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Scientists call for urgent trials to judge flu drugs for pandemics

Scientists still don’t know if two commonly-used flu drugs – Roche’s Tamiflu and GlaxoSmithKline’s Relenza – really work in seasonal or pandemic flu outbreaks and say robust clinical trials are urgently needed to find out. While such medicines are stockpiled by governments around the world and were widely used in the 2009/2010 H1N1 “swine flu” […]

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Neurocrine Announces Positive Results from Phase III Kinect 3 Study of NBI-98854 in Tardive Dyskinesia

SAN DIEGO, Oct. 8, 2015 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that NBI-98854, a highly selective small molecule VMAT2 inhibitor, showed a statistically significant reduction in tardive dyskinesia during the six weeks of placebo-controlled treatment in the Kinect 3 clinical trial. This Phase III trial included moderate to severe tardive dyskinesia patients […]

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Nobel discoveries on DNA repair now fueling cancer drug research

Cancer researchers are just beginning to understand the ramifications of the fundamental discoveries behind the 2015 Nobel Prizes in Chemistry, which were awarded on Wednesday to three scientists for explaining how cells repair mistakes in DNA that occur when cells divide. When deoxyribonucleic acid (DNA) repair mechanisms fail, they predispose people to cancer. That is […]

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MD Anderson Cancer Center and Theraclone Launch New Immuno-Oncology Company OncoResponse with $10 Million Series A

MD Anderson Cancer Center, located in Houston, Texas, announced yesterday that together with Seattle-based Theraclone Sciences, Inc., it was launching an immuno-oncology antibody discovery company, OncoResponse. In addition, OncoResponse closed a Series A financing round worth $9.5 million, co-led by ARCH Venture Partners, Canaan Partners and MD Anderson. Also participating were William Marsh Rice University […]

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Giant promotes four

Giant Creative/Strategy has promoted four to new positions within the agency. Janet D. Vennari has become business lead, overseeing multiple healthcare accounts. Vennari is responsible for strategically leading clients and account teams, as well as generating both organic and new business. She was VP, management supervisor at Giant. Vennari has nearly 20 years of healthcare experience […]

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Brain scans could predict patients at risk of major depression

Scientists studying people with depression say brain scans could be used to predict who is most likely to relapse, an approach that could help doctors make better decisions about who should stay on antidepressants and who should stop. In a small study of 64 patients, the researchers found that significant differences showed up in brain […]

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Electronic health records software often written without doctors’ input

(Reuters Health) – The reason why many doctors find electronic health records (EHR) difficult to use might be that the software wasn’t properly tested, researchers suggests. Current guidelines and industry standards suggest that new EHR software should be tested by at least 15 end users with a clinical background to make sure they are usable […]

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Valeant Fires Back at Critics, Supported by Investor

CHICAGO – In an Oct. 5 filing with the U.S. Securities and Exchange Commission, Valeant Pharmaceuticals International, Inc. (VRX) fired back at critics over its decisions to grow its pipeline through acquisitions and increase the cost of some newly acquired drugs.   In the filing, Valeant said it is not as dependent on the price […]

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Type of weight loss surgery matters for diabetes remission

(Reuters Health) – Diabetics considering weight-loss surgery to help send their disease into remission should opt for the most popular procedure, a gastric bypass, researchers suggest. In their study of different types of so-called bariatric surgeries, the biggest impact on diabetes remission was seen with gastric bypass, which can reduce the size of the stomach […]

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The Un-Marketing Channel

How EMRs will – and won’t – change the brand conversation By Gabriel Cangiano, Director, HCP & Payer Strategies, Intouch Solutions   If electronic medical records didn’t already exist, they’d probably crop up in the fevered dreams of overworked brand managers. After a long day of struggling to communicate with more and more reticent […]

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Amgen Fights Fire with Fire in the Biosimilars Market

Thousand Oaks, Calif.-based Amgen (AMGN), faced with generic and biosimilars competition as its blockbusters lose patent protection, is fighting back on a number of fronts.   On Oct. 2, 2015, Novartis (NVS) announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for its proposed biosimilar to Amgen’s Enbrel […]

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Express Scripts sees $750 million in spending on new cholesterol drugs

Express Scripts Holding Co, the largest manager of prescription drug plans for U.S. employers and health plans, said it has reached deals to cover two costly new cholesterol drugs and expects to spend no more than $750 million on them next year. The injected drugs – Repatha from Amgen Inc and Praluent from partners Regeneron […]

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FDA puts clinical hold on Advaxis cancer drug

Advaxis Inc said the U.S. Food and Drug Administration has put on hold the mid-stage trials of its experimental cancer drug after a patient died, sending its shares down 27 percent in extended trading yesterday. The clinical hold on the drug, axalimogene filolisbac, was issued after Advaxis submitted a safety report to the FDA, the […]

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Microsoft unveils new smartphones, tablet and fitness tracker

Microsoft Corp unveiled on Tuesday a new line of Lumia smartphones, a new Surface Pro tablet and an updated version of its wearable fitness tracker, Microsoft Band, that will run on Windows 10, its latest operating system. Windows 10, launched in July, is part of Microsoft’s push to win a bigger share of the market […]

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AmerisourceBergen to buy PharMEDium for $2.58 billion

Drug distributor AmerisourceBergen Corp agreed to buy PharMEDium Healthcare Holdings Inc for $2.58 billion from private equity firm Clayton, Dubilier & Rice, expanding its business of supplying compounded drugs to hospitals. Compounding is a process in which pharma products are diluted to create doses that are not sold commercially. Increased regulatory oversight following a fungal […]

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Novartis’ Alcon to Add 300 Jobs in $250 Million Atlanta Expansion for Contact Lens Manufacturing

ATLANTA – Alcon (ACL), a division of Novartis (NVS), is investing $250 million into an expansion of its Atlanta-area facility that will add more than 300 jobs, the Atlanta Business Chronicle reported this morning. The expansion will allow Alcon to focus on the manufacturing and development of contact lenses, including Dailies, AquaComfort Plus, Dailies Total1 […]

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Arena Stock Jumps as CEO and Co-Founder Resigns at Request of the Board

San Diego-based Arena Pharmaceuticals (ARNA) announced today that its president and chief executive officer, Jack Lief, will retire, as well as stepping down from the company’s board of directors. The announcement says that Lief’s retirement is “at the request of the Board of Directors.” His interim replacement will be Harry Hixson, a current board member. […]

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Roche says data shows Cotellic combination therapy effective

Swiss drugmaker Roche said final survival data from a Phase III clinical trial showed the Cotellic drug used in combination with Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer compared to Zelboraf alone.   Ongoing monitoring did not identify any new safety signals. Long-term safety data was expected later […]

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FDA asks duodenoscopes makers to study success of cleaning guide

The U.S. Food and Drug Administration has ordered three Japanese manufacturers of duodenoscopes to conduct studies to evaluate how the devices are being used, as part of its effort to prevent the transmission of infections through the device. Duodenoscopes are flexible, lighted tubes inserted down the throat to drain fluids from blocked pancreatic and biliary […]

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Alkermes’ schizophrenia drug Aristada gets FDA nod

The U.S. Food and Drug Administration on Monday approved Alkermes Plc’s longer-acting injectable version of blockbuster schizophrenia pill Abilify, making the treatment available in two doses. Abilify, developed by Japanese drugmaker Otsuka Pharmaceuticals and sold in the United States by Bristol-Myers Squibb Co, is already facing generic competition. Alkermes’ injectable version, Aristada, is expected to […]

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