Drugs
Senate majority leader Mitch McConnell (R-KY) has added to the Executive Calendar for 2/22 a cloture vote on FDA commissioner-nominee Robert Califf. The decision to proceed on the nomination came after Sen. Lisa Murkowski (R-AK) removed a hold on the confirmation following the agency’s decision
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices. The guidance identifies the types of UHMWPE currently in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions
Drugs
RedHill Biopharma has submitted to FDA a Phase 2 study protocol for Bekinda (ondansetron) 12 mg for its use in treating diarrhea-predominant irritable bowel syndrome. The company says it recently concluded a “successful” first-in-man pharmacokinetic study to support the planned Phase2I study. A Phase 3 study with
Devices
FDA has issued a draft guidance, Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices, to assist industry members who submit orthopedic devices using ultrahigh molecular weight polyethylene material to determine the appropriate information and testing to submit in 510(k)s, de novo requests, PMA applications, HDEs,
Drugs
The Chicago Tribune says it has been working with data scientists, pharmacologists, and cellular researchers at Columbia University Medical Center to determine if new mathematical analysis techniques could be used to find risky drug pairs. The initial results are positive, the newspaper says in a lengthy report. “The team has
FDA Policy/General
Federal Register Notice: FDA’s Pharmacy Compounding Advisory Committee will meet 3/8-9 to discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list: Quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The nominators
Drugs
AbbVie says it will file an NDA for Elagolix next year after announcing positive top-line results from the second of two replicate pivotal Phase 3 clinical trials evaluating the drug in premenopausal women who suffer pain from endometriosis. Trial results show that after six months of continuous treatment, both
Devices
FDA has cleared a Guerbet 510(k) for its OptiOne Single-Head Contrast Delivery System for CT imaging procedures. The device, which is available in ceiling-suspended and pedestal form, is designed for injecting radiopaque contrast agents in the vascular system to obtain diagnostic images in CT scan examinations. Each
Devices
FDA has cleared a Wenzel Spine 510(k) to market VariLift-LX as an interbody fusion device for stand-alone use in the lumbar spine. The device is designed to “simplify” to be implanted in a unilateral or bilateral capacity, it says. It has four large fenestrations and a bone
Devices
Cook Medical has recalled 360 lots of its Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays due to catheter tip fractures or separations. Globally, 17,827 devices are subject to the recall, according to a recall notice. The products are intended for use in venous or arterial
Devices
A Nevada federal grand jury has indicted Dmitriy Melnik on one count of conspiracy to traffic in counterfeit goods and to introduce into interstate commerce misbranded devices, four counts of trafficking in counterfeit goods, and five counts of introducing misbranded devices into interstate commerce. A Justice Department news release says
Drugs
FDA has accepted for priority review a KemPharm NDA for KP201/APAP, its investigational drug candidate for the short-term management of acute pain. The agency has set a user fee review action date of 6/9. The immediate release combination of KemPharm's prodrug of hydrocodone, KP201 (benzhydrocodone
Drugs
Eli Lilly and Anthem, Inc. health plans are proposing clarifications to federal law to confirm that drug manufacturers may speak openly with health plans about drugs going through the FDA approval process. The proposal would particularly relate to information on product efficacy, safety, and pharmacoeconomics. A statement from the two
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 3/3 entitled “Advancing the Development of Biomarkers in Traumatic Brain Injury.” It aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets
FDA Policy/General
The Biotechnology Innovation Organization (BIO) says there is a lack of cohesive process for programs involving multiple FDA Centers, specifically CDER and CDRH. Commenting on an agency draft guidance on best practices for communication between IND sponsors and FDA during drug development, BIO says FDA should specifically address combination products
Drugs
The 7th Circuit Court of Appeals has dismissed with prejudice a case seeking to avoid federal preemption of a state action against Qualitest, manufacturer of generic allopurinol, indicated to treat gout. The case was brought by a man who developed Stevens-Johnson-Syndrome after taking allopurinol. The federal government asked
Devices
FDA has cleared an MX Orthopedics 510(k) for the dynaMX Compression Staple for fracture fixation. The device, which is made of “superelastic nitinol,” allows the surgeon to control the opening of staple legs, according to the company. There is no post-insertion tamping required, and it allows easy intraoperative
Devices
FDA has cleared a Becton Dickinson 510(k) for the BD FACSPresto system and BD FACSPresto CD4/Hb Cartridge for use in testing CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples to manage HIV/AIDS patients. The automated multicolor fluorescent imaging cytometer and absorbance spectrometer provides absolute
Drugs
Drager Medical has begun a Class 1 recall of its emergency transport ventilators due to a system error that may lead to a halt in ventilation therapy. Affected devices include the Oxylog 2000 plus, Oxylog 3000, and Oxylog 3000 Plus ventilators distributed between 4/2007 and 12/2015. A recall
Drugs
Astellas senior vice president Jeffrey Bloss says it’s “time to create a modernized regulatory framework that encourages the development and dissemination of accurate, data-driven information, including real-world evidence, to achieve high-quality, high-value patient care.” Writing in a sponsored opinion piece on The Hill online, Bloss
Drugs
FDA’s Office of Orphan Product Development (OOPD) received 472 requests for orphan drug designations in 2015, five more than the record-setting 467 requests in 2014. Attorney Kurt Karst (Hyman, Phelps & McNamara), writing in his firm’s FDA Law Blog, says that OOPD “designated an amazing 354 products
Drugs
Amgen is asking the Court of Appeals for the Federal Circuit to uphold a district court decision that Apotex is required to provide 180-day notice to Amgen of its intent to market a biosimilar version of Amgen’s Neulasta (pegfilgrastim). In its brief, Amgen says that “because the district