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Teva’s New CEO Levin Urges “Fiscal, Strategic Discipline,” Reduces 2012 Guidance

 
• By Wendy Diller

In a hastily scheduled, between-quarters update, Teva takes down its 2012 guidance issued only five months ago. New CEO Jeremy Levin promises a full strategic rendering by year end, announces long-time Teva exec Allan Oberman as new head of U.S. generics and establishment of a global compliance committee.

Teva Pharmaceutical Industry Ltd.’s first-quarter earnings call on May 9 was a bit awkward, with outgoing CEO Shlomo Yanai presiding, and incoming CEO Jeremy Levin adhering to mostly stock comments, before being interrupted by a technical snafu that required everyone to dial back in. That said, Levin made one revelation: a review of the company’s previously announced 2012 financial performance estimates was under way.

Barely two weeks later, on May 24, in a hastily scheduled call, Levin was on the phone again with analysts, this time sharing results of his financial review of the...

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More from Europe

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Geography

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.