Pfizer, Merck KGaA lung cancer drug fails

The duo's checkpoint inhibitor Bavencio failed to beat out chemotherapy in the key setting of non-small cell lung cancer. 

By Lisa LaMotta • Feb. 15, 2018

Fresh data sets up showdown for Lilly's Taltz vs Cosentyx

In the highly competitive IL-inhibitor space, securing new indications has been a key strategy for drugmakers looking to gain an edge.

By Jacob Bell • Feb. 14, 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

Merck delivers latest Alzheimer's disappointment

The big pharma discontinued another trial, acknowledging its drug doesn't work in early-stage patients. 

By Lisa LaMotta • Feb. 14, 2018

New approval helps Vertex's 'cleanest growth story in biotech'

Symdeko, a combination treatment for cystic fibrosis, holds a price tag of $292,000 and could provide Vertex up to $200 million in revenue by year's end.

By Jacob Bell • Feb. 13, 2018

Trump pitches changes to 180-day generic exclusivity

The administration's budget includes a proposal to prevent generic drugmakers from abusing the current system.

By David Lim • Feb. 13, 2018

Despite trial win, Roche's new eye drug can't escape Eylea's shadow

While positive, the latest data for Roche's RG7716 doesn't answer how it will compete with Regeneron's market heavyweight.

By Jacob Bell • Feb. 12, 2018

Aveo, Eusa tout promise of tivozanib combo in kidney cancer

Early results from a trial testing tivozanib together with Opdivo showed enough merit to further explore combo treatment — in the companies' eyes, at least. 

By Suzanne Elvidge • Feb. 12, 2018

Fewer regs could lower drug costs: White House council

The Council of Economic Advisers also suggested creating an independent agency to oversee the 340B prescription drug program.  

By Les Masterson • Feb. 12, 2018

Boehringer ends Alzheimer's research for PDE9 blocker

After Phase 2 trials of the drug failed to show a cognitive benefit in Alzheimer's, Boehringer will refocus its work on PDE9 inhibition around schizophrenia.

By Ned Pagliarulo • Feb. 9, 2018

Prescribed Reading: Earnings point to restructuring, not M&A

As pharma companies continued to report full-year earnings, the M&A spree has stopped and the focus has shifted to fixing up the pipeline. 

By Lisa LaMotta • Feb. 9, 2018

Madrigal shares slide despite Phase 2 success

Although Madrigal touted its candidate's prospects in hypercholesterolemia, the market took a different take and sent shares in the biotech tumbling.

By Suzanne Elvidge • Feb. 9, 2018

Biogen drops Tysabri stroke program after Phase 2 miss

A study known as ACTION 2 showed treatment with the MS drug failed to improve clinical outcomes versus placebo in acute ischemic stroke.

By Suzanne Elvidge • Feb. 8, 2018

Array's stock zooms as melanoma combo beats out Zelboraf

With its target action date approaching, a combo drug from Array and Pierre Fabre shows it can cut the risk of death in BRAF-mutant melanoma.

By Suzanne Elvidge • Feb. 7, 2018

Bavarian Nordic unveils positive smallpox vaccine data

New data for the Imvamune smallpox vaccine boosts the potential for a shot that could protect the wider public against a bioterrorism attack.

By Suzanne Elvidge • Feb. 7, 2018

Will Allergan cannibalize Botox with ubrogepant?

New data for its CGRP inhibitor are promising, but analysts worry the drug will cut into revenues for one of its best-selling products. 

By Lisa LaMotta • Feb. 6, 2018

Spectrum advances neutropenia drug toward FDA filing

Positive results from a Phase 3 study of Rolontis keep Spectrum on track to submit an application for approval later this year.

By Suzanne Elvidge • Feb. 6, 2018

What you need to know about real-world evidence

In an effort to speed up drug reviews and lower development costs, both the industry and the FDA aim to add real-world evidence to their repertoires.

By Lisa LaMotta • Feb. 6, 2018

EyeGate eye treatment stumbles in mid-stage study

Company execs blamed a higher-than-expected placebo response for the Phase 2a miss. 

By Suzanne Elvidge • Feb. 6, 2018

Pfizer, Astellas peg Xtandi expansion on PROSPER data

Full results from the Phase 3 study in a non-metastatic patient population could double the prostate cancer drug's patient pool. 

By Lisa LaMotta • Feb. 5, 2018

Strong data lift profile of J&J's cancer drug apalutamide

Facing competition from Pfizer and with generic threats to Zytiga looming, J&J hopes apalutamide can help strengthen its prostate cancer franchise. 

By Ned Pagliarulo • Feb. 5, 2018

Biotech unicorn Intarcia cuts staff and stops trials

Intarcia is laying off 60 people, as well as cutting studies of its lead Type 2 diabetes product.

By Suzanne Elvidge • Feb. 5, 2018

Bristol-Myers talks up lung cancer data

New results for Opdivo and Yervoy in first-line non-small cell lung cancer could threaten Merck's dominance in the space. 

By Lisa LaMotta • Feb. 5, 2018

TG Therapeutics posts positive MS update

Six-month Phase 2 results for ublituximab build on last year's data for relapsing multiple sclerosis.

By Suzanne Elvidge • Feb. 5, 2018

Prescribed Reading: Tax changes disappoint, ho-hum earnings

Recent earnings reports shine a light on investor expectations for the tax code changes and M&A in 2018.

By Lisa LaMotta • Feb. 2, 2018

India's Semler sues FDA for $50M over suspicious spreadsheet

Semler is taking on the FDA over actions the CRO says were spearheaded by a disgruntled employee.

By Suzanne Elvidge • Feb. 1, 2018