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India's
Biocon in pact with Mylan for biologic drugs 6:53 AM 6/29/2009 Reuters - USA Indian biotechnology firm Biocon Ltd said it has signed a definitive
agreement with Mylan Inc to develop, manufacture, and supply generic biologic drugs globally.
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Biotech:
Generics Win a Round 4:33 AM 6/29/2009 BusinessWeek - USA The end of market exclusivity does not mean that the innovator makes critical
data available to generic companies as this article would suggest.
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New
Cancer Treatment Shows Promise 3:58 PM 6/28/2009 New York Times - United States The EnGeneIC method uses minicells generated from mutant bacteria
which can be loaded with chemicals and coated with antibodies that direct them toward tumor cells.
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Sanofi
Drug Cancer Risk Should Be Studied, Group Says 10:42 AM 6/27/2009 Bloomberg - USA Sanofi-Aventis SA’s Lantus diabetes drug gets linked to an increased
risk of cancer in studies in Germany and Sweden. Sanofi stands behind the safety of Lantus claiming the research
wasn’t conclusive.
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Takeda
fails to get US approval for diabetes drug 5:01 AM 6/27/2009 Reuters - USA Takeda Pharmaceutical's key diabetes drug failed to get US approval. The FDA wants
more safety data.
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FDA
panel backs Ista drug for eye allergies 3:41 AM 6/27/2009 The Associated Press FDA advisory panel finds that the anti-itching drug Bepreve from eye care
company Ista Pharmaceuticals is safe and effective.
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Smell-Loss
Drug Escaped FDA Review Under Homeopathic Label 8:27 PM 6/26/2009 Bloomberg - USA Matrixx International Inc was allowed to market homeopathic Zicam
for a decade without a review for safety or effectiveness. Over 900 people lose sense of smell. Common sense was
already missing.
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Roche
Pulling Acne Drug Accutane Off Market After Jury
Verdicts 5:27 PM 6/26/2009 Bloomberg -
USA Roche Holding AG is pulling its Accutane acne medicine from the US market after juries awarded at
least $33 million in damages to users with bowel disease.
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Sun
Pharma Awaits Clarity on FDA Move, Shares Slide 3:38 PM 6/26/2009 Wall Street Journal - USA Sun Pharmaceutical Industries is waiting for more clarity
on the US FDA's seizure of over 30 drugs made by the company's US unit Caraco Pharmaceutical Laboratories Ltd.
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Irish
court invalidates patent on Glaxo's top drug 2:26 PM 6/26/2009 Reuters - USA A key patent protecting GlaxoSmithKline's top-selling drug was found
invalid. Teva Pharmaceutical Industries' Ivax unit challenged the combination patent for Seretide (Advair in the
US) relating to the combination of the active ingredients salmeterol and fluticasone propionate expiring in 2013.
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Inotek
Pharmaceuticals Reports Positive Glaucoma Study
Results 12:04 PM 6/26/2009 Pharmaceutical
Business
Review - USA Inotek reported positive results from phase I/II clinical trial of INO-8875 in patients
with glaucoma.
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UCB
arthritis drug Cimzia wins EU watchdog approval 12:01 PM 6/26/2009 Reuters - USA EU recommends approval of UCB SA's Cimzia drug as a treatment for
rheumatoid arthritis.
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Expect
FDA Approval of AMAG Pharmaceutical's Feraheme 10:28 AM 6/26/2009 Seeking Alpha - New York,NY,USA The US FDA is about to decide on the marketing
application of AMAG Pharmaceuticals' Feraheme (ferumoxytol) for the treatment of iron deficiency in anemia
patients with chronic kidney disease (CKD).
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Conatus Pharmaceuticals Initiates Second Phase-II Hepatitis
Trial 8:49 AM 6/26/2009 Pharmaceutical
Business Review - USA Conatus Pharmaceuticals initiated the second phase-II clinical trial with drug candidate
CTS-1027 for the treatment of liver disease associated with Hepatitis C Virus (HCV) infection.
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FDA
Seeks More Data On Lundbeck's Serdolect Drug 4:34 AM 6/26/2009 Wall Street Journal - USA H. Lundbeck said the US FDA requested more data on its
Serdolect treatment for schizphrenia.
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