FDA Policy/General
HHS’s unprecedented overreach during the Trump Administration has drawn increased interest in making FDA an independent agency. “The durability and long-term effects of the department’s changes to FDA policy and its actions to limit the agency’s autonomy remain in question, but the public conversation about independence,
Drugs
FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) in combination with Bristol Myers-Squibb’s Opdivo (nivolumab) for treating patients with advanced renal cell carcinoma (RCC), which is the most common form of kidney cancer. “This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib
Drugs
FDA has given the green light to Ultragenyx Pharmaceutical to begin a seamless single-protocol Phase 1/2/3 study of UX701, an investigational AAV9 gene therapy being evaluated for treating Wilson Disease. “"The seamless Phase 1/2/3 clinical trial design will allow us to efficiently evaluate safety
Drugs
NJ attorney general Gurbir S. Grewal has announced a $5 million settlement with Insys Therapeutics founder John N. Kapoor to resolve allegations that he unlawfully bribed New Jersey doctors as part of a nationwide kickback scheme to boost sales of the company’s opioid drug Subsys. This is the first
Devices
The Medical Device Innovation Consortium (MDIC), which includes FDA as a member, will receive public comments until 2/22 on its External Evidence Methods Framework. An MDIC statement says the document is intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Specifically, the
Biologics
FDA has published an immediately effective guidance, Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During Covid-19 Public Health Emergency, to give manufacturers of such products risk-based recommendations to minimize potential transmission of the SARS-CoV-2 novel coronavirus. The document is intended to supplement
Drugs
FDA has accepted for priority review a Genentech supplemental NDA for Esbriet (pirfenidone) for treating unclassifiable interstitial lung disease. The agency is expected to make a review decision in May. Esbriet was originally approved in 2014 for treating idiopathic pulmonary fibrosis. The submission is based on data from a pivotal,
FDA Policy/General
Federal Register notice: FDA has announced the withdrawal of a draft guidance entitled Applications for Premarket Review of New Tobacco Products. The document is being withdrawn because the topics discussed in it are addressed in the final rule entitled “Premarket Tobacco Product Applications and Recordkeeping Requirements.” To view the notice,
Devices
FDA has cleared a Canon Medical Systems 510(k) for the Aquilion Exceed LB CT system, which is intended to provide clinicians the opportunity to see more during radiation therapy planning to improve accuracy, precision and speed. The device features a large bore opening (90 cm), edge-to-edge extended
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development Under the BPCI Act, should be revised to provide more complete guidance related to interchangeable products, including on: * consideration for developing presentations, container closure systems, and delivery
Drugs
FDA has approved ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for treating HIV-1 infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known
Drugs
FDA has accepted two Bristol-Myers Squibb sBLAs for new indications for its Opdivo (nivolumab). The first sBLA is to treat patients with resected esophageal or gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy. The agency granted the application priority review and set a PDUFA goal date
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Multix Impact C ceiling-mounted digital radiography (DR) system as well as the Multix Impact VA20, a new version of the established floor-mounted parent DR system. Both devices feature intuitive operating systems, versatile wireless detectors, motorized tube heads, and
Drugs
FDA has accepted for review an Impel NeuroPharma 5O5(b)(2) NDA for INP104 (dihydroergotamine mesylate) for the acute treatment of migraine headaches with or without aura in adults. The company says INP104 is intended to be delivered directly into the vascular-rich upper nasal space using Impel’s proprietary
FDA Policy/General
Federal Register notice: FDA has issued a final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule is intended to help ensure that PMTAs contain sufficient information for FDA to determine whether a
FDA Policy/General
Outgoing FDA commissioner Stephen Hahn said 1/19 that the agency does not support a memorandum of understanding (MOU) signed that day by Department of Agriculture (USDA) secretary Sonny Perdue and HHS assistant secretary Brett Giroir establishing a regulatory environment for agricultural animal biotechnology innovation. In a series of Tweets,
FDA Policy/General
Federal Register notice: FDA and HHS have revised proposal requests for reimporting insulin and the personal importation of prescription drugs that appeared in the 9/24/2020 Federal Register. Proposals submitted in response to the requests will be accepted and reviewed on a rolling basis, and until further notice. To
Drugs
FDA has denied without comment an 11/1/19 GlaxoSmithKline petition asking that the agency review four categories of information concerning the use of Zofran (ondansetron) in pregnancy and “either refrain from taking action to alter Zofran’s pregnancy-related labeling or take action to alter the labeling in light
Drugs
FDA has approved Merck’s Verquvo (vericiguat), a soluble guanylate cyclase stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. Merck says
Biologics
The Peggy Lillis Foundation for C. Diff Education and Advocacy is asking FDA to take several actions to improve the availability of microbiome treatments for C. difficile infections. The 1/12 petition asks FDA to: * engage patients and caregivers in developing agency guidelines for potential new therapies for C. difficile,
Drugs
FDA reportedly has verbally notified Histogen that the agency has additional questions about the company’s IND application package for a planned Phase 1/2 clinical trial of its HST-003, intended to evaluate the safety and efficacy of human extracellular matrix implanted within microfracture interstices and the cartilage defect
FDA Policy/General
Federal Register notice: FDA is issuing a final rule to provide additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also establishes general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications