Devices
FDA has cleared an Asensus Surgical 510(k) for its 5 mm diameter articulating instruments for use on the Senhance Surgical System technology platform. Articulating instruments offer better access to difficult-to-reach areas, according to the company. The surgical system is a digital laparoscopic platform that leverages machine learning.
Drugs
FDA is telling patients and healthcare professionals that the OCEAN study evaluating Oncopeptides’ Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. An agency drug safety alert says the trial compared Pepaxto with low-dose dexamethasone to pomalidomide (Bristol-Myers Squibb’s
FDA Policy/General
Federal Register notice: FDA has announced the fiscal year 2022 user fee rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities. The rates are: small business establishment fee ($5,824), the non-small business establishment fee ($18,999)
Drugs
FDA has accepted for priority review a Mycovia Pharmaceuticals an NDA for oteseconazole, an oral antifungal for treating recurrent vulvovaginal candidiasis (chronic yeast infection). The agency has set a 1/27/2022 user fee review action date. The submission is based on data from three Phase 3 trials involving more
Drugs
Johns Hopkins Center for Drug Safety and Effectiveness professor G. Caleb Alexander, who was on the advisory committee that voted 10-0-1 in 11/2020 not to recommend approval for Biogen’s Alzheimer’s treatment Aduhelm (aducanumab), has gone public with his concerns about the agency’s accelerated approval
Devices
FDA has approved a Synchron IDE application for its Stentrode motor neuroprosthesis. The company says an early feasibility study of the device will begin later this year at Mount Sinai Hospital in New York to assess device safety and efficacy in patients with severe paralysis. Outcomes will include the use
Biologics
FDA has granted Apic Bio a fast track designation for APB-102, a gene therapy candidate designed to treat SOD1 amyotrophic lateral sclerosis (ALS). The company is planning a Phase 1/2 clinical trial in early 2022. Apic says the three-part study is intended to evaluate the safety, tolerability,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.” The document provides product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence to support ANDAs for olodaterol hydrochloride; tiotropium bromide inhalation sprays. To view the notice,
Drugs
Regeneron Pharmaceuticals and AstraZeneca have entered into a collaboration to research, develop and commercialize small molecule compounds directed against the GPR75 gene for treating obesity and related co-morbidities. The pact builds on the recent discovery from the Regeneron Genetics Center involving rare genetic mutations in the GPR75 gene associated
Drugs
Five King & Spalding attorneys say an FDA draft guidance on safety event analysis and reporting for IND and bioavailability/bioequivalence studies signals the agency’s “current attention on the IND sponsor’s analysis of adverse events that may require expedited reporting to FDA and to all participating investigators.” In
Drugs
FDA has accepted for priority review an Aadi Bioscience NDA for its nanoparticle albumin-bound mTOR inhibitor Fyarro (sirolimus albumin-bound nanoparticles for injectable suspension) for treating advanced malignant PEComa, an ultra-rare sarcoma. The agency has set a user fee review action target date of 11/26. The submission
Devices
A CDRH 7/27 Webinar helped to clarify FDA’s current thinking on the distinction between medical device servicing and remanufacturing as discussed in a recent draft guidance. It also outlined specific cybersecurity challenges and opportunities associated with medical device servicing. During the Webinar staff from the CDRH Office of
FDA Policy/General
Federal Register notice: FDA is announcing the rates for biosimilar user fees for fiscal year 2022. The initial and annual biological product development fee is $57,184. The fee for an application requiring clinical data is $1,746,745, and the fee for an application not requiring clinical data is
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Reporting — 21 CFR Part 803” (OMB Control Number 0910-0437). The collection supports FDA regulations and FDA’s Medical Device Reporting program that require reporting of device adverse events. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the animal drug user fee rates and payment procedures for fiscal year 2022. The fees are: $580,569 for an animal drug application; $290,284 for a supplemental animal drug application for which safety or effectiveness data are required; $10,787 for an annual
Biologics
FDA has asked Pfizer/BioNTech and Moderna to expand their trials of Covid vaccines to include several thousand school children before they seek final emergency use authorization for their vaccines. The Washington Post reports the changes to ongoing pediatric trials could delay the availability of the vaccines for children ages
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for treating patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. The company says the approval is based on the Phase 3
Devices
FDA has givern 510(k) clearance to LifeSignals Group for its LifeSignals ECG remote monitoring patch platform, a wireless system used by healthcare professionals for the continuous collection of electrocardiography and heart rate monitoring in ambulatory, hospital, home, and healthcare settings. The company says healthcare professionals can remotely access patient
Drugs
FDA says it will meet with Petros Pharmaceuticals to discuss expansions and modifications to labeling for the company’s Stendra (avanafil) erectile dysfunction medication. The company says the meeting is scheduled for 9/2021. Petros says it is proposing that the time interval between administration of Stendra and nitrates be
Drugs
FDA has approved Sol-Gen Technologies’ Twyneo (tretinoin/benzoyl peroxide) cream 0.1%/3% to treat acne in adults and pediatric patients age 9 and older. The company says Twyneo uses its patented technology to entrap tretinoin and benz oyl peroxide within silica-based microcapsules to stabilize tretinoin from being
Devices
FDA has granted Evren Technologies a breakthrough device designation for its Phoenix earbud device and its use in treating post-traumatic stress disorder. The device is intended to provide transcutaneous auricular vagal nerve stimulation in a proprietary closed-loop system. To obtain the designaion, the company says it provided preliminary
FDA Policy/General
Federal Register notice: FDA has announced a 9/2-3 Cellular, Tissue and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss toxicity risks of adeno-associated virus vector-based gene therapy products. Specifically, they will discuss oncogenicity risks due to vector genome integration and safety issues identified