Drugs
SFJ Pharmaceuticals says it has closed the sale and transfer of assets related to bentracimab from PhaseBio Pharmaceuticals as part of a bankruptcy proceeding, and it is planning to file a BLA mid-year. Since 2020, the two companies had been co-developing bentracimab, a recombinant, human monoclonal antibody antigen-
Drugs
The Government Accountability Office (GAO) says HHS could improve its oversight of research involving enhanced potential pandemic pathogens. The GAO report faults a six-year-old HHS oversight framework that requires funding agencies to refer proposed research that is reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) says two Quality Management Maturity (QMM) pilots provided insights into how to design and implement a future QMM assessment protocol. Writing in the APPS Journal, OPQ staff say the program will continue to be developed with stakeholder input. “CDER is committed to providing
EIRs/483s
Federal Register notice: FDA is classifying prognostic tests for assessing liver-related disease progression into Class 2 (special controls). The devices are intended to measure one or more analytes obtained from human samples as an aid in assessing liver disease progression. The agency notes that they are not intended for
FDA Policy/General
An HHS Office of the Inpsector General (OIG) report says FDA should improve its management of contracts for acquiring information technology. As part of an audit program examining various HHS contracting operations, the OIG reviewed five FDA orders totaling $23.6 million paid to a contractor during fiscal years 2018-
Drugs
CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim says the Biosimilar User Fee Amendments 3 commitment letter includes goals for FDA to create foundational guidances for interchangeable biosimilar biological product development. Writing in an online CDER Conversation post, Yim says the intent is to develop guidances that cover
Drugs
A Florida woman was sentenced to three years in prison and three years of supervised release for making a false statement to an FDA investigator related to a clinical trial that studied the effectiveness of asthma drugs in children. The Department of Justice says Jessica Palacio of Miami was sentenced
Drugs
The DC Circuit Court of Appeals says Sandoz is not entitled to a solo period of marketing exclusivity for its generic version of Sanofi’s Aubagio (teriflunomide). Sandoz challenged the new chemical entity exclusivity granted to Aubagio, claiming that teriflunomide was previously “approved” as an impurity in the arthritis drug
Drugs
FDA is announcing a 3/8 workshop entitled “Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Using Real-World Evidence.” The workshop, which is mandated by the current drug user fee agreement, will be hosted by the Duke-Margolis Center for Health
Devices
FDA has approved Abbott’s latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, for treating people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. Aortic stenosis is the narrowing of the aortic valve’s opening, which restricts blood flow to the body.
Drugs
A 3/8-3/18/22 FDA inspection at Optum Infusion Services in Chandler, AZ, found “serious deficiencies” in the firm’s practices for producing drug products intended or expected to be sterile, which put patients at risk. A just-released 12/13/22 Warning Letter says the FDA inspector
Drugs
FDA has expanded its collaboration with CN Bio, described as a leading “organ-on-a-chip” company, for the second time. A company statement says the expanded collaboration will involve new research intended to evaluate multi-organ microphysiological systems and their applications using the PhysioMimix multi-organ system. “Building on
FDA Policy/General
FDA legislative and policy staff continue to have their sights on urging Congress to take up reforms for medical diagnostics, dietary supplement listing/registration, and supply chain information updates. These are some of the top priorities the agency’s legislative staff are working on this year, FDA deputy commissioner for
Drugs
FDA has released a draft guidance entitled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” which is intended to assist sponsors in identifying optimal dosage during clinical development and prior to submitting a marketing application. The guidance appears to aim at shaking
Biologics
The Western Texas federal court has granted an FDA motion to dismiss a lawsuit brought against the agency by a group of parents and the Children’s Health Defense who opposed the Covid-19 vaccines’ emergency use authorizations (EUAs) for use in children. In granting FDA’s motion, the court
Devices
Medtronic’s Coviden unit has recalled its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a “potential leaking condition within the hub of affected devices,” according to a recall notice. The leaking is due to an inter-lumen void in the hub component, which may result
Drugs
FDA has approved a Novo Nordisk label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg for a first-line treatment option for adults with Type 2 diabetes who have not previously started any treatment. “This update removes a previous limitation of use that stated the medication should not
Devices
Kambiz Youabian (Tarzana, CA) has pleaded guilty to a two-count information charging him with mail fraud and introducing misbranded medical devices into interstate commerce. The government says Youabian operated an almost $6 million scheme in which he knowingly sold used skin-tightening medical devices that were deliberately misbranded as
Drugs
AstraZeneca says it will permanently discontinue marketing and distributing Lumoxiti (moxetumomab pasudotox-tdfk) for injection 8/31. It is indicated for treating adults with relapsed or refractory hairy cell leukemia. In a company letter to healthcare professionals, it notes the discontinuation decision was not related to any safety or effectiveness
Biologics
FDA and CDC say a recent potential safety signal suggesting Pfizer’s bivalent Covid-19 vaccine may cause ischemic stroke in people aged 65 and older has not been validated after looking at various vaccine clinical trial and surveillance databases. The agencies note that the signal has not been identified
Drugs
An FDA inspection at the Alembic Pharmaceuticals solid oral drug formulation manufacturing facility in Jarod, Gujarat, India, resulted in an FDA-483 with five observations. The Indian financial news platform BQ Prime reports the company disclosed the 12/8-12/16/22 inspection in a financial exchange filing. BQ Prime
Biologics
FDA Vaccines and Related Biological Products Advisory Committee member Paul Offit, who is affiliated with the Vaccine Education Center at Children’s Hospital of Philadelphia and the University of Pennsylvania’s Perelman School of Medicine, says a lesson learned from the experience with bivalent Covid-19 booster shots is to