Merck stands by its CETP inhibitor for heart disease even as others flop

Despite the failures of Pfizer, Roche, and Eli Lilly, Merck is soldiering on with anacetrapib. 

By Nicole Gray • Nov. 15, 2015

Bioethics group: Gilead, Sanofi flunk the clinical trial transparency test

Almost half of drugs reviewed in 2012 had undisclosed phase 2/3 data, according to Bioethics International. 

By Nicole Gray • Nov. 13, 2015

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Amgen flexes biologics muscle as Humira biosim nails an equivalence test for RA

Last year, AbbVie's Humira (adalimumab) generated roughly $12 billion in sales. 

By Nicole Gray • Nov. 11, 2015

AstraZeneca may have a lupus blockbuster-in-waiting

There has only been one drug approved for lupus in the last 60 years. 

By Nicole Gray • Nov. 11, 2015

Another heart failure hopeful: Cytokinetics/Amgen med shows phase 2 promise

2015 is shaping up to be a milestone year for treatment advances in heart failure, which affects nearly 6 million Americans. 

By Nicole Gray • Nov. 10, 2015

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

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

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

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

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