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

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

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

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

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

What Lilly's CVD drug failure means for other pharmas

Eli Lilly's discontinuation of its CETP inhibitor, designed to raise HDL-C, raises tough questions for Merck and Amgen. But it could be good news for Sanofi/Regeneron.

By Nicole Gray • Oct. 13, 2015

AstraZeneca hits the brakes on 2 lung cancer trials after safety concerns

The halt is temporary. But there are concerns that a cocktail of lung cancer meds could be leading to adverse events.

By Nicole Gray • Oct. 12, 2015

Lilly faces crushing setback as it's forced to abandon lead heart drug

The decision on evacetrapib sent the company's shares tumbling in Monday morning trading. All eyes will now turn to Lilly's cancer candidates and Alzheimer's hopeful. 

By Sy Mukherjee • Oct. 12, 2015

Neurocrine's movement disorder drug shows promise, has blockbuster potential

If the drug is approved, it will be the first FDA-approved treatment for tardive dyskinesia.

By Nicole Gray • Oct. 9, 2015

Roche MS drug shows big promise in harder-to-treat form of disease

Patients with multiple sclerosis (MS) had such positive responses to ocrelizumab that some think it could shift the standard of care, especially during early treatment.

By Nicole Gray • Oct. 9, 2015

FDA halts Advaxis immuno-oncology trials after patient death

A woman with cervical cancer died during a clincal trial involving axalimogene, stoking fears that the drug was involved. The company says it wasn't.

By Nicole Gray • Oct. 8, 2015

Study: Merck hep C combo effective in kidney disease patients

Although Merck will most likely be third to market with its next-generation HCV drug, it's aiming to democratize treatment options even further.

By Nicole Gray • Oct. 7, 2015

Roche looks to Cotellic melanoma combo to boost Zelboraf sales

Cotellic (cobimentinib) combined with Zelboraf (vemuratenib) improved outcomes in melanoma patients compared with Zelboraf alone.

By Nicole Gray • Oct. 7, 2015

Spark inches closer to a pioneering US gene therapy approval

Recent results from a pivotal trial evaluating SPK-RPE65 therapy in patients with inherited night blindness were encouraging, sending the biotech's shares flying Monday. 

By Nicole Gray • Oct. 6, 2015

Amicus delays regulatory submission for Fabry drug

When Amicus announced that it would delay submission of Galafold (migalastat), the stock fell by 53% and lost $760 million in market value. It's rebounded 11% in early trading Monday.

By Nicole Gray • Oct. 5, 2015

Where are the women in HIV drug trials?

Women represent only 11% of the participants in HIV-related clinical trials, although they comprise half the global population of those who are HIV-infected.

By Nicole Gray • Oct. 5, 2015

WHO pushes for far more aggressive worldwide use of HIV meds

The agency says that anyone with an HIV diagnosis should start anti-retroviral therapy (ART) immediately.

By Nicole Gray • Oct. 1, 2015

10 top trends driving the biopharma industry today

From pricing controversies to the continued deluge of M&As, to put-up-or-shut-up moments for hotly anticipated drug candidates, here are 10 of the most important industry trends that biopharma professionals need to understand.

By Sy Mukherjee • Oct. 1, 2015

Sanofi hopes to broaden diabetes portfolio as FDA accepts lixisenatide submission

The investigational therapy is in the same class as Novo's Victoza and Lilly's Trulicity.

By Nicole Gray • Sept. 30, 2015

Can Lilly & Incyte elbow their way into a crowded market with promising RA drug?

Baricitinib is an oral JAK inhibitor intended for the treatment of rheumatoid arthritis (RA). 

By Nicole Gray • Sept. 30, 2015