Cyclacel's lead candidate flops in Phase 3

The clinical-stage company's stock fell more than 20% on news that its cancer medication didn't improve overall survival in elderly patients with leukemia.

By Jacob Bell • Feb. 23, 2017

Safety concerns reemerge for Roche hemophilia drug

Roche hopes to file for approval of emicizumab in certain hemophilia A patients this year, but a patient death reported this week refocuses attention on the drug's safety profile. 

By Ned Pagliarulo • Feb. 23, 2017

Explore the Trendline➔

Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

Bayer touts Xarelto strength on heels of COMPASS data

The blood thinner led the German company’s pharma growth last year, but Eylea, cancer drugs and a pulmonary hypertension treatment also played key roles.

By Judy Packer-Tursman • Feb. 23, 2017

DMC: little promise for Argos cancer therapy

Argos stock plummeted more than 66% on news that an independent data monitoring committee recommended stopping a Phase 3 study of its cancer drug.

By Jacob Bell • Feb. 22, 2017

Pfizer, Celltrion pushing for interchangeability with Inflectra

Positive data could support a claim of interchangeability for the biosimilar of Remicade. 

By Jacob Bell • Feb. 22, 2017

Trevena stock tanks despite positive late-stage results

The clinical-stage company's lead candidate outperformed placebo, but analysts questioned whether the pain medication's safety profile would get it to market.

By Jacob Bell • Feb. 21, 2017

Capricor scraps heart-failure drug to focus on cell, exosome therapies

The Los Angeles-based biotech is shifting gears to push forward with a cardiac cell therapy. 

By Judy Packer-Tursman • Feb. 20, 2017

Celgene notches clinical victory for its first MS drug

The highly anticipated drug, ozanimod, outperformed Biogen's Avonex in treating patients with relapsing multiple sclerosis.

By Jacob Bell • Feb. 17, 2017

Pfizer's Xeljanz falls short in match-up with Humira

Xeljanz monotherapy failed to beat out a combination of Humira and methotrexate, crimping hopes the JAK inhibitor could stand on its own in the competitive class. 

By Judy Packer-Tursman • Feb. 17, 2017

Daiichi, ArQule cancer drug fails in late-stage study

The companies have struggled to get the drug, tivantinib, through Phase 3 testing for different types of cancers, including liver and lung.

By Jacob Bell • Feb. 17, 2017

Prescribed Reading: Sage CEO embellishes, Merck stumbles

Plus, Valeant gets an approval, but is still in a tight spot; Allergan continues its deal spree; and PhRMA tries to deal with image issues. 

By Lisa LaMotta • Feb. 17, 2017

Alexion shutters further development of rare disease candidate

The rare disease drugmaker remains heavily dependent on sales of its main drug Soliris, and questions still linger from management turnover late last year. 

By Suzanne Elvidge • Feb. 17, 2017

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

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