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

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

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

Pioneering Novavax RSV vaccine passes protection to newborns, wins $89M from Gates Foundation

Mid-stage trial data on third-trimester pregnant women showed the vaccine protected infants, without any negative effects on the mothers. 

By Nicole Gray • Sept. 30, 2015

Aiming to cure blindness, UK team implants embryonic retinal cells in AMD patient

This regenerative surgery was carried out by Professor Lyndon Da Cruz at Mooresfield Eye Hospital, and was funded by Pfizer. 

By Nicole Gray • Sept. 30, 2015

Another kidney cancer hopeful: Exelixis med reduces tumor progression, death risk

Bristol-Myers' Opdivo wasn't the only cancer drug making news at the European Cancer Congress.

By Sy Mukherjee • Sept. 29, 2015

Arrowhead hep B treatment shows early promise, sends shares flying

Although the stock came back down by the end of Thursday, it's up about 5% in early Friday trading.

By Nicole Gray • Sept. 25, 2015

Amgen-Allergan's Avastin biosimilar shows promise in lung cancer trials

If the results hold, this could be a huge deal for U.S. biosimilars—and a major test for their savings prowess.

By Nicole Gray • Sept. 24, 2015