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

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

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

Partnering for drug discovery success

Kathryn Chapman, Executive Manager of The Milner Therapeutics Institute, and Charles McOsker, Senior VP of Technical Operations at BioMotiv, talk about how alliances with CRO/CMOs are becoming an integral part of R&D approaches as they contribute to building key scientific evidence for drug development programs for clinical success.

Nov. 3, 2017

Alnylam outshines Ionis with RNAi drug

Patisiran reverses impairment and improves quality of life in patients with a rare disease, paving the way for potential approval of the first RNAi treatment. 

By Suzanne Elvidge • Nov. 3, 2017

Aisling Capital raises $280M in latest fund

The New York-based life sciences investment firm looks to help clinical stage ventures bring treatments to market.

By Suzanne Elvidge • Nov. 3, 2017

Prescribed Reading: Cancer market facing several shake-ups

Merck pulled a Keytruda application in Europe, and AstraZeneca got a key approval for Calquence — decisions that could have dramatic impacts on different areas of the oncology space. 

By Lisa LaMotta • Nov. 3, 2017

Proving flexibility in oncology early clinical development

By remaining attuned to the dynamic nature of oncology drug development, time, cost and risk can all be efficiently minimized while successfully managing safety and ethical considerations during the early clinical development journey.

Nov. 2, 2017

Third flop dims hopes for AstraZeneca's asthma drug

The British pharma adds two more late-stage failures to an earlier setback for tralokinumab. 

By Lisa LaMotta • Nov. 1, 2017

Bluebird marks progress on Lentiglobin gene therapy

Manufacturing changes made last fall appear to have improved the biotech's treatment for sickle cell disease. But will the new data be enough to boost investor confidence? 

By Ned Pagliarulo • Nov. 1, 2017

AstraZeneca looks to build edge in early-stage lung cancer

Following a now well-worn path, AstraZeneca will pair its PD-L1 inhibitor Imfinzi with Incyte's epacadostat in hopes of building on strong data from its PACIFIC study. 

By Ned Pagliarulo • Oct. 31, 2017

Pharma's betting big on China, but R&D boom still to come

Despite a major regulatory shift, China's ascendency as the next global hub of drug R&D may still be a ways off.

By Ned Pagliarulo • Oct. 30, 2017

Late-stage ozanimod data brings Celgene closer to filing

After a challenging third quarter, RADIANCE and SUNBEAM Phase 3 MS results could shine light through Celgene's clouds.

By Suzanne Elvidge • Oct. 30, 2017

Swiss biotech GeNeuro jumps on redeeming MS analysis

A new post-hoc analysis in multiple sclerosis patients taking GNbAC1 showed new potential, boosting the drug's prospects. 

By Lisa LaMotta • Oct. 30, 2017

Prescribed Reading: Disappointing quarters all around

With some exceptions, third quarter reports so far have largely been a letdown for the sector, lowering expectations as investors turn toward 2018. 

By Lisa LaMotta • Oct. 27, 2017