Search Results for AbbVie

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Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B By Zachary Brennan - Published 02 October 2017

Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: AbbVie, Amgen, Humira, biosimilar, CMS

FDA Approves First Treatment for Chronic Graft Versus Host Disease By Zachary Brennan - Published 02 August 2017

The US Food and Drug Administration (FDA) on Wednesday expanded the approval of AbbVie’s Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after the failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Imbruvica, AbbVie, cGVHD

UK Patients to Get Early Access to AbbVie's HCV Combo By Michael Mezher - Published 10 May 2017

Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday.

Categories: News, Europe, MHRA, Drugs, Submission and registration

Tags: EAMS, Early Access to Medicines Scheme, Glecaprevir, Pibrentasvir, AbbVie

EMA Recommends Two Amgen Humira Biosimilars By Zachary Brennan - Published 27 January 2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended eight medicines for approval, including two Amgen biosimilars for AbbVie’s blockbuster Humira (adalimumab).

Categories: News, Asia, Europe, US, EC, EMA, FDA, Biologics and biotechnology

Tags: Humira, Amgen, AbbVie, blockbuster drugs

European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (25 August 2016) By Nick Paul Taylor - Published 25 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, Compliance, Crisis management, Drugs, Medical Devices

Tags: medical app, pharmacovigilance, Boehringer, AbbVie

Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels By Zachary Brennan - Published 03 August 2016

Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label.

Categories: News, US, FDA, Biologics and biotechnology, Labeling

Tags: Novartis, Amgen, Pfizer, Sandoz, AbbVie, Takeda, Boehringer, biosimilar, labeling guidance, biosimilar labels, interchangeability

FDA Staff Back Biosimilar to Compete With Blockbuster Humira By Zachary Brennan - Published 08 July 2016

Competition for one of the world’s top-selling biologics – AbbVie’s Humira (adalimumab) – is likely to come in the near future, as staff at the US Food and Drug Administration (FDA) said Friday that Amgen’s biosimilar has “no clinically meaningful differences” with the US-licensed Humira, in terms of safety, purity and potency.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Preclinical

Tags: Humira, AbbVie, Amgen, biosimilar

AbbVie, FDA Withdraw Two Cholesterol Drugs from US Market as Benefits No Longer Outweigh Risks By Zachary Brennan - Published 15 April 2016

The US Food and Drug Administration (FDA) on Friday announced that it’s withdrawing approval of AbbVie’s new drug applications (NDAs) for the cholesterol drugs Advicor (niacin extended-release [ER] and lovastatin) and Simcor (niacin ER and simvastatin) as new research shows the benefits of the drugs no longer outweigh the risks.

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

Tags: cholesterol drugs, Advicor, Simcor, AbbVie

Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers By Alexander Gaffney, RAC, Michael Mezher, Zachary Brennan - Published 02 October 2017

Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy, Research and development, Submission and registration

Tags: Priority Review Voucher, PRV, Neglected Tropical Disease, Neglected Tropical Disease Priority Review Voucher, Rare Pediatric Disease Voucher, Rare Pediatric Disease, FDASIA, FDAAA, Voucher, FDA Voucher, Guidance, AbbVie, United Therapeutics, Praluent

AbbVie Withdraws Legal Challenge Against EMA Regulatory Transparency Policy By Alexander Gaffney, RAC - Published 04 April 2014

Categories: EMA

Tags: AbbVie, Data Transparency, InterMune, Clinical Data, Lawsuit, Latest News, EU