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No link between celiac disease and autism, study shows 4:07 AM 9/27/2013
Medical News Today
Large studies show contradictory results. ...
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FDA Again Rejects Merck Surgery Drug 9:12 PM 9/22/2013
Wall Street Journal
The US FDA refused to approve drug Bridion (sugammadex) which reverses the effects of anesthesia after surgery. ...
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Test of Alzheimer's Drug Gets Large Federal Grant 8:44 AM 9/18/2013
New York Times
Clinical trials to test a treatment on symptom free people 60 to 75 having two copies of a gene known to greatly increase the risk of Alzheimer's. ...
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Glaxo-Theravance Lung Drug Anoro Wins US Panel Backing 7:04 AM 9/10/2013
Businessweek
Lung drug Anoro Ellipta won the backing to treat emphysema and chronic bronchitis. ...
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New IBD Drug, Vedolizumab, Receives Priority Review Status for ... 7:14 AM 9/7/2013
Pharmacy Practice News
Takeda Pharmaceutical receives priority review for investigational antibody drug vedolizumab for active Crohn’s disease (CD) and ulcerative colitis (UC). ...
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Novartis heart failure drug effective across patient groups 3:24 AM 9/2/2013
Reuter
Serelaxin is a form of a human hormone that relaxes blood vessels and eases stress on the heart and other organs. ...
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Novartis' MS drug Gilenya tied to rare brain infection 8:11 AM 8/29/2013
FiercePharma
The first case of progressive multifocal leukoencephalopathy (PML) in a patient taking Gilenya who had not already received MS drug Tysabri. ...
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Roche eye drug shows benefit in mid-stage trial 7:31 AM 8/27/2013
Reuters
Roche's lampalizumab helped slow the progression of an advanced form of age-related macular degeneration (AMD). ...
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Incyte pancreatic cancer drug improves survival in mid-stage trial 4:29 AM 8/21/2013
Reuters
Six month survival rate of patients treated with Jakafi (ruxolitinib) and chemotherapy was 31 percent above survival rate on placebo. ...
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FDA labels Novartis drug a 'breakthrough therapy' 8:39 AM 8/20/2013
Businessweek
BYM338 aims to treat the rare muscle-wasting disease sporadic inclusion body myositis. ...
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Pacira's Pain Drug Does Not Meet Primary Goal In Late-stage Study 10:01 AM 8/2/2013
NASDAQ
Results from a late-stage study with Exparel in intercostal nerve block did not meet the primary endpoint of pain reduction. ...
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FDA Rule Could Open Generic Drug Makers to Suits 7:41 AM 7/3/2013
New York Times
FDA may allow generic drug makers to change safety labels which opens the door to lawsuits. ...
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Supreme Court blocks generic drug liability suits 2:39 AM 6/25/2013
Los Angeles Times
Federal approval trumps a state's consumer-protection laws. ...
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New Drug May Be Best Treatment for Leukemia Yet 2:53 AM 6/20/2013
TIME
Ibrutinib targets cancer-causing processes as a potential breakthrough in treating chronic lymphocytic leukemia (CLL). ...
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Lilly Ends Alzheimer's Drug Study on Safety Concern 2:03 AM 6/14/2013
Wall Street Journal
Four patients taking LY2886721 had abnormal liver biochemical tests. ...
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Diabetes drug linked to cancer of the pancreas 10:36 AM 6/11/2013
Yorkshire Post
There could be a link between incretin mimetics used to treat type 2 diabetes and pancreas disease. ...
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Google allowing fake drug site ads, AG says 5:23 AM 6/7/2013
USA TODAY
The National Association of Attorneys General charges that Google allows consumers to obtain dangerous drugs without a prescription. ...
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Merck melanoma drug shrinks tumors in 38 percent of patients 4:43 AM 6/3/2013
Reuters
Nivolumab and lambrolizumab disable the programmed death 1 (PD-1) protein that keeps the immune system from destroying cancer cells. ...
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Drug Combo May Boost Melanoma Survival, Lessen Side Effects 8:46 AM 6/1/2013
Businessweek
Adding Sanofi's white-blood cell boosting drug GM-CSF to Bristol-Myers Squibb's melanoma drug Yervoy helped advanced skin cancer patients live longer. ...
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Merck's insomnia drug moves a step closer to US approval 5:26 AM 5/23/2013
Reuters
FDA's internal reviewers express concern about suvorexant's potential to cause next-day sleepiness and impaired driving. ...
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Amag says anemia drug caused fatal reaction in Switzerland 9:40 AM 5/21/2013
Reuters
Takeda Pharmaceutical is recalling a batch of Amag's anemia drug Rienso because of a death and several cases of hypersensitivity. ...
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New 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. ...
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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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