FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a Web page targeting providers with information on the efficacy of Mirati Therapeutics’ Krazati (adagrasib) tablets, for oral use, as shown in the KRYSTAL-1 trial, makes false or misleading claims about the drug’s benefits. An 8/1 untitled letter
Drugs
BeiGene says FDA has “deferred approval” for Tevimbra (tislelizumab) in first-line unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) because of a delay in scheduling clinical site inspections. The submission had a July user fee review action date that was missed, and there is no time
Drugs
Novo Nordisk says it has withdrawn a supplemental NDA for its weight-loss drug Wegovy (semaglutide) that is seeking a heart failure indication. “Based on interactions with the FDA, Novo Nordisk has decided to withdraw the file and expects to resubmit the file in the beginning of 2025 with additional
Drugs
Responding to a recent Novartis lawsuit against FDA that seeks a preliminary injunction to reverse its approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan), the agency says the motion should be denied because the company has not met its burden to show that it is “entitled
Devices
FDA has approved Medtronic’s Simplera continuous glucose monitor (CGM). The company says Simplera is its first disposable, all-in-one CGM that is half the size of previous company CGMs. “The discreet design simplifies the insertion and wear experience, eliminating the need for overtape,” it says.
Drugs
FDA has accepted for review an Exelixis supplemental NDA for Cabometyx (cabozantinib) and its use for treating adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated pancreatic and extra-pancreatic neuroendocrine tumors. The agency assigned a standard review with a user fee review action target date
Devices
CDRH has published a discussion paper on health equity for medical devices to solicit public input on the issue. In the paper, the Center describes factors and considerations that may be important for sponsors and other relevant parties as they develop medical device clinical studies. Specifically, it says, the paper
Drugs
Senators Jack Reed (D-RI) and Shelley Moore Capito (R-WV) have introduced a bipartisan bill entitled “Innovation in Pediatric Drugs Act” (S 4905) that would attempt to accelerate research and treatment advances for pediatric rare diseases. The measure would make changes to the Best Pharmaceuticals for Children Act and
Devices
Smiths Medical is correcting software used in its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to many issues that may occur if the device is not updated with the latest software. Potential issues that non-updated software can contribute to include upstream occlusion alarm failure, unresponsive stop
Drugs
Attorney James Beck (Reed Smith) says the Supreme Court decision in Loper Bright overturning judicial deference to administrative agencies could lead to significant changes to FDA’s ban on off-label speech. Writing online in the Drug and Device Law Blog, Beck says FDA has been relying on a “very
Devices
Medtronic is recalling (Class 1) its NIM Vital Nerve Monitoring System to conduct a product correction due to reports of false negative responses. These can occur during procedures when the device may fail to issue an electromyography tone when the NIM probe is placed on a nerve, a recall notice
Drugs
A 12/4-12/8/2023 FDA inspection at the Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. in Guangdong Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/1 Warning Letter says the specific violations were: * failing to establish laboratory controls that include
FDA Policy/General
Federal Register notice: FDA is announcing a 9/6 public workshop entitled “Enhancing Diversity in Therapeutics Development for Pediatric Patients” to discuss strategies to increase the enrollment of underrepresented populations in pediatric clinical trials and to help improve the strength and generalizability of the evidence for the intended use population.
Drugs
A Florida federal judge has sentenced Jonathan Cosie, of Chesterfield, VA, to two years in federal prison for introducing misbranded drugs into interstate commerce with the intent to defraud or mislead. A Department of Justice post says Cosie pleaded guilty on 5/30/2023. Court documents show that from about
Devices
Foundation Medicine is petitioning FDA to reclassify all next-generation sequencing oncology panel devices used for somatic or germline variant detection that include one or more companion diagnostic indications from Class III to Class II. Foundation’s just-released 6/28 petition says the genomics company believes “there is sufficient
Drugs
FDA says it inspected the Velocity Pharma drug manufacturing facility in Melville, NY, from 11/3-12/14/2023 after an agency inspection at Velocity’s ophthalmic drug contract manufacturer, Kilitch Healthcare India Limited, found violative conditions. A just-released 7/17 Warning Letter to Velocity says the Kilitch current
Devices
FDA has cleared a Pentax Medical 510(k) to acknowledge its DEC (Disposable Elevator Cap) Duodenoscope’s compatibility with Advanced Sterilization Products’ (ASP) Sterrad 100NX Sterilizer. “The collaboration between Pentax Medical and ASP has resulted in a groundbreaking advancement in addressing the ongoing challenges of duodenoscope reprocessing,” Pentax says. “The
Drugs
Public Citizen is urging HHS to use its authority under 28 USC. § 1498 to permit generic competitors to manufacture Novo Nordisk’s semaglutide, the active ingredient in diabetes drug Ozempic and weight-loss drug Wegovy. In an 8/5 petition, the advocacy group argues that its request for the government
Drugs
Federal Register notice: FDA is announcing the renewal of the Drug Safety and Risk Management Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/31/2026. To view the notice, click here.
Drugs
FDA has granted Labcorp a de novo marketing authorization for its PGDx elio plasma focus Dx kitted assay, a pan-solid tumor liquid biopsy test that enables tumor mutation profiling. PGDx elio is described as a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput
Devices
FDA has updated an Exactech recall involving its joint replacement devices manufactured between 2004 and 2021. The update includes links to company-provided information about the affected devices. FDA says many Exactech joint replacement devices (including knees, ankles, and hips) were shipped in defective packaging bags. “The defective bags were
Drugs
FDA has granted META Pharmaceuticals a rare pediatric disease designation for META-001-PH, an investigational drug for treating primary hyperoxaluria (PH), rare genetic disorder that can lead to kidney stone formation, renal failure, and can be life-threatening in severe cases. Those with PH overproduce oxalate that is then