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

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

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

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

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

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

Sellas gives positive clinical update

The company's multiple myeloma drug did well in a small Phase 2 study, confirming preliminary findings ahead of a move into late-stage testing.

By Suzanne Elvidge • March 2, 2017

NeuroDerm Parkinson's results ON point

The Israeli company’s therapy continuously delivers a liquid form of levodopa/carbidopato Parkinson's disease patients and some analysts say it compares well to an AbbVie product approved in 2015.

By Judy Packer-Tursman • March 2, 2017

Juno shelves JCAR015, shifts focus to earlier compound

Following major setbacks for its lead candidate, the CAR-T company is pumping additional resources into another one of its main cancer immunotherapies, JCAR017.

By Jacob Bell • March 1, 2017

Kite flying high on Zuma-1 data

The CAR-T specialist plans to fully submit its lead candidate for approval after Phase 2 data showed the drug effectively treated patients with non-Hodgkin lymphoma.

By Jacob Bell • Feb. 28, 2017

Merck antiviral cuts post-transplant infections

The big pharma readies an NDA submission after reducing CMV infection and boosting survival in bone marrow transplant patients.

By Suzanne Elvidge • Feb. 28, 2017

Industry Pulse: Who's spending on R&D?

As top-selling drugs age, biopharma continues to hunt for ever-elusive innovation. Here are eight charts explaining which pharmas need it most, and which are turning to internal R&D to capture it. 

By Ned Pagliarulo • Feb. 28, 2017

La Jolla surges on Phase 3 results for shock patients

The San Diego-based company says its synthetic formulation of a blood-pressure regulator offers a new level of treatment for shock patients who fail first- and second-line therapies in the ICU.

By Judy Packer-Tursman • Feb. 27, 2017

Bristol, Roche team up with Exelixis on cancer trials

The California-based biotech will test its drug, cabozantinib, in combination with Roche's Tecentriq and Bristol-Myers Squibb's Opdivo.

By Jacob Bell • Feb. 27, 2017

Cempra touting positive antibiotic results

A bit of good news for anti-infectives company after a difficult close to 2016.

By Suzanne Elvidge • Feb. 27, 2017

Prescribed Reading: Bristol M&A steals the show

Debate about the future of Bristol-Myers dominated news coverage this week, while several cancer drugs failed in late-stage trials. 

By Lisa LaMotta • Feb. 24, 2017

Merck writes off $2.9B as new hep C reality blooms

The accounting charge will drag down 2016 earnings per share and reflects shifting market and pricing dynamics, the drugmaker said. 

By Ned Pagliarulo • Feb. 24, 2017

Aveo's tivozanib finally moving forward after 4-year delay

The biotech's study provides data for the company's second go at approval.

By Suzanne Elvidge • Feb. 24, 2017

Resverlogix gets FDA input, redesigns kidney trial

This is the Canadian biotech’s third announcement over the past month on studies related to the potential of its lead candidate, apabetalone.

By Judy Packer-Tursman • Feb. 24, 2017