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Health and Pharmaceutical News
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Cancer Drugs Harness Power of Immune System 3:48 AM 5/16/2013 Wall Street Journal Bristol-Myers' melanoma treatment Yervoy and experimental nivolumab resulted in tumor regressions in nearly one-third of skin cancer patients.
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FDA
approves Glaxo/Theravance drug for COPD lung disease 8:58 AM 5/10/2013 Chicago Tribune Breo contains the corticosteroid fluticasone and long-acting beta-agonist vilanterol designed to open the airways.
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Eli
Lilly lymphoma drug fails in late-stage trial 7:37 AM 5/10/2013 Reuters Eli Lilly will end development of experimental lymphoma drug enzastaurin.
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Drug
fails to slow Alzheimer's 9:38 AM 5/7/2013 USA TODAY Baxter International's Gammagard failed to slow mental decline or to preserve physical function.
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Drug-resistant
strains of malaria parasite identified 6:54 AM 4/30/2013 Fox News Artemisinin resistance could derail global malaria control advances in recent years.
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Seizure
Drug Used in Pregnancy Boosts Baby's Autism Risk 1:53 AM 4/24/2013 Businessweek Epilepsy drug valproate was also tied to a three-fold increase of autism spectrum disorder including Asperger syndrome.
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FDA Approves Morning Sickness Drug Once Feared Unsafe 7:51 AM 4/9/2013
ABC News Duchesnay USA's Diclegis (doxylamine and pyridoxine) becomes the only FDA-approved drug to treat the pregnancy-related symptoms of nausea and vomiting.
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FDA
approves Biogen's oral MS drug, Tecfidera 3:21 PM 3/27/2013 Reuters Tecfidera activates the body's Nrf2 pathway protecting nerve cells from
damage and inflammation.
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Melanoma
Drug Succeeds in Late-Stage Trial 4:21 AM 3/20/2013 New York Times Patients treated with Amgen's talimogene laherparepvec (TVEC) experienced a significant shrinkage of tumors for six months.
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FDA
reviewers say Titan drug dose may be insufficient 2:36 PM 3/19/2013 Reuters Titan's Probuphine long-acting version of buprenorphine is implanted under the skin of the upper arm.
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Novartis
cleared by EU for eye-care drug Jetrea 1:12 AM 3/18/2013 MarketWatch Jetrea treats vitreomacular traction (VMT) which can cause holes in the eye's macula.
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FDA
Plans Looser Rules on Approving Alzheimer's Drugs 4:55 AM 3/14/2013 New York Times There might be approval at very early stages of the disease where improved performance on memory or reasoning tests can be proven.
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FDA
approves imaging drug for cancer lymph nodes 1:55 PM 3/13/2013 USA TODAY Navidea Biopharmaceuticals' radioactive imaging agent Lymphoseek is intended to find breast cancer or melanoma that has spread to lymph nodes.
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Experimental
Roche drug shows promise in reducing heart damage 6:33 PM 3/10/2013 Reuters Inclacumab blocks the p-selectin antibody associated with inflammation that can destabilize plaque in the arteries and lead to heart attack.
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Web
searches could expose new drug side effects 6:00 AM 3/8/2013 CNN International US FDA drug approvals don't include exhaustive studies of every potential combination of drugs.
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GlaxoSmithKline
files for European approval of diabetes drug
albiglutide 2:56 AM 3/7/2013 Reuters Albiglutide is a latecomer to the crowded GLP-1 market with regulatory approval pending in the US.
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Celgene
drug shown to be effective, safe in psoriasis trial 7:21 AM 3/2/2013 Reuters Apremilast inhibits the phosphodiesterase 4 enzyme (PDE4) reducing inflammation.
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FDA
Wants to Regulate Drug Firms on the Internet 1:59 AM 2/27/2013 Forbes The US FDA’s interpretation that a “Like” implies endorsement could be precedent setting.
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FDA
OKs drug for painful sex caused by menopause 2:29 PM 2/26/2013 CBS News Shionogi's Osphena treats menopausal symptoms that make vaginal tissue thinner and fragile.
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FDA
halts trials of Amgen drug in children, cites death 1:12 PM 2/26/2013 Reuters A 14-year-old patient dies while taking part in a study of Amgen's Sensipar.
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FDA rejects Dynavax adult hepatitis B vaccine 5:30 AM 2/25/2013 Reuters The US FDA wants additional data to evaluate Dynavax Technologies' faster-acting and less frequently needed vaccine.
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Takeda,
Affymax Recall Omontys Drug After 'Serious'
Reactions 4:47 AM 2/24/2013 Bloomberg The anemia treatment for kidney dialysis patients may cause “serious hypersensitivity reactions” that could be fatal.
