Law under the Microscope

Support for Fledgling Life Science Companies - Savvier and More Comprehensive

Coming off of a large project that kept me from blogging for a bit there, I was thinking more about how great some of the incubators I've recently visited are both for the companies they house and for the regions that host them. The energy you feel in these places, and the enthusiasm that the incubator directors display is infectious and makes you smile from seeing their passion and love for what they do. So I'm a big fan of incubators (the well-run ones, that is).

As more states, cities and regions struggle to find ways to encourage and support more innovation and entrepreneurialism, one idea that is starting to catch on and make some progress is incubators.  These have been around for manufacturers and tech companies for years, and several incubators for software and e-companies came and went during the late 90s. More and more incubators are now popping up that are either exclusively for life science companies or that house some life science companies among other tech companies. These can be critical for the very early-stage companies, before they get the larger rounds of funding.

            

UN Shelves Cloning Treaties for Now

Despite efforts by Costa Rica (and the US) on the one hand and Belgium on the other, the UN will not be making any decision this year on a treaty related to embryonic cloning. The UN shelved both of the draft treaties that had been up for consideration on the issue.

Poppies Bring About New Drug Use

For the second bright point in biotech news these days, Nature Biotechnology is publishing a research study on genetically modified poppies that produce Reticuline that could potentially be used in anti-cancer and anti-malarial drugs. Even better in the eyes of the DEA and DOJ, these poppies don't produce morphine or codeine in their latex and so they won't contribute to the illegal drug cartels.

When using RNA interference to turn off a set of 10 different genes in poppies, the production of morphine and codeine is stopped and the plants accumulate thebaine and oripavine, which are used for legal painkillers such as oxycodone and naloxone.

Viagra Ads too "Wild"

With all the murky, muddy news that seems to be filling the media these days about the biotech/pharma industry, there are a couple bright points that have made me smile.

The first bright point (at least for us television viewers - Pfizer might not be as amused) is the FDA demanding that Pfizer pull its Viagra ads featuring the song "Wild Thing."  It doesn't seem that the FDA is taking a page from Michael Powell's book at the FCC and is calling the ads racy; rather, Pfizer fails to clearly state that the drug is for erectile dysfunction and to list all of the drug's side effects in the ad.

More Troubles for Merck

I really do hate to harp on one major company's woes that are in the news, especially as I'm not a plaintiff's attorney and they are sure to do an excellent job highlighting the various ways that Merck failed to provide needed evidence regarding Vioxx research results. However, the latest bit to come out about Merck merits some discussion, if for no other reason but as guidance for other companies of all shapes and flavors about what not to say or use for lingo in your internal documents.

EU Members Agree to Allow Scientists to be Mobile

In a terrific show of unity to bring us into the weekend, the heads of 10 European countries have agreed to allow researchers to take some of their research funds with them to another country. In a region where it is so easy to move about from country to country and with tremendous cooperation (and attempts to lure scientists from other countries), this is probably what is needed to stop some of the concerns of scientists who start research in one place and then are offered more labs or money in another country to continue it and stop the feared "EU brain drain".

Stem Cell Research Sees Renewed Competition and Support

Following the passage of Prop. 71 in California, which allocates $3BN over 10 years to the California Institute for Regenerative Medicine (which will give out the grants and loans to the California universities and related labs) for stem cell research, most thought that it would reinvigorate the industry which had been in a bit of a lull due to the ban on federal funds for therapeutic cloning. But few predicted that it would be reinvigorated so quickly and with such enthusiasm.

Proposition 71 to Fund Stem Cell Research Passes in California

In addition to the big election for President and the myriad of other offices that were up for grabs last Tuesday, many ballot initiatives in the states made big news. Californians passed Proposition 71, which will put $3BN ($300MN for each of the next 10 years) toward stem cell research and, it is hoped, make California one of the world leaders in the industry.

FDA Concludes Review of Applications for Reuse of Certain Medical Devices

Every time you go to a hospital for, say, throat surgery, there are many different instruments that the surgeon will use to, say, excise some polops on your larynx. With the millions of surgeries performed in the U.S., that can add up to a lot of plastic or metal that would need to be disposed of - a big waste in the eyes of many. These instruments, or Single-Use Devices (SUDs), can sometimes be reused, so long as they have been properly sterilized and cleaned, of course.

Indian Pharma Companies Urge Space for Generics in IP Laws

As noted in a blog post on Thursday, India intends to introduce its new intellectual property (and other) policies in January that are focused on the biotech industry. The Indian Pharmaceutical Alliance (IPA) is urging lawmakers not to implement new patent laws that would hinder the development of generic drugs.