Drugs
AbbVie has submitted a supplemental NDA for venetoclax in combination with a hypomethylating agent or in combination with low-dose cytarabine for treating newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The submission is based on investigational data from two studies: M14-358, a
Devices
BioElectronics has submitted a 510(k) for ActiPatch and its over-the-counter adjunctive use in treating musculoskeletal pain. The device is currently cleared for adjunctive treatment of pain from knee osteoarthritis and plantar fasciitis. The expanded market clearance would allow for additional use for the back, neck, hip, shoulder,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.” The document provides recommendations related to product development, preclinical testing, and clinical trial design for such products. To view the notice, click here.
Biologics
FDA has accepted for review a Genentech BLA for a subcutaneous formulation of Herceptin (trastuzumab) and its use in FDA-approved breast cancer indications. This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE technology), which is approved and marketed under the Herceptin subcutaneous brand in
Drugs
In 12 years on the DC Court of Appeals, Supreme Court nominee Brett Kavanaugh has helped decide some cases in favor of FDA, while ruling against the agency in others. A Stat News analysis reports that Kavanaugh was part of an 8-2 majority when the appeals court upheld a
Drugs
An FDA pooled study of five registration trials of cyclin-dependent kinases 4/6 (CDK4/6) found that all subgroups of patients with estrogen receptor-positive HER2-negative metastatic breast cancer benefited from the addition of the kinases to endocrine therapy. An ASCOPost online story says the study results were
Drugs
FDA has published three new draft guidances on development of gene therapy products for specific diseases. The agency also has released new and comprehensive updates to three existing guidances that address manufacturing issues related to gene therapy. A statement from FDA commissioner Scott Gottlieb (includes links to all six guidances)
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products” (OMB Control Number 0910-0429). The guidance was issued to help individuals with procedures on formal meetings between FDA and sponsors
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.” The document is intended to assist sponsors in all phases for developing antiviral drugs for treating or preventing smallpox. It revises a 2007 draft guidance similarly named. To view
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that an Arog Pharmaceutical booth display and Web page for its investigational new drug Crenolanib besylate suggest that the drug is safe and effective for the purposes for which it is being investigated or otherwise promote the drug. A 6/28
Devices
FDA has approved a Medtronic PMA for a less-invasive implant approach for its HVAD System, a left ventricular assist device (LVAD) for patients with advanced heart failure. The device is the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral surgical incision between the
Drugs
The Department of Justice has launched a Task Force on Market Integrity and Consumer Fraud authorized under an Executive Order signed by President Trump to focus on combating fraud against consumers — particularly the elderly, service members, and veterans — and corporate fraud that victimizes the general public and the government. Deputy
Biologics
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating previously treated patients with advanced hepatocellular carcinoma. The submission is based on data from the Phase 2 KEYNOTE-224 trial, which were recently presented at the 2018 American Society of
Devices
FDA has cleared a Zebra Medical Vision 510(k) for its Coronary Calcium Scoring algorithm for automatically calculating a patient’s Agatston equivalent coronary calcium score from ECG gated CT scans. “Zebra’s algorithm could run on CT studies of the chest and potentially help identify people with cardiovascular risk
Drugs
AbbVie says it supports the FDA establishment of a public docket to assist with development of a guidance document on assessment of drug-drug interactions (DDI) for therapeutic proteins (TP). It recommends that characterization of DDIs for TPs be conducted clinically. It says that exceptions to this recommendation should only
Drugs
A Niskanen Center white paper says that over the years, FDA “has strayed from its mission by mandating clinical trials that require far more than evidence of safety and effectiveness.” The paper says this mission shift, which Congress has allowed to happen, has increased drug development times, costs, and prices.
Drugs
FDA is requiring safety labeling changes for fluoroquinolone antibiotics to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances, and to make the warnings more consistent across the labeling for all fluoroquinolones taken by mouth or given by injection. An agency news release
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency’s FY 2019 budget request includes a $100 million medical data enterprise proposal to build a modern system that would rely on the electronic health records from some 10 million lives. Writing in an FDA Voice blog post, Gottlieb says the new system
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping” (OMB Control Number 0910-0230). To monitor drug safety and efficacy of marketed drugs, the agency has issued regulations to implement reporting and recordkeeping requirements on the
Drugs
A 9/11-9/15/17 FDA inspection at Zhuhai United Laboratories, Zhuhai, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 6/27 Warning Letter says specific deviations were: * failing to adequately investigate and document out-of-specification results according to a
FDA Policy/General
Federal Register notice: FDA has announced an 8/3 joint Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee meeting. Panel members are scheduled to discuss results from assessments of the transmucosal immediate-release fentanyl medicines’ risk evaluation and mitigation strategy that was approved
Drugs
FDA has issued a draft guidance, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention, to assist sponsors in clinical development of drugs for treating or preventing smallpox infection. “Clinical efficacy trials of drugs for the treatment or prevention of smallpox are not feasible,” the document says, “and challenge