Food and Drug Administration

FDA Approves XCOPRI® (cenobamate tablets), an Anti-Epileptic Drug (AED) from SK Biopharmaceuticals, Co., Ltd., and U.S. Subsidiary SK Life Science, Inc.

Thursday, November 21, 2019 - 11:10pm

The FDA approval of XCOPRI for the treatment of partial-onset seizures is a welcome option for the epilepsy community."

Key Points: 
  • The FDA approval of XCOPRI for the treatment of partial-onset seizures is a welcome option for the epilepsy community."
  • The approval also marks the first time a Korean company has independently brought a compound from discovery to U.S. FDA approval.
  • XCOPRI was discovered and developed by SK Biopharmaceuticals and SK life science and is an FDA-approved anti-epileptic drug (AED) for the treatment of partial-onset seizures in adults.
  • SK life science, based in Paramus, New Jersey, is pursuing clinical development and the U.S. commercialization of XCOPRI.

IRRAS Announces FDA Clearance of New 510(K) Filing to Expand the Time of Use of IRRAflow®

Thursday, November 21, 2019 - 8:32pm

IRRAS received initial clearance from the US FDA for IRRAflow in July 2018.

Key Points: 
  • IRRAS received initial clearance from the US FDA for IRRAflow in July 2018.
  • "We are very pleased to have received this new clearance from the FDA.
  • The extended time of use will further enhance the usability of the transformative IRRAflow product for the benefit of neurocritical care patients.
  • IRRAS AB is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients.

IRRAS Announces FDA Clearance of New 510(K) Filing to Expand the Time of Use of IRRAflow®

Thursday, November 21, 2019 - 8:31pm

IRRAS received initial clearance from the US FDA for IRRAflow in July 2018.

Key Points: 
  • IRRAS received initial clearance from the US FDA for IRRAflow in July 2018.
  • "We are very pleased to have received this new clearance from the FDA.
  • The extended time of use will further enhance the usability of the transformative IRRAflow product for the benefit of neurocritical care patients.
  • IRRAS AB is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients.

Muscular Dystrophy Association to host first Patient Focused Drug Development Meeting for Pompe Disease March 9, 2020 in Washington D.C.

Thursday, November 21, 2019 - 5:15pm

NEW YORK, Nov. 21, 2019 /PRNewswire/ --The Muscular Dystrophy Association (MDA) announced today that the U.S. Food and Drug Administration (FDA) has approved its externally-led Patient Focused Drug Development (PFDD) meeting on Pompe disease on March 9, 2020 in Hyattsville, Maryland.

Key Points: 
  • NEW YORK, Nov. 21, 2019 /PRNewswire/ --The Muscular Dystrophy Association (MDA) announced today that the U.S. Food and Drug Administration (FDA) has approved its externally-led Patient Focused Drug Development (PFDD) meeting on Pompe disease on March 9, 2020 in Hyattsville, Maryland.
  • MDA is partnering with the Acid Maltase Deficiency Association (AMDA) and United Pompe Foundation (UPF) to bring the Pompe community to Washington, D.C. in person and online.
  • This input will help inform FDA's regulatory decision making and oversight during therapy development and in the regulatory review process.
  • This report will provide lasting lessons on life with Pompe disease and the community's viewpoints on potential therapeutic interventions.

Shareholder Alert: Robbins LLP Announces Another Complaint Filed Against Aclaris Therapeutics, Inc. (ACRS)

Thursday, November 21, 2019 - 4:39pm

Aclaris, a pharmaceutical company, identifies, develops, and commercializes therapies for dermatological and immune-inflammatory diseases.

Key Points: 
  • Aclaris, a pharmaceutical company, identifies, develops, and commercializes therapies for dermatological and immune-inflammatory diseases.
  • According to the complaint, in May 2018, Aclaris announced the launch of ESKATA, touting the product as the "first and only FDA-approved topical treatment for seborrheic keratosis."
  • Despite these warnings, Aclaris' officers and directors allowed advertisements for ESKATA that exaggerated the drug's efficacy and understated its risks.
  • Since this news, Aclaris' share price has fallen $3.35, an almost 66% decline from its June 19, 2019 closing price of $5.11.

