DIA: Transforming trials - Insights drive better care at lower cost and risk

The traditional model of three discrete, fixed trial phases lacks flexibility and analytical power to develop complex new therapies that can target the increasingly heterogeneous population seen today.

June 8, 2017

AbbVie's JAK-1 inhibitor notches Phase 3 win in RA

Upadacitinib is under investigation for several indications, and could hit peak annual revenues of at least $3.5 billion across them should it lock down approval, according to Jefferies.

By Jacob Bell • June 8, 2017

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

More good news for Teva in migraine

Teva's fremanezumab hit its Phase 3 goal in episodic as well as chronic migraine.

By Suzanne Elvidge • June 8, 2017

Novartis' CAR-T stacks up to Kite in lymphoma

Results from the Swiss pharma's JULIET study showed similar overall and complete response rates to Kite Pharma's axi-cel in diffuse large B-cell lymphoma. 

By Ned Pagliarulo • June 7, 2017

Jazz strikes positive tone for sleep drug following late-stage hits

Positive readouts from a trio of Phase 3 trials reinforced the efficacy and safety of JZP-110, which should help beef up Jazz's sleep portfolio.

By Jacob Bell • June 7, 2017

Gain a new perspective on your clinical research at BIO 2017

At the forefront of drug discovery and development, small to midsize biotech/biopharma companies are the leaders of innovation.

By Peter Benton, president and COO of Worldwide Clinical Trials • June 6, 2017

ASCO17: Chi-Med, Lilly tout cancer med's efficacy in colorectal setting

Median overall survival was about three months longer for patients receiving fruquintinib versus those on placebo.

By Jacob Bell • June 6, 2017

ASCO17: CAR-Ts steal the show

Impressive data from Bluebird Bio and Nanjing Legend Biotech point to CAR-T's relevance outside of leukemias and lymphomas. 

By Ned Pagliarulo • June 6, 2017

ASCO17: Juno marks progress with second-gen CAR-T

Updated results for JCAR017 looked competitive in lymphoma as Juno hopes to recover from its earlier safety setbacks with its now shuttered JCAR015 program. 

By Ned Pagliarulo • June 5, 2017

ASCO17: Merck touts Keytruda bladder benefit post Tecentriq failure

Data announced for Keytruda in bladder cancer raises questions about the differences in checkpoint inhibitors after Roche's recent failure in the space. 

By Suzanne Elvidge • June 5, 2017

ASCO17: J&J seeks label expansion for Zytiga

The pharma's prostate cancer drug was a big winner at ASCO, with data showing a 38% reduction in the chance of death for high-risk patients when adding Zytiga to standard hormonal therapy.

By Jacob Bell • June 5, 2017

ASCO17: Roche's Alecensa bests Xalkori in lung study

The ALK inhibitor from the Swiss pharma dramatically improved progression-free survival over Xalkori, potentially positioning itself as the new standard of care. 

By Ned Pagliarulo • June 5, 2017

ASCO17: Roche's Perjeta cuts risk in Aphinity, but is it enough?

The large Phase 3 study has been closely watched as potentially practice-changing, but the modest benefit could limit its impact somewhat in adjuvant treatment of breast cancer. 

By Ned Pagliarulo • June 5, 2017

ASCO17: AstraZeneca's Lynparza stays step ahead of PARP rivals

Data showing a 42% risk reduction in disease worsening compared to chemo in breast cancer patients should help build Lynparza's profile outside of ovarian cancer. 

By Ned Pagliarulo • June 4, 2017

ASCO17: Incyte pads its IDO numbers

IDO inhibitors have been pegged as the next step in immuno-oncology combinations, but Incyte's rising market value prompts questions over what that's worth. 

By Ned Pagliarulo • June 3, 2017

ASCO17: Loxo shows promise of biomarker approach to cancer

Clinical data presented Saturday showed treatment with Loxo Oncology's larotrectinib shrank tumors in three-quarters of patients with a range of 17 different advanced cancers. 

By Ned Pagliarulo • June 3, 2017

Prescribed Reading: Combos to take center stage at ASCO

On the eve of ASCO, some question the validity of certain combination testing for oncology drugs, pointing to the increased number of combo trials taking place. 

By Lisa LaMotta • June 2, 2017

The perils of building clinical trials on a shaky foundation

With the odds stacked against clinical trial success, drug developers need all the tools in their arsenal to make sure they recruit patients quickly and design trials effectively. 

By Craig Morgan • June 1, 2017

Critical considerations for successful immunotherapy trials

Every cancer immunotherapy trial is different, but there are several best practices biopharmaceutical companies can follow to shorten the distance from lab to life.

June 1, 2017

Phase 3 success keeps Teva in migraine race

No headache for Teva as it announces positive trial results for its migraine drug, one of several new treatments nearing potential approval. 

By Suzanne Elvidge • June 1, 2017

Lilly's Cyramza scores in bladder cancer

The positive data could set the company up to compete with a range of checkpoint inhibitors in the indication.

By Lisa LaMotta • May 31, 2017

NLS touts Mazindol's efficacy as it takes on ADHD market

The clinical-stage pharma revealed that the majority of patients taking its ADHD drug in a Phase 2 trial had at least a 50% reduction in disease symptoms.

By Jacob Bell • May 31, 2017

Gilead tees up filing for HIV triple combo after Phase 3 wins

The biotech hopes the therapy, if approved, will accelerate the adoption of its portfolio of newer HIV treatments, which have become more important as HCV sales fall fast. 

By Ned Pagliarulo • May 30, 2017

Finding the other 90%: Attracting naïve patients to RA studies

There is significant research being targeted towards the treatment of rheumatoid arthritis (RA), but how can the industry attract more clinical trial participants?

May 30, 2017

Novo Nordisk seeks expanded label for Tresiba

The DEVOTE study showed non-inferiority in cardiovascular safety and improvement in hypoglycemia — but will this be enough for the FDA?

By Suzanne Elvidge • May 30, 2017