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FDA
approves Roche drug for late-stage breast cancer 3:16 PM 2/22/2013 Reuters The US FDA approves Kadcyla (ado-trastuzumab emtansine) for patients whose cancer cells contain increased amounts of HER2 protein.
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Fatal
drug overdoses in US increase for 11th consecutive
year 1:00 PM 2/19/2013 Los Angeles Times Over three quarters of overdoses involved central nervous system depressant like Valium, Xanax, or Ativan.
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US
FDA okays Novartis drug to prevent liver transplant
rejection 4:19 PM 2/15/2013 Reuters Novartis' Zortress approved for preventing organ rejection in adult patients receiving a liver transplant.
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Novo
Nordisk sinks on disappointing drug news 8:30 AM 2/11/2013 MarketWatch The US FDA rejects new drug applications for long acting insulin Tresiba and related Ryzodeg.
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Modified
Smallpox Vaccine Stymies Liver Cancer in Study 10:33 AM 2/10/2013 Bloomberg Jennerex Inc's Pexa-Vec (JX-594) reduced size of tumors in liver cancer patients and extended survival more than a year.
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FDA
approves Celgene drug for multiple myeloma 1:31 PM 2/8/2013 Reuters The US FDA approves Pomalyst (pomalidomide) for the most difficult-to-treat multiple myeloma patients.
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Lilly
stops development of rheumatoid arthritis drug 1:33 PM 2/7/2013 Reuters Tabalumab will be tested as a treatment for the autoimmune disorder systemic lupus erythematosus and multiple myeloma.
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Biogen's
purchase of MS drug ends rocky partnership with Elan 1:07 AM 2/7/2013 Reuters Biogen gains full control of multiple sclerosis drug Tysabri which is poised for further growth.
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Gilead's
two hepatitis C drug trials meet study goals 2:09 PM 2/4/2013 Reuters Nucleotide sofosbuvir was tested for 12 weeks in previously untreated patients who have chronic hepatitis C virus (HCV) infection.
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Sanofi's
diabetes drug Lyxumia approved in Europe 7:33 AM 2/4/2013 Reuters Lyxumia (lixisenatide) is an injectable diabetes treatment marketed in Europe.
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Merck
Delays Osteoporosis Drug 12:53 PM 2/1/2013 New York Times Merck is delaying its market application for new drug odanacatib.
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FDA
approves new drug for the chronic management of urea cycle
disorders 9:53 AM 2/1/2013 FDA.gov The US FDA approved Ravicti (glycerol phenylbutyrate) for the chronic management of certain urea cycle disorders (UCDs) in patients over the age of two.
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European
Officials Say Drug Makers Paid to Delay Generic
Version 3:13 AM 2/1/2013 New York Times Johnson & Johnson and Novartis accused of colluding to delay availability of less expensive generic cancer pain drug.
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Roche
Blood Cancer Drug Meets Key Goal In Trial 12:47 PM 1/31/2013 Wall Street Journal The experimental medicine could become
a successor to the company's best-selling drug.
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FDA
Approves Genetic Drug to Treat Rare Disease 1:15 AM 1/30/2013 New York Times Isis/Genzyme's Kynamro could become the first commercial success for antisense gene silencing technique.
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Biogen's
Longer-Lasting MS Drug Meets Goals in Late Trial 10:57 AM 1/24/2013 Bloomberg Injectable multiple sclerosis drug peginterferon beta-1a reduced risk of relapse by 36 percent when given every two weeks. ... See
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Pancreatic
Cancer Drug Found to Extend Life 1:02 AM 1/23/2013 New York Times Celgene's Abraxane prolonged
lives of patients with advanced pancreatic cancer by almost two
months not seen as a breakthrough.
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Lilly
Drug Extends Survival in Gastric-Cancer Study 7:02 PM 1/22/2013 Fox Business Survival advantage of less two months for ramucirumab could prompt regulators to wait for further testing.
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Rapidly Produced Flu Vaccine Wins FDA Approval 2:19 AM 1/17/2013
New York Times
Protein Sciences' process does not require a virus grown in chicken eggs allowing vaccines ready weeks earlier.
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Pfizer moves may signal drug-unit breakup
3:35 AM 1/16/2013
San Francisco Chronicle The world's largest drugmaker may be preparing to split in two.
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GSK
files for US approval of new diabetes drug 3:43 AM 1/14/2013 Reuters GlaxoSmithKline files for US approval of once-weekly diabetes drug albiglutide to compete with Victoza and Byetta and Bydureon.
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Glaxo
Future Hangs in Balance on 2013 Drug Approvals 1:46 AM 1/11/2013 Businessweek Five new drugs submitted to regulators may signal that help is on the way.
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