Clinical Trials: Page
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FDA
Illumina to provide personalized oncology diagnostics for big-pharma studies
AstraZeneca, Sanofi, and Johnson & Johnson will use Ilumina’s next-generation sequencing (NGS) platform to better understand the individualized genomics of study subjects.
By Nicole Gray • Aug. 22, 2014 -
Amgen kidney drug for dialysis patients hits phase III targets again
Results from a second phase III trial show that AMG 416 reduces thyroid levels in kidney disease patients.
By Nicole Gray • Aug. 20, 2014 -
Explore the Trendline➔
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TrendlineRadiopharmaceuticals
A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.
By BioPharma Dive staff -
FDA
US Justice Department stops investigation of AstraZeneca's Brilinta trial
DOJ says there is no evidence of wrongdoing associated with the PLATO study, which is evaluating the effect of Brilinta (ticagrelor) in more than 19,000 patients.
By Nicole Gray • Aug. 19, 2014 -
Amgen's multiple myeloma drug fails in phase III single-drug study
Kyprolis (carflizomib) did not meet its primary endpoint -- overall survival -- in phase III. Amgen's stock dropped on Wednesday, but rebounded this morning after investors took other factors into consideration.
By Nicole Gray • Aug. 15, 2014 -
Deep Dive
Black box warnings and drug market withdrawals, by the numbers
The rise of FDA-approved drug market withdrawals and black box warnings corresponds with faster approval times and a reliance on industry fees to fund the agency's budget.
By Sy Mukherjee • Aug. 15, 2014 -
AstraZeneca's severe asthma drug breezes into phase III trials
AZ presented strong mid-stage data at this year’s American Thoracic Society (ATS) meeting.
By Nicole Gray • Aug. 14, 2014 -
Pfizer, 23andMe team up to study the genetics of bowel disease
The goal of this collaboration is to explore the underlying biology of inflammatory bowel disease (IBD) and ulcerative colitis (UC) by learning more about the genetic profiles of those living with the conditions.
By Nicole Gray • Aug. 14, 2014 -
Celltrion submits FDA filing for biosimilar Remicade
This South Korean company is making history by filing the first submission for a biosimilar monoclonal antibody using the FDA’s new biosimilar pathway.
By Nicole Gray • Aug. 14, 2014 -
FDA
AstraZeneca drug routs gout in phase III trials
Lesinurad reduced serum uric acid (sUA) levels in gout patients, achieving primary endpoints in a phase III trial.
By Nicole Gray • Aug. 13, 2014 -
UPDATED: WHO endorses experimental treatments for Ebola patients
"[I]n the special circumstances of this Ebola outbreak, it is ethical to offer unregistered interventions as potential treatments or prevention," said WHO assistant director general Marie-Paule Kieny.
By Sy Mukherjee • Aug. 12, 2014 -
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 -
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
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