Drugs
AstraZeneca has told development partner Innate Pharma that it is discontinuing a monalizumab study after a planned futility interim analysis of the INTERLINK-1 Phase 3 study, sponsored by AstraZeneca, did not meet a pre-defined threshold for efficacy. The INTERLINK-1 study was evaluating monalizumab in combination with cetuximab
Drugs
FDA has published a final guidance entitled “Changes to Disposable Manufacturing Materials: Questions and Answers.” The document describes chemistry, manufacturing, and controls post-approval changes related to disposable manufacturing materials that applicants can use in drug and biological product manufacturing. It addresses questions the agency has received about the limited
Devices
Law firm Sidley has drawn attention to a recent southern Florida federal court dismissal of a whistleblower lawsuit that declined to “embrace the arguments asserted in a Statement of Interest filed by Department of Justice (DoJ).” In a post on Sidley’s False Claims Act (FCA) blog, the law firm
Drugs
FDA has granted Omeros an orphan drug designation for OMS906 and its use in treating paroxysmal nocturnal hemoglobinuria (PNH). The rare, life-threatening disease is characterized by red blood cell destruction, blood clots and impaired bone marrow function. The company says that based on OMS906’s mechanism of action as
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Acceleron Pharma’s Reblozyl (luspatercept-aamt), indicated for treating anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. The regulatory review period is 3,041 days, of which 2,822
Devices
FDA has cleared a Siemens Healthineers 510(k) for the ARTIS icono ceiling, a ceiling-mounted angiography system designed for routine and advanced procedures in interventional radiology and cardiology. The device’s new rotational capabilities and simplified cabling of its C-arm permit cone beam CT data acquisitions in 2.
FDA Policy/General
The Federal Trade Commission (FTC) has published in the 7/26 Federal Register long-anticipated draft proposed revisions to its “Guides Concerning the Use of Endorsements and Testimonials in Advertising.” Comments can be submitted by 9/26. An online post by Kleinfeld, Kaplan & Becker attorney Samantha Hong expects the
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 5/20 Federal Register announcing the approval withdrawals for 21 ANDAs involving multiple applicants. Bionpharma, Sunny Pharmtech, and Unicorn Pharmaceuticals subsequently notified the agency that the referenced ANDAs should not be withdrawn and FDA is correcting the notice
Drugs
FDA commissioner Robert Califf warned 7/28 that FDA employees affected by user fee funds could start getting layoff notices in early September if House and Senate leaders don’t complete the user fee reauthorization legislative package in the coming weeks. Lawmakers are at a standstill over language added to
Devices
An FDA safety communication warns consumers about the potential risk of injury associated with using certain brands of ultraviolet (UV) wands. “Do not use these UV wands for disinfection because they may expose the user or any nearby person to unsafe levels of ultraviolet-C radiation and may cause injury
Drugs
Attorney Daniel Feith (Sidley Austin) says a recent New Jersey federal court decision in a failure-to-warn case involving Merck’s Fosamax (alendronate sodium) helps industry broaden preemption of such claims. Writing in a Washington Legal Foundation Legal Backgrounder, Feith says the case was returned to the New Jersey
Drugs
The National Cancer Institute (NCI) says researchers at the biotechnology company Xilis have used micro-organospheres to accurately predict in a small study of eight colorectal cancer patients whether oxaliplatin would shrink their tumors. The researchers, funded in part by NCI, created the micro-organospheres with tissue from a patient’
Drugs
FDA has accepted for review an Acer Therapeutics NDA resubmission for ACER-001 (sodium phenylbutyrate) for oral suspension for treating patients with urea cycle disorders (UCDs). The resubmission addresses items raised by the agency in a complete response letter issued last month, which identified the company’s third-party contract
Devices
Medtronic’s Covidien unit has recalled (Class 1) its Palindrome and Mahurkar catheters due to a defect in the hub that connects both extension catheters. “There is a potential leaking condition within the hub of specific chronic dialysis catheters,” a recall notice says. “This may be noticed when flushing one
Drugs
A bill that would establish a task force between the U.S. Patent and Trademark Office (USPTO) and FDA to improve communication and coordination in implementing each agency’s activities related to drug patents has been advanced by voice vote in the Senate Judiciary Committee. The Interagency Patent Coordination and
Devices
FDA has approved a Lenstec PMA for its SBL-3 IOL (Segmented Bifocal Lens), described as a next-generation asymmetric multifocal refractive intraocular lens (IOL) that provides patients with near, intermediate and distance vision. The lens is designed to improve patient contrast sensitivity and minimize halo and glare (dysphotopsias) commonly
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings.” The document discusses the inclusion of patients who have not previously received available therapy (commonly referred to as existing treatment options) for their cancer in the non-curative
FDA Policy/General
Federal Register notice FDA is announcing the fiscal year 2023 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities. The small business establishment fee is $5,941, non-small business establishment fee is $18,661, and the reinspection
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers — Patient Labeling Recommendations.” The document recommends content and formatting for patient labeling information for LASIK devices. FDA is issuing this guidance to help ensure that physicians can share and patients can understand
FDA Policy/General
Federal Register notice: FDA has announced the fee rates and payment procedures for fiscal year 2023 for animal drug user fees. Under the fee schedule, an animal drug application is $659,364 and a supplemental animal drug application is $329,682. To view the notice, click here.
Drugs
Lawmakers, patient advocates, and others are continuing to raise questions about a long-delayed review of prescription painkillers promised by FDA commissioner Robert Califf when he was commissioner in 2016, according to an Associated Press report. The story also says Califf commissioned a National Academy of Sciences (NAS) report that
Drugs
FDA is listing the accomplishments from the first year’s work of the Generic Drug Cluster, a multi-country forum working toward a common understanding of each member agency’s generic drug regulatory requirements and toward increased scientific alignment. An online report says the cluster meetings “enabled an agreement for