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Will The Pfizer-Mylan Deal Face Antitrust Hurdles?

 
• By Brenda Sandburg

It's possible the US Federal Trade Commission could require Mylan or Pfizer's Upjohn to divest some pharmaceuticals as the companies have more than 70 overlapping products.

WASHINGTON, DC - MAY 4: Federal Trade Commission Headquarters in downtown Washington, DC on May 4, 2015.
Pfizer-Mylan proposed transaction faces FTC scrutiny

As the US Federal Trade Commission begins its review of Pfizer Inc. and Mylan NV's plan to merge Mylan with Pfizer's Upjohn off-patent branded and generic medicines business into a new company, a key question is how many products regulators might require them to sell.

The agency routinely has made its approval of pharma mergers and acquisitions contingent on the parties divesting overlapping products. The...

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EU Fines Alchem Over Buscopan API Cartel

 
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After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

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Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

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Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
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In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.