Takeda, PRA expand R&D partnership into Japan

Less than half a year after first pairing up, the two companies are creating a new joint venture to support Takeda's drug development work in its home base. 

By Suzanne Elvidge • Feb. 16, 2017

Ardelyx asserts kidney drug is back on track

Despite positive trial data, skepticism remains for Ardelyx's tenapanor after previous trial failures, safety concerns and partners backing away. 

By Judy Packer-Tursman • Feb. 16, 2017

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

Gilead reports strong findings in HIV

The big biotech offered a wave of new clinical results for its investigational HIV treatments, headlined by positive news from late-stage studies of Genvoya.

By Judy Packer-Tursman • Feb. 15, 2017

Merck scraps late-stage study of Alzheimer's candidate

An independent data monitoring committee saw no hope for finding a positive clinical effect in a Phase 3 study testing the BACE inhibitor verubecestat. 

By Ned Pagliarulo • Feb. 15, 2017

Sage forges ahead with depression drug after positive Phase 2 results

Success in an open label study of SAGE-217 builds on positive momentum from last year, which saw progress from Sage's lead candidate SAGE-547. 

By Jacob Bell • Feb. 14, 2017

Axovant value drops on mixed preliminary dementia data

Interim results from a Phase 2 study leave unanswered questions for Axovant's nelotanserin.

By Suzanne Elvidge • Feb. 14, 2017

5 trends being impacted by biomarkers

The role of biomarkers in immuno-oncology and other cancer treatments is becoming increasingly important and is driving investment into multiple industries, including liquid biopsies and diagnostics. 

By Ned Pagliarulo , Lisa LaMotta • Feb. 13, 2017

Intercept cuts targets for pivotal NASH study

The biotech pleased investors when it changed the endpoints in its late-stage NASH trial. 

By Suzanne Elvidge • Feb. 13, 2017

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

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