Clinical

Amicus seeks to upset Fabry market

Amicus seeks to upset Fabry market

By

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

By

AstraZeneca announced the end of the investigation Tuesday.

Kyprolis fails to wow in survival trial

Kyprolis fails to wow in survival trial

By

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

By

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

By

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

By

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

By

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

By

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

By

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.

ASCO highlights immuno-oncology challenges

ASCO highlights immuno-oncology challenges

By

The potential of immunotherapy is great, but the news from the 2014 medical meeting shows that great may not be gargantuan in terms of treatment reach.

CDC: un-vaccinated behind measles outbreak

The CDC said Thursday that most of the 288 recent US measles cases were caused by un-vaccinated travelers who brought the virus home with them.

FDA invests in clinical trial data

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

BI's Pradaxa antidote progresses

The drugmaker is set to start patient testing.

GSK drug fails in lymphoma bid

GSK drug fails in lymphoma bid

By

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.

Email Newsletters