Merck KGaA meets with FDA on cladribine; InterMune gets a date for advisory panel review

> Merck KGaA says it met with the FDA last month to discuss the approval process for cladribine, a closely-watched MS drug that's been delayed by the regulatory agency. But the company was staying tight-lipped about the discussion and says there's no clear timeline yet on its resubmission plans. Report

> The FDA has scheduled a March 9 advisory committee review of InterMune's lung drug. Story

> The CEO of ImmunoGenetix Therapeutics is still raising the $3 million to $5 million the developer needs to make its way through an early trial of a new AIDS vaccine, but Jim Laufenberg is already mapping out what it sees as a potential $100 million exit strategy. Report

> AB SCIEX is launching a new company dedicated to life science analytical technologies. Release

> Asuragen is teaming up with academic researchers to develop a new miRNA-based diagnostic test for pancreatic cancer. Story

> Resverlogix has elected Arthur J. Higgins, CEO of Bayer HealthCare and chairman of the Bayer HealthCare Executive Committee, to its board. Release

Pharma News

> After last week's trend piece about the many reasons why Big Pharma is looking to Russia as another growth market, Daniel Vasella told journalists at the World Economic Forum that his company sees Russia as its next big emerging-markets opportunity. Story

> Who'll be tops in Japan for generic drugs? Well, don't look at the world's largest generics maker, Teva Pharmaceutical Industries. Pfizer will be the No. 1 player in Japanese generics, Pfizer Japan's Hiroshi Matsumori tells Reuters, even though it hasn't yet entered that market. Story

> How is former Indianapolis Mayor Bart Peterson fitting in as SVP of corporate affairs at Eli Lilly? Item

> And the winner of Mepha is ... Cephalon. The U.S. company won an auction for the Swiss generics maker, agreeing to pay $588 million (or 622.5 million Swiss francs) in the takeover. Story

> Two Zyprexa-related events last week underscore the difficulties--and opportunities--Eli Lilly faces with the antipsychotic drug. Report

 

women taking commonly used forms of antidepressant drugs may experience delayed lactation after giving birth. Release

Biotech IT News

> A maker of security software for the management of confidential documents earned membership into an exclusive life sciences club--the Massachusetts Biotechnology Council. Report

> A large--but unnamed--drugmaker conducting a Phase II trial for a urology treatment will use electronic diaries to collect patient-reported outcome data. The 750-subject trial spans 22 countries on three continents and requires use of 34 languages, according to an announcement. Report

> GlaxoSmithKline has deployed the DocXP document- and data-capture system for eventual use in clinical trials. Story

> Performance measurement is tops among the areas that companies say they need to improve for product portfolio management purposes. It's especially the case at mid-sized companies but true across the board, according to a survey conducted recently by ClearTrial. Item

> Identification of capacity planning as the critical capability for drug developer survival by Tufts last week represents a bar set high. Story

> The European Medicines Agency says it plans to do something about the high attrition rate of drugs in development. And without saying so explicitly, it implies an increased role for automation both within its own organization and among its industry constituents. Story

And Finally... According to a new study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism, women taking commonly used forms of antidepressant drugs may experience delayed lactation after giving birth. Release

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