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

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

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

Vical axes CMV vaccine and half its staff in bid to stay afloat

After a Phase 3 failure last month, Vical is scrambling to restructure, narrowing its focus to candidates for HSV-2 and fungal infection.

By Suzanne Elvidge • Feb. 1, 2018

Vertex looks to own CF market before shifting focus

The biotech revealed the two triple combo regimens it's taking into Phase 3 as it closes in on serving 90% of the cystic fibrosis market.

By Jacob Bell • Jan. 31, 2018

Patient death, clinical hold sink Bellicum shares

Three patients treated with the biotech's BPX-501 developed encephalopathy, causing the FDA to halt all U.S.-based trials of the drug.

By Jacob Bell • Jan. 31, 2018

FDA to decide on Mylan, Theravance's inhaled COPD drug by November

An approval later this year would add a new treatment to the increasingly competitive COPD space. 

By Suzanne Elvidge • Jan. 30, 2018

Sunovion Parkinson's drug scores in Phase 3

An under-the-tongue version of apomorphine significantly outperformed placebo, aiding Sunovion's bid to file the drug for approval this spring.

By Jacob Bell • Jan. 30, 2018

When real-world evidence becomes a real headache

After devoting considerable time and resources to find out how a product works in everyday life, drugmakers can be left with more questions than answers.

By Jacob Bell • Jan. 29, 2018

Payers wade into real-world evidence, but tread lightly

Insurers and pharmacy benefit managers are wary about the quality of data underlying real-world evidence.

By David Lim • Jan. 29, 2018

5 Drivers spurring use of real-world evidence

Healthcare shifts are driving drugmakers, payers and regulators alike toward greater use of data collected outside the randomized clinical trial setting. 

By Ned Pagliarulo • Jan. 29, 2018

Nordic biopharmas seek turn in spotlight

As the EMA prepares to move to Amsterdam, biotech companies in various parts of Europe hope to capitalize on the regulator's proximity. 

By Suzanne Elvidge • Jan. 26, 2018