Drugs
FDA has granted fast track designation for Surface Oncology’s SRF 388 for treating patients with hepatocellular carcinoma who have been previously treated with standard therapies such as vascular endothelial growth factor targeted agents and programmed death-ligand blockade. The company says SRF 388 is enrolling patients with advanced solid
Drugs
FDA has cleared a Nanowear 510(k) for its cloth-based diagnostic platform SimpleSense, a multi-parameter remote diagnostic undergarment and machine learning digital platform that monitors and assesses the heart, lungs, and upper vascular system. “Gender-neutral and size adjustable, the SimpleSense platform effectively replaces the digital stethoscope, multi-
Drugs
FDA has issued Eli Lilly an emergency use authorization (EUA) for its investigational monoclonal antibody therapy bamlanivimab for treating mild-to-moderate Covid-19 in adult and pediatric patients. The therapy is authorized for patients 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and
Drugs
A 2/24-2/28 FDA inspection at the Nartex Laboratorios Homeopaticos drug manufacturing facility in Coahuila de Zaragoza, Mexico, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. An 11/4 Warning Letter says specific violations were: * failing to establish adequate written procedures for production and
Drugs
Amgen and AstraZeneca say their investigational asthma drug tezepelumab achieved positive topline results in the Phase 3 NAVIGATOR trial. A statement from the companies says tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma. The statement says the drug was very well tolerated
Drugs
With FDA pausing many foreign drug manufacturing facility inspections due to the Covid-19 pandemic, Sens. Elizabeth Warren (D-MA) and Tina Smith (D-MN) are asking the agency for information on the inspections still being held and measures being taken to protect FDA staff who conduct those inspections. In
FDA Policy/General
Federal Register notice: FDA has made available a revised final guidance on “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.” The guidance supersedes the now withdrawn and same titled final guidance issued in 5/2018. The revision removes Section VI.B. regarding the “same product as
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Regulatory Considerations for Microneedling Products. The document is intended to assist industry in understanding when a microneedling product is a device as defined in the federal Food, Drug, and Cosmetic Act. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs. The guidance recommends approaches that sponsors of clinical trials intended to support an NDA/BLA to increase enrollment of underrepresented populations in their clinical trials.
Drugs
Supernus Pharmaceuticals says it received a complete response letter from FDA for its NDA for SPN-812 (viloxazine HCl) to treat attention-deficit hyperactivity disorder in pediatric patients ages 8-17. A company statement says the primary issue cited in the FDA letter related to the firm’s in-house
Drugs
Beginning next year, CDER Office of Prescription Drug Promotion (OPDP) is revising its core launch review process. “Our goals with these revisions include improving efficiencies, providing timely feedback to firms and maximizing OPDP resources,” acting director Catherine Gray told a Food and Drug Law Institute (FDLI) 10/29 virtual conference.
Devices
FDA says the 9/21 Stryker Neurovascular recall of its Trevo XP ProVue Retriever due to a core wire issue is Class 1. The device is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke. An agency recall
Drugs
Using pooled data from 32 trials of approved schizophrenia drugs representing over 14,000 patients, CDER researchers from the Office of Clinical Pharmacology and Office of New Drugs say they have identified two ways to make Phase 3 trials of these drugs more efficient, less costly, and potentially more likely
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 7/15 notice about a draft guidance #61 entitled Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species. FDA is taking this action in response to a request
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Nartex Laboratorios Homeopaticos, Coahuila de Zaragoza, Mexico (11/4): FDA inspected the firm 2/24-2/28 and found significant GMP violations
Biologics
Pfizer and BioNTech have reported data from an interim efficacy analysis showing that its Covid-19 vaccine is more than 90% effective in preventing the virus based on the evaluation of 94 Covid cases in participants. Pfizer says an emergency use authorization submission could be completed later this month, which
Drugs
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has voted 8 to 1 that a study involving Biogen’s Alzheimer’s drug did not provide strong evidence to support its effectiveness. The panel also voted 7 to 0 (4 votes uncertain) that a second study did not provide
Drugs
President-elect Joe Biden’s transition team has announced the formation of the Transition Covid-19 Advisory Board, which is co-chaired by former FDA commissioner David Kessler. “The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed
Drugs
CDER has released a report on Global Participation in Clinical Trials: 2015-2019 that summarizes the Center’s Drug Trials Snapshot program by illustrating the demographic groups represented in the clinical trials for new drug approvals from 2015-2019. It says that 300,000 patients participated in these trials, and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Insanitary Conditions at Compounding Facilities. The document is intended to help compounding facilities and state regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious
Drugs
FDA has released a final guidance on “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.” The guidance provides information on the the new fee structure created by the statute, and the types of fees for which sponsors are responsible. It describes the types of user fees
Drugs
FDA has issued a final guidance on Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs. The document provides the agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches. “This guidance offers