Clinical

BI Spiriva combo has Phase-III success

BI Spiriva combo has Phase-III success

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The company said in a statement that the findings indicated the Spiriva-Striverdi combination treatment could help patients "return to a more independent life."

Lilly basal bests Lantus in T1D, despite safety concerns

Lilly basal bests Lantus in T1D, despite safety concerns

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Lilly's long-acting insulin showed it's more effective in type 1 diabetics than Lantus, but concerns about its overall profile persist.

New lipid agents are high on potency, low on doc awareness

New lipid agents are high on potency, low on doc awareness

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The new PCSK9 class of cholesterol-lowering antibodies continues to look promising, but many doctors—particularly PCPs—have never even heard of the experimental drugs.

Research links estrogen and binge eating

Baylor College of Medicine researchers have found that an estrogen replacement suppressed binge-eating behavior among lab mice.

Novartis may have game-changing drug

Novartis may have game-changing drug

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Key opinion leaders indicate they are ready to embrace Novartis's experimental heart failure medication LCZ696. Such a move could upend heart failure treatment protocols.

Lilly takes on Amgen's Enbrel

Lilly takes on Amgen's Enbrel

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Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.

Amicus seeks to upset Fabry market

Amicus seeks to upset Fabry market

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Phase-III tests indicate patients may be able to switch from injectable enzyme-replacement therapies, like Fabrazyme, to the firm's oral drug.

DOJ closes Brilinta investigation

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AstraZeneca announced the end of the investigation Tuesday.

Kyprolis fails to wow in survival trial

Kyprolis fails to wow in survival trial

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Amgen now hopes a separate study will be enough to support the drug's advancement to a second-line therapy, but the lackluster results may impinge on its EU filing schedule.

Kyprolis data fuel Amgen oncology aspirations

Kyprolis data fuel Amgen oncology aspirations

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Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen.

J&J pulls morcellator from market

The company is calling the move a withdrawal, as opposed to a recall.

Study questions HDL medication benefit

A study indicates they may do little to reduce the risk of stroke or heart attack.

NIH: HPV test beats Pap for cancer assessment

HPV testing provides an edge over Pap screenings when it comes to detecting cervical cancer risk.

Next target for hep. C drugmakers: co-infections

Next target for hep. C drugmakers: co-infections

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An international AIDS conference this weekend kicked off a new battle in the war against hepatitis C: demonstrating high cure rates in those who are co-infected.

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.

Lilly's Cyramza misses liver-cancer target

Cyramza patients had more favorable overall survival rates than placebo patients, but the differences were not statistically significant.

Study unlinks testosterone and heart attacks

The Wall Street Journal notes that a new study on testosterone therapy has some weaknesses, including its sole focus on men who received injections—leaving out pills, patches and gels.

Study links DPP-IV medication to heart failure, hospitalization

Editorial says risk is small, researchers say it could be clinically relevant.

ACP says no need for pelvic exams

The American College of Physicians says most women do not need an annual pelvic exam. The American College of Obstetrics and Gynecologists disagrees.

FDA wants male breast cancer patients

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

Panel votes against AZ's olaparib

Panel votes against AZ's olaparib

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An FDA advisory panel voted 11-2 against an accelerated approval for AstraZeneca's experimental PARP inihibitor. The panel recommends getting more data before giving the drug the all-clear.

BMS cuts nivo' trial short, eyes approval pathway

BMS cuts nivo' trial short, eyes approval pathway

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The firm ended the Phase III trial for its ballyhooed immunotherapy, which showed superior survival compared to chemo in advanced melanoma.

Expanding weightloss drug doesn't wow

An experimental Gelesis weight-loss drug seeks the middle ground between surgery and appetite suppressants.

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.

BI calls it quits in hep. C

BI says there is no unmet need for faldaprevir.

Marketing tone sinks GSK recruiter

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

Triglycerides, not HDL, may be cardio bad guys

Gene mutations lead researchers to rethink ways to protect the heart.

Novartis says it buried studies

The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.

Higher dose of Victoza helped patients drop weight

Higher dose of Victoza helped patients drop weight

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Patients taking a high-dose form of Novo Nordisk diabetes drug Victoza saw an average weight loss of 5.9% of their body weight, data from a study show.

Genentech cancer med nabs Breakthrough status

The FDA granted the label for Genentech's experimental metastatic urothelial bladder cancer treatment.

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