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Insmed drug fails in genetic disorder study, shrs tank 3:33 AM 6/26/2009
Reuters - USA
Insmed Inc said a mid-stage trial on its drug Iplex for the treatment of myotonic muscular dystrophy (MMD) failed meet the majority of the goals. ...

Mylan sues Teva Pharmaceutical Industries over generic inhaler 2:32 AM 6/26/2009
Pittsburgh Tribune-Review - Pittsburgh,PA,USA
Mylan sued Teva Pharmaceutical Industries to prevent it from selling a generic version of the Perforomist (formoterol fumarate) inhaler for chronic bronchitis and emphysema. ...

Astra, Bristol diabetes drug recommended in Europe 3:44 PM 6/25/2009
Reuters - USA
European regulators have recommended approval of Onglyza, a new diabetes drug from AstraZeneca and Bristol-Myers Squibb for type 2 diabetes. ...

Genzyme drugs to be on hold longer than expected 2:24 PM 6/25/2009
Boston Globe - United States
Genzyme Corp said it estimates the sales interruption for two of its drugs Cerezyme and Fabrazyme will be longer than it previously estimated so vaporized hydrogen peroxide can be dispersed throughout the purification area. ...

Biotech Drugs Should Get Generic Competition, White House Says 1:54 PM 6/25/2009
Bloomberg - USA
Biologic drugs should be subject to generic competition in the US after seven years seen by Obama as a "generous compromise." If only they could figure out how to make safe and effective copies without performing clinical trials. ...

Novartis drug combo cuts pancreatic tumor size 10:18 AM 6/25/2009
Reuters - USA
Afinitor in combination with Sandostatin LAR from Novartis AG cut the size of pancreatic neuroendocrine tumors in more than 80 percent of patients in a mid-stage study. ...

Japan approves first generic biotech drug 4:55 AM 6/25/2009
guardian.co.uk - UK
Japanese regulators approved human growth hormone Somatropin from Novartis AG's generics unit Sandoz. This is the first in Japan for a biosimilar or generic version of a biotech drug. ...

US FDA staff: Problems in River Plate drug studies 2:22 AM 6/25/2009
Reuters - USA
Food and Drug Administration reviewers determined that one of River Plate Biotechnology's key studies lacked a "robust treatment effect" for sodium hyaluronate ...

Sanofi to Dive into Generic Drugs 12:05 AM 6/25/2009
Wall Street Journal - USA
Sanofi-Aventis SA is preparing to market generic drugs and a cut research spending as it gets ready for the loss of patent protection on one of its best selling drugs. ...

FDA Approves Generic Plan B Emergency Contraceptive for Children 4:54 PM 6/24/2009
Wall Street Journal - USA
The US FDA approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets available by prescription only for girls ages 17 and under referring to them as "women". Merriam-Webster defines women as adult (fully developed and mature) female persons. ...

Osiris drug fails to improve lung function 11:23 AM 6/24/2009
Forbes - NY,USA
Osiris Therapeutics' interim data from a mid-stage trial show that its experimental adult stem cell treatment did not improve lung function in patients with chronic obstructive pulmonary disorder. ...

OncoGenex gets FDA nod for prostate cancer trial design 6:30 AM 6/24/2009
Reuters - USA
OncoGenex Pharmaceuticals Inc reached an agreement with US FDA to amend the design of a late-stage trial of its lead prostate cancer drug OGX-011. ...

FDA rejects GlaxoSmithKline experimental drug for nausea, vomiting ... 3:10 PM 6/23/2009
Los Angeles Times - CA,USA
The US FDA rejected GlaxoSmithKline's application to approve experimental drug casopitant for nausea and vomiting that occurs after surgery or is triggered by chemotherapy. More data are needed. ...

Johnson & Johnson says pain drug is now available 2:20 PM 6/23/2009
Forbes - NY,USA
Painkiller Nucynta is now on the market following approval from the US FDA and DEA. Immediate-release Nucynta tablets are available with a prescription in 50 mg, 75 mg, and 100 mg strengths to treat moderate to severe acute pain in patients 18 and older. ...

Dream Stocks for Biotech Investors 1:10 PM 6/23/2009
Motley Fool - USA
Market cap of at least $100 million. Three-year revenue growth rate of at least 25%. Price-to-earnings ratio of less than 25. ...

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