says the company and its owner, production manager, and quality control manager violated the FFDCA by distributing adulterated and
Drugs
Mallinckrodt has agreed to pay $260 million to resolve allegations that it violated the False Claims Act by knowingly underpaying Medicaid rebates due for its drug H.P. Acthar Gel, and using a foundation as a conduit to pay illegal co-pay subsidies for the product in violation of the
Drugs
FDA has denied a 9/12/2013 petition submitted by two Weill Cornell Medical Center doctors asking that the agency add a warning to labeling for over-the-counter (OTC) drugs with anticholinergic effects. The FDA response says the petition stated that the impairment of thinking caused by the ingredients
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Regeneron says an FDA draft guidance on considerations for using real-world data (RWD) and real-world evidence (RWE) to support regulatory decision-making for drug and biological products should acknowledge the rapidly advancing state of science about RWE. “This guidance should make clear that this is a dynamic topic