Drugs
FDA has denied a 10/21/21 petition submitted by BioDelivery Sciences International, Raleigh, NC, asking the agency to take certain actions on applications for follow-on buprenorphine buccal film products. Specifically, the petition asked that the agency: * require any applicant for a low or high pH buprenorphine buccal film
Biologics
The American Medical Association (AMA) has bestowed its Award for Outstanding Government Service on CBER director Peter Marks, recognizing his leadership during the Covid-19 pandemic. “Dr. Marks has worked tirelessly throughout the Covid-19 pandemic to make sure the Covid-19 vaccine development process was transparent, based on rigorous
FDA Policy/General
Federal Register notice: FDA has updated its current listing of medical devices that have received an Emergency Use Authorization during the Covid-19 public health emergency. To view the notice, click here.
Drugs
Provention Bio has resubmitted its BLA for teplizumab for the delay of clinical Type 1 diabetes (T1D) in at-risk individuals. The agency has set an 8/17 user fee review action target date. In 7/2021, FDA issued a complete response letter stating that a single, low-dose pharmacokinetic/
Drugs
FDA has approved Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab-rmbw), described as a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a fixed-dose intravenous infusion, for treating adult and pediatric patients age 12 and older with unresectable or metastatic melanoma. The company
Drugs
The Association for Accessible Medicines (AAM) says there are steps the Federal Trade Commission and Department of Justice could take to modernize the enforcement of antitrust laws regarding mergers. In its 3/21 response to the agencies’ 1/18 request for information, AAM addresses the anticompetitive challenges caused by merger
Devices
FDA and representatives of the medical device industry have reached an agreement on provisions to send to Congress to reauthorize MDUFA. An FDA announcement says that under the agreement, the agency would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding,
Devices
FDA has cleared a Quantum Surgical 510(K) for its Epione, described as a new category of interventional oncology robotics dedicated to liver cancer treatment. The robotic-assisted device is designed to plan, target, deliver and confirm tumor ablation. “Epione enables clinicians to perform safe and effective percutaneous tumor ablations,
Drugs
Federal Register notice: FDA has announced an Emergency Use Authorization issuance to Eli Lilly for bebtelovimab and its use in treating mild-to-moderate Covid-19 in certain adults and pediatric patients who are at high-risk for progression to severe disease, including hospitalization or death. To view the notice,
Drugs
FDA has published an immediately-in-effect guidance, Certain Ophthalmic Products: Regarding Compliance with 21 CFR Part 4, with information on compliance with the regulatory requirements for ophthalmic drugs packaged with eyecups, eye droppers, or other dispensers. The document says FDA was issuing it without advance time for comments because
FDA Policy/General
Federal Register notice: FDA has established a docket to solicit comments that will assist the agency in determining how best to prioritize the addition of maximum daily exposure (MDE) information for inactive ingredients that do not currently include MDE information in CDER’s Inactive Ingredient Database (IID) and whether to
FDA Policy/General
Federal Register notice: FDA has corrected a 3/10 notice on a draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” It now reflects that either electronic or written comments can be submitted until 5/9. To view the notice, click here.
Biologics
FDA has announced a 4/6 virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future Covid-19 vaccine booster doses and the process for selecting specific coronavirus strains for vaccines to address current and emerging variants. The agency says no product-specific discussion
Drugs
FDA has posted a Cadila Healthcare (a Zydus Lifesciences company) Form FDA-483 that provides details of GMP violations identified in a 3/10 FDA Webview story. For example, during FDA’s inspection of the firm’s Jarod, Gujarat (India) injectable facility between 2/24 and 3/10, the 483
FDA Policy/General
Federal Register notice: FDA has corrected a 3/10 notice on a draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” It now reflects that either electronic or written comments can be submitted until 5/9. To view the notice, click here.
Drugs
AstraZeneca says new preclinical authentic “live” virus data from Washington University School of Medicine demonstrated that the company’s Evusheld (tixagevimab co-packaged with cilgavimab) “retains potent neutralizing activity against the emerging and highly transmissible Omicron SARS-CoV-2 BA.2 subvariant. The data also showed that Evusheld retains activity
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for treating patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test. The therapy is indicated for those who have disease progression following prior systemic therapy in any setting
Devices
FDA is offering “conservation strategies” for healthcare professionals using prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/flush syringes due to potential supply shortages. The devices are in shortage “because of an increase in demand during the Covid-19 public health emergency, as well as recent vendor supply chain
Devices
FDA has classified as Class 1 a Philips Respironics recall of certain V60 and V60 Plus ventilators because some of the devices had parts that were put together using an expired adhesive. “If the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the
FDA Policy/General
EUA for Abbott’s BinaxNow Revoked 3/18/2022 Federal Register notice: FDA has revoked an Emergency Use Authorization (EUA) issued to Abbott Diagnostics Scarborough for the BinaxNOW Covid-19 Ag Card 2 Home Test. FDA says Abbott never marketed the test under the EUA, and the product is subsequently
Drugs
DEVICES FDA has cleared a Hologic 510(k) for the Cynosure body contouring product, SculpSure, to treat the back and inner and outer thighs. The SculpSure treatment is already FDA-cleared for treating abdomen and love handles (flanks). Hologic says the device uses a selective wavelength laser to precisely target
FDA Policy/General
OncoImmune has entered into an exclusive option and license agreement with Pfizer for ONC-392, a novel, differentiated preclinical anti-CTLA4 monoclonal antibody, in a deal worth up to $250 million in upfront and potential milestone payments. Under the terms of the agreement, Pfizer plans to evaluate ONC-392 up