FDA asks Sarepta for more data on muscular dystrophy drug

Shares of Sarepta jumped 25% higher in late trading Monday, as investors continue to hope for a path to approval for eteplirsen. 

By Ned Pagliarulo • June 7, 2016

Regeneron/Sanofi's dupilumab shines in phase 3 eczema trial

Analysts are looking for up to $2.5 billion in peak sales for dupilumab. 

By Nicole Gray • June 6, 2016

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

Study: Bristol-Myers' immunotherapy combo boosts response in lung cancer

Previous studies of Opdivo and Yervoy administered together had shown benefit in treating melanoma. 

By Nicole Gray • June 6, 2016

Roche positioning Tecentriq as first-line therapy in bladder cancer

It is the first new therapy approved for bladder cancer in 30 years. 

By Nicole Gray • June 6, 2016

Mylan's Herceptin biosim shows comparable efficacy/safety

There has not been one biosimilar approved in the EU or the U.S. to treat cancer. 

By Nicole Gray • June 6, 2016

AbbVie lung cancer drug shows promise, but has high expectations to meet

The drug, called Rova-T, was acquired by AbbVie earlier this year after its acquisition of Stemcentrx. 

By Ned Pagliarulo • June 5, 2016

Global cancer drug spending rises, set to surpass $150 billion by 2020

A wave of new drugs entering the market over the past five years has helped drive spending higher, according to a new report from IMS Health.

By Ned Pagliarulo • June 2, 2016

Kite Pharma rides CAR-T momentum into ASCO

BioPharma Dive spoke to the immuno-oncology biotech to find out how its lead cell therapy is progressing as it aims for a 2017 launch.

By Nicole Gray • June 2, 2016

Daiichi Sankyo halts late-stage study of lung cancer drug

But the company stood by the underlying science of patritumab and said it would press forward with development in head and neck cancers. 

By Nicole Gray • June 1, 2016

BioMarin ends Duchenne program, withdraws EU application for drisapersen

The decision brings BioMarin's current Duchenne program to a close, two years after the company paid $680 million to acquire Prosensa for rights to drisapersen.

By Ned Pagliarulo • May 31, 2016

Contract researcher BioClinica reportedly weighing sale

The CRO market has been consolidating with major mergers announced or rumored over the past year. 

By Nicole Gray • May 27, 2016

Roche's Gazyva notches early trial success

The Swiss company hopes the blood cancer drug can be a new source of growth as several older drugs face biosimilar competition. 

By Ned Pagliarulo • May 27, 2016

FDA rejects AstraZeneca hyperkalemia drug, boosting competitor Relypsa

AstraZeneca had acquired the drug last fall in a $2.7 billion deal for ZS Pharma. 

By Ned Pagliarulo • May 27, 2016

EMA reportedly reviewing clinical guidelines in wake of fatal drug trial

A report from French regulators concluded Portuguese drugmaker Bial and CRO Biotrial made several key mistakes in a January trial which left one man dead and hospitalized five others. 

By Nicole Gray • May 25, 2016

Despite recent R&D setbacks, Lilly aims to launch 20 new drugs by 2023

Although Lilly has struggled to replace aging drugs, CEO John Lechleiter sees the decade from 2014 to 2023 as "the most prolific period of new launches" in the company's history. 

By Ned Pagliarulo • May 24, 2016

After setback, GSK's Breo gets boost from real-world data

A late-stage study of Breo had failed to meet its primary endpoint last September, but GSK hopes the new data demonstrates the lung medicine's everyday utility. 

By Ned Pagliarulo • May 24, 2016

Lilly hopes to catch rivals with abemaciclib data

Pfizer already has its CDK 4/6 drug Ibrance on the market, while Novartis' ribociclib recently demonstrated positive results in a late-stage trial. 

By Nicole Gray • May 24, 2016

Novartis' Entresto gets boost from leading US cardiology groups

The American College of Cardiology, the American Heart Association and the Heart Failure Society of America have jointly updated guidelines giving the drug a class one recommendation for management of heart failure. 

By Nicole Gray • May 23, 2016

Oramed's oral insulin shines in mid-stage trials

ORMD-0801 significantly reduced nocturnal hypoglycemia in type 2 diabetes patients.

By Nicole Gray • May 23, 2016

Ahead of key panel vote, FDA staff raises concerns over Novo diabetes drug

Novo Nordisk hopes to best Sanofi, which has a similar combination drug up for FDA review. 

By Ned Pagliarulo • May 23, 2016

Merck KGaA/Pfizer's PD-L1 skin cancer drug shows encouraging interim results

Avelumab is a checkpoint inhibitor candidate for treatment of a rare and deadly form of skin cancer.

By Nicole Gray • May 20, 2016

Immunotherapies from Merck and Bristol-Myers help extend life, new data shows

Both Keytruda and Opdivo were boosted by overall survival data released ahead of the ASCO annual meetings next month. 

By Ned Pagliarulo • May 19, 2016

Novartis launches ambitious clinical program for Entresto

The FortiHFy clinical program is comprised of 40 clinical trials and is enrolling patients in 50 countries. 

By Nicole Gray • May 19, 2016

Novartis breast cancer drug proves efficacy, trial stopped early

The positive results could set up Novartis to compete with Pfizer's similar cancer drug Ibrance. 

By Nicole Gray • May 19, 2016

AstraZeneca's gastric cancer drug falls short in phase 3

Lynparza is a cornerstone of AstraZeneca's DNA damage-response research program and is already approved for treatment of advanced ovarian cancer. 

By Nicole Gray • May 19, 2016