Search Results for insulin

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The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US By Zachary Brennan - Published 05 September 2017

Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: insulin, Merck, Lilly, Sanofi, Admelog, 505(b)(2), biosimilars

Novo Nordisk Warns of Possible Cracks in Insulin Devices By Zachary Brennan - Published 05 July 2017

Novo Nordisk A/S on Wednesday warned people with diabetes that it has detected that the insulin cartridge holder used in a select number of NovoPen Echo and NovoPen 5 lots may crack or break if exposed to certain chemicals, including certain cleaning agents.

Categories: News, Canada, US, Crisis management, Due Diligence, Medical Devices

Tags: Novo Nordisk, insulin pen, insulin device, NovoPen Echo, NovoPen 5

New Maryland Law to Restrict Generic Drug Price Increases By Zachary Brennan - Published 30 May 2017

A new Maryland law to keep generic drug prices from increasing by too much goes a step further than price transparency bills and laws in other states, but it’s leaving some with more questions about its broader impact.

Categories: News, US, Biologics and biotechnology, Business Skills, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug prices, state drug price legislation, drug price increases, Nevada insulin

Insulin: The First Truly Miracle Drug By Max Sherman - Published 08 December 2016

This article will discuss diabetes, the process of the discovery of insulin and provide brief biographies of two intrepid people involved.

Categories: Features, Canada, Biologics and biotechnology, Research and development

Tags: Diabetes, Insulin, Drug Discovery

MHRA Cautions Against Sudden Switches of Insulin Devices By Zachary Brennan - Published 27 October 2016

The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday said it has become aware of patients directly contacted by a manufacturer or other organization inviting them to trial a new insulin delivery system.

Categories: News, Europe, MHRA, Government affairs, Medical Devices

Tags: insulin devices, diabetics and insulin, insulin news

FDA Approves First Automated Insulin Delivery Device By Zachary Brennan - Published 28 September 2016

The US Food and Drug Administration (FDA) on Wednesday approved Medtronic’s artificial pancreas, known as the MiniMed 670G hybrid closed looped system, which is the first device approved in the US to automatically monitor glucose and provide appropriate basal insulin doses in people 14 and older with type 1 diabetes.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: artificial pancreas, Medtronic, automated insulin

UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges By Zachary Brennan - Published 16 August 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges.

Categories: News, Europe, MHRA, Crisis management, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Quality

Tags: Roche, insulin pumps, leaking insulin pumps, patients with diabetes, MHRA alerts

Asia Regulatory Roundup: India Allows Parallel Submission of Trial Filings for Insulins, mAbs (9 August 2016) By Nick Paul Taylor - Published 09 August 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, PMDA, Biologics and biotechnology, Business Skills, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: DCGI, insulin, RCGM, mAb, Asia Regulatory Roundup

Korean Device Firm Denies FDA Inspection By Zachary Brennan - Published 02 March 2016

A South Korean insulin syringe and pen needle manufacturer on Wednesday became the fifth foreign company to currently have its products banned from entry into the US after denying an inspection by the US Food and Drug Administration (FDA).

Categories: News, Korea, FDA, Compliance, Crisis management, Manufacturing, Medical Devices, Quality

Tags: insulin manufacturing, foreign device inspection, FDA inspection

EMA Updates its Biosimilar Insulin Guideline By Michael Mezher - Published 12 March 2015

The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the original document and gives additional detail on study design parameters.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Preclinical, Quality, Regulatory strategy, Research and development, Submission and registration

Tags: Biosimilars, guideline, human insulin

Citing Disease Transmission Risk, FDA to Require Stronger Labels on Some Diabetes Injectors By Alexander Gaffney, RAC - Published 26 February 2015

The US Food and Drug Administration (FDA) said it will require manufacturers of multi-dose diabetes pen devices to label their products with more prominent warnings that patients should not share the devices.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Diabetes, Safety Warning, Insulin Pen, Injectable Diabetes Medicine