Archive for February 10th, 2009

FDA Green Lights Stem Cell Trial

February 10th, 2009 | No Comments | Source: Economist

It’s a debate whether the Big O’s trillion-dollar economic Hail Mary will work and how well, but no one can argue that the man instantly put America back in the stem cell business.

greenbaypackerstemcell 300x228 FDA Green Lights Stem Cell TrialJust 3 days after the inauguration, the FDA green-lighted Geron to carry out the nation’s first clinical trial of stem cell technology.

We can’t even get a pizza delivered in 3 days! 

Geron was free to seek approval and the FDA free to grant it before the election since the Bush Administration’s ban did not impact privately funded research.  But Bush appointees at the FDA weren’t going to give the light of day to any stem cell proposals.

And when Bush banned federal funding for stem cell research, the firestorm frightened off private investors too. Hopefully when the Big O waves the magic wand these investors come back.

In the Geron trial, scientists will recruit 8-10 people with recent severe spinal-cord injuries to assess whether it’s safe to administer oligodendrocytes into the injured tissue one to 2 weeks after the injury. 

Of course everything will be scoured for signs the underlying condition has changed. A successful outcome would beget larger safety trials and on we go. 

Geron’s scientists can transform embryonic stem cells into oligodendrocytes which are not nerves but rather nearby cells that produce myelin, which in turn is a gummy substance that forms a sheath around neurons. Myelin is essential to the neurons’ ability to transmit electrical signals down their length.

In rats, oligodendrocytes administered this way help repair native myelin sheaths and yes, restore to some extent the neuron’s ability to transmit signals.

But since neurons themselves are not being replaced, the treatment proposed by Geron will have limited applications. Still, it’s a critical step towards eventually reconnecting the brain and extremities of people with spinal cord injuries.

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VC Funding falls off a Cliff

February 10th, 2009 | No Comments | Source: Wall Street Journal

youpanicyoudie1 300x199 VC Funding falls off a CliffIn Q4, 2008 the Great Economic Crisis matured into a fire-breathing dragon that stomped on everything including start-ups and the venture capitalists that fund them.

In that quarter, VC investment dropped 30% to levels not seen since Q1, 2005, according to VentureSource.

Venture capital firms invested $5.5 billion into US companies during Q4, compared with $7.9 billion the previous year. A total of 554 VC deals went down during the quarter, compared with 718 in Q4, 2007.

“Very few new deals are getting done, and a lot of people are trying to make sure their portfolios are protected,” Faysal Sohail, of San Francisco-based CMEA Ventures told the Wall Street Journal.

runforyourlife VC Funding falls off a CliffThe dragon blasted venture capital firms 2 ways. First, these firms typically generate revenue when a portfolio company is acquired, merged or goes public, but just about none of that is happening these days.

Second, the firms need to raise cash from institutional investors for investment purposes, but those guys have fled for the hills.

The downturn affected Tech start-ups in particular. They posted their worst investment quarter since 1998. A total of $2.2 billion was invested in 266 Tech deals in Q4, down nearly 40% from that invested in Q4, 2007, according to VentureSource.

Health care start-ups also got nailed, dropping to levels not seen since 2005. For the quarter, 137 deals netted roughly $1.5 billion worth of investment in health care.

For the year 2008 as a whole, venture capitalists invested $28.8 billion in 2,550 deals, down from $31.4 billion invested in 2,823 deals in 2007, according to VentureSource.

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e-Prescribing: Try it, You’ll Like it!

February 10th, 2009 | No Comments | Source: Wall Street Journal

They’re handing out free lollipops to all physicians who’ll e-prescribe, so step right up ladies and gentlemen!

Medicare now gives e-prescribin’ docs a bonus. Some private plans give away handheld devices to those who step up, and a tech coalition distributes free software to docs that ditch the pen and pad.

nothingtoit 300x199 e Prescribing: Try it, Youll Like it!That doubled in one year the number of e-prescribing physicians in the US, to about 70,000 out of the 900,000 or so physicians in the land.

Why the handouts?

Well for one thing, e-prescribing reduces medication errors by checking orders against a list of the patient’s allergies, screening for drug-drug interactions and catching dosing mistakes.

Studies have shown that up to 4% of the 4 billion prescriptions written each year in the US contain errors that pose significant risk to the patient.

“There are more than 1.5 million people hurt every year by preventable medication errors, and the evidence is strong that patients are far better off when we e-prescribe than when we don’t,” Janet Marchibroda, chief executive of eHealth Initiative told the Wall Street Journal.

e-prescribing systems also save money for patients by checking whether low-cost generic alternatives are available in a given prescribing situation.

In addition they make it more likely that patients actually fill their prescriptions by making the process more convenient. 

Besides all that, physicians dig ‘em once they get the hang of ‘em.

Now if we can just straighten up those silly Federal drug laws that prohibit e-prescribing controlled substances like narcotics and sleepers, the number of e-prescribin’ physicians might just double again this year.

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