Monday, March 30, 2020

Monday, March 30, 2020

Latest News

GRUNETHAL GROUP: Averitas Pharma Announces FDA Acceptance of sNDA Filing for QUTENZA® (capsaicin) 8% Patch for the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

PDUFA date set for July 19, 2020. If approved, QUTENZA would be the first topical treatment with a TRPV1 agonist indicated for the treatment of neuropathic pain associated with diabetic peripheral neuropathy.

U.S. FDA: Statement on National Academies of Sciences, Engineering, and Medicine report on framing opioid prescribing guidelines for acute pain

In August 2018, the U.S. Food and Drug Administration contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for opioid analgesic prescribing for acute pain resulting from specific conditions or procedures.

U.S. FDA: First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.

U.S. FDA: Trump Administration takes historic steps to lower U.S. prescription drug prices

Proposed rule could allow certain prescription drugs to be imported from Canada; draft guidance explains how manufacturers could import drugs, biological products originally intended for sale in another country

U.S. FDA: FDA approves new type of therapy to treat advanced urothelial cancer

U.S. Food and Drug Administration granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers.

U.S. FDA: Statement on low-cost biosimilar and interchangeable protein products

Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients.

U.S. FDA: FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

The U.S. Food and Drug Administration approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher.

U.S. FDA: FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing

The U.S. Food and Drug Administration cleared for marketing in the U.S. the first fully disposable duodenoscope.

U.S. FDA: FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system

The U.S. Food and Drug Administration authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).

AMERICAN SOCIETY OF HEMATOLOGY: ASH and FDA Unveil New Recommendations to Guide Clinical Development of Sickle Cell Disease Therapies

Joint FDA/ASH Led Initiative Highlights Importance of Using Patient Reported Outcomes and Biomarkers in Clinical Trials to Advance SCD Therapies

U.S. FDA: Sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk

Liveyon Labs Inc. and Liveyon LLC warned that their stem cell products lack required FDA approval and represent a potential risk to the public health

U.S. FDA: FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

The U.S. Food and Drug Administration today announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device.

SK LIFE SCIENCE, INC.: Announces FDA Acceptance of IND Application for Anti-Epileptic Drug Candidate SKL24741

Acceptance of the IND application will allow the company to begin Phase I clinical trials for SKL24741 in 2020

U.S. FDA: FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection

The U.S. Food and Drug Administration approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media).

FDA Health News