Clinical

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.

Study links patient confidence to Rx adherence

Study links patient confidence to Rx adherence

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Researchers found a correlation between patients feeling involved and how well they stick—if they stick—to their medication regimens.

Alkermes to submit schizophrenia med this year

Phase-III results prompted the drugmaker to pursue a third-quarter filing.

Study: Anti-vaxxers immune to PSAs

Researchers find public service announcements and physician information don't change minds, but a California practice found one way it could.

Lilly's CDK 4/6 inhibitor a cancer contender

Lilly's CDK 4/6 inhibitor a cancer contender

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Analysts say the Indianapolis, IN, drugmaker's Phase-I results show CDK 4/6 inhibitors will have a role in breast cancer treatment and that Pfizer's palbociclib will not clear the field.

Pfizer palbociclib news divides investors

Pfizer palbociclib news divides investors

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Sunday's data readout has divided the Street between the enthusiastic and the disappointed. The key reason: progression-free survival gains were not as high as anticipated.

GSK stops lung-cancer vaccine trial

The drugmaker is ceasing a trial called MAGRIT after it was unable to identify patients who could benefit from MAGE-A3.

Sanofi reports on Phase-II PCSK9 trial

The drugmaker saw positive results in demonstrating LDL reductions in Japanese patient populations.

Trials confirm potent efficacy of PCSK9s

Trials confirm potent efficacy of PCSK9s

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Detailed Phase-III results from several PCSK9 candidates confirm the clinical ability of the newest class of cholesterol-lowering treatments.

Novartis announces good heart drug results

Novartis announces good heart drug results

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The drugmaker said successful results prompted an independent Data Monitoring Committee to recommend stopping the trial. The news follows an uneven week of pipeline drug news.

New OTC Nexium approved

The FDA has approved a 24-hour version of Pfizer's heartburn medication.

Possible Zohydro competitor surfaces

Possible Zohydro competitor surfaces

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A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.

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.

Lipid agents come under FDA scrutiny

Lipid agents come under FDA scrutiny

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Sanofi and the firm with which it's co-developing alirocumab disclosed that regulators want some patients to be assessed for neurocognitive side effects.

AbbVie's all-oral HCV combo shines in trial

AbbVie's all-oral HCV combo shines in trial

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Data presented at a conference yesterday suggest AbbVie's all-oral regimen may be more effective than Gilead's at curing the virus in certain patients, but will it confer an edge?

Doctors, not friends, source of many opioids

A study says that more opioid abusers get their medications via prescription than they do second-hand.

Sanofi's heir to Lantus meets endpoint in trials

Sanofi's heir to Lantus meets endpoint in trials

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Sanofi top-lined positive clinical data today from its investigational basal insulin, as it seeks to defend its position in this fast-growing segment.

Orexigen could enter weight-loss race June 2014

Orexigen could enter weight-loss race June 2014

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The drugmaker says interim trial data meets FDA review requirements and is hoping for June 2014 approval.

Amgen PCSK9 drug passes safety test

New results from its Phase II safety trial show the LDL-cholesterol lowerer was not associated with a major increase in adverse events vs. standard of care.

GSK misses on late-stage CV drug

GSK misses on late-stage CV drug

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An investigational cardiovascular heart drug failed to reduce the risk of heart attack or stroke, a miss which some on Wall Street say raises questions about the drugmaker's ability to deliver in late-stage trials.

Lemtrada's future in doubt after reviewers flag safety issues

Lemtrada's future in doubt after reviewers flag safety issues

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Safety reviewers' reservations about the MS drug's risk profile, unveiled in briefing documents ahead of an ad-com meeting, suggest it won't be smooth sailing for the drug in the US.

Pfizer picks fight with NICE

The drugmaker blasted the price-control agency for being shortsighted and underestimating the industry's role in health and savings.

Ariad pulls Iclusig from the market after FDA request

Ariad pulls Iclusig from the market after FDA request

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The drug company is ceasing US distribution and marketing the leukemia drug after the FDA said it was worried about blood clots among clinical trial patients.

Amarin's hopes for Vacepa dim

The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.

Pediatricians want greater condom access

The AAP says greater access and education are critical in curbing STIs.

FDA briefing documents: Sofosbuvir safe, effective

The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.

Good news/bad news for Merck's pipeline

Word came of Breakthrough Designation for an HCV hopeful, a day after a hiccup in a heart drug trial.

Poll suggests oncologists already using GSK melanoma drugs off-label

A report says oncologists may be using GSK's Tafinlar and Mekinist together in a non-FDA approved combination therapy.

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