FDA Policy/General
Celgene has agreed to acquire for $7 billion Impact Biomedicines and its JAK inhibitor program targeting myelofibrosis. Privately-held Impact is developing fedratinib, a highly selective JAK2 kinase inhibitor, for patients with treatment-naïve myelofibrosis, a bone marrow disorder that disrupts normal production of blood cells. Impact picked up fedratinib
Drugs
FDA says an unidentified drug manufacturer has alerted the agency about a drug shortage related to a manufacturing site affected by the coronavirus. “The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” FDA commissioner Stephen Hahn says. “It is important to
Drugs
The Association for Accessible Medications (AAM) is stepping up pressure on Congress to reject legislation to change FDA’s 180-day marketing exclusivity award for “first generics” that are the first to challenge brand-drug patents. The bill, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics
Drugs
FDA has approved an Esperion NDA for Nexlizet (bempedoic acid and ezetimibe) as an adjunct to diet and maximally tolerated statin therapy for treating adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. Nexlizet is the first non-statin, LDL-C lowering
Drugs
FDA has launched a new pilot program to simplify public awareness about guidance documents that seek to modernize drug clinical trials and accelerate drug development. FDA says the Guidance Snapshot Pilot is a “communication tool that provide highlights from guidance documents using visuals and plain language.” During the Pilot, the
Devices
FDA has cleared a Companion Medical 510(k) for its InPen bolus insulin calculator for fixed dosing and meal estimation. The device takes into consideration each user’s current glucose level and active insulin (the calculation of the amount of insulin still lowering glucose from previous bolus doses), the company
Drugs
FDA has approved a Cerovene ANDA for the first generic copy of Vyera Pharmaceuticals’ Daraprim (pyrimethamine) tablets for treating toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide. Severe toxoplasmosis is more likely in pregnant women and individuals who have weak immune systems, such as
Devices
FDA has cleared a Baxter International 510(k) for its Peri-Strips Dry with Veritas Collagen Matrix (PSDV). The company says the device is a staple line reinforcement material that bariatric surgeons have used to mitigate staple line complications for more than 15 years. The new generation device is two
FDA Policy/General
Federal Register notice: CDRH has announced a voluntary “Electronic Submission Template and Resource (eSTAR) Pilot.” The pilot is intended to improve consistency and efficiency in both industry’s preparation and FDA’s review of 510(k) submissions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry #264 entitled “Standardized Medicated Feed Assay Limits.” The agency says that standardized medicated feed assay limits allow predictability in the review process as sponsors can determine early in the drug development process what assay limits they should expect
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts to clarify through draft guidance the appropriate mechanisms and pathways for combination product sponsors to obtain agency feedback, including the inclusion of best practices regarding interactions between FDA and combination product sponsors. “While PhRMA appreciates the inclusion of
Drugs
FDA has extended by three months its review of a Zogenix NDA for Fintepla (fenfluramine oral solution) for treating seizures associated with Dravet syndrome. The new user fee review action target date is 6/25. The extension allows the agency time to review additional data submitted by Zogenix in response
Devices
The National Evaluation System for health Technology Coordinating Center (NESTcc) has published the NESTcc Data Quality Framework and NESTcc Methods Framework. The group says the frameworks were developed by subcommittees of experts from FDA, health systems, academia, and industry to provide guiding principles for medical device ecosystem stakeholders to ensure
Drugs
FDA says American Health Packaging recalled 2/27 11 lots of ranitidine tablets, 150 mg, 100-count unit dose blisters due to the potential for N-Nitrosodimethylamine amounts above levels established by FDA. An agency notice says the recall was initiated in response to a recall by the manufacturer, Amneal
Drugs
FDA’s Oncologic Drugs Advisory Committee has delivered a mixed vote (six to five) to support approval of Eli Lilly’s supplemental BLA for Cyramza (ramucirumab) and its use in combination with Roche’s erlotinib for patients with untreated metastatic EGFR-positive non-small cell lung cancer. The panel based
Devices
FDA has classified as Class 1 a King Systems recall of its King Vision Video Laryngoscope (adapter size 1/2) because they may display a reversed image, which could potentially result in difficulty navigating during intubation or delay intubation. Affected device images may appear normal, but user’s actions will
Drugs
FDA says it has received reports of “spot shortages” of some medical devices due to the global coronavirus outbreak. An FDA spokeswoman tells FDA Webview 2/27 that the agency is “currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC and
Devices
FDA has posted a safety communication to alert consumers and healthcare providers to the fact that the agency has not authorized for market any products using ozone gas or ultraviolet light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories. The notice says that most often
Drugs
A New York federal judge has ruled that data from clinical trials conducted for not-yet-approved drugs and medical devices over a 10-year period between 2007 and 2017 must be published online at ClinicalTrials.gov. The ruling comes in a 2018 suit against HHS, FDA, and the National
Drugs
FDA has approved an Acacia Pharma Group NDA for Barhemsys (amisulpride injection) for preventing and treating postoperative nausea and vomiting (PONV) in adult patients. Approval of the selective dopamine D2 and D3 antagonist was based on data from four positive Phase 3 studies involving more than 3,300 surgical patients
Drugs
HHS deputy inspector general for evaluation and inspections Suzanne Murrin says the Office of Inspector General has identified risks associated with medical device safety and security and safety concerns with FDA-regulated drugs. In testimony before the House Appropriations Committee, Murrin says FDA: * needs to further mitigate the risk of
Devices
Attorneys Jeffrey Gibbs and Véronique Li (Hyman, Phelps & McNamara) say an increased tendency for CDRH to miss a variety of deadlines is a concern and starts to form “a troubling pattern.” Writing online in their firm’s FDA Law Blog, Gibbs and Li give examples of the types of