Armetheon amends Phase 3 ahead of NDA filing

The California company describes the agency’s decision as "unprecedented" for an anti-thrombosis/cardiovascular drug.

By Judy Packer-Tursman • Feb. 13, 2017

Liquid biopsies: The next frontier in cancer?

Money is flooding into the space as dozens of companies work to develop reliable tests for cancer from a simple blood draw. 

By Ned Pagliarulo • Feb. 13, 2017

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

How biomarkers cost Bristol-Myers the lung cancer market

A risk-averse approach to biomarkers opened the door for Merck's Keytruda to surpass Bristol-Myers' Opdivo in the highly important lung cancer market. 

By Lisa LaMotta • Feb. 13, 2017

Tracon stumbles in glioblastoma study

The Phase 2 trial failed to show an improvement in progression-free survival. But Tracon has a Phase 3 study ready to go testing the drug in angiosarcoma. 

By Suzanne Elvidge • Feb. 13, 2017

Biomarker bonanza: New molecular markers fuel diagnostic development

Sequencing of the human genome has shifted the development of diagnostics to include biomarker tests that are revolutionizing drug development. 

By Malorye A. Branca • Feb. 13, 2017

A biomarker could tackle one of worst diseases in sports

Exosome Sciences is investigating a potential biomarker for a rare neurodegenerative disease that has plagued veterans and professional athletes.

By Jacob Bell • Feb. 13, 2017

Prescribed Reading: When will Gilead tap its cash hoard?

2017 looks bleak for Gilead's hepatitis C business, Lundbeck reports yet another Alzheimer's trial failure and a new pricing controversy bubbles up. 

By Lisa LaMotta • Feb. 10, 2017

Microbiome work reignites after Seres' initial flame-out

Despite a trial failure from the first public microbiome-focused company's lead product, market analysts say investment is still flowing and the field could show dramatic growth over time. 

By Judy Packer-Tursman • Feb. 10, 2017

Acorda speeds toward filing of Parkinson's drug

An inhalable version of levodopa showed positive results in Phase 3, setting up the biotech for a potential approval. 

By Lisa LaMotta • Feb. 9, 2017

Janssen touts Xarelto's broader uses, halts CV trial early

The blockbuster blood thinner has proven so effective at preventing heart attack and stroke in certain patients that a global Phase 3 study is being stopped more than a year early.

By Judy Packer-Tursman • Feb. 9, 2017

Amgen secures FDA approval for hormone drug

The approval should help ease the threat Amgen faces as generics move in on the company's older drug for a similar indication. 

By Jacob Bell • Feb. 8, 2017

Lundbeck brings latest Alzheimer's failure

The Danish drugmaker reported two late-stage failures that put an end to its 5-HT6 antagonist in yet another setback for the space. 

By Lisa LaMotta • Feb. 8, 2017

Express Scripts says branded drug prices rose nearly 11% last year

The large PBM contrasted those rising costs with the slower cost growth experienced by its members, touting its efforts to secure rebates from drugmakers.

By Jacob Bell • Feb. 6, 2017

Innate's cancer immunotherapy falls short in Phase 2

The French drugmaker has licensed rights to lirilumab to Bristol-Myers Squibb, which is testing the anti-KIR drug in combination with other cancer agents, including Opdivo. 

By Ned Pagliarulo • Feb. 6, 2017

Amgen buoyed by Repatha success, earnings beat

Repatha met its goal in a closely watched cardiovascular outcomes trial, potentially giving the slow-growing drug a competitive edge over rival Praluent. 

By Judy Packer-Tursman • Feb. 3, 2017

Prescribed Reading: A week dominated by politics and earnings

Pharma's sit down with President Trump was a hot topic in earnings calls this week as markets tried to gauge the new administration's approach to the industry. 

By Lisa LaMotta • Feb. 3, 2017

Catabasis' DMD drug fails in Phase 2

The rare disease drugmaker revealed top-line data showing its treatment for Duchenne muscular dystrophy did not significantly outperform placebo.

By Jacob Bell • Feb. 1, 2017

Pfizer counts on Ibrance as Prevnar sales slip

Sales of the breast cancer drug continued to grow strongly in the fourth quarter, bolstering the company's confidence it can stave off potential inbound competition. 

By Ned Pagliarulo • Jan. 31, 2017

Ocera tumbles 70% after phase 2 failure

Top-line results floor share value as Phase 2b study doesn't show statistical significance.

By Suzanne Elvidge • Jan. 31, 2017

Regulus hits further setbacks as clinical hold upheld

Stock dropped by 20% after hours on Friday following an FDA request for more data on the microRNA-targeting drug RG-101.

By Suzanne Elvidge • Jan. 30, 2017

Prescribed Reading: J&J closes $30B deal, FDA talks regen med

J&J finally closes the deal with Actelion, despite poor data for Opsumit, while the FDA creates a new designation and Biogen looks to woo payers with data. 

By Lisa LaMotta • Jan. 27, 2017

Pfizer set to move C. diff vaccine into Phase 3

An interim analysis of data from a Phase 2 study showed positive immunogenic effects from treatment with the experimental vaccine. 

By Judy Packer-Tursman • Jan. 27, 2017

Vertex touts CF drugs, but sees promise in pain

The Boston-based company anticipates sales growth for its cystic fibrosis drug Orkambi in Europe this year, but some analysts see movement there as slow-going.

By Judy Packer-Tursman • Jan. 26, 2017

Novartis aims to gain ground on I/O leaders

Merck, Roche and Bristol-Myers have seized the lead in immuno-oncology, but Novartis hopes to build a broad portfolio of second-generation immunotherapies that can close the gap. 

By Ned Pagliarulo • Jan. 25, 2017

FDA report stresses importance of Phase 3 testing

Several rumored candidates for FDA chief under President Trump have previously criticized the FDA approval process as being too slow. 

By Judy Packer-Tursman • Jan. 25, 2017