Food and Drug Administration

Luminex Receives FDA 510(k) Clearance for the ARIES® MRSA Assay

Retrieved on: 
Tuesday, October 1, 2019
Medical specialties, Infectious diseases, Natural sciences, Laboratory techniques, Luminex Corporation, Bacterial diseases, Healthcare-associated infections, Staphylococcaceae, Antibiotic-resistant bacteria, Methicillin-resistant Staphylococcus aureus, Luminex, Food and Drug Administration

AUSTIN, Texas, Oct. 1, 2019 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ARIES MRSA Assay.

Key Points: 
  • AUSTIN, Texas, Oct. 1, 2019 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ARIES MRSA Assay.
  • "MRSA causes more than 80,000 severe infections and kills more than 11,000 people in the U.S. each year.1 The 510(k) clearance of our ARIES MRSA Assay marks an exciting moment for our ARIES product line and, most importantly, for patients throughout the United States," said Homi Shamir, President and CEO of Luminex.
  • The system features six FDA and seven CE-IVD cleared assays, as well as the ability to run laboratory-developed tests.
  • "This assay adds another foundational test to our ARIESplatform, increasing its value for customers and patients," said Mr. Shamir.

Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain

Retrieved on: 
Tuesday, October 1, 2019
Drugs, Psychoactive drugs, RTT, Medicine, Meloxicam, Pain management, Bupivacaine, Nonsteroidal anti-inflammatory drug, Local anesthetic, Food and Drug Administration, Ketamine

"HTX-011 was designated by the FDA as a Breakthrough Therapy for postoperative pain management and has the potential to be an important new pain management option for patients that can significantly reduce postoperative pain, including severe pain, and help patients significantly reduce the need for opioids."

Key Points: 
  • "HTX-011 was designated by the FDA as a Breakthrough Therapy for postoperative pain management and has the potential to be an important new pain management option for patients that can significantly reduce postoperative pain, including severe pain, and help patients significantly reduce the need for opioids."
  • HTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.
  • Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018.
  • Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer.

Scott+Scott Attorneys at Law LLP Announces the Filing of a Securities Class Action Against electroCore, Inc. (ECOR)

Retrieved on: 
Tuesday, October 1, 2019
Legal, Professional services, Food and Drug Administration, United States Public Health Service, Health, Government agencies, Articles

The lawsuits allege that Defendants misled investors by failing to disclose material facts about electroCores business, operations, and prospects.

Key Points: 
  • The lawsuits allege that Defendants misled investors by failing to disclose material facts about electroCores business, operations, and prospects.
  • On September 25, 2019, electroCore revealed that FDA requested more information and analysis of clinical data for electroCores 510(k) submission.
  • Scott+Scott has significant experience in prosecuting major securities, antitrust, and employee retirement plan actions throughout the United States.
  • The firm represents pension funds, foundations, individuals, and other entities worldwide with offices in New York, London, Amsterdam, Connecticut, California, and Ohio.

CHF Solutions submits 510(k) application for Use of Aquadex FlexFlow® System with Pediatric Patients

Retrieved on: 
Tuesday, October 1, 2019
Food and Drug Administration, United States Public Health Service, Health, Government agencies, Articles

EDEN PRAIRIE, Minn., Oct. 01, 2019 (GLOBE NEWSWIRE) -- CHF Solutions, Inc. (Nasdaq:CHFS) today announced that it has submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more.

Key Points: 
  • EDEN PRAIRIE, Minn., Oct. 01, 2019 (GLOBE NEWSWIRE) -- CHF Solutions, Inc. (Nasdaq:CHFS) today announced that it has submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more.
  • We are excited to have achieved this significant milestone in our corporate strategy to make the Aquadex FlexFlow technology available to pediatric patients, said John L. Erb, chairman and CEO of CHF Solutions.
  • Following FDA clearance, we look forward to expanding use for these most vulnerable patients, who have limited alternative solutions.
  • The company has submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more.

Lannett Enters Into Distribution Agreement For Generic ADVAIR DISKUS®

Retrieved on: 
Tuesday, October 1, 2019
Fluticasone/salmeterol, RTT, Health, Food and Drug Administration, Articles

Under the agreement, Lannett will commence U.S. distribution of the product after FDA approval.

Key Points: 
  • Under the agreement, Lannett will commence U.S. distribution of the product after FDA approval.
  • The term of the agreement is 10 years, which begins upon commencement of distribution.
  • "Moreover, Respirent has substantial capabilities around inhalation products and the distinction of being one of the few companies that have progressed generic ADVAIR DISKUS through the clinical stage.
  • "Generic ADVAIR DISKUS represents a potentially large market opportunity, especially for a company of our size.

Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas, on measuring the progress being made through implementing the FDA Food Safety Modernization Act

Retrieved on: 
Monday, September 30, 2019
Articles, Health, Food and drink, Food safety, Food science, Foodservice, Product safety, Food safety in the United States, Safety, Food and Drug Administration, FSMA, FDA Food Safety Modernization Act

As the seven foundational rules of FSMA reach their compliance dates over the next several years, it's important to begin to track their impact on the food safety system.

