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Amgen
Drug Reduces Bone Breaks in Prostate Patients 8:21 PM 2/8/2010
BusinessWeek
Amgen Inc's denosumab cut the risk of bone fractures better than Novartis’ Zometa in patients with prostate cancer whose malignancy had spread to their bones.
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Alzheimer's
drug Dimebon helps Huntington's 5:11 PM 2/8/2010
Reuters
Medivation Inc's Dimebon (latrepirdine) appears to be safe for Huntington's patients and has minimal side effects. The potential Alzheimer's disease drug helped Huntington's patients improve thinking, learning, and memory skills.
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FDA
staff questions Cell Therapeutics drug data 11:24 AM 2/8/2010
Reuters
The US FDA questioned effectiveness data from Cell Therapeutics Inc for experimental lymphoma drug Pixuvri (pixantrone) saying it carried substantial side effects.
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Almirall
gets EU approval for prostate drug 5:05 AM 2/8/2010
Reuters
Almirall received European Commission approval to sell silodosin to treat the enlargement of the prostate gland (BPH).
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Par
Pharma unit says FDA declines nausea drug approval 3:00 PM 2/5/2010
Reuters
Par Pharmaceutical Cos Inc's Strativa Pharmaceuticals unit said the US FDA declined to approve its nausea drug Zuplenz. FDA was unable to perform an inspection of the clinical and analytical sites for a bioequivalence study due to an agency-wide restriction on foreign travel in India.
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FDA
Finds Drug Official Had No Conflict, Stepped Aside
Voluntarily 5:07 AM 2/5/2010
Baltimore
Sun
US FDA determines that collaboration between top official Janet Woodcock and scientists for Momenta Pharmaceuticals while the firm had a drug application pending did not constitute a conflict of interest. Competitor Amphastar Pharmaceuticals Inc disagrees.
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New
malaria vaccine shows promise in children 5:08 PM 2/3/2010
Reuters
A new vaccine from GlaxoSmithKline targets the malaria parasite as it is actively infecting red blood cells and causing fever and illness.
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Vertex
cystic fibrosis drug shows promise in trial 3:03 PM 2/3/2010
Reuters
Vertex Pharmaceuticals Inc said preliminary analysis of data from a 28-day trial of drug VX-809 showed patients experienced a decline in sweat chloride.
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Auxilium
says FDA approved hand drug Xiaflex 2:31 PM 2/3/2010
BusinessWeek
Auxilium Pharmaceuticals received US FDA marketing approval for a drug to treat a condition that constricts the fingers and causes them to bend inward.
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Neurosearch
shares leap on Huntington's drug study 5:31 AM 2/3/2010
Reuters
Danish biopharmaceuticals firm Neurosearch A/S announced positive results from a Phase III trial with drug candidate Huntexil for Huntington's disease.
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Glaxo
in up to $330 million deal with Austrian biotech 3:21 AM 2/3/2010
Reuters
GlaxoSmithKline has bought rights to Apeiron Biologics' APN01 experimental medicine in Phase I development for the treatment of acute respiratory distress syndrome.
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FDA
to review Teva biosimilar of Amgen's Neupogen 10:14 AM 2/2/2010
Reuters
The US FDA accepted Teva Pharmaceutical Industries Ltd's Biologics License Application for a drug similar to Amgen Inc's Neupogen. XM02 (to be branded Neutroval) is already being sold under the name TevaGrastim in several European countries. FDA application treats XM02 as a new product.
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Onyx
says FDA agrees on blood cancer drug trial design 9:19 AM 2/2/2010
Reuters
Onyx Pharmaceuticals Inc reached an agreement with the US FDA on the design of the late-stage trial of its blood cancer drug carfilzomib in combination with certain other compounds.
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Lancet
Formally Retracts Study Linking Child Vaccine to
Autism 7:54 AM 2/2/2010
Bloomberg
The Lancet medical journal retracts a study that linked a routine childhood vaccine to autism and bowel disease after an investigation found the original 1998 paper was flawed.
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Protalix
says FDA seeks more data on Gaucher drug 5:07 AM 2/2/2010
Reuters
The US FDA would like additional manufacturing information on Protalix Biotherapeutics Inc's experimental drug for Gaucher disease.
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Herbal
remedies, heart drugs don't mix: review 5:08 PM 2/1/2010
Reuters
Ginkgo biloba, St. John's wort, and other herbal supplements may increase the potency of prescription drugs for heart disease or make them less effective.
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Cephalon
to buy Mepha 10:15 AM 2/1/2010
Bizjournals.com
Cephalon Inc will buy generic and branded pharmaceutical firm Mepha AG of Switzerland in a deal that will double Cephalon's international business. Mepha markets 120 products in 50 countries with 50 pipeline drugs that could be ready within five years.
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Scientists
say crack HIV/AIDS puzzle for drugs 5:10 PM 1/31/2010
Reuters
British and US researchers have grown a crystal that enable them to see the structure of the integrase enzyme which is found in retroviruses like HIV and is a target for some of the newest HIV medicines.
