Drugs
Aquestive Therapeutics, which is testing Libervant (diazepam) buccal oral film for seizure clusters, is asking FDA to stay approval of Neurelis’ 505(b)(2) NDA for Valtoco (diazepam intranasal solution) until additional clinical studies have been conducted that would allow for adequate labeling as requested by Aquestive. An Aquestive 11/
Drugs
Tonix Pharmaceuticals says that for its Phase 3 study of Tonmya (cyclobenzaprine sublingual tablets) to treat post-traumatic stress disorder (PTSD), the timing of the primary endpoint analysis has been changed from week 4 to week 12. The company also says it plans to add an interim analysis that allows
FDA Policy/General
Politico’s Prescription Pulse online newsletter says that FDA principal deputy commissioner Amy Abernathy has been named the agency’s acting chief information officer and begun an overhaul of its tech structure. She tells Prescription Pulse she became acting chief information officer “because it became clear that the first thing
Devices
FDA says that as of 9/1, 1,002 patients have been enrolled in a Bayer Essure medical device postmarket study, with 329 enrolled in the group who elected Essure and 673 in the group who elected laparoscopic tubal ligation. The agency also updated its information on device removal reports
Drugs
Fagron has recalled its Lets Gel Kit Convenience Packs due to potential microbial contamination of non-sterile products. The packs are used as a topical anesthetic and packaged in boxes containing lidocaine hydrochloride, epinephrine bitartrate, tetracaine hydrochloride, sodium metabisulfite, suturagel methylcellulose base, an adapter cap and syringes, according to a
Devices
Philips Medical Systems has recalled (Class 1) the Forte Gamma Camera System due to a “nonconforming material/component.” The camera is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel. According to a recall notice, an
Drugs
FDA has approved a RedHill Biopharma NDA for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg /250 mg/12.5 mg for treating Helicobacter pylori (H. pylori) infection in adults. The company says Talicia is the only rifabutin-based therapy approved for treating the infection and is
Devices
FDA has cleared a DiFusion 510(k) for the Xiphos-ZF Spinal interbody device. The device uses a new biomaterial called ZFuze, according to the company. Multiple studies have shown that the ZFuze material elicits pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6,
FDA Policy/General
Hep D Virus Drug Development Guide Federal Register notice: FDA makes available a draft guidance entitled “Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.” 11/01/2019 Draft Guide on Generic Drug User Fees Federal Register notice: FDA makes available a draft guidance entitled “Assessing User Fees under the
FDA Policy/General
Ligand Pharmaceuticals has entered into a worldwide license agreement with xCella Biosciences to permit xCella to use the OmniRat, OmniMouse and OmniFlic platforms to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive annual platform access payments, development and regulatory milestone payments and royalties for each product
FDA Policy/General
DEVICES FDA has approved an Acclarent de novo petition to permit marketing of the Aera Eustachian Tube Balloon Dilation System for treating persistent eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. FDA has approved a Medtronic PMA for the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.” The document addresses the agency’s current recommendations for the overall development program and clinical trial designs for developing such drugs/biologics. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessing User Fees under the Generic Drug User Fee Amendments of 2017.” The document provides stakeholders information about user fee policies and procedures. It revises and replaces FDA’s earlier draft guidance under the same titled published 10/2017.
FDA Policy/General
President Donald Trump 11/1 nominated MD Anderson chief medical officer Stephen Hahn to be FDA commissioner. Current acting commissioner Ned Sharpless is unexpectedly heading back to his previous position as National Cancer Institute dirctor. While Hahn navigates the Senate confirmation process, HHS assistant secretary for health Brett Giroir will
FDA Policy/General
Federal Register notice: FDA has announced a 12/10 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Correvio International NDA for vernakalant HCl solution for the proposed indication of rapid conversion of recent onset atrial fibrillation to sinus rhythm for non-surgery patients. To
Drugs
Novartis says its EXCEED head-to-head trial comparing Cosentyx (secukinumab) to AbbVie’s Humira (adalimumab) in patients with active psoriatic arthritis (PsA) “missed statistical significance for superiority” in the composite measure ACR 20, but Cosentyx did show numerically higher results versus Humira. “Statistically significant advantages of Cosentyx versus Humira
Drugs
An FDA update on an ongoing investigation about a contaminant known as N-Nitrosodimethylamine (NDMA) found in ranitidine (Zantac) says that preliminary testing on numerous ranitidine products has found NDMA levels that are similar to levels consumers would normally be exposed to in foods like grilled or smoked meats. “We
Devices
FDA has cleared an Xact Robotics 510(k) for its robotic system and its use during computed tomography guided percutaneous interventional procedures. The company says its technology is the “first hands-free robotic system combining image-based planning and navigation with insertion and steering of various instruments to a desired
Devices
Thoratec Switzerland has recalled its CentriMag Acute Circulatory Support System Motor, which is a component of the CentriMag Extracorporeal Blood Pumping System, because of the potential for electromagnetic interference. A recall notice says that reports have been received about the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic
FDA Policy/General
Federal Register notice: FDA has determined that Boehringer Ingelheim’s Mexitil (mexiletine hydrochloride) capsules, 150 mg, 200mg, and 250 mg, were not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference Mexitil if all other legal and regulatory requirements are met.
Devices
FDA has cleared a Stryker 510(k) for its Sahara Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology. The company says the 3D-printed lateral expandable fusion device “features passive expansion capabilities that are designed to allow surgeons to achieve up to 30 degrees of sagittal spinal correction
Devices
Sens. Elizabeth Warren (D-MA), Patty Murray (D-WA), and Tina Smith (D-MN) are raising additional questions on the CDRH software pre-certification program after receiving the 6/19 response from FDA acting commissioner Ned Sharpless and CDRH director Jeffrey Shuren to the senators’ initial 10/18/18 questions.