ObsEva's endometriosis win puts it back in investors' good graces

The biotech is now looking to take two doses of linzagolix into Phase 3 for pain associated with the condition.

By Jacob Bell • June 18, 2018

Cytokinetics says early SMA treatment shows promise

Investors, however, were not so convinced, sending shares in the biotech sliding Monday morning.

By Suzanne Elvidge • June 18, 2018

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

Prescribed Reading: J&J sells off units; another Alzheimer's defeat

Big pharma extended its string of divestitures and portfolio streamlining this week. Meanwhile, manufacturers can't seem to beat Alzheimer's disease.

By Lisa LaMotta • June 15, 2018

Bluebird's changes to LentiGlobin begin to pay off

The gene therapy continued to show promise in two genetic blood disorders, but questions of durability remain.

By Ned Pagliarulo • June 15, 2018

Lilly's Olumiant delivers positive Phase 2 lupus data

The trial win is likely welcome news for Lilly and partner Incyte in light of the drug's narrow and disappointing approval in rheumatoid arthritis.

By Suzanne Elvidge • June 15, 2018

GSK touts two-drug HIV therapy, intends to file this year

Success of the doublet should help GSK better compete with Gilead, its main competitor in the HIV market. 

By Jacob Bell • June 14, 2018

Flex calling it quits after trial stop

Safety concerns for its lead candidate are forcing the company to abandon development and pursue strategic options.

By Lisa LaMotta • June 13, 2018

Galmed stock jumps sky-high on mixed results for NASH drug

While the company touted the drug's impact on liver fat, a closer look at the study results raises questions about how effective the treatment really is.

By Suzanne Elvidge • June 13, 2018

Lilly, AstraZeneca pull the plug on Alzheimer's trials

Two late-stage trials for the debilitating neurological condition were stopped for futility, further weakening the amyloid hypothesis. 

By Lisa LaMotta • June 12, 2018

Allergan notches another CGRP success, but faces changing migraine market

The pharma's atogepant succeeded in a late-stage study, advancing its plans in the space. Rivals, however, look set to jump ahead.

By Ned Pagliarulo • June 11, 2018

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

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