Amgen's Repatha shows CV benefit, but falls short of expectations

Results from the hotly anticipated FOURIER trial showed the PCSK9 inhibitor cut the risk of heart attack and stroke, but will it be enough to buoy the drug to commercial success? 

By Ned Pagliarulo • March 17, 2017

Following failure, Proteon tweaks Phase 3 study

After FDA discussions, Proteon has changed the size and endpoints of its PATENCY-2 study.

By Suzanne Elvidge • March 17, 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

Optimizing clinical trials: What you need to know

BioPharma Dive takes a closer look at the technology, trial design and site selection tools that pharma companies are using to speed up the clinical trial process. 

By Lisa LaMotta • March 16, 2017

Immunomedics results bolster case for efficacy in aggressive breast cancer

Results published in the Journal of Clinical Oncology give a boost to Immunomedics' lead candidate amid a turbulent time for the biotech. 

By Suzanne Elvidge • March 16, 2017

AstraZeneca staves off Tesaro threat to PARP crown

Impressive results from Lynparza as maintenance therapy for ovarian cancer dampened hopes Tesaro's niraparib might be a best-in-class PARP inhibitor.

By Ned Pagliarulo • March 14, 2017

Actionable consent data helps avoid wasted trials: One story of an estimated $100M saved

How one company brought together diverse data and gained meaningful insights that helped avoid a costly trial that had a low probability of success.

March 14, 2017

Good Repatha data for Amgen ahead of FOURIER

Positive news expected later this week from a key cardiovascular outcomes trial could help open up the PCSK9 market. 

By Suzanne Elvidge • March 14, 2017

Argos axes over a third of staff in retrench

The staff cutbacks followed disappointing Phase 3 results for Argos' cancer immunotherapy last month.

By Suzanne Elvidge • March 14, 2017

Investors have high expectations for cannabinoids

The pipeline is moving forward for cannabis-mimicking pharmaceuticals as investors' interest grows and new clinical data spark approval hopes. 

By Jacob Bell • March 13, 2017

FDA puts partial hold on Karyopharm's cancer drug

The pharma stresses that the FDA’s hold, while halting new patient enrollment until it’s lifted, is due to errors on written materials, not safety problems.

By Judy Packer-Tursman • March 12, 2017

Prescribed Reading: More backlash to drug pricing

Negotiating Medicare prices is now on the table, lawmakers are not happy with Marathon, and PTC is pushing back at the FDA. 

By Lisa LaMotta • March 10, 2017

Ocera touts liver drug prospects despite earlier failure

Shares in the biotech rose yesterday after Ocera announced new data it hopes to discuss with the FDA later this year.

By Judy Packer-Tursman • March 9, 2017

FDA lifts trial holds for Seattle Genetics' cancer med

The agency is allowing two early-stage trials testing the treatment in patients with AML to continue, but the company is not continuing a Phase 1/2 study.

By Jacob Bell • March 7, 2017

Ionis drug shows efficacy amid lingering safety worries

Declining platelet counts in some patients, mirroring an earlier issue, caused the biotech’s shares to fall the day it reported positive efficacy results for volanesorsen.

By Judy Packer-Tursman • March 7, 2017

How pharma is using mobile to call on patients

Companies like mProve Health are using mobile platforms to help pharma recruit and engage patients throughout the clinical trial process. 

By Lisa LaMotta • March 6, 2017

Modern solutions to recurring roadblocks in clinical testing

Investigators are turning to technologies such as Skype and the cloud to curb the time and safety problems that have plagued clinical trials in the past.

By Malorye A. Branca • March 6, 2017

Lessons learned: Two biotechs talk clinical trial site selection

Site selection for clinical trials is costly and time-consuming, but two companies' experiences offer lessons on how to manage the process as smoothly as possible.

By Judy Packer-Tursman • March 6, 2017

Changes to MYSTIC could set AstraZeneca up for success

The British pharma is attempting to catch immuno-oncology leaders Bristol-Myers and Merck by adapting the trial to boost durvalumab's chance of competing. 

By Ned Pagliarulo • March 6, 2017

5 trends changing clinical trials

Cutting the cost and time it takes to perform clinical trials is a constant struggle for the pharma industry. Emerging shifts in how studies are performed could help.

By Lisa LaMotta • March 6, 2017

J&J's psoriasis drug performs well in Humira match-up

Janssen reported positive results from two more late-stage studies evaluating guselkumab in plaque psoriasis, comparing well to market leaders. 

By Judy Packer-Tursman • March 6, 2017

Prescribed Reading: Icahn stokes M&A flames

The billionaire activist investor makes a new biotech hire; the CAR-T space heats up; and the FDA cooperates with EMA to improve manufacturing. 

By Lisa LaMotta • March 3, 2017

AstraZeneca, Sanofi partner on infant respiratory drug

Sanofi Pasteur is dropping at least $127 million to help MedImmune bring its drug for respiratory syncytial virus to market.

By Jacob Bell • March 3, 2017

FDA touts own role in women's heart health

The agency highlighted its efforts to curb heart disease in women, an oft-overlooked area of healthcare. 

By Judy Packer-Tursman • March 3, 2017

Roche props up breast cancer prospects, driving down Puma

The big pharma reports positive data for its breast cancer drug Perjeta, pushing down the stock of a close rival. 

By Suzanne Elvidge • March 3, 2017

PTC abandons CF indication after latest failure

The biotech notched another failure in cystic fibrosis, prompting it to pull its application in Europe and diminishing its prospects in DMD. 

By Lisa LaMotta • March 2, 2017