Devices
FDA has authorized the first over-the-counter hearing and software device that is used with compatible versions of the Apple AirPods Pro headphones. An agency statement says that the authorized Apple Hearing Aid Feature (HAF) enables compatible versions of the AirPods Pro to operate as an over-the-counter
Biologics
FDA has approved Johnson & Johnson’s Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). Approval was based on data from the ongoing Phase 2b/3 QUASAR study evaluating Tremfya in adult patients with moderately to severely active UC who experienced an inadequate response or
Biologics
Gilead Sciences says data from an interim analysis from a second pivotal Phase 3 clinical trial investigating its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, showed that it reduced HIV infections by 96% compared to background HIV incidence. “There were two incident cases among 2,180 participants, corresponding to
Biologics
GSK says it is moving its mRNA seasonal influenza vaccine program into Phase 3 after reporting favorable Phase 2 data that demonstrated positive A and B strain immune responses relative to standard of care in both younger and older adults. “Interim data suggest the vaccine candidates have an acceptable safety
FDA Policy/General
Federal Register notice: FDA is announcing an 11/7 meeting of the Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel to review an IceCure Medical de novo request for its ProSense Cryoablation System. The discussion is intended to focus on the sponsor’s proposed indication: “for use
Drugs
FDA has added a Warning to labeling for Astellas’ menopausal hot flashes drug Veozah (fezolinetant) indicating it can cause rare but serious liver injury. A 9/12 drug safety communication says the agency made the labeling update after reviewing a postmarketing report of a patient with elevated liver blood test
Drugs
A new National Academies book, Regulatory Processes for Rare Disease Drugs in the United States and European Union: Flexibilities and Collaborative Opportunities, has recommendations based on the Academies’ study of processes for evaluating the safety and efficacy of drugs for rare diseases in the U.S. and the European Union.
Drugs
The newly launched CDER Quantitative Medicine (QM) Center of Excellence (CoE) provides the organizational framework to foster collaboration and cooperation in QM efforts across CDER and facilitate engagement with all stakeholders to advance therapeutic medical product development, inform regulatory decision-making, and promote public health, That’s the explanation provided
Drugs
FDA has published a guidance, ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA, explaining to applicants how the assessment goals established in the GDUFA 3 agreement apply to amendments to either ANDAs or prior approval supplements submitted to FDA under section 505(j) of the Federal Food, Drug,
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Cyclomedica Australia’s Technegas (technetium Tc 99m-labeled carbon), indicated for visualization of pulmonary ventilation and evaluation of pulmonary embolism when paired with perfusion imaging. The regulatory review period is 4,322 days, of which
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Marinus Pharmaceuticals’ Ztalmy (ganaxolone), indicated for treating seizures associated with cyclin-dependent kinase-like 5 deficiency disorder in patients two years of age and older. The regulatory review period is 10,382 days, of which
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has cited AbbVie in a just-released untitled letter over its television direct-to-consumer advertisement for migraine drug Ubrelvy (ubrogepant). The ad, featuring tennis great Serena Williams, contains misleading information about the drug's efficacy, OPDP says. The TV commercial
Drugs
As required by the PDUFA 7 reauthorization agreement, FDA has issued its draft strategy document outlining the specific actions it will take over the course of PDUFA 7 (2023-2027) to facilitate the use of innovative manufacturing technologies, including addressing barriers to their adoption. The document says the actions are
Devices
FDA has sent Warning Letters to Mid-Link Testing Company in Tianjin, China, and Sanitation & Environmental Technology Institute of Soochow University in Suzhou, China, about laboratory oversight failures and animal care violations. An agency statement (contains links to the letters) says the firms provide third-party testing and validation
Drugs
The Washington, DC District Court 9/10 dismissed as not ripe for review a Vanda Pharmaceuticals lawsuit against FDA that challenged the agency’s bioequivalence determination of a generic competitor to sleep drug Hetlioz, calling it arbitrary and capricious, in violation of the Administrative Procedure Act (APA). Vanda argued that
Drugs
FDA says a confirmatory trial for Intercept Pharmaceuticals’ liver disease drug Ocaliva (obeticholic acid), which received accelerated approval on 5/27/2016 to treat primary biliary cholangitis (PBC) in conjunction with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate
Biologics
GSK is not advancing the development of its investigational herpes simplex virus (HSV) vaccine candidate, GSK3943104, based on a data analysis of a recent Phase 1-2 study. “Results show that GSK3943104 did not meet the study’s primary efficacy objective,” the company says, adding that it will not progress
Devices
FDA has cleared a Hinge Health 510(k) for its Enso 3, a wireless device that the company says is clinically proven to reduce musculoskeletal pain. “The new Enso 3 delivers electrical nerve stimulation that achieves non-invasive, non-addictive pain relief within minutes,” it says. The clearance was based
Drugs
A 4/15-4/23 FDA inspection at the Zydus Lifesciences Limited drug manufacturing facility in Taluka, Waghodia, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/29 Warning Letter says specific violations were: * failure to thoroughly investigate any unexplained discrepancy or
Devices
A 2/26-3/1 FDA inspection at the Optikem International facility in Denver, CO, found multiple violations in the firm’s manufacturing of the Sereine brand of ophthalmic medical device solutions. A just-released 8/13 Warning Letter says the products are adulterated due to Quality System regulation violations.
Drugs
The Medical Information Working Group (MIWG) says it has concerns about a revised FDA question-and-answer draft guidance on addressing misinformation about medical devices and prescription drugs. In its comment, the MIWG says that despite improvements made in the current revision, it still has concerns about the guidance’s
Devices
FDA has granted 510(k) clearance to Sonic Incytes Medical Corp’s Velacur Determined Fat Fraction, a measuring tool the company says is integrated into the Velacur device software combining quantitative measures of ultrasound attenuation and backscatter. A company statement says device results correlate well with the MRI proton density