Drugs
FDA commissioner nominee Robert Califf says he’s a “fan” of the accelerated approval process but wants to see changes to speed confirmatory trials to determine if therapies that are given accelerated approval deliver the benefit they claim. Speaking as a member of a panel on accelerated approval at the
Drugs
FDA has placed a clinical hold on Dyne Therapeutics’ IND for a clinical trial of its DYNE-251 in patients with Duchenne muscular dystrophy amenable to skipping exon 51. The agency requested additional clinical and non-clinical information for Dyne-251, the company says. Dyne says it expects to submit
Drugs
Aurobindo Pharma has been issued an FDA Warning Letter over GMP deficiencies cited 8/2021 at its Hyderabad, India-based Unit 1 active pharmaceutical ingredient (API) manufacturing facility. This is the second Warning Letter issued to the company in the past 15 months. Its U.S subsidiary, AuroLife Pharma, was
Drugs
Mylan Pharmaceuticals has recalled one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens due to the potential for the label to be missing on some prefilled pens within a labeled carton (each containing five pens). The affected batch was manufactured by
Devices
FDA has granted Sensydia a breakthrough device designation for its Cardiac Performance System (CPS) that measures critical cardiac function. The cardiac monitoring device is designed to report critical heart performance measurements to physicians for comprehensive evaluation of patients with advanced and persistent heart failure, without requiring an in-hospital catheterization
FDA Policy/General
FDA has extended until 2/4 a temporary postponement of certain inspection activities due to the spread of the omicron variant. Late last year, the agency said it had temporarily postponed until 1/19 all face-to-face domestic and foreign inspectional work except for “mission-critical” inspections (see earlier
Drugs
The latest annual user fee program data show the agency met or exceeded many of its goals under PDUFA and BsUFA. The report says the agency met or exceeded the performance level for 10 out of 12 review goals for FY 2020 final performance. And, it says, FDA is currently
Drugs
After 20 years at FDA, CDER Office of Neuroscience deputy director Eric Bastings has retired and joined Ionis Pharmaceuticals as vice president of development strategy. Bastings’s retirement comes at a difficult time for the Office of Neuroscience, which oversaw last year’s controversial approval of Biogen’s Alzheimer’s
Drugs
FDA has told Revance Therapeutics that to address a recent BLA complete response letter on DaxibotulinumtoxinA for Injection, indicated for treating glabellar lines, will require qualification of a new working cell bank (WCB). The qualification, which the company says is in progress, will need to be verified by a reinspection
Drugs
FDA has agreed to Akari Therapeutics using a next-generation manufacturing process to produce nomacopan for use in two Phase 3 trials. The company says the new process increases the final yield of nomacopan by at least five-fold, significantly lowering the cost of goods for clinical studies and commercialization.
Devices
FDA will provide an overview of its draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, in a free 90-minute 2/10 Webinar. Topics to be covered in the Webinar include an overview of digital health technologies (DHT); regulatory considerations for DHTs for remote data acquisition
Drugs
FDA has placed a partial clinical hold on multi-dose clinical trials of Yumanity Therapeutics’ YTX-7739 that is being developed to treat Parkinson’s disease. The company says the agency has not halted all clinical programming and is permitting Yumanity to proceed with its planned single-dose clinical trial.
Biologics
FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as a first-line treatment in advanced non-small cell lung cancer (NSCLC). The user fee review action target date is 9/19. Libtayo was approved last year as
FDA Policy/General
Three Skadden Arps attorneys say life sciences companies may face policy changes and increased enforcement activity from FDA and the Department of Justice (DoJ) as 2022 plays out. Writing in an online post, the attorneys say that so far the Biden administration’s FDA and DoJ have focused their efforts
Drugs
Gilead says an unauthorized network of drug distributors and suppliers sold pharmacies more than $250 million in counterfeit versions of two of its HIV drugs over the last two years. The company said it had determined that 85,247 bottles of drugs including its Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)
Devices
Getinge has recalled its Vaporizer Sevoflurane Maquet filling due to the potential chemical breakdown of Sevoflurane, a general surgical anesthetic. A recall notice says that if the chemical breakdown occurs, it could result in inhalation of, or skin exposure to, harmful chemicals that may cause serious patient harms, including irritation
Drugs
A 5/7-6/23/21 FDA inspection at the Professional Disposables drug manufacturing facility in Orangeburg, NY, found significant violations of Current Good Manufacturing Practice (CGMP) regulations and Field Alert Reporting regulations. A 1/7 Warning Letter says the company failed to thoroughly investigate any unexplained discrepancy or failure
FDA Policy/General
Federal Register notice: FDA is correcting a 10/22/2021 notice that announced the withdrawal of 216 ANDAs. The document was published with an incorrect date, and it wrongly indicated that Bio-Nucleonics’ ANDA 075941 for strontium chloride SR–89 injection was being withdrawn. To view the notice, click here.
Devices
CDRH has released its Health of Women Program Strategic Plan that intends to boost related regulatory science, and identify and address current and emerging issues in medical device research and regulation. The plan identifies three strategic priorities to guide the Center’s “understanding of how medical devices work for women
Devices
Medtronic says three-month results from a clinical trial showed meaningful pain relief using DTM SCS endurance therapy, a modified lower-energy version of its Differential Target Multiplexed (DTM) Spinal Cord Stimulation (SCS) therapy for chronic overall back or leg pain. The company says DTM SCS endurance therapy enables long-
Drugs
A 1/12-2/18/21 FDA inspection at Sunstar Americas’ drug and medical device manufacturing facility in Schaumburg, IL, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and Quality System regulations for medical devices. A just-released 12/21/21 Warning Letter says specific
Drugs
FDA has published case study examples to educate stakeholders and provide innovation in the area of complex innovative trial designs (CID). An agency notice says the CID pilot meeting program, launched in 2018, is intended to advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. “The