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Glaxo
to cut more jobs as generics bite-reports 11:37 AM 1/31/2010
Reuters
GlaxoSmithKline plans to cut up to 4,000 jobs as competition from new generic drugs weighs on sales.
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Gates
pledges $10bn for vaccine development 6:27 AM 1/31/2010
Financial Times
Bill Gates pledged to give $10 billionn over the next 10 years split between accelerating delivery of existing vaccines in the poorest countries and development of new vaccines for killer infectious diseases.
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Scientists
a step closer to human vaccine for chikungunya virus 11:34 AM 1/30/2010
Los Angeles Times
US researchers have developed a prototype vaccine that protects monkeys and mice against the emerging chikungunya virus which is mosquito-borne and causes rash, a high fever, and a severe arthritis that can persist for years.
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FDA
OKs expanded use of Glaxo breast cancer drug 4:02 PM 1/29/2010
Reuters
The US FDA broadened the approval of GlaxoSmithKline's breast cancer drug Tykerb to be used in combination with the Novartis breast cancer drug Femara to treat hormone positive and HER2-positive advanced breast cancer in post-menopausal women.
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Theravance
reports new delay in infection drug OK 4:01 AM 1/29/2010
BusinessWeek
The US FDA is not satisfied with Theravance Inc's new data on infection drug candidate Vibativ. Further clinical study may be required to win marketing approval.
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Merck says EU approves fertility drug Elonva 3:41 PM 1/28/2010
Forbes
Merck and Co received clearance to market its fertility drug Elonva a single injection intended to help women ovulate.
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FDA
extends date for Sepracor drug candidate 6:56 AM 1/28/2010
Boston Globe
The US FDA anticipates completing its review of Sepracor Inc's Stedesa on April 30 as an adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
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Otsuka
Hldgs to go public by summer 5:21 AM 1/28/2010
Reuters
Otsuka Holdings Co Ltd is preparing to conduct an initial public offering. The deal would make the company the fourth-largest in the Japanese pharmaceuticals sector.
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Pfizer
trims drug pipeline after Wyeth merger 2:36 PM 1/27/2010
Reuters
Pfizer Inc has cut more than 15 percent of its combined drug development programs following the recent merger with Wyeth.
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Spectrum
to end development of enlarged-prostate drug 11:39 AM 1/27/2010
Reuters
Spectrum Pharmaceuticals Inc will stop developing its experimental Ozarelix treatment for enlarged prostate to cut costs and focus on other drug candidates.
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EpiCept's
pain drug gets orphan drug status 10:09 AM 1/27/2010
Reuters
EpiCept Corp's experimental neuropathic pain drug received orphan drug status from the US FDA.
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Court
rules for Teva in Merck cancer drug suit 3:24 PM 1/26/2010
BusinessWeek
A US District Court ruled that a patent on Merck & Co's chemotherapy drug Temodar (temozolomide) is unenforceable which clears the way for Teva Pharmaceutical Industries Ltd to sell a generic.
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J&J
Heated Catheter Better Than Drugs for Irregular
Heartbeats 2:34 PM 1/26/2010
Bloomberg
Johnson & Johnson’s Navistar ThermoCool catheter works better than drugs to control irregular heartbeats in people not responding to at least one drug.
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Novo
Nordisk's Victoza Gets US Approval 5:27 AM 1/26/2010
Wall Street Journal
Danish pharmaceutical company Novo Nordisk's drug Victoza for treatment of type-2 diabetes received US FDA marketing approval with a warning for thyroid cancer.
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Cephalon
Sues Novartis To Block Generic Nuvigil Drug 2:34 PM 1/25/2010
Wall Street Journal
Cephalon Inc has filed a patent-infringement lawsuit against a unit of Novartis to block it from selling a generic version of Cephalon's narcolepsy drug Nuvigil.
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Alternative
prostate cancer vaccine shows promise 2:33 PM 1/25/2010
Reuters
The vaccine Prostvac-VF being developed by BN ImmunoTherapeutics helped patients with advanced and otherwise untreatable cancer live longer.
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Abbott
sues Teva over Simcor patents 12:28 PM 1/25/2010
Reuters
Abbott Laboratories asked a federal court to block Teva Pharmaceutical Industries Ltd from making a generic version of Abbott's Simcor (niacin extended-release/simvastatin) cholesterol treatment.
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FDA
clears MS drug co-owned by Biogen Idec 12:09 PM 1/25/2010
Bizjournals.com
Ampyra is the first drug to be US FDA approved to improve walking in multiple sclerosis patients. It will be marketed by Acorda Therapeutics in the US and Biogen Idec elsewhere.
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Keryx
cancer drug improves survival in mid-stage trial 8:47 AM 1/25/2010
Reuters
Keryx Biopharmaceuticals Inc's mid-stage trial showed colon cancer drug KRX-0401 (perifosine) improved overall survival in patients with advanced metastatic colon cancer.
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Spectrum
says FDA asks for more data on cancer drug 6:04 AM 1/25/2010
Reuters
The US FDA has asked Spectrum Pharmaceuticals Inc for additional data on its experimental Fusilev (levoleucovorin) treatment for advanced metastatic colorectal cancer. Fusilev is already approved in patients with osteosarcoma.
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