Clinical Trial

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.

Roche halts lung drug combo test

Roche said an onartuzumab and Tarceva mix did not help advanced non-small cell lung cancer patients with MET-positive tumors.

GSK stops Phase-II lupus trial

The drugmaker said JAK inhibitor GSK2586184 showed no effect in Phase II and has put an ulcerative colitis test on hold.

Novartis enhances data access

The drugmaker says researchers will be able to view patient-level data and promises less jargon-filled summaries by year-end.

Lilly's GLP-1 contender takes a step forward

Lilly's GLP-1 contender takes a step forward

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Phase-III results, top-lined today, show Lilly's investigational GLP-1 drug is well-positioned to eat into the multi-billion-dollar diabetes market now dominated by Novo Nordisk.

Lilly's ramu' has squamous, non-squamous potential

Lilly's ramu' has squamous, non-squamous potential

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The drugmaker was scant on details, but Phase-III ramucirumab results among non-small cell lung cancer patients showed increased overall and progression-free survival vs. placebo.

Startup clinical trial app

TapTrak seeks to apply behavioral tracking to clinical trials.

Complaint heaps more concerns on Brilinta study

A sealed complaint, reported on by the Wall Street Journal, builds on concerns that were already surrounding the now-controversial Plato study.

Janssen signs onto Yale data-sharing project

The school will act as an independent panel for the drug maker, reviewing requests from investigators for access to anonymized, clinical-trial data.

Medivation's Xtandi could eat into Zytiga turf

Medivation's Xtandi could eat into Zytiga turf

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A clinical trial shows that using Xtandi before chemotherapy—Zytiga's indication—improves progression-free survival.

NIH wants to end bad data

The US agency says we've got too much data that cannot be reproduced.

Roche schizophrenia drug fails

Additional studies of bitopertin, which is meant to target the condition's negative symptoms, are ongoing.

Drugmakers carve out immuno-oncology turf

Drugmakers carve out immuno-oncology turf

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Merck and Celgene are exploring a combination that could solidify their immuno-oncology footholds.

Amgen bone-builder bests older meds: trial

Amgen bone-builder bests older meds: trial

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Mid-stage data show the drug, romosozumab, was associated with significant increases in bone mineral density compared to Lilly's Forteo and off-patent Fosamax.

Sanofi, Regeneron PCSK9 trial uses new recruitment tool

The American College of Cardiology is contributing its Pinnacle registry to identify clinical trial patients.

Patients sound off on helping pharma find new molecules

Patients sound off on helping pharma find new molecules

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A recent poll shows a strong desire among web-savvy patients to play a more active role in medical research.

Lundbeck, Otsuka collborate on Alzheimer's

Vaccine LU AF20513 is the their third Alzheimer's collaboration.

Lilly dustbins edivoxetine depression indication

The drug failed to hit its Phase III targets.

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