Devices
FDA 5/16 issued an Emergency Use Authorization (EUA) for the Labcorp’s Covid-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test. It is the first Covid-19 direct-to-consumer test that also detects and differentiates influenza A
Drugs
FDA has removed a clinical hold on Gilead Sciences’ injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis. The company previously announced that the agency hold was placed on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue. “FDA removed the clinical hold following
Drugs
A March FDA inspection of Novel Laboratories (dba Lupin Somerset) has resulted in a 13-item FDA Form-483. A 2020 agency inspection at the Novel facility led to a 6/11/21 Warning Letter citing three significant violations of current good manufacturing practice regulations for finished drugs. In the
Drugs
FDA has rejected an emergency use authorization request filed by University of Minnesota Medical School infectious disease physician David Boulware and other researchers to allow the use of generic drug fluvoxamine maleate for outpatient treatment of Covid-infected adults to prevent progression to severe disease or hospitalization. Fluvoxamine is currently
FDA Policy/General
HIV Tests Down Classified to 510(k) 05/13/2022 Federal Register notice: FDA is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests, which are postamendments Class 3 devices with the product code MZF,
FDA Policy/General
DEVICES FDA has cleared a K2M Group Holdings 510(k) for its Yukon Oct Spinal System, a device intended to facilitate fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine. The device features “newly designed top-loading, high angulation, polyaxial screws that provide up to 105
Drugs
Ethicon has acquired Torax Medical, which manufactures and markets the LINX Reflux Management System for treating gastro-esophageal reflux disease. The device is based on magnetic sphincter augmentation (MSA) technology and the procedure is currently available in the U.S. and European medical centers. BioLineRx Ltd. has acquired Agalimmune Ltd.
Drugs
A just-published article in the journal Nature examines the problems with FDA’s accelerated approval program and potential reforms to reduce any gaming by the pharmaceutical industry. “Part of the problem is that drug companies aren’t upholding their end of the bargain with timely post-market studies confirming
FDA Policy/General
Federal Register notice: FDA is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests, which are postamendments Class 3 devices with the product code MZF, into Class 2 (special controls), subject to premarket notification. The
Drugs
BridgeBio Pharma has entered into a definitive agreement with an undisclosed purchaser to sell its priority review voucher for $110 million. The voucher was awarded by FDA in 2/2021 after it approved the company’s Nulibry (fosdenopterin), for treating an ultra-rare disease called molybdenum cofactor deficiency (MoCD) Type
Drugs
FDA has issued UCB a complete response letter on its BLA for bimekizumab for treating adults with moderate to severe plaque psoriasis. The letter says preapproval inspection observations must be resolved before the submission can be approved. In 8/2021, bimekizumab received marketing authorization in the European Union and Great
Drugs
A scathing 23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries’ Halol manufacturing facility (Gujarat, India). The company announced earlier in the week that the inspectional observation form was issued 5/9 at the conclusion of its inspection, and the agency has now released the redacted
Drugs
FDA has approved an Eli Lilly NDA for Mounjaro (tirzepatide), a once-weekly injection to improve blood sugar control in adults with Type 2 diabetes, as an addition to diet and exercise. “Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which
Devices
FDA has cleared a BD (Becton, Dickinson) 510(k) for its new automated, high-throughput infectious disease molecular diagnostics platform. The first test available on the new BD COR system is the BD CTGCTV2 molecular assay, a single test that detects the three most prevalent non-viral sexually transmitted infections
Devices
FDA has approved a Medtronic PMA for the Onyx Frontier drug-eluting stent (DES), indicated for treating patients with coronary artery disease, which is caused by plaque buildup on the inside of the coronary arteries. The device is designed to improve deliverability and will “continue to help interventional cardiologists treat
Devices
Pharmatech Associates managing director Stephanie Gaulding says proposed revisions to FDA’s Quality System Regulation for medical devices “is a significant step toward global harmonization and reduces the amount of U.S.-specific regulations for medical device manufacturers, especially relating to structure and requirements for a medical device quality management
Drugs
Bristol Myers Squibb has detailed two-year results from its POETYK PSO long-term extension (LTE) trial showing durable efficacy and a consistent safety profile with deucravacitinib treatment in adult patients with moderate to severe plaque psoriasis. A deucravacitinib NDA is under review at FDA, with a user fee review
FDA Policy/General
Federal Register notice: FDA is announcing a 6/7 public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The meeting will include presentations from FDA on topics related to the financial management of certain user
Drugs
FDA says an 11th Circuit Court of Appeals 9/30/21 decision in Catalyst Pharms v. Becerra will adversely affect the incentives for research and development of medical products for rare diseases. In an online review of the decision, the agency says the court addressed the scope of orphan drug
Biologics
CBER director Peter Marks wants to continue the “Operation Warp Speed” attention and quick approval process given to Covid-19 vaccines after the public health emergency has ended and apply the processes to certain priority products. Speaking at an Alliance for a Stronger FDA briefing 5/10, Marks said a
Drugs
FDA has approved an oral suspension formulation of Mitsubishi Tanabe Pharma America’s Radicava (edaravone) for treating adults with amyotrophic lateral sclerosis (ALS). Radicava was originally approved in 2017 as an intravenous (IV) infusion to treat ALS (Lou Gehrig’s disease). Radicava ORS is self-administered and can be taken
Devices
The Government Accountability Office (GAO) says FDA should develop a policy for using enforcement discretion regarding unauthorized diagnostic tests in future public health emergencies. “This policy should include the conditions under which FDA would begin and end the use of such discretion,” a GAO report says. GAO says it was