FDA Policy/General
Joint Panel to Review Pfizer Osteoarthritis BLA Federal Register notice: FDA has announced a 3/24 joint meeting of the Arthritis and the Drug Safety and Risk Management Advisory Committees. Panel members are scheduled to discuss a Pfizer BLA for tanezumab subcutaneous injection, indicated for relieving signs and symptoms of
FDA Policy/General
Catalent Pharma Solutions has broken ground on a $34 million extension to its Madison, WI biologics manufacturing facility. When completed, the additional 22,000 square feet of space will accommodate two 2,000 liter single-use bioreactor systems, allowing the company to support late-phase clinical and commercial production of
FDA Policy/General
FDA has issued a revised final guidance entitled “Investigational Covid-19 Convalescent Plasma.” The agency has revised the recommendations in the guidance addressing convalescent plasma donors. The revisions discuss when individuals who have received an investigational Covid-19 monoclonal antibody therapy as a participant in a clinical trial, or received
Drugs
FDA has announced a 3/23 virtual public workshop entitled “Roadmap to 2030 for New Drug Evaluation in Older Adults” to discuss the current status of including older adults in clinical trials and strategies to ensure safe and effective drug use in the elderly. FDA says it is concerned about
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Application for FDA Approval To Market a New Drug” (OMB Control No. 0910-0001). The revision pertains to provisions established through the agency’s user fee programs, most recently authorized under the FDA Reauthorization Act of 2017.
Drugs
Federal Register notice: FDA has issued a priority review voucher to Alnylam Pharmaceuticals in response to its rare pediatric disease product application for Oxlumo (lumasiran) injection, indicated for treating primary hyperoxaluria Type 1 to lower urinary oxalate levels in pediatric and adult patients. To view the notice, click here.
Devices
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Device Tracking — 21 CFR Part 821” (OMB Control Number 0910-0442). FDA regulations provide it the authority to require by order that a manufacturer adopt a method for tracking a Class 2 or 3 medical
Biologics
FDA continues to struggle to inspect firms within its user fee application review timelines. The latest company impacted is Mallinckrodt, advised by the agency that action on one of its BLAs is being deferred pending a manufacturing site inspection that can’t be conducted due to Covid-19-related travel
Devices
FDA has granted BrainQ’s artificial intelligence (AI)-powered technology for ischemic strokes a breakthrough device designation based on the company’s latest randomized controlled clinical trial results. BrainQ says it is developing the AI-powered electromagnetic field therapy that aims to enhance recovery and reduce disability after neurological damage
FDA Policy/General
A provision in a budget reconciliation bill moving its way through the U.S. House of Representatives would provide FDA with a $500 million boost for Covid-19 activities. On 2/11, the House Energy and Commerce Committee considered portions of the bill, which will next be consolidated with reconciliation
Biologics
Moderna says it discussing with FDA a proposal to increase Covid-19 vaccine doses in each vial from 10 to 15 doses. The move would help increase the vaccination pace in the U.S. “Implementation of any such changes would be expected to be completed in approximately a two- to
Drugs
Ndal Mfg Inc. has recalled one lot of Manukaguard Allercleanse after determining the products were contaminated with yeast. “The use of Allercleanse (manuka honey) nasal spray contaminated with yeasts, in the population most likely to use it (children, adults, and elderly), may result in adverse events that necessitate medical or
Devices
FDA has classified as Class 1 a Boston Scientific recall of its Emblem S-ICD subcutaneous electrode because of an increased risk of fractures at the distal to the proximal sense ring. If the device fractures during use, it could become unable to deliver therapy to slow very fast heartbeats
Devices
FDA has cleared an Access Vascular 510(k) for its HydroMID midline catheter, which is made using the company’s proprietary biomaterial that it says has been shown to reduce thrombus accumulation by up to 97% when compared to standard polyurethane catheters. HydroMID is described as a 4 French, single
Drugs
CDER’s Office of Pharmaceutical Quality (OPQ) says that early this year it will begin using its Knowledge-aided Assessment & Structured Application (KASA) tool for solid oral dosage forms, manufacturing, and biopharmaceutics regulatory assessments. KASA has been under development for years to improve efficiency, effectiveness, and quality assessment consistency
Drugs
The 2020 annual report of the CDER Office of Generic Drugs shows that 948 ANDAs -- 223 or 19% fewer than in 2019 -- were approved or tentatively approved in 2020, including 72 first generic drugs. The report also shows that 187 product-specific guidances were issued for industry and other stakeholders,
Biologics
CBER director Peter Marks says FDA is starting to think about how to resequence vaccines to cope with emerging virus variants. Appearing as a guest on an American Medical Association Webinar, Marks says that for the Pfizer and Moderna mRNA vaccines, it requires only changing a computer program to change
Devices
Only 10% of artificial intelligence (AI) products cleared by FDA for use in breast imaging provided a breakdown of racial demographics of the data used to validate the algorithm’s performance in public summaries filed by manufacturers. A Stat analysis says the remaining 90% only said that they have been
Drugs
A new study (STEP) finds that 35% of those taking Novartis’ semaglutide for treating obesity lost more than one-fifth of their total body weight, according to University College London researchers. “Three quarters (75%) of people who received semaglutide 2.4mg lost more than 10% of their body weight and
FDA Policy/General
Some 94 oncology physicians, researchers, and leaders have signed a 2/11 letter to President Joseph Biden urging the selection of FDA acting commissioner Janet Woodcock to be the agency’s next commissioner. Those signing the letter include some who served on Biden’s Cancer Moonshot Blue Ribbon Panel when
Biologics
FDA has approved a Regeneron Pharmaceuticals BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza works by binding to and blocking the function of
Drugs
CDER Drug Safety Priorities 2020, the sixth annual report detailing the Center’s safety programs and activities, “highlights key safety-related milestones and accomplishments of 2020 and focuses on the programs and initiatives at the core of CDER’s drug safety operations,” the report says. It also looks at the