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

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

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

Roche's much-anticipated immontherapy wins early approval for bladder cancer

Atezolizumab, or Tecentriq, is the first PD-L1 inhibitor approved in the U.S., joining related anti-PD1 drugs from Bristol-Myers and Merck. 

By Ned Pagliarulo • May 19, 2016

Bristol-Myers extends lead with new Opdivo indication

Opdivo has been battling Merck's Keytruda for immuno-oncology market share.

By Ned Pagliarulo • May 17, 2016

AstraZeneca asthma drug clears phase 3 studies, boosting respiratory pipeline

Benralizumab was once pegged for $2 billion-a-year sales but potential competition from other drugs already on the market has crimped estimates. 

By Ned Pagliarulo • May 17, 2016

Aduro's pancreatic immunotherapy fails phase 2, sending stock tumbling

Chief executive Stephen Isaacs called the results "unexpected," but pointed toward upcoming results from a combo trial with Bristol-Myers Squibb's Opdivo. 

By Nicole Gray • May 16, 2016

New phase 3 data boosts Pfizer's meningitis vaccine

Pfizer's vaccines business has performed particularly well recently, boosting revenue in the first quarter. 

By Nicole Gray • May 15, 2016

After shutting down cancer drug, Clovis now facing government investigations

Earlier this month, Clovis said it expected rociletinib to be rejected by the FDA, prompting the company to terminate clinical trials. 

By Ned Pagliarulo • May 12, 2016

NIH-funded malaria vaccine shows safety, efficacy in early trial

While GlaxoSmithKline already has a vaccine on the market, protection against malaria is still a huge unmet medical need.

By Nicole Gray • May 12, 2016

Pfizer planning first triple-drug immuno-oncology study

Expected to begin sometime next year, the early-stage trial will combine the checkpoint inhibitor avelumab with two other drugs. 

By Nicole Gray • May 11, 2016

NewLink Genetics writes off pancreatic cancer immunotherapy after phase 3 failure

Patients treated with the vaccine had three months shorter overall survival times than those in the control group.

By Nicole Gray • May 10, 2016

Wave Life Sciences touts more effective Duchenne drug

Just last week, Pfizer and Wave agreed to a potentially $911 million deal for advancing development of several genetic therapies for metabolic diseases.

By Nicole Gray • May 10, 2016