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FTC Narrowly Okays AbbVie/Allergan Merger As Dissenter Slams Divestitures To AstraZeneca, Nestlé

 
• By Brenda Sandburg

Commissioner Chopra says candy maker Nestlé cannot take Allergan’s place in the market and AstraZeneca would get a windfall without paying anything for a valuable drug development project. AbbVie/Allergan must divest enzyme replacement therapies Zenpap and Viokace to Nestlé and investigational IL-23 inhibitor brazikumab to AstraZeneca. 

Close-up Of King Chess Pieces On Wooden Blocks With Mergers And Acquisitions
FTC Commissioners disagree on adequacy of AbbVie/Allergan divestitures

The US Federal Trade Commission once again was sharply divided on a pharma merger, voting 3-2 to permit AbbVie Inc.'s $63bn acquisition of Allergan PLC to go forward on the condition that they divest three drugs. But Democratic Commissioners Rohit Chopra and Rebecca Kelly Slaughter criticized the divestitures as inadequate and Chopra harshly objected to the divestiture of two products to non-drug company Nestle SA.

On the evening of 5 May, the FTC announced the proposed

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• By Jessica Merrill

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Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

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Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data Requirements

 
• By Francesca Bruce

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.