> FDA won't let Genzyme make its uber-expensive Pompe disease treatment Myozyme at its Boston plant because of a small difference between the batches of Myozyme Genzyme makes now and the new larger batches it was to produce; the regulatory crackdown will leave the drug in short supply in the U.S. and depress Genzyme's 2008 earnings. Report [1]
> Ranbaxy inked a deal with Orchid Chemicals & Pharmaceuticals for multiple finished dosages and active pharmaceutical ingredients. Release [2]
> A Nevada judge ordered Wyeth to post a $58 million bond and pay $1.6 million in attorney's fees for acting in 'bad faith' during settlement talks in the case of three women who sued over the Prempro hormone replacement therapy. Report [3]
> Two drug companies outsourced chunks of their IT systems: Nycomed hired British Telecommunications and Hewlett-Packard to provide it with IT infrastructure, and Janssen Pharmaceuticals tapped Porthus to manage all its electronic customs programming in Belgium. Report [4]
> Celgene got regulatory approval to sell its thalidomide drug in the EU, for use in combination with two other meds for treating multiple myeloma. Report [5]
> Roche's Japanese unit Chugai upped its full-year profit expectations to ¥29 billion from ¥17 billion after government drug-price cuts came in smaller than expected. Report [6]
> Mylan got the FDA nod for its copycat version of AstraZeneca's blood pressure pill Plendil. Report [7]
> Four of San Diego's biggest research institutions are teaming up to form the San Diego Consortium for Regenerative Medicine, a group aimed at advancing stem cell work. And they're planning a $115 million research "collaboratory" that would open in 2010. Report [8]
> Cambridge, MA-based Stromedix has landed $25 million in a Series B round of venture capital. Report [9]
> The bill on sequencing a genome has fallen from a few billion dollars to about $60,000 in just five years. And now two companies want to use nanotech to knock that price down to just $100. Report [10]
> University of Cincinnati researcher Melissa DelBello is getting some added scrutiny for failing to disclose large sums of money she received from AstraZeneca a year after completing a study of Seroquel for bipolar disease. Report [11]
And Finally... "Chemo brain" symptoms may not be byproducts of fatigue and depression associated with cancer treatment, but side effects of a common chemo drug, 5-fluorouracil, a new study found. Report [12]
Links:
[1] http://www.fiercebiotech.com/press-releases/genzyme-provides-update-myozyme-manufacturing
[2] http://www.fiercebiotech.com/press-releases/ranbaxy-and-orchid-announce-strategic-business-alliance
[3] http://www.pharmalot.com/2008/04/wyeth-acted-in-bad-faith-in-prempro-case/
[4] http://www.outsourcing-pharma.com/news/ng.asp?n=84780-nycomed-bt-hewlett-packard-it-telecommunications
[5] http://www.fiercebiotech.com/press-releases/thalidomide-pharmion-granted-full-marketing-authorization-treatment-newly-diagnosed-m
[6] http://www.forbes.com/markets/feeds/afx/2008/04/22/afx4916414.html
[7] http://www.fiercebiotech.com/press-releases/mylan-announces-final-fda-approval-felodipine-extended-release-tablets-usp-0
[8] http://www.fiercebiotech.com/story/san-diego-institutes-plan-115m-stem-cell-lab/2008-04-21
[9] http://www.fiercebiotech.com/story/stromedix-gets-25m-for-mab-work/2008-04-21
[10] http://www.fiercebioresearcher.com/story/biotechs-use-nanotech-in-pursuit-of-100-sequencing-bill/2008-04-22
[11] http://www.fiercebioresearcher.com/story/delbello-draws-added-scrutiny-for-undisclosed-funds/2008-04-22
[12] http://news.bbc.co.uk/2/hi/health/7360127.stm