Drugs
Bristol Myers Squibb (BMS) has reported that its COMMANDS Phase 3 study evaluating Reblozyl (luspatercept-aamt) met its primary endpoint in first-line treatment of anemia in adult patients with myelodysplastic syndromes who require red blood cell transfusions. The endpoint was the significant and clinically meaningful improvement in red blood
Devices
FDA is recommending that health care providers discuss alternative magnetic resonance imaging (MRI)-guided breast biopsy options for patients if facilities are unable to perform these due to a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables. Late last month, Philips issued a
Devices
FDA is alerting patients and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. “A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited,” an agency notice
Devices
FDA has cleared a Fresenius Medical 510(k) to implement changes to its 2008T hemodialysis machines that include use of modified silicone tubing in the hydraulics of the machine, specifically platinum catalyst silicone tubing. The clearance addresses certain machines that FDA warned about earlier this year about the potential risk
Biologics
FDA has issued Gilead a complete response letter on its BLA for bulevirtide, an investigational entry-inhibitor for treating adults with hepatitis delta virus (HDV) infection and compensated liver disease. FDA’s letter cited concerns about the “manufacture and delivery of bulevirtide,” according to the company, adding that no new
Drugs
FDA is relaxing advertising and promotion restrictions placed on six Covid-19 emergency use authorizations (EUA) after determining that “there may be benefit in clarifying the condition” for “EUA sponsors that wish to include in promotional materials information about the safety and efficacy data that supported the EUA’s issuance.
Drugs
FDA has posted a seven-item Form FDA-483 from an inspection of New England Life Care (dba Advanced Compounding Solutions) earlier this year. During the inspection, the agency cited the firm’s failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its
Biologics
FDA’s Oncologic Drugs Advisory Committee 10/28 voted 16 to 0 that Y-mAbs Therapeutics’ BLA for I-omburtamab, seeking an indication for treating pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, did not provide sufficient evidence to conclude that omburtamab improves overall survival. FDA medical reviewers told panel
Drugs
FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10/26 to recommend approval of GlaxoSmithKline’s (GSK) anemia drug daprodustat for use in treating chronic kidney disease (CKD) in adult patients on dialysis, but it did not support approval in those who are not on dialysis. Panel members voted
Devices
A California state court has upheld PMA preemption in a case involving a Medtronic spinal cord stimulator. Attorney Michelle Yeary (Dechert) writes in the Drug and Device Law blog that the plaintiff in the case brought claims for strict liability, failure to warn, negligence, and negligent misrepresentation. Yeary says Medtronic
Drugs
CDER director Patrizia Cavazzoni says Don Ashley is retiring after more than 29 years in federal service, including the last six years as director of CDER’s Office of Compliance (OC). Cavazzoni says Ashley transformed OC into a higher-performing organization with a well-defined strategic focus and wide-ranging
Drugs
FDA principal deputy commissioner Janet Woodcock told a Council for Federal Cannabis Regulation Webinar that the agency is exploring what flexibilities it might have as part of President Biden’s order for a marijuana scheduling review. But Woodcock cautioned that while FDA will lead the scientific and medical evaluation of
Drugs
FDA has made available a draft guidance entitled “Clostridioides difficile Infection (CDI): Developing Drugs for Treatment, Reduction of Recurrence, and Prevention.” The document says clinical trials for drugs to treat CDI should be randomized, double-blinded, and controlled. “Sponsors should use an active control in trials for CDI treatment and
Drugs
Three FDA officials say the agency is continuing to work with stakeholders to advance treatment options for children. Writing in an FDA Voice post, the three say FDA is working to: * improve the timeliness of pediatric medical product development; * engage patients and their families in clinical research; and * collaborate with
Drugs
FDA medical reviewers say they are unable to establish a substantive risk/benefit relationship for using Y-mAbs Therapeutics’ I-omburtamab in pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. The reviewers raised their concerns in a briefing paper released in advance of a 10/28 meeting of the Oncologic
Devices
The CDRH Digital Health Center of Excellence has published “Spotlight: Digital Health Regulatory Science Opportunities” highlighting important research areas identified by FDA and external stakeholders. The document describes the current regulatory science areas of interest in digital health for stakeholders to consider. “Advances in digital health occur rapidly,” CDRH says,
Drugs
GSK has abandoned plans to seek FDA approval for otilimab, an investigational monoclonal antibody targeting granulocyte-macrophage colony-stimulating factor (GM-CSF) as a treatment for moderate to severe rheumatoid arthritis (RA) in patients who did not respond to earlier treatments. The company says it based its decision on data
Drugs
FDA has published the Fiscal Year 2023 GDUFA Science and Research Priority Initiatives that were developed in collaboration with industry and the public. The document lists eight areas encompassing scientific challenges that the generic drug industry and the FDA generic drug program identified as being significant over the next five
Devices
FDA says Baxter International issued 10/21 an urgent medical device correction for its WatchCare incontinence management system due to the potential for radio frequency interference with other medical devices. An agency notice says that to date, interference in all cases but two occurred at distances less than one meter.
Devices
FDA has published a guidance, Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions, to help agency staff develop a request for additional information needed to decide on a medical device marketing application under the “least burdensome” provisions of the Federal Food, Drug, and Cosmetic Act. FDA
Devices
The Medical Device Innovation Consortium (MDIC) has published its first industry benchmark report assessing the cybersecurity maturity of the medical technology industry. The report was prepared by Booz Allen under a 4/2021 contract with MDIC. It ranks survey responses from medical device manufacturers on the Healthcare Sector Coordinating Councils’
Devices
Speaking at the 10/25 AdvaMed Medtech Conference, FDA commissioner Robert Califf said his preference would be for Congress to pass legislation on the regulation of laboratory-developed tests (LDTs). Asked how he would respond if Congress fails to act, Califf said, “That’s a tough question. You know, it’