Novartis eyes showdown with Roche as cancer drug hits goal

The Swiss rivals are both chasing Pfizer's Xalkori, the standard option for first-line treatment of ALK+ non-small cell lung cancer.

By Joe Cantlupe • Sept. 26, 2016

AbbVie sees high marks in hep C study

Competition in the hepatitis C market has grown, as drugmakers seek to steal market share from Gilead's top-selling drugs Sovaldi and Harvoni. 

By Joe Cantlupe • Sept. 26, 2016

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

J&J firms up efficacy data on hep C triple combo

Updated results showed the cocktail of three drugs led to sustained viral responses 12 weeks after treatment in 100% of patients receiving the combo. 

By Suzanne Elvidge • Sept. 26, 2016

Lundbeck failure in Alzheimer's reverberates

The company's drug idalopirdine missed the mark in a Phase 3 study, a setback that could have repercussions for other drugs in the AD pipeline. 

By Suzanne Elvidge • Sept. 23, 2016

Gilead shutters study for anti-MMP9 drug

Although the experimental drug failed a Phase 2/3 trial in ulcerative colitis, Gilead intends to push on with other studies testing the drug in various indications. 

By Ned Pagliarulo • Sept. 22, 2016

Novartis continues data push for Entresto

Sales of the new heart failure drug have been slow to take off. But that hasn't stopped Novartis from ramping up its clinical development program.

By Suzanne Elvidge • Sept. 21, 2016

Amgen adds data for Repatha to boost profile

Hoping to improve uptake of its slow-moving drug, Amgen releases Repatha data showing changes to the underlying atherosclerotic disease.

By Suzanne Elvidge • Sept. 21, 2016

Ultragenyx gets lift from early data on bone drug

The California-based biotech is focused on development of therapies for rare and ultra-rare diseases. 

By Suzanne Elvidge • Sept. 20, 2016

Vical stumbles with latest vaccine failure

The San Diego-based drugmaker announced negative results for a mid-stage trial of their vaccine in kidney transplant patients. 

By Lisa LaMotta • Sept. 19, 2016

Novartis' MS hopes expand after positive trial

An experimental drug for secondary progressive MS showed promise in a late-stage trial, setting up a potential successor to Novartis' Gilenya. 

By Suzanne Elvidge • Sept. 19, 2016

Novo's Victoza follow-on showing heart benefits

Strengthening evidence for semaglutide could help Novo compete with Eli Lilly's Trulicity, which has performed well over the first six months of the year. 

By Lisa LaMotta • Sept. 16, 2016

Novavax short on options after vaccine fails trial

Shares in the Maryland-based company collapsed on news of the Phase 3 miss, dropping over 80% and erasing nearly $2 billion in market capitalization. 

By Ned Pagliarulo • Sept. 16, 2016

Takeda partners with PRA on drug development

About 300 Takeda employees have the option to move downstream to new positions at PRA in the U.S. and Europe. 

By Suzanne Elvidge • Sept. 15, 2016

Pfizer, Merck ready diabetes combos

The big pharmas announced positive results for their SGLT2 inhibitor in combination with other classes. 

By Lisa LaMotta • Sept. 15, 2016

AcelRx stock jumps after trial success

Positive results from a third and final Phase 3 trial of AcelRx's opioid painkiller clear the way for an NDA by the end of the year. 

By Ned Pagliarulo • Sept. 15, 2016

Roche bolsters evidence for MS drug Ocrevus

New post-hoc data showed Ocrevus helped better control relapsing MS better than Roche's Rebif, while also showing efficacy in primary progressive MS. 

By Ned Pagliarulo • Sept. 14, 2016

Foamix shares bubble up on Phase 2 data

A topical minocycline foam developed by the specialty pharma helped control rosacea symptoms. 

By Suzanne Elvidge • Sept. 14, 2016

PhRMA highlights industry's autoimmune drug pipeline

A new report from the industry association touts the 300+ drug pipeline, which could bring a wave of new meds to autoimmune disease patients.

By Suzanne Elvidge • Sept. 14, 2016

How to expedite FDA approvals of orphan drugs

A rare disease drug approval was pushed through with the support of PK models to inform dosing strategies.

Sept. 13, 2016

Aveo halts study of lung cancer drug

The Cambridge-based oncology company has struggled to shrug off other troubles tied to its lead candidate, settling fraud charges with the SEC in March. 

By Ned Pagliarulo • Sept. 12, 2016

AstraZeneca searches for differentiator in diabetes market

The big pharma begins multiple outcomes studies for its type 2 diabetes drug. 

By Lisa LaMotta • Sept. 12, 2016

Lexicon, Sanofi tout positive T1 diabetes data

The pair announced strong results in Phase 3 for an SGLT2 inhibitor in type 1 diabetes patients. 

By Lisa LaMotta • Sept. 9, 2016

J&J pushes forward with hep C triple-combo

Interim results released Friday by J&J partner Achillion showed promise for treating the liver disease in a shorter time period than existing options.

By Ned Pagliarulo • Sept. 9, 2016

Repros climbs on Phase 2 data

Results from an ongoing trial showed Repros' endometriosis drug cut pain pill use by half in women with moderate to severe endometriosis. 

By Suzanne Elvidge • Sept. 8, 2016

Bluebird proceeds with late-stage trial after key improvement

Shares of Bluebird moved higher on news the Cambridge-based biotech would be able to proceed with an improved manufacturing process in its Phase 3 trial. 

By Ned Pagliarulo • Sept. 8, 2016