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New
study may deal final blow to acne drug Accutane 5:27 AM 11/7/2009
Los Angeles Times
Roche Holding pulled blockbuster Accutane off the market in June
amid signs that the drug was linked to inflammatory bowel disease. A new study finds that users have almost
twice the odds of developing a serious bowel disorder.
...
Gloucester Pharmaceuticals wins OK on cancer drug 2:22 AM 11/7/2009
Boston Globe
Gloucester Pharmaceuticals won approval from the US FDA to market its
first drug in the US. Istodax (romidepsin) treats a rare skin cancer known as cutaneous T-cell lymphoma (CTCL)
affecting about 20,000 people in the US.
...
Boston
Scientific Reaches $296 Million Settlement In Guidant Case 9:21 AM
11/6/2009
CNNMoney.com
Boston Scientific Corp agreed to pay $296 million
to resolve a Justice Department investigation into to product advisories at its Guidant defibrillator unit.
Guidant pleads to two misdemeanor charges related to improper reporting to the US FDA.
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Micromet
buys remaining rights to cancer fighting drug 12:22 PM 11/5/2009
Bizjournals.com
Micromet has bought out MedImmune Inc’s stake in cancer-fighting protein
blinatumomab. It gains rights to commercialize the drug in North America.
...
Sunesis'
Voreloxin Receives FDA Orphan Drug Designation for Acute Myeloid
Leukemia 9:00 AM 11/5/2009
Reuters
The US FDA
has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML). Sunesis is
currently conducting two Phase 2 clinical trials of voreloxin in AML.
...
Experimental
vaccine cures pre-cancer vulvar growths 5:06 AM 11/5/2009
Reuters
Unlike Cervarix and Gardasil the new vaccine is designed as a treatment
for precursor growths known as vulvar intraepithelial neoplasia.
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Daiichi Sankyo begins
late-stage trials of flu
drug 3:36 AM 11/5/2009
Reuters
Daiichi Sankyo
has begun a late-stage trial in Japan for the influenza treatment laninamivir to prevent new H1N1 flu as well as
bird flu infections.
...
Shire
Gaucher drug gets FDA priority review 11:12 AM 11/4/2009
Boston Globe
The US FDA designation speeds up the regulatory review process for drug candidate
velaglucerase alfa for Gaucher disease, a rare enzyme disorder that can cause liver and neurological problems.
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The
Swine Flu Vaccine Screw-Up 8:33 AM 11/4/2009
CBS
News
Vaccines can be tricky and less than profitable to manufacture going out of style with every microbial
mutation.
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Merck,
now No. 2 drugmaker, set for future buys 7:42 AM 11/4/2009
The Associated Press
Merck & Co leapfrogs from number 8 after the maker of vaccines,
cholesterol, and diabetes drugs bought Schering-Plough Corp for $41.1 billion.
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GenVec
cancer drug gets orphan status, shares soar 7:38 AM 11/4/2009
Reuters
Clinical-stage biopharmaceutical company GenVec Inc said its experimental
cancer drug TNFerade got orphan drug designation from US FDA to treat locally advanced pancreatic cancer by
stimulating the production of TNF-alpha.
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ThromboGenics
drug pipeline on track 7:08 AM 11/4/2009
Reuters
ThromboGenics NV is on track with its drug development pipeline and its partnership
with Roche AG. Its lead product is microplasmin for treatment of back-of-the-eye disease.
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Novartis buys China
vaccine stake for $125 mln 4:43 AM 11/4/2009
Reuters
Novartis is buying an 85 percent stake in privately owned Chinese vaccines company
Zhejiang Tianyuan for $125 million. Novartis is also investing $1.25 billion in research facilities in China.
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J&J
Plans Staff Cut Of Up to 8200 Jobs 2:24 AM 11/4/2009
Wall Street Journal
Johnson & Johnson will eliminate as many as 8,200 jobs (7% of its work
force) to help the company cope with what it expects will be a slow economic recovery. That brings industry job
losses to nearly 50,000.
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GTx
shares continue fall on FDA request 11:23 AM 11/3/2009
Forbes
The US FDA asked biotechnology company GTx for additional late-stage study data on bone
drug candidate toremifene.
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