Search Results for Allergan

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GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits By Zachary Brennan - Published 02 November 2017

Republicans on Thursday rolled out their new tax reform bill, which among other provisions to lower taxes for Americans and businesses, proposes to repeal a provision that might cause the biopharma industry some concern.

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

Tags: orphan drug tax credit, orphan drug research, BIO, Allergan

Court Finds Restasis Patents Invalid, Raises Concerns About Allergan, Mohawk Tribe Agreement By Zachary Brennan - Published 16 October 2017

In a setback for Allergan, four of the company’s patents covering its blockbuster eye drug Restasis were ruled invalid on Monday by the US District Court for the Eastern District of Texas. Allergan has said it will appeal the decision, but what might have a wider ripple effect was another order that raised questions about Allergan’s decision to pay to transfer the patents to a Native American tribe and prolong the launch of Restasis generics.

Categories: News, US, Biologics and biotechnology, Drugs, Due Diligence, Government affairs

Tags: Restasis, Allergan, Saint Regis Mohawk Tribe

Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council By Zachary Brennan - Published 17 April 2017

Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: J&J, Pfizer, Allergan, combination products and FDA

Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule By Zachary Brennan - Published 16 February 2017

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: PhRMA, BIO, intended use, Allergan, rulemakings

FTC Continues Crackdown on Pay-for-Delay Agreements By Zachary Brennan - Published 23 January 2017

The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements that often keep generic drugs from entering the US market.

Categories: News, US, FTC, Generic drugs, Due Diligence, Government affairs, Regulatory strategy

Tags: pay-for-delay settlements, Endo, Allergan, Watson Laboratories, Impax

Teva to Divest 79 Generic Drugs to Settle FTC Concerns With Allergan Generics Acquisition By Zachary Brennan - Published 27 July 2016

The Federal Trade Commission (FTC) on Wednesday announced that generic drugmaker Teva Pharmaceuticals has agreed to sell its rights and assets to 79 pharmaceuticals to settle FTC charges that its proposed $40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anticompetitive.

Categories: News, US, FTC, Crisis management, Generic drugs, Manufacturing, Project management

Tags: Teva, Allergan, generic drugs, generic drug competition

Asia Regulatory Roundup: Japanese Regulators Receive Orphan Drug Training from EMA (6 October 2015) By Nick Paul Taylor - Published 06 October 2015

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

Categories: News, Asia, EMA, MHRA, PMDA, Biologics and biotechnology, Drugs, Government affairs, Orphan products, Regulatory intelligence

Tags: Asia Regulatory Roundup, orphan medicines, Gardasil, Fosun Pharma, Allergan

US Regulators Approve Fourth Breast Implant Product, Call for Extensive Safety Testing By Alexander Gaffney, RF News Editor - Published 21 February 2013

Categories: FDA, CDRH

Tags: Allergan, Breast Implant, PMA, approval