Drugs
FDA has granted Reneo Pharmaceuticals a Fast Track designation for REN001 and its use in treating patients with primary mitochondrial myopathies (PMM). The company describes REN001 as an oral selective peroxisome proliferator-activated receptor delta agonist currently in clinical development for genetic mitochondrial diseases that typically present with myopathy and
Drugs
FDA has approved a Pacira BioSciences supplemental NDA to expand Exparel’s (bupivacaine liposome injectable suspension) label to include use in patients six years of age and older for single-dose infiltration to produce postsurgical local analgesia. The company says the approval provides an alternative to opioids, the current standard
FDA Policy/General
Federal Register notice: FDA is publishing a list of PMAs that have been approved from 10/1/2018 through 12/31/2020. The list is intended to inform the public of the availability of the PMA safety and effectiveness summaries. To view the notice, click here.
Biologics
AstraZeneca is being scrutinized over data it presented in a press release about its Covid-19 vaccine. In the release, the company touted data showing efficacy of 79% at preventing symptomatic Covid-19 and 100% efficacy at preventing severe disease and hospitalization (see story). Late 3/21, the study’s
Drugs
Oramed Pharmaceuticals says it has screened the first patients for the second of two concurrent Phase 3 studies of its ORMD-0801 oral insulin capsule for treating Type 2 diabetes. The company says the studies are being conducted under an FDA-approved protocol to treat Type 2 diabetes patients who
Drugs
Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage are jointly asking FDA not to authorize the New Mexico Health Department’s Section 804 drug importation program application and to disclose the identities of the foreign seller, importer, and FDA-registered
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for a 10/28 notice entitled “The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Request for Comments.” Electronic or written comments can now be submitted by 6/22. To view the notice, click
Drugs
A 3/19 petition filed by Loeb & Loeb on behalf of an unnamed client asks FDA to take specific actions about the adequacy of safety labeling for Incyte’s Jakafi (ruxolitinib) tablets, one of the JAK inhibitor drug products. The petition asks that: * FDA open a public docket to
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation. The approval was
Devices
An Alabama federal court has granted summary judgment to Sanofi-Aventis on both medical causation and preemption grounds in a case involving a Class 3 medical device that is a gel-like substance injected into a knee to reduce pain. Attorney Michelle Yeary (Dechert) writes in an online post that
Drugs
FDA is proposing to include quinacrine HCl on the list of bulk drug substances (active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding. A Federal Register notice says the substance is not a component of an FDA-approved drug and was nominated by the agency to compound oral
Drugs
The Department of Justice says Fresenius Kabi Oncology was sentenced to pay $50 million in fines and forfeiture for concealing and destroying records before a 2013 FDA plant inspection. A department statement says the company agreed to plead guilty to the misdemeanor offense. A Nevada federal judge accepted the company’
FDA Policy/General
FDA principal deputy commissioner and acting chief information officer Amy Abernethy will be leaving the agency in the next few weeks. “Throughout multiple commissioner transitions and a historic pandemic, Amy’s focus on the FDA’s core technology operations has resulted in a remarkable modernization of the agency’s technology
Devices
FDA has cleared a Recovery Force 510(k) for the Movement and Compressions System, a data-driven mobility measurement device designed for hospital and home use. The device provides therapeutic compressions to the lower leg and displays real-time patient mobility data. According to the company, it provides bedside caregivers
Drugs
FDA has given Cybrexa Therapeutics the green light to begin a clinical trial for solid tumor therapy CBX-12 (alphalex-exatecan). “Preclinical studies of CBX-12 show a strong efficacy and safety profile, and we expect that the Phase 1 clinical trial will help us learn more about the potential
Drugs
FDA says a Pfizer BLA for osteoarthritis drug tanezumab subcutaneous injection has a modest treatment effect and some safety concerns. In a briefing document released in advance of a 3/24-25 advisory committee meeting, agency reviewers said superior efficacy was not demonstrated with tanezumab over non-steroidal anti-inflammatory
Biologics
AstraZeneca is likely weeks away from seeking an FDA emergency use authorization for its Covid-19 vaccine after reporting interim data from a U.S. Phase 3 trial showing efficacy of 79% at preventing symptomatic Covid-19 and 100% efficacy at preventing severe disease and hospitalization. The company said vaccine
Drugs
FDA issued Warning Letters to two companies for selling products labeled as containing cannabidiol (CBD). FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved NDA, the agency says. The letters explain that
Drugs
FDA has announced a 4/23 virtual public workshop entitled “Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.” The workshop is intended to discuss nonclinical and clinical pharmacology data and clinical trial design issues for these drugs. Topic areas also include: * Animal models * Trial design considerations, such as
Devices
FDA has granted Tiger Tech Solutions an emergency use authorization for the first machine learning-based Covid-19 non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation. The device identifies certain biomarkers that may be indicative of Covid-19 infection
FDA Policy/General
SUNSET Rule Effective Date Postponed 03/19/2021 Federal Register notice: HHS is postponing, pending judicial review, the effective date of a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET final rule) that was published 1/19. The SUNSET final rule was scheduled to take effect 3/
Devices
FDA has announced a 5/4 virtual public meeting entitled “Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices.” Sources of patient generated data, data quality measures, interoperability, and potential impacts of the data in regulatory and healthcare settings will be discussed during the meeting. To