Search Results for Novo Nordisk

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Novo Nordisk Pays $58M to Settle REMS Allegations By Michael Mezher - Published 06 September 2017

Danish drugmaker Novo Nordisk on Tuesday agreed to pay $58 million to settle allegations that the company failed to follow the risk evaluation and mitigation strategy (REMS) for its blockbuster diabetes drug Victoza (liraglutide).

Categories: News, US, DOJ, FDA, Advertising and Promotion, Communication, Drugs

Tags: Novo Nordisk, Victoza, REMS

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

EMA Recommends Nine Drugs for Approval By Zachary Brennan - Published 11 November 2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: EMA CHMP, marketing authorisation in EU, Gilead, Sanofi, Novo Nordisk

European Regulatory Roundup: Clinical Trial Delays Prompt EMA to Consider Revising Guidance (18 August 2016) By Nick Paul Taylor - Published 18 August 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: European Regulatory Roundup, clinical trial guidance, EFPIA, Novo Nordisk, HTA

Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals? By Zachary Brennan - Published 01 April 2016

Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated.

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

Tags: emerging device safety signals, AdvaMed, MDMA, GE, Merck, Novo Nordisk

Public Citizen Again Calls for Ban on Diabetes Drug Victoza By Alexander Gaffney, RAC - Published 06 June 2014

A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths.

Categories: News, US, CDER, Drugs, Postmarket surveillance, Product withdrawl and retirement

Tags: Novo Nordisk, Victoza, GLP-1, Public Citizen, Petition, Safety

Timing of Complete Response Letter Disclosure Leads to Investigation into Novo Nordisk By Alexander Gaffney, RF News Editor - Published 10 December 2013

Tags: Novo Nordisk, CRL, Denmark, warning letter, EU

Sterility Violations Form Basis of FDA Warning Letter to Novo Nordisk By Alexander Gaffney, RF News Editor - Published 07 February 2013

Categories: FDA

Tags: 483, Sterility, Novo Nordisk, Denmark, warning letter, Latest News

Orange Book Listings Lesson: An overly broad use code may lead to legal challenges By Jane Wright-Mitchell, PharmD, JD - Published 23 July 2012

The US Supreme Court's recent Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S decision highlights the different viewpoints of the courts in the pharmaceutical arena, in particular drawing attention to the interaction of pharmaceutical patents to the US Food and Drug Administration (FDA)-generated Orange Book.

Categories: FDA

Tags: Caraco Pharmaceuticals, Orange Book, Novo Nordisk, Court, SCOTUS, ANDA, It's the Law, decision, legal

Public Citizen to FDA: Diabetes Drug Unsafe, Should Be Pulled By Alexander Gaffney - Published 20 April 2012

Categories: FDA

Tags: Rosebraugh, Liraglutide, Victoza, Diabetes, Novo Nordisk, Wolfe, Public Citizen, Latest News, risks

Supreme Court Rules Company Can Sue Novo Nordisk For Delaying Generic Medication By Alexander Gaffney - Published 18 April 2012

Tags: Entry, Caraco, Kagan, Novo Nordisk, 505(b)(2), Delay, SCOTUS, Generic, Latest News

Report: Comments on Draft Biosimilar Guidelines Mostly Trend Negative By Alexander Gaffney - Published 16 April 2012

Categories: FDA

Tags: Novo Nordisk, Comments, Genentech, Latest News, BPCI, testing, biosimilar, draft guidance, guidance, Biosimilars