Biologics
Pfizer and BioNTech say they have submitted Phase 2/3 clinical trial data on their mRNA Covid-19 vaccine in children aged 5 to under 12 to FDA and will seek an emergency use authorization for that group in the coming weeks. The companies announced 9/20 positive topline results
Drugs
FDA has published a draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products, to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records (EHRs) or medical claims data in
Drugs
FDA says its review of a Web site and social media pages maintained by Supplement Science Corp., doing business as Condemned Labz, Brooklyn, NY, found significant violations of the Federal Food, Drug, and Cosmetic Act, including selling misbranded unapproved new drugs. A 9/22 Warning Letter lists claims the company
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s ongoing efforts to advance investigational drug safety reporting and provide guidance about sponsor responsibilities for safety assessments. In a 9/24 comment letter on an agency draft guidance, Sponsor Responsibilities — Safety Reporting Requirements for IND and Bioavailability/Bioequivalence
Drugs
FDA has granted priority review for ViiV Healthcare’s NDA for investigational, injectable cabotegravir long-acting for pre-exposure prophylaxis for preventing HIV. The company says the drug already received breakthrough therapy designation from FDA. The agency set a PDUFA target action date of 1/24/22. ViiV says the
Devices
Affordable Healthcare Solutions pleaded guilty in a Florida federal court to receiving adulterated medical devices in interstate commerce and delivery for pay with intent to defraud or mislead. The court fined the company and ordered it to forfeit $837,000 worth of medical devices seized during a search warrant executed
Drugs
FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The user fee review action target date is 1/30/2022. The submission is based on data
Biologics
Eisai has initiated a rolling BLA submission for lecanemab (BAN2401), the company’s investigational anti-amyloid beta (AB) protofibril antibody for treating early Alzheimer’s disease. The BLA, which is seeking accelerated approval, is based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in
Drugs
Pfizer has submitted a clinical trial protocol amendment to a Phase 3 gene therapy trial for fordadistrogene movaparvovec in Duchenne Muscular Dystrophy patients after three severe adverse events were reported. Based on these adverse events, individuals with mutations (exon deletion, exon duplication, insertion, or point mutation) affecting exons 9 through
FDA Policy/General
Federal Register notice: FDA has announced a 10/13-14 public workshop entitled “Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age.” The purpose of the public workshop is to discuss the state of science, data gaps, and challenges in drug
Drugs
Eli Lilly has recalled one lot of its Glucagon Emergency Kit for Low Blood Sugar (glucagon for injection, 1 mg per vial; diluent for glucagon, 1 mL syringe) after receiving a product complaint reporting that a vial of glucagon was in liquid form instead of the powder form. A company
Drugs
FDA has accepted for review two Bristol Myers Squibb supplemental BLAs for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. The agency has set
Devices
FDA says it intends to exercise enforcement discretion regarding a requirement for informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable. The requirement is articulated in a 2006 guidance document, but FDA now believes it is “possible in certain circumstances for IVD
Drugs
FDA has removed a clinical hold against a GeneTx Biotherapeutics and Ultragenyx Pharmaceutical clinical trial of GTX-102, an investigational treatment for Angelman syndrome. The companies are now permitted to begin dosing naive patients in a Phase 1/2 study in the U.S. in pediatric patients with Angelman syndrome.
Drugs
FDA and the United Kingdom are expanding their ongoing mutual recognition agreement (MRA) to include animal drug inspections. FDA says this will allow them to rely on each other’s inspection reports and related information, which will avoid duplication of some animal drug inspections and enable regulators to devote more
Devices
FDA is alerting health care providers on recent information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device. “The FDA is evaluating a study published in the Journal of the American Medical Association (JAMA) Cardiology,” an agency
Drugs
CDER director Patrizia Cavazzoni says agency inspectors are highlighting during inspections the importance of having in place effective risk-based change management and risk-based quality control. Speaking at the Parenteral Drug Association’s annual regulatory conference 9/27, Cavazzoni said this is part of FDA’s push for quality
FDA Policy/General
Sunscreen OTC Monograph Proposed Order Available 9/24/2021 Federal Register notice: FDA has made availability of an over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled “Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.” The order would amend and revise an
FDA Policy/General
Eli Lilly has acquired ARMO BioSciences at a price of $50.00 per share in cash (27.5 million outstanding shares). The transaction gives Lilly promising clinical immunotherapy asset, pegilodecakin, to its oncology portfolio. Roche has agreed to acquire all outstanding shares of Cambridge, MA-based Foundation Medicine that will
FDA Policy/General
DEVICES Alere Inc. has received FDA 510(k) clearance for its Alere i Strep A test for detecting Group A Streptococcus bacteria in throat swab specimens in eight minutes or less. FDA has cleared a Bruker 510(k) for library and methods expansion for the MALDI Biotyper CA clinical microbiology
Devices
Armstrong Medical has recalled its Amsorb Plus Prefilled G-Can 1.0L due to reports that some canisters have difficulties with gas flow that may cause a reduced flow of air to the patient. A recall notice says the difficulties in flow may cause a failure in the pre-use
FDA Policy/General
Federal Register notice: FDA has made availability of an over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled “Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.” The order would amend and revise an administrative order concerning nonprescription sunscreen drug products established by