Key Points: 
  • As the seven foundational rules of FSMA reach their compliance dates over the next several years, it's important to begin to track their impact on the food safety system.
  • However, this is an encouraging start as industry, the FDA and our regulatory partners work together to improve food safety and protect consumers.
  • The new dashboard introduces metrics for food safety outcomes, associated measures and initial data for certain aspects of FSMA.
  • The data will ultimately help the agency identify trends in food safety, continue to improve our risk-based food safety framework, and modernize the agency's food safety approaches in a way that will help prepare us for a New Era of Smarter Food Safety.

FDA and DEA warn website operators illegally selling opioids

Retrieved on: 
Monday, September 30, 2019
Government, Drug Enforcement Administration, Food and Drug Administration, Health, Opioid, Agencies of the United States government, Euphoriants, RTT

"Today's effort is also noteworthy because while the FDA partners regularly with the DEA, this is the first time we have issued joint warning letters with them.

Key Points: 
  • "Today's effort is also noteworthy because while the FDA partners regularly with the DEA, this is the first time we have issued joint warning letters with them.
  • We remain committed to using all available regulatory and enforcement tools to stop the illicit flow of opioids online."
  • The FDA remains concerned that the easy availability of opioids online further fuels the crisis.
  • "Issuing these warning letters is not only an effort to deter the availability of dangerous illegal opioids, but it is also a testament to the close cooperation between DEA and FDA," said Acting DEA Administrator Uttam Dhillon.

Triangle Manufacturing Company Accelerates Growth with The Copley Consulting Group and Infor ERP

Retrieved on: 
Monday, September 30, 2019
Business, Articles, ERP software, Economy, Supply chain management, Information technology management, Food and Drug Administration, United States Public Health Service, Medical device, Enterprise resource planning

WOBURN, Mass., Sept. 30, 2019 /PRNewswire-PRWeb/ --Triangle Manufacturing Company, a premier contract manufacturer to OEMs of medical instrumentation and implantable devices, is realizing significant benefits since implementing The Copley Consulting Group's FDA Extended Solution based on the Infor CloudSuite Industrial (CSI) Enterprise Resource Planning (ERP) application.

Key Points: 
  • WOBURN, Mass., Sept. 30, 2019 /PRNewswire-PRWeb/ --Triangle Manufacturing Company, a premier contract manufacturer to OEMs of medical instrumentation and implantable devices, is realizing significant benefits since implementing The Copley Consulting Group's FDA Extended Solution based on the Infor CloudSuite Industrial (CSI) Enterprise Resource Planning (ERP) application.
  • "With our prior, legacy systems, we lacked a unified platform that melded Quality Control, FDA Regulatory Compliance, and Shop Floor Control," said Dax Strohmeyer, President at Triangle Manufacturing Company.
  • "With Copley and Infor, we have successfully implemented a solution that provides real-time production feedback, allowing us higher visibility into margin contributions while enhancing our planning and scheduling.
  • We feel the efficiencies we have gained with the Infor and Copley FDA solution will accelerate our growth trajectory, while maintaining our core values of quality and delivery performance."

Lysogene Reports First Half 2019 Financial Results and Provides Operational Update

Retrieved on: 
Monday, September 30, 2019
Health, Genetics, Clinical trials, Pharmaceutical, Biotechnology, Food and Drug Administration, United States Public Health Service, Health, Government agencies, Articles

Revenues and other income, according to IFRS15 standard, Lysogene achieved 6.8 million revenues in the first half of 2019.

Key Points: 
  • Revenues and other income, according to IFRS15 standard, Lysogene achieved 6.8 million revenues in the first half of 2019.
  • The Companys net loss, for the first half of 2019 amounted to 1.9 million compared to 7.2 million in the first half of 2018.
  • A successful pre-IND meeting with FDA in 2Q 2019 cleared the path towards the submission of the IND by end 2019.
  • i Limited review procedures on the financial statements as of June 30, 2019, have been performed in accordance with professional standards applicable in France.

Endo Announces Successful Culmination of Litigation Regarding FDA Compounding Policy

Retrieved on: 
Monday, September 30, 2019
Health, Compounding, Pharmacy, Endo International plc, Food and Drug Administration, Endo, Articles

DUBLIN, Sept.30, 2019 /PRNewswire/ --Endo International plc ("Endo") (NASDAQ: ENDP) today announced the successful culmination of two litigation matters before the U.S. District Court for the District of Columbia regarding the unlawful compounding of vasopressin from bulk drug substances.

Key Points: 
  • DUBLIN, Sept.30, 2019 /PRNewswire/ --Endo International plc ("Endo") (NASDAQ: ENDP) today announced the successful culmination of two litigation matters before the U.S. District Court for the District of Columbia regarding the unlawful compounding of vasopressin from bulk drug substances.
  • In October 2017, Endo initiated a lawsuit against the U.S. Food and Drug Administration ("FDA") challenging the FDA's interim policy authorizing the bulk compounding of drugs.
  • At FDA's and the Department of Justice's request, Endo stayed its lawsuit to allow FDA time to complete this process.
  • "Endo congratulates FDA on the successful and well-reasoned implementation of Section 503B of the DQSA, and was very pleased to assist in the subsequent defense of separate litigation regarding those actions," said Matthew J. Maletta, Executive Vice President and Chief Legal Officer of Endo.