Genzyme taps Gilead vet for compliance help; Medicines Co cuts workforce;

> Genzyme has hired biotech industry veteran Ron Branning to take charge of global quality control following a manufacturing crisis that led to the temporary closure of the biotechnology company's plant in Boston. Report

> The Medicines Co. says it cut 10 percent of its workforce, or 31 employees, and expects to take a related charge in the first quarter. Report

> The U.S. Court of Appeals for the Firth Circuit has rejected the argument by a generic drugmaker that federal law preempts a state-law failure-to-warn claim filed by a user of their generic Reglan. Report

> Celgene forecast 2010 earnings that were below analysts' expectations, but it forecast higher-than expected revenue and strong sales for its multiple myeloma drug, Revlimid. Report

> An FDA advisory panel rejected broader use for Forest Laboratories' high blood pressure drug Bystolic; Forest wants to market the drug to reduce death and hospitalizations in heart failure patients. Report

Biotech News

> Australia's Pharmaxis announced today that it plans to acquire Topigen Pharmaceuticals in an all-stock deal. Pharmaxis will issue 3.2 million shares of its stock on closing with an additional 5 million shares to be issued subject to the achievement of milestones specified in the purchase agreement. The deal is expected to close within the next 60 days. Topigen is developing treatments for chronic respiratory and immune disorders that Pharmaxis says complement its own pipeline of drugs. Report

> Vical's Japanese partner AnGes MG got a special protocol assessment approval from U.S. health regulators for a late-stage clinical trial of Collategene to treat peripheral arterial disease. The SPA provides a company with a written agreement that the design and analysis of the trial are adequate to support a marketing application submission to the FDA, Vical says. Story

> San Diego-based VentiRx Pharmaceuticals has rounded up $25 million in a Series A Extension to bring its total first round of VC funding to $51.8 million. It was MedImmune Ventures, the VC arm of AstraZeneca's MedImmune, that led the round. Report

> The annual J.P. Morgan confab in San Francisco is a great place to check the pulse of the country's biotech industry.  Last year you couldn't miss the dangerously erratic beat as the financial crisis played out. But my sampling of CEO plans on the first day picked up a strong tempo. This set of New Year's resolutions sounded distinctly bullish. Story

Biotech Research News 

> With California lawmakers facing a daunting economic challenge, the state's groundbreaking stem cell agency has adopted a simple approach to staying relevant. Rather than finance only blue-sky stem cell research work, Executive Director Alan Trounson wants to support programs that have a shot at near-term clinical success. Story

> Over the past few years a number of scientists have maintained that stem cells' biggest initial commercial opportunity isn't in therapeutics. Early-stage drug discovery offers the most immediate rewards, they say. Now researchers at UC San Diego say that they have created genetically modified embryonic stem cells that more reliably contain target disease genes. And by creating human cells with the disease, the scientists say they can be much more effective than animals for studying genetic diseases. Report

> A scientific team from UCLA is touting a groundbreaking discovery into the role two cellular proteins play in the development of hepatitis C. Heat shock factors 40 and 70 play a big role in infection, the researchers determined. And if new therapies targeted cellular proteins rather than viral proteins, developers could create significant new drugs for hep C. Story

> Researchers at Wake Forest University Baptist Medical Center (WFUBMC) have identified the first genetic variant associated with aggressive prostate cancer-a finding that shows genetic information may one day be used in combination with other factors to guide treatment decisions. Report

And Finally... The Indian government is planning to create special zones for pharma products at international cargo terminals. Report

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.