Biologics
FDA has accepted for priority review a Biogen and Eisai BLA for aducanumab, an investigational treatment for Alzheimer’s disease. The agency has set a user fee review action date of 3/7/2021. If approved, aducanumab would be the first therapy for reducing Alzheimer’s “clinical decline,” according to
Drugs
FDA has made available a draft guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to help sponsors determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing a systematic, risk-based approach. When evaluating the potential for a DDI, FDA
Drugs
FDA has approved Genentech’s Evrysdi (risdiplam) for treating spinal muscular atrophy (SMA) in adults and children two months of age and older. SMA is a rare and often fatal genetic disease affecting muscle strength and movement. The hereditary disease causes weakness and muscle wasting because patients lose lower motor
Devices
FDA has cleared a Joimax PMA for its Intracs, an electromagnetic navigation tracking and control system, which the company says allows spinal procedures to be carried out with minimal X-ray control. Joimax says all of the device's instruments and scopes can be tracked and navigated with sensors,
Drugs
California has reached a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Frauds Prevention Act involving the marketing of Humira (adalimumab), indicated for treating arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. “AbbVie agreed to reform its Humira marketing practices
Drugs
FDA has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) as a complete regimen for treating HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed on a stable regimen with no history of treatment failure and no known resistance to the individual components of Dovato.
Drugs
The FDA FY 2019 annual report on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) shows that the majority of the requirements and commitments were completed or are moving toward completion according to the original schedule. “Very few PMRs/PMCs are ‘delayed,’” the agency says in a statement
FDA Policy/General
Federal Register notice: FDA has made available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.’’ The document provides information on implementing the pathway which is a provision of the 21st Century Cures Act. To view the notice, click here.
Drugs
The Rare Disease Clinical Trial Network (RDCRN) funded by the National Institute of Health says there is a need for a Rare Disease Clinical Trial Resource Center that could be leveraged by existing research networks or consortia doing global clinical research in rare diseases. The recommendation is part of the
Drugs
FDA has granted GlaxoSmithKline accelerated approval for Blenrep (belantamab mafodotin-blmf) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Approval was based on data from the DREAMM-2,
Drugs
Ferring Pharmaceuticals has recalled all lots of DDAVP (desmopressin) nasal spray 10 mcg/0.1mL, desmopressin acetate nasal spray 10 mcg/0.1mL, and Stimate (desmopressin) nasal spray 1.5 mg/mL. The products are being recalled due to superpotency concerns, an out-of-specification result detected during routine testing.
Biologics
FDA commissioner Stephen Hahn has written a Washington Post opinion column to reassure Americans that “all FDA decisions (on Covid-19 vaccines) have been, and will continue to be, based solely on good science and data. The public can count on that commitment.” In the column, Hahn says that while
Drugs
The Department of Justice says an Ohio federal grand jury on 7/31 returned a 19-count indictment charging eight people with participating in a scheme to defraud eight drug companies and FDA through conducting fraudulent clinical trials. A department statement says the eight were charged with conspiracy to commit
Biologics
More than 250 experts in virology, epidemiology, vaccinology, infectious disease, clinical care, and public health have signed a letter to FDA commissioner Stephen Hahn urging that no Covid-19 vaccine be made widely available until FDA has been able to evaluate safety and efficacy data from completed Phase 3 clinical
Devices
FDA will hold an 8/12 virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-Cov-2. An agency notice says the purpose of the town hall is to help answer technical questions about the development and validation of tests
Drugs
The White House says President Trump is signing 8/6 an Executive Order to increase American production of essential medical supplies and cut down U.S. reliance on foreign drug producers. Under the order, FDA is directed to create a list of drugs, medical countermeasures, and “critical inputs” that are
Devices
FDA has cleared a Surmodics 510(k) for its Sublime Radial Access 0.014 Rapid Exchange percutaneous transluminal angioplasty dilatation catheter. The device allows below-the-knee access through a transradial approach by providing a long working length (250 cm), according to the company. Outer balloon diameters range from 2.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Extralabel Drug Use for Animals — 21 CFR 530” (OMB Control Number 0910–0325). The collection supports FDA’s requirement that an analytical method be developed for detecting residues from the extralabel use of a drug. To view the
Drugs
The Justice Department is pursuing claims against Purdue Pharma worth nearly $13 billion in penalties, after finding evidence of criminal and civil misconduct in the company’s alleged role in fueling the opioid crisis in the U.S. Reuters reports in an exclusive story that the details of the government’
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-A Ti Anterior Lumbar Spacer System, intended for use for anterior fusion procedures. The company says the device comes in multiple footprint sizes and in various heights to accommodate individual patient anatomies and pathologies to promote fusion. It features
Devices
CME America has recalled its BodyGuard Infusion Pump System because the device may have a slower than expected delivery of medication (under-infusion), faster than expected delivery of medication (over-infusion) or a delay in therapy. A recall notice says the reason for the infusion errors is not known. “Depending