Clinical Trials: Page 145
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Intercept Pharma's shares fly high on positive liver drug results
Shares were up as much as 65% as the market closed on Monday.
By Nicole Gray • Aug. 12, 2014 -
All gone for now: Ebola drug ZMapp supply exhausted
Mapp Biopharmaceutical says it is out of its much-sought experimental Ebola treatment, ZMapp, after sending doses to West African countries afflicted by the epidemic.
By Sy Mukherjee • Aug. 12, 2014 -
Explore the Trendline➔
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TrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
Astellas, Cancer Research Technology team up for pancreatic cancer research
Cancer Research Technology (CRT) is the commercial arm of Cancer Research UK. Research will be conducted in the UK.
By Nicole Gray • Aug. 11, 2014 -
WHO panel to debate ZMapp, ethics of experimental Ebola treatments
The World Health Organization (WHO) is convening a panel on Monday to discuss the ethical issues surrounding administering largely untested experimental treatments during public health emergencies.
By Sy Mukherjee • Aug. 11, 2014 -
GSK eases expectations on Ebola vaccine: 'Long, complex process'
GlaxoSmithKline has been developing an early-stage Ebola vaccine with the National Institutes for Health (NIH) -- but don't expect approval anytime soon, the pharma giant warns.
By Sy Mukherjee • Aug. 11, 2014 -
Actelion focusing on patient experience through PatientsLikeMe initiative
The initiative involves creation of a patient-reported outcomes tool for patients with a rare form of non-Hodgkin’s lymphoma.
By Nicole Gray • Aug. 7, 2014 -
FDA
Cytori's stock plummets as stem-cell clinical trials are halted
The San Diego-based company has halted clinical trials of its stem-cell therapy in heart-failure patients due to safety concerns.
By Nicole Gray • Aug. 7, 2014 -
Can an aspirin a day keep the cancers away?
A new study suggests the answer is yes.
By Nicole Gray • Aug. 6, 2014 -
FDA
AbbVie's glioblastoma drug granted orphan status in US, EU
Promising phase I data prompted ABT-414's orphan drug designation.
By Nicole Gray • Aug. 6, 2014 -
Amgen's multiple myeloma drug meets phase III targets
Kyprolis (carfilzomib), used in combination with other medications, increased progression-free survival by 8.7 months in relapsed multiple myeloma patients.
By Nicole Gray • Aug. 5, 2014 -
Postdoctoral fellow admits to faking Novartis brain tumor study results
A paper was published in the journal Cancer Research in 2013 based on the false data, which documented prolonged survival times in mice treated with an investigational compound.
By Nicole Gray • Aug. 4, 2014 -
High-dose estrogen birth control may increase breast cancer risk, study finds
The new data, published in the latest issue of Cancer Research, relies on electronic pharmacy records instead of self-reporting and is consequently considered more reliable than previous studies.
By Nicole Gray • Aug. 4, 2014 -
WHO plans $100 million emergency response as Ebola deaths top 700
“The scale of the Ebola outbreak, and the persistent threat it poses, requires WHO and Guinea, Liberia and Sierra Leone to take the response to a new level,” said WHO Director-General Dr. Margaret Chan.
By Sy Mukherjee • July 31, 2014 -
Bad news for Bayer/Amgen's blockbuster Nexavar in late-stage breast cancer trials
Using Nexavar in conjunction with chemotherapy did not improve progression-free survival in women with advanced breast cancer.
By Nicole Gray • July 28, 2014 -
Investigation raises new questions about Boehringer's blood thinner
Boehringer Ingelheim goes on the defensive as British Medical Journal investigators express concerns about the drug's clinical study design and data calculations.
By Nicole Gray • July 25, 2014 -
Puma stock soars nearly 300% on positive breast cancer drug trial results
Puma’s stock was up more than 275% on news that neratinib hit its target for improving disease-free survival rates in breast cancer patients.
By Nicole Gray • July 23, 2014 -
Could evolocumab become the gold-standard in cholesterol reduction?
Many in the clinical community say ‘yes’ based on extensive data published in NEJM.
By Nicole Gray • July 23, 2014 -
EMD Serono's Egrifta effective against drug-induced fatty liver disease in trial
Up to 40% of HIV-infected patients receiving antiretroviral (ARV) treatment have fatty liver disease.
By Nicole Gray • July 22, 2014 -
Regeneron and Bayer's DME drug shows promise in phase III trials
Regeneron Pharmaceuticals and Bayer's Eylea led to significant improvements in patients' eyesight in a phase III clinical trial.
By Nicole Gray • July 22, 2014 -
Deep Dive
Niacin: the poster child for post-marketing drug surveillance
More than ever, long-term post-marketing surveillance matters.
By Nicole Gray • July 21, 2014 -
Could Gilead's Sovaldi also treat Hep C in HIV patients?
The results of a new clinical trial were excellent news for Gilead, but women and patients with cirrhosis were underrepresented in the study.
By Nicole Gray • July 21, 2014 -
Study: GSK's combo melanoma drug bests Roche's Zelboraf
Interim analysis shows improved overall survival rates in patients with metastatic melanoma -- one of the most serious forms of the cancer.
By Nicole Gray • July 21, 2014 -
FDA fast-tracks review of Avastin as supplemental cancer drug
Encouraging phase III data in cervical cancer trials bodes well for the drug's chances of approval.
By Nicole Gray • July 17, 2014 -
GSK, Theravance's new COPD drug moves to Phase III testing
Can a newly formulated triple combo inhaled medication reduce exacerbations more than existing once-daily COPD treatments?
By Nicole Gray • July 16, 2014 -
FDA tackles informed consent concerns with new guidance
In clinical trials, informed consent ensures the rights and the well-being of subjects. This guidance presents the latest updates.
By Nicole Gray • July 16, 2014
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