Clinical Trials: Page 130
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Advantage grows for Lilly's Jardiance with more stellar heart failure data
Jardiance (empagliflozin) reduces the combined risk of hospitalization or death due to heart failure by 39%, according to expanded results released by the company on Monday.
By Nicole Gray • Nov. 10, 2015 -
Novo's Victoza fails the 'Jardiance test,' doesn't improve heart outcomes in trial
In a 300-person clinical trial, Victoza (liraglutide) did not delay death or hospitalization in advanced heart failure patients, falling short of a new standard set by Eli Lilly and Boehringer Ingelheim.
By Nicole Gray • Nov. 9, 2015 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
Cellectis makes history as CAR-T therapy clears terminal leukemia in baby girl
The results are (very) preliminary. But doctors are already hailing them as "almost a miracle"—and other CAR-T therapy hopefuls like Juno, Kite, and Novartis are officially on notice.
By Sy Mukherjee • Nov. 6, 2015 -
Why biotech darling Bluebird crashed on Thursday despite solid gene therapy data
A year ago, the same results would likely have sent the company's stock shooting into the stratosphere.
By Nicole Gray • Nov. 6, 2015 -
Pfizer late to immunotherapy game, teaming up with Merck for lung cancer treatment
The companies are enrolling patients to evaluate avelumab, a check-point inhibitor, in patients with non-small cell lung cancer (NSCLC).
By Nicole Gray • Nov. 5, 2015 -
The Jardiance effect: Novo hopes Victoza will show heart benefit, but wary of CV study design
The diabetes game has truly changed after the success of Lilly & Boehringer's medication in a major CV outcomes trial.
By Nicole Gray • Nov. 5, 2015 -
The next HIV breakthrough? Glaxo, J&J's long-acting shot as effective as 3-pill daily combo
Trial data announced by the companies is already being lauded as the latest milestone in HIV treatment.
By Sy Mukherjee • Nov. 3, 2015 -
Sponsored by Cenduit
Three trends to help manage rising costs and complexity of clinical trials
Outsourcing, increased patient engagement and mobile technology are providing solutions for clinical trial management.
By Roni Robbins • Nov. 3, 2015 -
Deep Dive
Hep C and long-term costs: Why safety is suddenly part of the value equation
We spoke with Brian Overstreet, President of Advera Health Analytics, about AbbVie's Viekira Pak’s safety signals and why safety will increasingly be seen as part of overall medication costs.
By Nicole Gray • Oct. 30, 2015 -
A 1st gen Pfizer Alzheimer's drug may help keep patients out of the nursing home
Treatment with Aricept (donepezil) reduces the likelihood of ending up in a nursing home from 37% to 20% in late-stage Alzheimer's patients, according to new research.
By Nicole Gray • Oct. 28, 2015 -
Glaxo faces another cardio R&D failure for a lead candidate
Losmapimod is the company's second cardiovascular drug to fail in phase 3 in two years.
By Nicole Gray • Oct. 28, 2015 -
A mixed bag for Merck despite data showing Keytruda extends lung cancer survival
Despite boosting overall survival, the immuno-oncologic did not achieve the target endpoint for progression-free survival in the overall treatment population.
By Nicole Gray • Oct. 27, 2015 -
Decade-old Novartis Parkinson's drug redeemed as FDA sees no CVD risk
The agency has said that the label for Stalevo, which was first approved in 2003, will not change.
By Nicole Gray • Oct. 26, 2015 -
WHO: Introduction of first malaria vaccine should be delayed
GlaxoSmithKline's (GSK) Mosquirix must be administered in four doses to be effective.
By Nicole Gray • Oct. 25, 2015 -
Bristol-Myers' new HIV drug shines in mid-stage trials
BMS-955176 from Bristol-Myers Squibb (BMS) is a second-generation maturation inhibitor.
By Nicole Gray • Oct. 25, 2015 -
Merck plans to enter hep C market, take on Gilead & AbbVie with faster-acting combo drug
Merck's latest mid-stage hep C combo-drug study evaluated 8-week treatment regimens.
By Nicole Gray • Oct. 21, 2015 -
Deep Dive
A Boehringer SVP and BioSig's CEO dish on the 'heart' of innovation
BioPharma Dive spoke with Dr. Sabine Luik, Senior Vice President of Medicine & Regulatory Affairs at Boehringer Ingelheim and Greg Cash, CEO of BioSig Technologies, about different strategies for reducing the risk of stroke in patients with atrial fibrillation—and what makes their products innovative.
By Nicole Gray • Oct. 20, 2015 -
Massive gov't study promotes smaller drug doses, more talk therapy for schizophrenia
The full National Institute of Mental Health-sponsored study is being published Tuesday in the American Journal of Psychiatry—and it could have big ramifications for the way schizophrenia care is delivered in the U.S.
By Sy Mukherjee • Oct. 20, 2015 -
J&J's psoriasis star Stelara found effective for Crohn's patients in phase 3
Stelara is currently indicated for treatment of psoriasis and psoriatic arthritis. Now, Johnson & Johnson is planning to file for moderate-to-severe Crohn's in global markets.
By Nicole Gray • Oct. 20, 2015 -
Novartis cancer med Tasigna may hold promise for Parkinson's patients
In a small, early-stage trial, the drug improved Parkinson's patients' cognition and motor skills. And it has the medical community excited.
By Nicole Gray • Oct. 19, 2015 -
Bristol-Myers, Novartis score big in major blood cancer drug cost-benefit analysis
The National Comprehensive Cancer Network (NCCN) has completed an "Evidence Block" for multiple myeloma and chronic myelogenous leukemia (CML)—the first in a series of such analyses for cancer medications.
By Nicole Gray • Oct. 19, 2015 -
Deep Dive
Breast Cancer Awareness Month: A look at recent innovations in breast cancer
This month marks the 30th year of Breast Cancer Awareness Month (BCAM). In recognition of the milestone, here is a brief look at recent innovations in diagnosis, surgery, and medical treatment for the disease.
By Nicole Gray • Oct. 16, 2015 -
J&J bullish that its own SGLT2 diabetes med will show Jardiance-like CV benefit
Now that Jardiance (empagliflozin) from Lilly/Boehringer Ingelheim has been clinically proven to reduce cardiovascular (CV) events and related deaths, Johnson & Johnson expects the same for Invokana (canagliflozin).
By Nicole Gray • Oct. 15, 2015 -
The curious case of Zafgen's stock and a phase 3 patient death
The company finally revealed on Wednesday that a patient had died during a phase 3 trial of its lead drug, beloranib. The cause of death is unknown—and so is the reason why the firm waited so long to say anything as shareholder value plummeted.
By Nicole Gray , Sy Mukherjee • Oct. 15, 2015 -
Deep Dive
Diabetes therapeutics: A hotbed of innovation and reservoir of pharma progress
The recent CV data on Jardiance is the latest breakthrough in diabetes therapeutics. We spoke with Boehringer Ingelheim's Dr. Thomas Seck; a treating physician; and a marketing specialist about what comes next.
By Nicole Gray • Oct. 14, 2015