Drugs
FDA has expanded an Eli Lilly emergency use authorization (EUA) for bamlanivimab 700 mg and etesevimab 1,400 mg administered together for post-exposure prophylaxis in certain individuals for preventing Covid-19 infection. Lilly says the combination’s “neutralizing antibodies can now be used together to treat high-risk individuals
Drugs
Researchers in the UK and Italy say there should be more selective use of surrogate endpoints when evaluating new drugs so that they are restricted to use in chronic diseases, especially when collecting data on patient-relevant clinical outcomes requires trials with unattainably long follow-up. Writing in thebmj, the
Devices
Massachusetts General Hospital researchers say deviations in FDA policy during the Covid-19 pandemic may offer a blueprint for regulatory oversight of laboratory-developed tests (LDTs). The study was published in the Journal of Molecular Diagnostics. A hospital news release says that during the pandemic, FDA (1) required makers of
Drugs
FDA has extended by three months the review of a Calliditas Therapeutics NDA seeking accelerated approval for Nefecon (budesonide) for treating primary IgA nephropathy (IgAN). The major amendment extension was ordered to provide the agency more time to review additional analyses of the company’s NeflgArd trial data which was
Drugs
FDA and the European Medicines Agency (EMA) are starting a pilot program to provide parallel scientific advice to applicants of ANDAs for FDA’s complex generic drug products and marketing authorization applications (MAAs) for EMA’s hybrid products. An FDA statement says the pilot expands the two agencies’ existing parallel
Biologics
In a briefing document prepared for a 9/17 meeting of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, FDA does not take a position on whether there is a current need for a booster shot of the Pfizer Comirnaty Covid-19 vaccine. “Some observational studies have
Drugs
Amylyx Pharmaceuticals says it is planning to submit an NDA in the coming months for AMX0035 (sodium phenylbutyrate and taurursodiol) for treating amyotrophic lateral sclerosis (also known as Lou Gehrig’s disease). The decision to file the NDA comes after the company has held recent discussion with FDA reviewers, including
Drugs
FDA has granted accelerated approval for BeiGene’s Brukinsa (zanubrutinib) for treating adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen. Approval is based on efficacy data from two single-arm clinical trials, with overall response rate (ORR) as the
Devices
FDA is reminding healthcare providers about the potential for aluminum leaching and exposing patients to high levels of aluminum as a result of using certain fluid warmers. An agency statement says information reviewed by FDA indicates that aluminum leaching may occur when the fluid warmer is designed with an aluminum
FDA Policy/General
FDA says it is creating an Office of Digital Transformation reporting directly to the FDA commissioner to advance the agency’s information technology (IT) transformation with improved data and information technology competencies that enhance agency operations. The new Office of Digital Transformation will house IT, data management, and cybersecurity functions,
Devices
FDA has released a revised guidance entitled Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease Public Health Emergency. The revised document addresses barrier face coverings intended for medical purposes but not intended to provide liquid barrier protection. It includes recommendations
Drugs
A 9/1 decision by the U.S. Court of Appeals for the Federal Circuit highlights the potential impact of contradictory positions taken before FDA and the U.S. Patent and Trademark Office (USPTO). That’s the view of three Cooley attorneys in an online analysis of Belcher Pharmaceuticals v.
Drugs
Researchers say issues involving innovator and generic drug companies strategically “parking” 180-day generic drug exclusivity to delay generic entry and competitive drug markets now occur infrequently. When parking does occur, the authors write in the Yale Journal of Health Policy, Law, and Ethics, it tends to relate to changes
Drugs
Astellas says the patient in its ASPIROS trial evaluating an investigational drug in patients with X-linked myotubular myopathy who suffered a serious adverse event leading to a pause in the trial has died. A company statement says the cause of death is still pending and the company is gathering
Biologics
House Republican whip and Select Subcommittee on the Coronavirus Crisis ranking member Steve Scalise (R-LA) and House Committee on Oversight and Reform ranking member James Comer (R-KY) say they are concerned that the Biden White House is pressuring career FDAers to recommend Covid-19 vaccine booster shots before
Drugs
FDA says there are things the U.S. Patent and Trademark Office (USPTO) could do to increase drug competition and help address the high cost of medicines. In a 9/10 letter, FDA acting commissioner Janet Woodcock says that while FDA recognizes that patents are critical to fostering innovation, the
Drugs
Jacobus Pharmaceutical Co. has recalled three lots of Ruzurgi (amifampridine) 10 mg tablets due to potential contamination with yeast, mold, and aerobic bacteria. The product is indicated for treating Lambert Eaton Syndrome patients aged six to 17 years. According to a recall notice, oral products heavily contaminated with yeast, mold,
Devices
FDA has cleared an inTravent Medical Partners 510(k) for the SoloPass system for aiding in the frontal placement of intra-ventricular catheters. The device is designed to provide imaging and guidance to improve the placement of external ventricular drains, according to the company. inTravent says the device allows health
Drugs
FDA has accepted for review an Axsome Therapeutics NDA for AXS-07 (meloxicam-rizatriptan) for the acute treatment of migraine. The submission is supported by data from two Phase 3 randomized, double-blind, controlled trials, MOMENTUM and INTERCEPT, which the company says demonstrated statistically significant elimination of migraine pain compared
Devices
FDA has granted Nyxoah a breakthrough device designation for its Genio bilateral hypoglossal nerve stimulation system and its use in treating patients with moderate to severe obstructive sleep apnea and complete concentric collapse of the soft palate. The designation is based on data from the company’s BETTER SLEEP trial.
Devices
FDA has given an additional 510(k) clearance to Anika Therapeutics’ Tactoset injectable bone substitute. The company says the new indication expands the use of Tactoset to include augmentation of hardware and the support of bone fragments during surgical procedures. Anika describes Tactoset as a calcium phosphate-based, biocompatible bone
Drugs
FDA has lifted a clinical hold against KalVista Pharmaceuticals and its Phase 2 clinical trial of KVD824 for oral prophylactic treatment of hereditary angioedema (HAE). The company says the hold was removed after FDA reviewed its responses to an FDA request for further information and analysis related to certain preclinical