Vical abandons herpes vaccine after mid-stage miss

It's the latest in a series of trial failures that have pummeled the San Diego biotech's stock over the last several years.

By Jacob Bell • June 11, 2018

FDA lays out biosimilar guidance for agency meetings

One aim of the draft guidance is to speed biosimilars' path to market by improving communication with the regulator. 

By Suzanne Elvidge • June 6, 2018

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

ASCO18: 3 unanswered questions from oncology's largest conference

This year's ASCO meeting showcased dozens of major advances in cancer care, but several major questions remain in the red-hot field of immunotherapy. 

By Ned Pagliarulo • June 6, 2018

BIO18: Pfizer (sort of) inches back to neuro; Building ties with FDA

Day Three of the BIO International convention shined a light on the neuroscience space and its evolution.

By Lisa LaMotta • June 6, 2018

ASCO18: Who were the big winners and losers?

Merck, Loxo and Bluebird departed Chicago looking stronger, while mixed results from Roche, Nektar and a few others left investors unimpressed.

By Ned Pagliarulo , Jacob Bell • June 6, 2018

AbbVie to submit upadacitinib to FDA after 5th trial win

Analysts see approval of the JAK inhibitor as likely, but whether the drug would escape a black box warning for thrombosis is still unclear. 

By Suzanne Elvidge • June 6, 2018

Lilly's experimental colitis drug posts positive Phase 2 data

The pharma plans to advance its antibody drug into late-stage testing for the inflammatory condition later this year.

By Suzanne Elvidge • June 6, 2018

ASCO18: Bristol-Myers fights for its place in first-line lung cancer

Results from updated data did not impress everyone, but the pharma still sees an opening for its immunotherapy combo of Opdivo and Yervoy.

By Ned Pagliarulo • June 5, 2018

Accelerating human gene transfer trials

Learn how emerging biotechs are avoiding costly delays and creating efficiencies in their gene therapy trials with coordinated IRB and IBC review  

By Daniel Kavanagh, PhD and Currien MacDonald, MD, CIP • June 5, 2018

ASCO18: Jounce plummets further on weak efficacy data

Few participants in the ICONIC trial, which is testing a Jounce drug alone and paired with Opdivo, showed partial responses, according to early data.

By Jacob Bell • June 4, 2018

ASCO18: AbbVie blood cancer combo off to a strong start in Phase 2

Though still early, data from CAPTIVATE showed a high response rate among patients treated with Imbruvica and Venclexta.

By Jacob Bell • June 3, 2018

ASCO18: Celgene makes its case as CAR-T rival in lymphoma

Having spent $9 billion to buy Juno and its CAR-T pipeline, Celgene needs JCAR017 to outperform on-market therapies from Gilead and Novartis.

By Ned Pagliarulo • June 3, 2018

ASCO18: Merck raises the bar in lung cancer with Keytruda data

Highly anticipated results from two studies of the PD-1 inhibitor show Merck's edge in first-line lung cancer will be hard to beat.

By Ned Pagliarulo • June 3, 2018

ASCO18: Bristol-Myers, Nektar forge ahead with Phase 3 tests for cancer combo

Investors, though, appeared unconvinced by data from the companies' combo of Opdivo and NKTR-214, sending shares in the biotech down 40% Monday.

By Ned Pagliarulo • June 2, 2018

ASCO18: So far, so good for Loxo's gene-focused cancer therapy

The biotech has made its name by developing drugs that target specific mutations rather than by tumor site.

By Jacob Bell • June 2, 2018

ASCO18: Positive readout marks step forward for Bluebird's CAR-T

Results presented at ASCO highlighted the cell therapy's efficacy in multiple myeloma, bolstering hopes of its blockbuster potential. 

By Ned Pagliarulo , Jacob Bell • June 1, 2018

ASCO18: Tecentriq scores again in lung cancer, but Keytruda looms in background

Positive data from IMpower-131 are another milestone for Roche's drug, but competing data from Merck make for a tough comparison. 

By Jacob Bell • Updated June 4, 2018

Prescribed Reading: M&A slow ahead of BIO, ASCO

With two of the industry's biggest conferences coming up, the biopharma deal space took a breath. 

By Lisa LaMotta • June 1, 2018

Gilead's filgotinib clears mid-stage test in arthritis

Separately, the big biotech also revealed a data monitoring panel had recommended the JAK inhibitor advance into Phase 3 testing for ulcerative colitis. 

By Ned Pagliarulo • May 31, 2018

What you need to know about NASH

BioPharma Dive is taking a deeper look at how this market is changing, the challenges drugmakers will face if they reach commercialization and the shifting market sentiment.

By Lisa LaMotta • May 31, 2018

Vertex, CRISPR gene-editing therapy hit with clinical hold

Though CTX001 now faces a delay in the U.S., CRISPR and Vertex still plan to initiate a Phase 1/2 study of it in Europe later this year.

By Jacob Bell • May 31, 2018

Madrigal scores in mid-stage NASH study

The closely watched results could give a boost to the emerging market for the liver disease. 

By Lisa LaMotta • May 31, 2018

AstraZeneca won't submit lung drug for COPD after 2nd study miss

​In the second of two Phase 3 trials, Fasenra failed to help patients with the pulmonary disease, crimping the pharma's plans to expand the drug's market. 

By Ned Pagliarulo • May 30, 2018

Novo's oral semaglutide outperforms Jardiance in late-stage study

Treatment with Novo's GLP-1 delivered superior improvement of HbA1c levels versus Jardiance. But results comparing the effect on weight loss were mixed. 

By Suzanne Elvidge • May 30, 2018

Tecentriq trial wins boost Roche bid to compete with Merck

Combining the PD-L1 blocker with chemo helped advanced lung cancer patients live longer in a Phase 3 study, the third to show an OS benefit to Roche's drug. 

By Ned Pagliarulo • May 29, 2018