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FTC Vote On BMS-Celgene Acquisition Splits Over Drug Pricing

 
• By Brenda Sandburg

Divesting Celgene's psoriasis drug Otezla will remedy anticompetitive harm from acquisition, US Federal Trade Commission votes 3-2. Dissenting Democrat commissioners want broader review of pharma mergers.

WASHINGTON, DC - MAY 4: Federal Trade Commission Headquarters in downtown Washington, DC on May 4, 2015.

The US Federal Trade Commission revealed a sharp divide in voting 3-2 to give the go-ahead for Bristol-Myers Squibb Co.'s acquisition of Celgene Corp. with the divestiture of Celgene's blockbuster psoriasis drug Otezla (apremilast). The two dissenting commissioners said it was not sufficient to look solely at overlapping products and that high drug prices and other consequences of pharmaceutical mergers should be considered.

The FTC announced on 15 November that it had accepted a proposed consent order to remedy the anticompetitive effects resulting...

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UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.