> The FDA has approved Merck's Isentress for HIV. This is a new type of drug, which prevents HIV from inserting its DNA into human DNA, stunting its ability to infect cells. Release [1]
> The FDA has approved GlaxoSmithKline's Hycamtin for lung cancer. Release [2]
> Labopharm has formally appealed its second approvable letter from the FDA on its once-daily formulation of tramadol. Release [3]
> In response to an FDA approvable letter, Pozen has submitted more data on its migraine drug Trexima. Report [4]
> Gene Logic has sold its genomics assets to India's Ocimum Biosolutions for $10 million. Report [5]
> The FDA has granted Innovive orphan drug status for Tamibarotene, an experimental treatment for adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid and arsenic trioxide. Release [6]
> The FDA has lifted its clinical hold on Telik's clinical trials for the cancer drug Telcyta. Release [7]
> The new Sanofi CEO has some radical idea. In his first interview since taking the helm at Sanofi-Aventis, CEO Gérard Le Fur (photo [8]) told the Financial Times that drug makers ought to cut prices and rely on volume for profits. Report [9]
> Pharma is one of few industries where patent law doesn't inspire a yawn. So when the U.S. Patent Office introduced unfriendly rules governing patent continuations--vital to protecting brand-name meds--GlaxoSmithKline was first in line to sue. Report [10]
> Pfizer is crashing an online party for physicians. The drug maker has inked a deal with Sermo, a sort of Facebook for docs who want to gossip about their practices--drug side effects included. Report [11]
And Finally… Early detection and improved therapies are getting most of the credit for an accelerating decline in the United States' cancer death rate. Article [12]
Links:
[1] http://www.fiercebiotech.com/press-releases/press-release-fda-approves-isentress
[2] http://www.fiercebiotech.com/press-releases/press-release-gsk-receives-approval-hycamtin-capsules
[3] http://www.fiercebiotech.com/press-releases/press-release-labopharm-appeals-fdas-tramadol-decision
[4] http://www.chron.com/disp/story.mpl/ap/fn/5214332.html
[5] http://www.chron.com/disp/story.mpl/ap/fn/5214561.html
[6] http://www.fiercebiotech.com/press-releases/press-release-innovive-pharmaceuticals-announces-receipt-fda-orphan-drug-designation-
[7] http://www.fiercebiotech.com/press-releases/press-release-telik-says-fda-removes-partial-hold-lung-cancer-drug
[8] http://www.fiercepharma.com/story/sanofi-aventis-ceo-gerard-le-fur/2007-10-15
[9] http://www.fiercepharma.com/story/sanofi-ceo-cap-drug-prices/2007-10-15
[10] http://www.fiercepharma.com/story/gsk-sues-over-new-patent-rules/2007-10-15
[11] http://www.fiercepharma.com/story/pfizer-wants-party-docs-online/2007-10-15
[12] http://www.chron.com/disp/story.mpl/health/5213477.html