Lilly changes endpoint for phase 3 Alzheimer's trial

The endpoint change for solanezumab will affect data analysis, but not the actual conduct of the trial. 

By Nicole Gray • March 16, 2016

As EMA investigates, Gilead halts six clinical trials of cancer drug

Gilead has been working to expand the indications of Zydelig, hoping to break into oncology.

By Ned Pagliarulo • March 15, 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

Roche signs potential $1 billion cancer immunotherapy deal with Cambridge biotech

Separately, the FDA boosted the prospects of Roche's bladder cancer drug atezolizumab, granting the immunotherapy priority review status. 

By Ned Pagliarulo • March 15, 2016

GW Pharma stock doubles after positive phase 3 cannabis drug results

In a trial involving 120 patients, treatment with Epidiolex resulted in a median 39% reduction in seizures, compared with 13% in placebo-treated patients. 

By Nicole Gray • March 15, 2016

EU regulators investigating Gilead's Zydelig after infection deaths

Higher rates of adverse events were seen in three clinical trials involving Zydelig and other cancer drugs. 

By Nicole Gray • March 14, 2016

Sanofi's sarilumab bests blockbuster Humira in Phase 3 study

The IL-6 antibody is slated for a regulatory decision from the FDA by Q4 2016. 

By Ned Pagliarulo • March 11, 2016

Death from French drug trial likely due to high doses of compound

The drug trial left one man dead and five others in the hospital in January. Portuguese drugmaker Bial had been testing an FAAH-enzyme inhibitor for the treatment of pain and mood disorders. 

By Ned Pagliarulo • March 10, 2016

French regulator halts manufacturing at HIV-focused biotech

A November inspection by ANSM turned up 45 manufacturing deficiencies, including five critical flaws. 

By Nicole Gray • March 10, 2016

Novartis' Cosentyx proves superior to Janssen's Stelara in head-to-head comparison

The efficacy data further bolsters the profile of Cosentyx, which recently had its label expanded to include indications for ankylosing spondylitis and psoriatic arthritis.

By Nicole Gray • March 7, 2016

In high-profile failure, Celldex's cancer vaccine crashes in phase 3

The biotech ended its study early after an interim analysis showed patients treated with the gliobastoma drug fared slightly worse than the control group.

By Ned Pagliarulo • March 7, 2016

AbbVie paying Boehringer $595M upfront to gain access to psoriasis drug

The compound, an anti-IL23 antibody, is currently in phase 3 development for the treatment of psoriasis. Two other phase 2 studies are evaluating the drug against Crohn's disease, asthma, and psoriatic arthritis. 

By Ned Pagliarulo • March 7, 2016

New study strengthens link between Zika and serious birth defects

Published in NEJM, the small study found 29% of pregnant women infected by Zika had fetuses showing serious abnormalities in ultrasound readings. 

By Nicole Gray • March 7, 2016

GSK's asthma drug Nucala boosted by long-term safety study

The company also published post-marketing safety results for its Advair Diskus product, showing comparable safety results to a common corticosteroid. 

By Nicole Gray • March 7, 2016

Much-anticipated trial shows Novo's Victoza reduces CV risk

The results could help keep Victoza competitive with Eli Lilly/Boehringer Ingelheim's Jardiance, which became the first diabetes drug to demonstrate a cardiovascular benefit. 

By Ned Pagliarulo • March 4, 2016

Merck forges ahead with phase 3 trial of Humira biosimilar

A number of other companies, including Amgen, Novartis, and Boehringer Ingelheim, are developing other biosim versions, hoping to wrest away some of Humira's $14 billion in 2015 sales. 

By Nicole Gray • March 3, 2016

San Diego-based Conatus takes aim at unmet medical need in cirrhosis

While new meds from Gilead, AbbVie, and Merck have been game-changers for hepatitis C treatment, few options exist for liver cirrhosis. 

By Nicole Gray • March 2, 2016

AstraZeneca's mesothelioma drug fails monotherapy testing

Tremelimumab did not improve overall survival in patients with advanced mesothelioma. 

By Nicole Gray • March 2, 2016

Roche's asthma drug stumbles on mixed phase 3 results

The Swiss drugmaker did, however, receive some good news when its lymphoma drug won second-line approval from the FDA. 

By Nicole Gray • March 1, 2016

FDA offering $2 million in new grants for rare disease research

The grants will fund natural history studies into the progression of rare diseases in patients over time.

By Shalina Chatlani • Feb. 29, 2016

Novo Nordisk notches another phase 3 success for GLP-1 drug

The weekly diabetes candidate semaglutide successfully completed four prior phase 3 trials which compared Novo's next-gen hopeful to existing treatments. 

By Nicole Gray • Feb. 25, 2016

Amgen's bone-building osteo drug dazzles in phase 3, but could face hefty competition

The candidate's significantly more convenient dosing option could still give it a leg up over a potentially more effective competitor from Radius Health.

By Nicole Gray • Feb. 24, 2016

Why uptake of new PCSK9 cholesterol meds has been so slow

More accelerated uptake of Sanofi/Regeneron's Praluent and Amgen's Repatha by both payers and doctors is not expected until there is convincing outcomes data available. 

By Nicole Gray • Feb. 24, 2016

Do big name journals have a 'marketing trial' problem?

A team of medical journal editors found that a fifth of 194 trials published in six well-regarded medical journals could be classified as oriented toward marketing. 

By Nicole Gray • Feb. 24, 2016

Startup AvroBio touts gene therapy candidates for blood cancer, Fabry disease

The Toronto-based company hopes to begin phase 1 programs for both candidates in early to mid-2016. 

By Nicole Gray • Feb. 22, 2016

The flip side of the T-cell hype: Experts urge caution on huge costs, safety concerns

From the estimated half-million dollar cost of production to potentially devastating adverse events, at least one analyst is pointing out potential problems with the much-hyped therapy.

By Nicole Gray • Feb. 21, 2016