Clinical Trial

Social media perceived as clinical trial risk

The Wall Street Journal reports that patients are sharing a plethora of information about their clinical trial experiences, from how to get picked, to how to figure out who is in a control group.

Bayer's Nexavar disappoints in breast cancer

The drug did not hit its Phase III primary target of improving progression-free survival.

Alzheimer's study to use healthy patients

Novartis and the nonprofit Banner Alzheimer's Institutes are testing a theory that treating healthy patients could prevent or delay Alzheimer's disease.

Allergan updates pipeline

Allergan updates pipeline

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Allergan's latest pipeline news was a mix of the good and the bad. The good: a potential Lucentis competitor is progressing. The bad: migraine medication Semprana has stalled.

FDA wants male breast cancer patients

The regulator wants men to be part of breast cancer clinical trials.

Vertex to submit CF drug combo to FDA this year

Vertex to submit CF drug combo to FDA this year

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Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.

Marketing tone sinks GSK recruiter

GlaxoSmithKline dismissed a marketer over its approach to clinical trial recruiting.

Clinical researchers dip toe into social media

Clinical researchers dip toe into social media

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Researchers are increasingly using social media to recruit patients, albeit oftentimes in an arms-length manner.

Study finds researchers are social-media shy

Study finds researchers are social-media shy

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Researchers find worries about being misunderstood or mixed in with "junk" news are among the reasons academic researchers are keeping their data points out of the social media swirl. Researchers say this fear is at the expense of a faster way to make an impact on public policy.

FDA invests in clinical trial data

The regulator is allocating almost $38 million to improve data-guided decision-making.

GSK drug fails in lymphoma bid

GSK drug fails in lymphoma bid

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The companies announced Tuesday that Arzerra, already indicated for leukemia, failed to outdo Roche's Rituxan in the lymphoma setting.

Clinical trial nabs SEC attention

The Securities and Exchange Commission alleges that two doctors illegally exploited their clinical trial affiliation for financial gain.

BI, InterMune tout lung drugs

BI, InterMune tout lung drugs

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Both companies revealed Phase-III data for idiopathic pulmonary fibrosis treatments. The progressive disease generally kills patients within three years of diagnosis.

NIH wants gender trial parity

The National Institutes of Health wants female lab animals to be part of the animal testing mix.

Bayer joins transparency push

The drugmaker announced Wednesday that researchers would be able to access clinical trial data.

GSK heart drug misses endpoint

GlaxoSmithKline announced Tuesday its Phase-III drug from the Human Genome Sciences acquisition failed to hit its primary endpoint.

BI opens up data files

The company announced Monday that researchers will be able to seek out clinical trial data going back to 1998.

Sarepta plans for 2015 drug review

Sarepta plans for 2015 drug review

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The company said it plans to file its rare-disease drug with the FDA later this year, for a 2015 review.

Roche wraps quarter with two fewer pipeline medications

Roche wraps quarter with two fewer pipeline medications

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Roche also announced first-quarter sales shrank 1%.

Merck looks poised to challenge Gilead

Merck looks poised to challenge Gilead

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Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.

Halozyme pancreatic drug study on FDA hold

Halozyme pancreatic drug study on FDA hold

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The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.

Analyst gives PCSK9 preview

Analyst gives PCSK9 preview

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Analyses by Jefferies indicate that although doctors are interested in the experimental anti-cholesterol drugs, CV data will be a critical differentiator.

J&J to submit schizophrenia drug in 2014

J&J to submit schizophrenia drug in 2014

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The drugmaker halted Phase III trials of a three-month medication based on good efficacy feedback.

GSK drug fails in lung patients

The company says it will continue to test its MAGE-A3 cancer drug among a subset of non-small cell lung cancer patients and among melanoma patients.

ASCO defines meaningful

A working group set out parameters for what counts as a meaningful outcome for pancreatic, breast, lung and colon cancer clinical trials.

Clinical trial awareness campaign launches

PhRMA and the National Minority Quality Forum's "I'm In" campaign seeks to tackle clinical trial diversity (or the lack thereof).

Prevnar 13 hits goals, but impact is uncertain

Prevnar 13 hits goals, but impact is uncertain

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Pfizer hit its endpoints for preventing pneumonia among the elderly, but the data may not be robust enough to spur vaccination.

Nexavar fails recurrence target

Nexavar fails recurrence target

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Bayer and Amgen's Onyx subsidiary announce an oncology drug failed a Phase-III trial goal among liver cancer patients.

Merck adds heat to HCV competition

Merck adds heat to HCV competition

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Phase-II data show reduced hepatitis-C RNA levels among HIV-positive patients, the drugmaker shared at a medical meeting. Boehringer also released co-infection data.

BMS jumps to Ph.III lung cancer study

BMS jumps to Ph.III lung cancer study

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The drugmaker announced Tuesday that it will pursue a Phase-III Yervoy-nivolumab study.

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