Tuesday, November 12, 2019

Tuesday, November 12, 2019

Latest News

U.S. FDA: Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations

A federal court has ordered two Tennessee-based companies and their owner to stop distributing drugs, dietary supplements and devices until the companies comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in a consent decree.

ASTEX PHARMACEUTICALS: Announces That Its Novel, Oral Hypomethylating Agent ASTX727 Has Been Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes (Including Chronic Myelomonocytic Leukemia) by the US FDA

Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, announces that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s orally administered fixed-dose combination of cedazuridine and decitabine (ASTX727 or C-DEC) for the treatment of myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

ARTHROSURVACE: Receives FDA Clearance for BOSS™ Toe Fixation System

New joint preserving implant compatible with the Toe HemiCAP DF® and ToeMotion™ Systems

MEVION MEDICAL SYSTEMS: Mevion’s CBCT Imaging Solution from medPhoton Receives FDA Clearance

The cutting-edge CBCT imaging system, an integrated solution with 2D and 3D imaging, is now available to Mevion systems in the U.S.

Applications for new drugs, biological products dip slightly in FY2019

New drug and biological product application filings were down slightly in the first three quarters of the current fiscal year, compared to the same period in the previous year, according to data released by the U.S. Food and Drug Administration.

ICUS: Simple CEUS Scan Helps Diagnose Liver Cancer When MRI is Uncertain

A new study shows that a simple, non-invasive “contrast enhanced ultrasound” (CEUS) scan can be more accurate and reliable than a more expensive MRI procedure for diagnosis of liver tumors and determining whether they are cancerous.

RIDGEBACK BIOTHERAPEUTICS LP: Announces receipt of Breakthrough Therapy designation from FDA for mAb114

Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation.

ENDO: Announces Submission of Biologics License Application to FDA for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite

Endo International plc (NASDAQ: ENDP) announced today that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.

BARDY DIAGNOSTICS: Receives FDA 510(k) Clearance for 14-Day Carnation Ambulatory Monitor (CAM) Patch

Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the 14-Day version of the Carnation Ambulatory Monitor ("CAM™"), the industry's only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.

WONTECH: Holmium laser 'Holinwon Prima' Received FDA approval

WONTECH, a leading Korean medical device company, announced that its Holmium laser device, Holinwon Prima, received U.S. Food and Drug Administration approval.

BIOGENNIX: Launches Agilon Bone Grafting Solution

Company’s New Collagen-Enhanced Bone Graft Material Receives US FDA 510(k) Clearance and Enters Domestic Market

ANSI: National Accreditation Board (ANAB) Accredits Global Standards S.C. (GSSC) to Certify Foreign Food Supplies under U.S. FDA-FSMA Program

The ANSI National Accreditation Board (ANAB), a wholly-owned subsidiary of the American National Standards Institute, has accredited Global Standards S.C. (GSSC) in accordance with the international standard, ISO/IEC 17065, Conformity assessment—Requirements for bodies certifying products, processes, and services, and pertinent certification scheme requirements and regulations under the U.S. Food and Drug Administration (FDA)'s Food Safety Modernization Act, or FSMA.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on improving adverse event reporting of compounded drugs to protect patients

Compounded drugs can serve an important medical need for certain patients, however, they also present risksExternal Link Disclaimer to patients since they are not evaluated by the FDA for safety, effectiveness and quality.

VANTAGE SOLUTIONS: Supports FDA Pilot for Verification Router Service

Vantage Solutions, the manufacturing efficiency experts, today announced it is supporting the Food and Drug Administration (FDA) Pilot for Verification Router Service (VRS) testing sponsored by rfxcel.

CLUEPOINTS: FDA Extends CRADA with CluePoints to Further Explore a Data-Driven Approach to Quality Oversight in Clinical Trials

FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research.

NETECH CORPORATION: Netech Obtains FDA 510(k) Clearance for Delta 3300 - Defibrillator/Pacemaker Analyzer

Delta 3300 Is A Compact and Light Weight Precision Instrument Ideal for Testing all Defibrillators and Pacemakers

UNITED THERAPEUTICS CORPORATION: Announces FDA Acceptance Of Trevyent New Drug Application For Review

United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH).

CHECKPOINT SURGICAL: Receives FDA Breakthrough Designation for Nerve Regeneration Device

Checkpoint Surgical, Inc., a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Checkpoint brief electrostimulation therapy (BEST) system.

FDA held 10 drug application meetings in first 9 months of FY 2019

The U.S. Food and Drug Administration held 10 public meetings related to the review of license applications for drugs and biologics during the first three quarters of fiscal-year 2019, the regulatory agency reported last month.

FDA Reporter