What cheap data means for understanding the patient experience in clinical trials

More nuanced, dynamic insights into patient experience can decrease the burden on patients by extrapolating from objective data sources and reducing the number of questionnaires being asked.

By Paul O'Donohoe Medidata Solutions Scientific Lead, eCOA and Mobile Health • Sept. 24, 2018

One bottle of hope for one amazing kid

How Fisher Clinical Services, by Thermo Fisher Scientific worked with a drug company to create a special clinical trial to save a patient with late stage brain cancer.

Sept. 24, 2018

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

Narcan developer secures grant for counter to opioid weaponization

BARDA is concerned that repeat doses of naloxone would not be available in a large-scale terrorist attack involving weaponized opioids. So it's tapped Opiant to develop a long-acting opioid overdose agent. 

By Suzanne Elvidge • Sept. 21, 2018

How do doctors feel about robots in the exam room?

ZS’s 2018 research finds that only 25% of doctors are comfortable letting AI help with diagnosis.

By Paul Darling • Sept. 21, 2018

Phase 3 win underscores that Astellas is more than Xtandi

Though better known for the prostate cancer med, Astellas gets considerable revenue from bladder drugs and reported positive data Thursday for an experimental chronic kidney disease therapy.

By Jacob Bell • Sept. 20, 2018

Pharming knocked back with CRL from FDA

Regulators are looking for more data from Pharming to support an expanded approval of the company's HAE drug Ruconest. 

By Suzanne Elvidge • Sept. 20, 2018

Does your brand need behavioral science?

Does your brand need a behavioral science solution? Find the right solution to meet your needs.

By Meredith Terry, PHD, Lead Behaviorist, Innovation and Practice MicroMass Communications, Inc. • Sept. 19, 2018

Clovis, execs pay up to settle charges of misleading investors

The SEC had accused Clovis, along with its CEO and former CFO, of knowingly misrepresenting the efficacy of its cancer candidate rociletinib.

By Suzanne Elvidge • Sept. 19, 2018

Viking shares soar as NASH drug impresses

Positive results from a small study suggested the San Diego-based biotech could compete in the race to develop therapies for the liver disease.

By Ned Pagliarulo • Sept. 18, 2018

Argenx's auto-immune drug headed for Phase 3 in ITP

Data from a proof-of-concept study showed "clinically meaningful" platelet count improvements for a variety of primary immune thrombocytopenia patients.

By Suzanne Elvidge • Sept. 18, 2018

FDA lifts clinical hold on Mersana study, but shares slide

Mersana will soon restart the paused trial of a cancer candidate with modified dosing and tweaked protocols. Markets, though, didn't seem all that relieved.

By Suzanne Elvidge • Sept. 18, 2018

More data bolster AstraZeneca's 3-in-1 inhaler as other assets face setbacks

After clinical misses from Fasenra and Bevespi Aerosphere, AstraZeneca is hoping PT010 could give it another product to play with in the COPD market.

By Jacob Bell • Sept. 17, 2018

Pfizer showcases JAK pipeline with mid-stage results

The pharma will advance its JAK3 inhibitor in alopecia areata, while focusing its TYK2/JAK1 blocker on psoriasis, Crohn's and ulcerative colitis.

By Suzanne Elvidge • Sept. 17, 2018

UK accelerator secures cell and gene therapy production licenses

Autolus, Cell Medica, Adaptimmune and Freeline are some of the companies already working with the accelerator.

By Suzanne Elvidge • Sept. 13, 2018

Bristol-Myers' psoriasis drug proves itself in mid-stage study

Known for its prowess in cancer, the pharma trails rivals in developing new drugs for inflammation-related conditions.

By Ned Pagliarulo • Sept. 12, 2018

Vital Therapies plunges on liver treatment failure

Shares of the San Diego biotech plummeted 90% as its only product candidate flopped in a pivotal trial, leaving the company in a precarious position.

By Andrew Dunn • Sept. 12, 2018

Bavencio combo shows benefits in kidney cancer

Pfizer and Merck KGaA are playing catch up with Bavencio as the rest of the checkpoint inhibitor market charges ahead.

By Suzanne Elvidge • Sept. 12, 2018

FINCH-2 data bodes well for Gilead, Galapagos JAK inhibitor

The rheumatoid arthritis study showed no patients taking filgotinib experienced deep venous thrombosis, a key concern leading up to the data readout.

By Jacob Bell • Updated Sept. 12, 2018

Merck's pneumonia antibiotic stacks up in pivotal study

Dubbed ASPECT-NP, the study showed Zerbaxa was non-inferior to meropenem in treating two kinds of bacterial pneumonia.

By Jacob Bell • Sept. 11, 2018

GSK touts Nucala data after COPD miss

After last week's bruising slate of news, GSK was quick to highlight research showing a competitive edge for its lung drug in severe asthma.

By Suzanne Elvidge • Sept. 11, 2018

GSK's pitch for Nucala in COPD turned down by FDA

The Complete Response Letter GSK received Friday isn't entirely unexpected: An FDA advisory panel last month found the lung drug's data in COPD lacking.

By Ned Pagliarulo • Sept. 7, 2018

Gilead, Galapagos build case for JAK inhibitor with Phase 2 win

Though filgotinib offers significant benefits to patients with ankylosing​ spondylitis, the drug's real test seems to be whether it can compete in the rheumatoid arthritis market.

By Jacob Bell • Sept. 6, 2018

Sangamo pitches gene therapy progress, yet investors stay skeptical

The biotech's zinc finger gene therapy showed signs of efficacy in two patients with Hunter syndrome. Other findings, though, raised questions.

By Ned Pagliarulo • Sept. 5, 2018

With 12 more patients dosed, Bluebird reinforces strong profile for Lenti-D

Updated data from the STARBEAM trial underscored the gene therapy's efficacy and safety, positioning it well for a 2019 approval filing.

By Jacob Bell • Sept. 5, 2018

AstraZeneca's lupus drug fails in pivotal trial

The British drugmaker's candidate, once considered a potential blockbuster, failed to meet its primary endpoint.

By Andrew Dunn • Aug. 31, 2018