Upcoming Changes to FDA's OTC and Sunscreen Monograph

Thursday, November 21, 2019 - 1:37pm

TEANECK, N.J., Nov. 21, 2019 /PRNewswire/ --With the upcoming changes to FDA's OTC and Sunscreen Monograph, it is more important than ever to ensure that your entire manufacturing process is fully compliant and up to date.

Key Points: 
  • TEANECK, N.J., Nov. 21, 2019 /PRNewswire/ --With the upcoming changes to FDA's OTC and Sunscreen Monograph, it is more important than ever to ensure that your entire manufacturing process is fully compliant and up to date.
  • With everything currently going on in the testing world, it is simply too risky to take everyone's word at face value.
  • For more information on how the upcoming regulatory changes can impact your brand and your label claims, please reach out to Validated Claim Support at info@validatedcs.com .
  • We'd also welcome you to visit us at the Glenpointe Center in Teaneck to learn more about the upcoming monograph changes and get to meet the team helping the industry to validate its claims ethically and transparently.

Merit Medical Receives FDA Breakthrough Device Designation for WRAPSODY™ Endovascular Stent Graft System

Thursday, November 21, 2019 - 2:25pm

SOUTH JORDAN, Utah, Nov. 21, 2019 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the Merit WRAPSODY Endovascular Stent Graft System.

Key Points: 
  • SOUTH JORDAN, Utah, Nov. 21, 2019 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the Merit WRAPSODY Endovascular Stent Graft System.
  • The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
  • Under the program, the FDA provides priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
  • The WRAPSODY system is nearing completion of its First in Man studies, and is not currently available for sale.

STI Pharma Announces US Launch of Generic BICNU® for Injection

Thursday, November 21, 2019 - 1:05pm

NEWTOWN, Pa., Nov. 21, 2019 /PRNewswire/ -- STI Pharma, LLC today announced the US launch of Carmustine for Injection, USP: 1 Kit (100mg per Vial & Diluent), a generic version of AVET's (formerly Heritage) BiCNU.

Key Points: 
  • NEWTOWN, Pa., Nov. 21, 2019 /PRNewswire/ -- STI Pharma, LLC today announced the US launch of Carmustine for Injection, USP: 1 Kit (100mg per Vial & Diluent), a generic version of AVET's (formerly Heritage) BiCNU.
  • STI received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
  • "The launch of Carmustine Injection is an important milestone for STI, representing our first oncology injectable approval," said STI President Frank Mullery.
  • STI Pharma, located in Newtown, PA, was founded in 2008 by a team of industry veterans.

Arakoda™ (Tafenoquine) Tablets, First Prescription Drug Approved for Malaria Prevention by US FDA in Over 18 Years, Now Available in US

Thursday, November 21, 2019 - 1:01pm

This significant milestone complements the regulatory approval of Arakoda by the United States Food and Drug Administration (FDA).

Key Points: 
  • This significant milestone complements the regulatory approval of Arakoda by the United States Food and Drug Administration (FDA).
  • Arakoda (tafenoquine) is approved for the prevention of malaria in adults and was the first anti-malarial product approved for prevention in over 18 years.
  • Arakoda has the potential to protect thousands of U.S. travelers and military personnel from the devastating and life-threatening effects of malaria.
  • 60P continues to work closely with distribution networks and third-party insurance companies to provide extensive access to the product.

Medical Design & Manufacturing (MD&M) West Conference Celebrates 35 Years of Medtech Innovation, Improving Medical Device Time-to-Market, and Much More

Thursday, November 21, 2019 - 2:00pm

Driven by the aging population, advancements in technology, and the consumerization of healthcare, the medical device manufacturing market is expected to exceed $600 billion by 2025 .

Key Points: 
  • Driven by the aging population, advancements in technology, and the consumerization of healthcare, the medical device manufacturing market is expected to exceed $600 billion by 2025 .
  • Selecting the best materials for use in your medical device is key to optimizing your design for manufacturing, assembly, packaging, sterilization, and testing.
  • Depending on the application and classification of a medical device and its accessories, the use of the right material will make all the difference.
  • This will affect the regulatory requirements in the U.S. as well as affect how FDA performs their inspections of medical device manufacturers.