Tuesday, November 12, 2019

Tuesday, November 12, 2019

Latest News

U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

The U.S. Food and Drug Administration issued warning letters to two marketers and distributors of kratom products – Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina – for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make claims about treating pain, as well as other medical conditions like depression, anxiety and cancer.

‘This is nuts’: FDA program set to help doctors navigate bureaucracy

Health care experts are expressing doubts about the FDA’s new call center, Project Facilitate, which is designed to assist physicians treating cancer patients.

Doctors, not FDA, should be empowered to deal with opioid crisis, association says

The Food and Drug Administration recently unveiled a new draft guidance for tackling opioid addiction, and scheduled a public hearing for Sept. 17 to discuss the crisis.

U.S. FOOD AND DRUG ADMINISTRATION: FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps

The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks.

LANNETT COMPANY, INC.: FDA Clears Path For The Continuing Review Of Lannett Company's New Drug Application

Lannett Company, Inc. (NYSE: LCI) commented on the U.S. Food and Drug Administration's (FDA) denial of a Citizen Petition submitted by Genus Lifesciences requesting that the FDA refuse to accept any submissions related to Lannett's 505(b)(2) New Drug Application (NDA) for Cocaine Hydrochloride Topical Solution, 4% and 10%.

LUMINEX CORPORATION: Luminex Submits ARIES MRSA Assay for FDA Clearance

Luminex Corporation (NASDAQ: LMNX) announced that the company submitted the ARIES® MRSA Assay to the U.S. Food and Drug Administration (FDA) for clearance on Friday, June 28, 2019.

PREMIER INC.: Premier’s ProvideGx™ Program to Make the First FDA-Approved Version of Cysteine Hydrochloride Available to Providers

Premier Inc. (NASDAQ: PINC), through its ProvideGx™ program, is now supplying cysteine hydrochloride injection to providers, a critical drug for pediatric and adult patients that require total parenteral nutrition (TPN). Cysteine hydrochloride has been in shortage in the U.S. since 2015.

FDA OK'd 227 drugs in June

The U.S. Food and Drug Administration approved 227 drug products in June, according to an online list the agency updated this week.

GILEAD SCIENCES, INC.: Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year

Gilead Sciences, Inc. (NASDAQ: GILD) announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib.

GRIFOLS: Announces FDA Approval of Xembify®, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies

Xembify® is Grifols' first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies

Study says new drug applications are almost always disclosed by drug companies

A new research study in the JAMA Internal Medicine said most new drug applications are acknowledged by drug companies.

Mortality linked to paclitaxel-coated devices remains unresolved

A two-day Food and Drug Administration advisory committee meeting found conflicting reports related to increased late mortality rates in using paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs), according to the Regulatory Affairs Professionals Society (RAPS).

Flaws in the system allow Clinicaltrials.gov to host illegal trails

The website Clinicaltrials.gov is home to a broad spectrum of clinical trials, both legitimate and illegal, according to FDAMap.com.

Drug companies want clarity on FDA guidelines for bispecific antibodies

A group of major pharmaceutical companies is asking the US Food and Drug Administration to consider changes to the agency's guidelines on developing bispecific antibodies.

Doctor says FDA should do more to combat opioid crisis

The Food and Drug Administration unveiled yet another draft guidance on opioid addiction, but one doctor remains unimpressed.

ICOTEC MEDICAL: icotec AG Granted FDA Clearance To Market VADER®one Pedicle Screw System

icotec AG, a Swiss company, today announced the VADER®one pedicle screw system was granted U.S. Food and Drug Administration (FDA) 510(k) clearance for both minimally-invasive and open spine surgical procedures.

ANATOMAGE: Releases Anatomage Cloud Platform Featuring One-Click Review to Provide HIPAA Compliant, FDA Approved Free DICOM Sharing and Medical Image Viewing

Anatomage Inc., a market leader in 3D medical imaging technology, released an update to the Anatomage Cloud platform that allows medical and dental professionals to quickly send 3D DICOM volumetric data to colleagues for one-click review.

FDA Reporter