Biologics
FDA has accepted for review a Samsung Bioepis BLA for SB2, a biosimilar candidate referencing Janssen’s Remicade (infliximab) for treating rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the U.S. If
Drugs
FDA has cleared an Avantis Medical Systems 510(k) for the Third Eye Panoramic device for use as a multi-use imaging product for colonoscopies. Previously cleared as a disposable device, the new clearance now allows the device to be marketed for use multiple times prior to disposal. Avantis Medical
Devices
FDA has cleared an EndoChoice Holdings 510(k) for the Orca sterile, single-use air/water and suction valves for Olympus 160, 180 and 190 Series flexible endoscopes. The company says the device is designed to eliminate the need to clean and disinfect reusable valves. It adheres to recently published
Devices
FDA should require more rigorous clinical studies for high-risk medical devices used in obstetrics and gynecology than currently required, according to researchers from Northwestern University. Their study, published in the journal Obstetrics and Gynecology, found that some high-risk devices were approved based on flawed data. “We found that
Drugs
FDA reviewers have serious questions about a Sanofi NDA for its combination insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist for treating Type 2 diabetes. On 5/25, the agency’s Endocrinologic and Metabolic Drugs Advisory Committee will meet
Drugs
The Senate Committee on Homeland Security and Governmental Affairs has written FDA commissioner Robert Califf urging the agency to exercise its flexibilities when making a review decision this week on a Sarepta Therapeutics NDA for eteplirsen and its use in treating Duchenne muscular dystrophy. In April, the agency’s Peripheral
FDA Policy/General
DEVICES FDA has cleared a Bone Index 510(k) for the Bindex point-of-care instrument, which is intended to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a density index, a parameter which estimates bone mineral density at the
FDA Policy/General
BIOLOGICS FDA Renews Blood Panel Federal Register Notice: The FDA has renewed the charter of the Blood Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/13/18. To view this notice, click here. Blood Products Panel
Drugs
FDA has awarded BioPharma Services a five-year, $20 million contract with CDER to conduct in vivo studies involving generic drug products in human subjects. The contract is intended to support CDER generic drug regulatory science issues, according to BioPharma. They will “proactively address scientific questions in developing generic approval
Drugs
The International Academy of Oral Medicine & Toxicology and the Fluoride Action Network have filed a petition urging FDA to take regulatory action to remove from the market all unapproved fluoride drugs, which are commonly known as fluoride supplements. Fluoride supplements are sodium fluoride-containing drops, tablets, and lozenges sold
Drugs
FDA has set an 8/5 joint meeting of its Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to review an NDA resubmission from Pain Therapeutics for Remoxy (oxycodone) extended-release capsules in an abuse-deterrent formulation for treating pain. The agency has
Devices
FDA has granted Profound Medical Investigational Device Exemption approval to begin a pivotal clinical trial to evaluate the efficacy of the TULSA-PRO System in patients with localized prostate cancer. The device is designed to combine real-time Magnetic Resonance Imaging with “transurethral robotically-driven ultrasound and closed-loop thermal
Drugs
Acorda Therapeutics says it will discontinue developing Plumiaz (diazepam) Nasal Spray, an investigational therapy being studied for treating seizure clusters in people with epilepsy. Data from ongoing clinical trials do not demonstrate its bioequivalence to Valeant Pharmaceutical’s Diastat rectal gel, which is needed to file a 505(b)(2)
Drugs
FDA has granted orphan drug designation to Anavex Life Sciences’ Anavex 2-73 for treating Rett syndrome. The company describes the disease as a rare non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments and is characterized by near constant repetitive
Drugs
ResQ Pharma, Inc. has submitted an Investigational New Drug application to FDA for LipidRescue Therapy (LRT) as a last resort in treating local anesthetic systematic toxicity. The company says LRT refers to administrating a lipid emulsion with the intent of reducing the life-threatening clinical manifestations of toxicity from excessive
FDA Policy/General
Federal Register Notice: FDA has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2015. These are CBER’s Blood Products Advisory Committee, National Center for Toxicological Research’s Science Board to the National Center for Toxicological Research,
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment. It is intended to assist sponsors in designing a clinical development program for new drug products for treating chronic obstructive pulmonary disease. This document revises the draft guidance of
FDA Policy/General
Federal Register Notice: FDA is publishing a list of 14 premarket approval applications that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency’s Division of Dockets Management. These PMAs include
FDA Policy/General
Federal Register Notice: FDA plans a meeting of the Blood Products Advisory Committee 6/20 from 9:30 a.m. to 1 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee members will
Devices
B. Braun Medical has agreed to pay the U.S. government $7.8 million to resolve its criminal liability for selling contaminated pre-filled saline flush syringes in 2007. The syringes had a B. Braun label but were manufactured by another company, according to a Justice Department (DoJ) release. The
FDA Policy/General
Federal Register Notice: CDER is sponsoring a public workshop 8/29 entitled “Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).” Its purpose is to have a forum for dialog with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm
FDA Policy/General
Federal Register Notice: The FDA commissioner has renewed the Drug Safety and Risk Management Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/31/18. To view this notice, click here.