> Officials of GlaxoSmithKline said in an email sent in 2001 that they were "almost certain" the drug Paxil was related to heart defect's in a patient's fetus, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury. Article [1]
> Bayer HealthCare will invest more than $100 million at its Berkeley facility--its largest single investment in the site--with a new manufacturing process to produce future versions of its Kogenate hemophilia therapy. Article [2]
> Millennium said the FDA has agreed to give the company an expedited review to Millennium's request to update its label for Velcade. The drug was approved as a front-line treatment for multiple myeloma in mid 2008 and Millennium wants to augment the drug's existing label with data about VELCADE'S long-term survival benefits. Article [3] l Release [4]
> Health Discovery announced that former Deputy FDA Commissioner John A. Norris has been appointed as chief operating officer of the company. Release [5]
Biotech News
> Arena Pharmaceuticals is touting the results of a major Phase III study of its weight loss drug lorcaserin. Article [6]
> Wyeth Pharmaceuticals, and Ambrx have formed a discovery, development, and commercialization alliance covering protein drug candidates for three undisclosed targets in multiple therapeutic areas. Article [7]
> Bioheart (BHRT) shares are up 22 percent today on the news that a Phase II/III clinical trial of its stem cell treatment for heart failure is producing promising results. Article [8]
And Finally... A 20-year follow-up study revealed a dramatic drop in liver cancer cases among 6- to 19-year-olds who were vaccinated for the hepatitis B virus at birth, according to a study published online September 16 in the Journal of the National Cancer Institute. Release [9]
Links:
[1] http://www.bloomberg.com/apps/news?pid=20601202&sid=aNwFCG0.ZVII
[2] http://sanfrancisco.bizjournals.com/sanfrancisco/stories/2009/09/14/daily58.html
[3] http://www.boston.com/business/ticker/2009/09/fda_will_review.html
[4] http://www.fiercebiotech.com/press-releases/fda-grants-priority-review-status-supplement-containing-long-term-survival-data-velca
[5] http://www.fiercebiotech.com/press-releases/former-deputy-fda-commissioner-john-norris-appointed-chief-operating-officer-health-d
[6] http://www.fiercebiotech.com/story/arenas-weight-lost-drug-its-phase-ii-goal/2009-09-18
[7] http://www.fiercebiotech.com/story/ambrx-wyeth-ink-antibody-dev-deal/2009-09-18
[8] http://www.fiercebiotech.com/story/bioheart-stem-cell-treatment-achieves-positive-response/2009-09-18
[9] http://www.fiercebiotech.com/press-releases/cases-liver-cancer-reduced-younger-population-vaccinated-hbv