Tuesday, February 25, 2020

Tuesday, February 25, 2020

Latest News

GOJO: Takes Immediate Action on Communication from the FDA

GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17.

AAO: Reports Congressmen Write Letter to the FDA and FTC Regarding SmileDirectClub, While California Board of Dentistry Moves to Dismiss SmileDirectClub's Lawsuit

The American Association of Orthodontists (AAO) - in the interests of the health, safety, and well-being of patients seeking orthodontic care - reports that on January 6, nine members of the U.S. House of Representatives authored a letter to the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) "to express [their] concern regarding SmileDirectClub."

LILLY: Receives FDA Priority Review for the Selpercatinib New Drug Application

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) for selpercatinib (LOXO-292), for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.

AMERICAN REGENT: Introduces FDA Approved Zinc Sulfate Injection, USP

American Regent, Inc. announced the introduction of FDA approved Zinc Sulfate Injection, USP.

BECKMAN COULTER DIAGNOSTICS: Beckman Coulter's Access PCT Procalcitonin Assay receives U.S. FDA 510(k) clearance

The Access PCT strengthens industry's most extensive portfolio of in-vitro diagnostic testing for sepsis identification and management

ALKERMES: Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder

Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.

CLENE NANOMEDICINE: Announces Formal Acceptance of CNM-Au8 for HEALEY ALS Platform Trial as Center Receives FDA Approval to Proceed

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the receipt of formal acceptance from the U.S. Food and Drug Administration (FDA) to proceed with its CNM-Au8 as one of the first three drug regimens in the HEALEY ALS Platform Trial being conducted by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.

BAZE: Boston-Based Personalized Nutrition Startup, Baze, Announces FDA Approval For Blood-Based Testing Kits

Regulatory approval enables company to expand reach of at-home kits, empowering consumers nationwide to take control of their health

BIOHAVEN PHARMACEUTICALS: Biohaven's Verdiperstat Receives FDA May Proceed Letter To Initiate Trial In Amyotrophic Lateral Sclerosis Conducted By The Healey Center For ALS At Mass General

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a biopharmaceutical company with multiple late-stage neuroscience drug candidates in development, announced today that the U.S. Food and Drug Administration (FDA) has notified its collaborators at the Sean M. Healey & AMG Center for Amyotrophic Lateral Sclerosis (ALS) at Massachusetts General Hospital (MGH) that they may proceed with clinical investigation of verdiperstat, Biohaven's novel myeloperoxidase (MPO) inhibitor, in ALS.

CELULARITY: Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy

Company to Initiate First U.S. Clinical Investigation of Allogeneic NK Cell Therapy administered Intravenously or Intratumorally in Patients with Glioblastoma Multiforme (GBM)

THE FCS FOUNDATION: Familial Chylomicronemia Syndrome Foundation Commends FDA Decision to Create New Advisory Group to Support Rare Disease Drug Review Processes

Action aligns with requests from FCS Foundation for FDA to be more flexible and hear the patient voice when considering review of drugs to treat FCS

VIVALNK: Announces World's First FDA Cleared Wearable ECG Sensor Platform

Reusable patch and software development kit gives solution providers direct control over data

GLAXOSMITHKLINE: US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma

Biologics License Application based on results from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) in heavily pre-treated patient population who was refractory to an immunomodulatory drug and a proteasome inhibitor, and refractory or intolerant to an anti-CD38 antibody

POLARYX THERAPEUTICS: Receives IND Approval for PLX-200 From the FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis

Polaryx Therapeutics, a biotech company developing patient-friendly small molecule therapeutics for lysosomal storage disorders announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of LINCL patients with PLX-200.

U.S. FDA: Michigan-based food manufacturer agrees to stop production after repeated food safety violations

U.S. District Judge Sean F. Cox entered a consent decree of permanent injunction between the U.S. and Home Style Foods, Inc., and the company’s owner, Michael J. Kowalski, and quality manager, Juan Valesquez. Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.

FDA Reporter