Health and Pharmaceutical News
Novo
Nordisk Diabetes Drug Victoza Gets EU Approval 6:42 AM 7/3/2009
Wall Street Journal - USA
Novo Nordisk said the European Commission has given market authorization for its diabetes treatment Victoza (liraglutide) in the European Union member states.
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Biogen
Buys Rights to Acorda's MS Pill Outside US 2:25 PM 7/2/2009
Bloomberg - USA
Biogen Idec Inc will pay as much as $510 million for rights to market Acorda Therapeutics Inc’s experimental MS pill Fampridine SR outside the US.
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Johnson
& Johnson Buys Access to Alzheimer's Drug 8:39 AM 7/2/2009
New York Times - United States
Johnson & Johnson will acquire nearly all of the assets and rights of Elan related to its Alzheimer’s Immunotherapy Program through a new company. J&J will also invest $1 billion in Elan in exchange for American depositary receipts equivalent to 18.4 percent of Elan.
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Europe
biotechs see light at end of funding tunnel 7:39 AM 7/2/2009
Reuters - USA
Drug discovery firms have struggled to raise funds during the financial crisis. Industry insiders see some signs of confidence creeping back into the sector.
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Blood
pressure drugs slow eye problems in diabetes 5:37 AM 7/2/2009
Reuters - USA
Merck's blood pressure drugs Vasotec (enalapril) and Cozaar (losartan) slowed progression of diabetic eye damage in more than 65 percent of patients.
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Sanofi
wins FDA approval for Multaq heart drug 3:32 AM 7/2/2009
Forbes - NY,USA
Sanofi-Aventis won approval to sell heart drug Multaq in the US which could be the blockbuster that helps the company as patents expire on drugs like cancer treatment Taxotere and blood thinner Plavix.
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Discovery
Labs says lung drug unlikely to get FDA nod 10:01 PM 7/1/2009
Reuters - USA
Discovery Laboratories Inc said its lung drug surfaxin was not likely to get US FDA approval in the near term. Discovery will focus on other development programs.
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Two
Sepracor drugs suffer setback, shares tumble 4:51 PM 7/1/2009
Reuters - USA
Sepracor Inc suffered a double setback as its experimental depression drug SEP-225289 failed a Phase II study and the US FDA halted two pediatric studies of its blockbuster Lunesta insomnia drug.
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Pfizer,
Glaxo anti-smoking drugs need warning -FDA 3:06 PM 7/1/2009
Reuters - USA
The US FDA ordered Pfizer and GlaxoSmithKline to add strong "black box" warnings on their anti-smoking drugs Chantix and Zyban to highlight the risk of serious mental health problems including thoughts of suicide.
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Pfizer's
Sutent fails in colon cancer, trial halted 5:34 AM 7/1/2009
Reuters - USA
Pfizer Inc said a late stage trial of its cancer drug Sutent in advanced colon cancer was discontinued. Sutent was no better than standard chemotherapy.
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Astra,
Pozen seek US approval for new pain drug 2:34 AM 7/1/2009
Forbes - NY,USA
AstraZeneca and drug development partner Pozen submitted their experimental two-in-one pain drug PN400 for regulatory approval in the US. Vimovo is a combination of AstraZeneca's ulcer drug Nexium and anti-inflammatory naproxen.
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FDA
panel: Lower maximum daily dose of Tylenol 5:34 PM 6/30/2009
The Associated Press
Government experts want to see a reduction in the maximum dose of Tylenol and elimination of Vicodin and Percocet. Acetaminophen overdose is the leading cause of liver failure in the US.
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Geron
inks stem-cell deal with GE Healthcare 2:04 PM 6/30/2009
Bizjournals.com - Charlotte,NC,USA
GE Healthcare and biotechnology firm Geron Corp will work to develop tests based on human embryonic stem cell lines. Geron licenses the lines from the Wisconsin Alumni Research Foundation.
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AMAG
anemia drug wins US approval, shares jump 12:34 PM 6/30/2009
Forbes - NY,USA
AMAG Pharmaceuticals Inc said the US FDA approved its injectable anemia drug Feraheme.
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Abbott
Told To Pay J&J $1.67 Billion Over Patent 5:00 AM 6/30/2009
Wall Street Journal - USA
A federal jury upheld the patent on Johnson & Johnson's arthritis treatment Remicade ordering Abbott Laboratories to pay $1.7 billion for infringing the Centocor Ortho Biotech patent.
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Cost-Effectiveness
of Cancer Drugs Is Questioned 3:54 AM 6/30/2009
Wall Street Journal - USA
Treating a lung-cancer patient with Erbitux at $80,000 per 18-week regimen prolongs survival by only 35 days. Extending life one year would cost $440 billion if that math were applied to the 550,000 Americans who die of cancer annually.
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FDA
orders more trials on PPD diabetes drug 3:44 PM 6/29/2009
Bizjournals.com - Charlotte,NC,USA
The US FDA requests that PPD Inc conduct additional tests on diabetes drug alogliptin being developed with Takeda Pharmaceutical Co.
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Roche
recasts itself as a Big Biotech 12:31 PM 6/29/2009
FierceBiotech - Washington,DC,USA
Roche is dropping out of PhRMA and takes Genentech's top position in BIO. Genentech and Roche say BIO's purpose is closely aligned with the direction of the new company and interests in Washington.
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Needle-free
injections OK'd for Teva growth hormone 9:34 AM 6/29/2009
Bizjournals.com - Charlotte,NC,USA
Antares said needle-free injectors for human growth hormone protein is the first approval in the Teva-Antares collaboration.
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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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