Ardelyx scraps late-stage drug in another pipeline setback

The move leaves Ardelyx's pipeline with a single Phase 3 candidate that has faced trouble in the clinic and skepticism among investors.

By Jacob Bell • Nov. 21, 2017

New data for Roche's Hemlibra could expand market

Positive data for the drug in hemophilia A patients without inhibitors boosts the treatment's profile beyond its recent approval in a narrower population. 

By Suzanne Elvidge • Nov. 21, 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

Acorda shuts down tozadenant after patient deaths

After disclosing last week that five patients had died in a trial, Acorda chose to stop all development of its Parkison's disease drug. 

By Lisa LaMotta • Nov. 20, 2017

Roche lung cancer results boost Tecentriq versus I/O rivals

Tecentriq's success in the closely watched IMpower150 study could position the PD-L1 inhibitor to challenge Merck's Keytruda in first-line lung cancer.

By Ned Pagliarulo • Nov. 20, 2017

Galapagos continues in Vertex's shadow

In spite of positive new data for one of its cystic fibrosis candidates, Galapagos hasn't convinced some analysts it has the stuff to compete with market leaders.

By Jacob Bell • Nov. 20, 2017

AstraZeneca touts Tagrisso's CNS benefit

A subgroup analysis of the positive FLAURA study showed Tagrisso cut the risk of CNS disease progression by half when compared to standard of care.

By Suzanne Elvidge • Nov. 20, 2017

MDX mice for Duchenne's

All models are wrong, but some are useful: Novel ways of using MDX mice to study a devastating childhood disease.

By By Toni Ahtoniemi, Senior Manager, Client Services, Charles River Laboratories • Nov. 20, 2017

Prescribed Reading: FDA on approval streak, I/O shines

The regulatory agency granted seven approvals this week, including the first pill with a digital sensor, as well as the go-ahead for a new hemophilia drug. 

By Lisa LaMotta • Nov. 17, 2017

KemPharm eyes 2018 filing for ADHD drug

A recent meeting with the FDA was "successful," the company says, clearing a path forward for development of the drug. 

By Suzanne Elvidge • Nov. 17, 2017

Janssen picks up second GI drug from Ionis

While the $5 million license fee may not mean much to Ionis, Janssen's decision signals continued interest in the biotech's antisense drug platform.

By Ned Pagliarulo • Nov. 16, 2017

Mirati reroutes resources to I/O combo, KRAS programs

The biotech is deprioritizing one of its lead candidates to focus on other assets — namely sitravatinib, which investigators are studying in combination with Opdivo.

By Jacob Bell • Nov. 16, 2017

Acorda faces new trouble with trial halt, safety problems

Serious safety signals in a late-stage trial of its Parkinson's disease drug have pushed the company to stop enrollment into two studies and amend another. 

By Lisa LaMotta • Nov. 15, 2017

Navigating through Fair Market Value ambiguity

Determining Fair Market Value benchmarks are a vital factor to global compliance and critical to study start-up timelines. However, establishing FMV is an opaque subject with rather unclear guidelines.

By Russell John, Global Director of Grants Management, Clintrax Global • Nov. 15, 2017

Argos finds silver lining for I/O candidate

A negative interim analysis crushed optimism for rocapuldencel-T earlier this year, but new data has Argos leadership believing the drug may still have potential. 

By Jacob Bell • Nov. 13, 2017

Novartis' eye drug clearly works, but edging out Eylea won't be easy

The Swiss pharma has flagged brolucizumab as one of its most promising drugs, alongside Cosentyx, canakinumab and the migraine drug erenumab.

By Jacob Bell • Nov. 13, 2017

Seattle Genetics wins new OK for Adcetris

The Washington biotech's main drug is now approved for use in certain types of cutaneous T-cell lymphoma, an area that has seen few clinical advances.

By Suzanne Elvidge • Nov. 13, 2017

Translating cognitive decline in mice

How touchscreen-based assays can change the way cognitive impairment is tested in Alzheimer’s disease mouse models – a Q&A with Dr. Maksym Kopanitsa from Charles River Laboratories

Nov. 13, 2017

Juno analysis of shuttered study offers clues for CAR-T

The company's hunt for answers to what went wrong in the ROCKET trial didn't point to just one smoking gun, but the findings could help improve CAR-T's safety.

By Ned Pagliarulo • Nov. 10, 2017

Otonomy shares surge on positive Ménière's data

The biotech plans to discuss the results with the FDA, potentially putting its inner ear disease remedy back on track after a damaging clinical setback earlier this year.

By Suzanne Elvidge • Nov. 10, 2017

Prescribed Reading: Buyer's remorse for biopharma

Most of the major deal developments of late have been companies handing back the rights to assets they previously licensed as they try to right-size portfolios. 

By Lisa LaMotta • Nov. 10, 2017

Sage shares boom on success of postpartum depression drug

Results from two Phase 3 trials showed the biotech's treatment reduced depressive symptoms, setting up a likely filing for approval next year. 

By Ned Pagliarulo • Nov. 9, 2017

Novartis pushing Kisqali into younger patients to gain edge

Topline results from a Phase 3 study in younger women with breast cancer could give the CDK 4/6 inhibitor an advantage over competitors. 

By Lisa LaMotta • Nov. 8, 2017

FDA lifts clinical hold on Cellectis CAR-T

Cellectis agreed to several changes to two Phase 1 trials testing its allogeneic CAR-T candidate, both of which had been halted after a patient death in late August.

By Ned Pagliarulo • Nov. 7, 2017

Could pain data give Lilly's baricitinib back its edge?

After its put-down from the FDA earlier this year, pain data could boost the profile of the drugmaker's arthritis hopeful.

By Suzanne Elvidge • Nov. 6, 2017

Reata buoyed by positive data for kidney disease drug

Results from a mid-stage study could boost confidence in Reata's treatment for patients with an inherited form of CKD.

By Suzanne Elvidge • Nov. 6, 2017