Biologics
Senior CBER officials and executives from BrainStorm Cell Therapeutics have agreed on a potential regulatory pathway for the company’s NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The company says that repeated intrathecal administration of NurOwn is currently being evaluated in
Drugs
FDA has placed a clinical hold on a LogicBio Therapeutics IND for LB-001 for treating methylmalonic acidemia (MMA) pending resolution of certain clinical and nonclinical questions. The company says it submitted the IND 1/2020 to support the initiation of a Phase 1/2 clinical trial in patients with
Drugs
The Washington Legal Foundation (WLF) is asking the 9th Circuit Court of Appeals to enjoin a California law that would presume that every drug company patent settlement is unlawful if it gives a generic manufacturer “anything of value,” including an “exclusive license,” and postpones generic market entry for even a
Drugs
Since its founding in 2015, the FDA Office of Pharmaceutical Quality (OPQ) has worked to “assure that all drugs marketed in the U.S. meet quality standards so that every dose is safe and effective, and free of contamination and defects.” In its 2019 annual report, OPQ says it has
Drugs
FDA has lifted its clinical hold on a Marker Therapeutics planned clinical trial investigating the safety and efficacy of its novel MultiTAA T-cell therapy in patients with post-transplant acute myeloid leukemia. The hold was initiated 11/12/19 when FDA requested additional information and technical specifications for two
Drugs
The Physicians Committee for Responsible Medicine says FDA should require that all product packaging and labeling for erectile dysfunction drugs disclose information on the role of cardiovascular disease in erectile dysfunction and the role of diet and lifestyle in cardiovascular health. The committee’s petition suggests wording that should be
Devices
FDA has cleared a Rist Neurovascular 510(k) for the Rist Cath Radial Access Long Sheath and its use to introduce interventional devices into the peripheral, coronary, and neurovascular system. The company says it is the first device specifically designed for accessing the neurovasculature through the radial artery in the
Drugs
Eli Lilly says it does not plan to pursue an NDA submission for solanezumab for treating patients with dominantly inherited Alzheimer’s disease, also known as autosomal dominant Alzheimer’s disease, based on recent clinical trial results. The company says that an analysis performed by Washington University School of Medicine
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health” (OMB Control Number 0910-0769). The collection involves information voluntarily submitted to CDRH on actual or potential health risk concerns about a medical device
Drugs
FDA has accepted for review a Janssen Pharmaceutical supplemental BLA for Darzalex (daratumumab) for use in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for relapsed/refractory multiple myeloma. The submission is supported by data from the Phase 3 CANDOR study, which compared treatment with the triple therapy to carfilzomib
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension on “Testing Communications on Medical Devices and Radiation-Emitting Products” (OMB Control Number 0910-0678). The agency conducts educational and public information programs related to medical device and radiation-emitting product safety. FDA says improving communications about devices
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed.” To view the notice, click here.
FDA Policy/General
President Trump has proposed a relatively flat (1.6% increase) $6.2 billion budget for FDA’s fiscal year 2021 budget, which includes $3.3 billion for budget authority and $2.9 billion in user fees. The only medical product program area seeing any increase (5%) is medical devices with
FDA Policy/General
A new FDA literature review on cell phone radiofrequency radiation (RFR) exposure on human health has found “no quantifiable adverse health effects in humans caused by exposures at or under the current cell phone exposure limits.” The review looked at peer-reviewed in vivo and epidemiological studies published from 2008
FDA Policy/General
2 Guides on Drug Interaction Studies Federal Register notice: FDA releases two final guidances on drug interaction studies. 02/7/2020 Priority Review Voucher for Vyondys 53 Approval Federal Register notice: FDA issues a priority review voucher for the approval of a rare pediatric disease product application — Sarepta Therapeutics’ Vyondys
FDA Policy/General
Aptevo Therapeutics, a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, has completed the sale of three of its marketed products (WinRho SDF, HepaGam B, and Varizig) to Saol Therapeutics for $74.5 million. Mallinckrodt has acquired InfaCare Pharmaceutical Corp., a privately held specialty pharmaceutical company focused
FDA Policy/General
Federal Register notice: FDA has classified human immunodeficiency virus (HIV) drug resistance genotyping assays using next generation sequencing (NGS) technology into Class 2 (special controls). The action is in response to a 3/19 de novo classification request by Vela Diagnostics USA for its Sentosa SQ HIV Genotyping Assay. The
Biologics
Two U.S. senators have asked FDA whether it has the necessary resources to ensure active pharmaceutical ingredients and other medical products and food imported from China are safe in light of the current coronavirus outbreak. In a 2/6 letter to FDA commissioner Stephen Hahn, senators Marco Rubio (R-
Devices
FDA has cleared an In2Bones Global 510(k) for the Quantum Total Ankle. The device treats patients who suffer from arthritis and is designed to improve patient mobility and increase stability, the company says. It features an anatomically designed talus with a dual radius of curvature to improve the dorsi
Devices
FDA has permitted the de novo marketing of Caption Health’s software to assist medical professionals in capturing cardiac ultrasound or echocardiography images. The software, called Caption Guidance, is considered an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help users capture images of a patient’s
FDA Policy/General
Federal Register notice: FDA has announced a draft guidance entitled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.” The document provides recommendations on submitting a BLA supplement to add a condition of use that previously has been licensed
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Premarket Approval of Medical Devices” (OMB Control Number 0910-0231). To view the notice, click here.