Devices
FDA has cleared a Medtronic 510(k) for its UNiD Spine Analyzer v4.0 planning platform, which includes a new “Degen Algorithm” for degenerative spine procedures. The algorithm uses machine learning to assist surgeons with planning and personalizing procedures for patients undergoing lower lumbar spine surgery, according to the company.
Devices
FDA has given 510(k) clearance to Onkos Surgical for its My3D personalized pelvic reconstruction system. The company says the system includes 3D printed implants, instruments, and models, as well as an advanced planning service to treat deformity, trauma, disease, and revisions where other treatments or revisions have failed. Included
Drugs
Citing its inability to conduct inspections in China due to Covid-19 travel restrictions, FDA has deferred action on a BeiGene BLA for tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma. The company says it was informed that FDA is delaying action
Biologics
FDA has completed an inspection in Denmark of Bavarian Nordic’s monkeypox vaccine manufacturing plant, a step that will lead to the release of thousands of doses for shipping to the U.S., according to an AP report. A recent investigative article in New York Magazine criticized the agency’s
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Kris A. Hampton-Bey II for a period of five years from importing or offering for import any drug into the U.S. FDA says it based the debarment on a finding that he engaged in a pattern of importing or
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Dr. Reddy’s Xeglyze (abametapir), indicated for the topical treatment of head lice infestation in patients six months of age and older. The regulatory review period is 4,573 days, of which 2,797 days
FDA Policy/General
Federal Register notice: FDA has determined that Hikma Pharmaceuticals Reglan (metoclopramide injection, USP) was not withdrawn due to safety or effectiveness issues. The determination allows FDA to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Reglan is indicated for relieving symptoms associated
Drugs
Washington Legal Foundation (WLF) says the California First District Court of Appeal should review and then overturn a trial court ruling that advances a “radical new theory for manufacturers of non-defective prescription drugs.” A WLF news release says plaintiffs in the case alleged injury from Gilead Science’s HIV/
Devices
FDA has approved PMAs for three additional Centinel Spine cervical total disc replacement devices. The company says the newly-approved units are the prodisc C Vivo, prodisc C Nova, and prodisc CSK, bringing to four the company’s PMA-approved total disc devices.
FDA Policy/General
Legislation proposed by Rep. Rosa DeLauro (D-CT), chair of the House Appropriations Committee, and Sen. Dick Durbin (D-IL) would remove food safety from FDA’s list of responsibilities by creating a separate Food Safety Administration. In a statement (includes links to the bill text and a fact sheet)
Devices
FDA says the American Contract Systems 5/1 recall of 166,400 Covid Test Kits Nonsterile and Clean Catch Urine Kits is Class 1. An FDA notice says the kits were distributed between 2/1/21 and 3/31/22 and were recalled because they were assembled in an uncontrolled
FDA Policy/General
FDA commissioner Robert Califf wants to see evidence generation greatly improved during his tenure as the agency’s chief executive, a tenure that he foreshadowed will likely run through the end of the current Administration. Speaking during an Alliance for a Stronger FDA online fireside chat 7/12, Califf said
Drugs
In a joint blog post, FDA commissioner Robert Califf and U.S. Patent and Trademark Office (USPTO) director Kathi Vidal discuss initiatives their two agencies are undertaking to execute the Biden administration’s agenda to lower drug prices and promote competition. “These initiatives will strengthen our relationship and expand the
Devices
FDA has accepted a PMA module from Empirical Spine for its LimiFlex Dynamic Sagittal Tether (DST), a spinal implant for grade 1 degenerative spondylolisthesis (degen spondy) patients with spinal stenosis. The submission included module II, which the company says was accepted and closed by the agency, and module 3 is
Devices
FDA has granted de novo marketing authorization for the Apollo Endosurgery Apollo ESG and Apollo Revise endoscopic systems for patients with obesity. The company says they are the first medical devices authorized by FDA for endoscopic sleeve gastroplasty and endoscopic bariatric revision.
Biologics
FDA has granted an emergency use authorization for Novavax’s Covid-19 Vaccine, Adjuvanted for preventing disease caused by severe acute respiratory syndrome coronavirus 2 in individuals 18 years of age and older. This is the fourth Covid vaccine permitted for use in the U.S., joining vaccines from Pfizer/
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for AbbVie’s Rinvoq (upadacitinib), indicated for treating adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The review period is 2,604 days, of which 2,
Devices
FDA has given 510(k) clearance to the Philips SmartSpeed artificial intelligence (AI)-powered MR acceleration software. The company says SmartSpeed adds advanced AI data collection algorithms to its existing Compressed SENSE MR acceleration engine to deliver higher image resolution with three times faster scan times and virtually no loss
Drugs
Citrus Pharmaceuticals says that as a result of a pre-BLA meeting with FDA, it plans to submit a BLA later this year for I/ONTAK (denileukin diftitox) to treat patients with persistent or recurrent cutaneous T-cell lymphoma. The company says I/ONTAK is a purified and more bioactive
Drugs
FDA has lifted the clinical hold placed on the Greenwich LifeSciences Flamingo-01 Phase 3 clinical trial of the company’s GLSI-100 as a treatment for some invasive breast cancers. Greenwich says FDA placed the hold due to concerns over manufacturing and the pharmacy process. The statement says discussions
Drugs
Catalyst Pharmaceuticals says it has settled ongoing patent infringement litigation with Jacobus Pharmaceutical Co. and PantherRx Rare. Catalyst had asserted that Jacobus and PantherRx induced infringement by third parties of Firdapse (amifampridine)-related patent rights in their marketing and distribution of Ruzurgi (amiframpridine). Catalyst says that as part of the
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a draft guidance entitled “Risk Management Plans to Mitigate the Potential for Drug Shortages.” Comments can now be submitted by 8/31. To view the notice, click here.