Liver Meeting '15 wrapup: Battling more hep C genotypes, shortening treatment regimens

The face of hepatitis treatment has transformed in the past two years. But drug makers aren't through reaching for even greater heights.

By Sy Mukherjee • Nov. 18, 2015

Beyond trials: Real-world studies strengthen case for PrEP in HIV prevention

A clinical study in three STD infection clinics showed that pre-exposure prophylaxis (PrEP) works in real-world settings. 

By Nicole Gray • Nov. 17, 2015

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Lucentis more effective than lasers for reversing diabetes-induced blindness in new study

The research shows that treatment with Lucentis (ranibizumab for injection) is more effective than laser therapy for proliferative diabetic retinopathy (PDR).

By Nicole Gray • Nov. 17, 2015

Liver Meeting '15: AASLD calls out payers on HCV med coverage; WHO's plan to wipe out hep C & B by 2030

On the second-to-last day of the annual Liver Meeting, the World Health Organization plotted an ambitious plan for eliminating viral hepatitis, and several pharma companies continued to present data on new, next-gen drug combos.

By Sy Mukherjee • Nov. 17, 2015

Liver Meeting 2015: Merck combo shines for IV drug abusers, Genfit preps phase 3 for pioneering NASH med

BioPharma Dive is at the American Association for the Study of Liver Diseases (AASLD) annual meeting in San Francisco. Here's what you need to know.

By Sy Mukherjee • Nov. 16, 2015

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

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