Ultragenyx close to learning whether gene therapy gamble will pay off

Two therapies acquired in a 2017 buyout of Dimension are poised to enter late-stage testing, if results due soon look good.

By Jonathan Gardner • July 19, 2019

Neon to advance cancer vaccine after early results suggest added benefit

The Cambridge biotech aims to prove that adding its personalized vaccine to drugs like Opdivo can improve responses across several solid tumors. 

By Ned Pagliarulo • July 15, 2019

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

GSK poses challenge to rival AstraZeneca with positive PARP data

Results from the PRIMA study show GSK's Zejula improved progression free survival when used as a frontline maintenance treatment for ovarian cancer.

By Jacob Bell • July 15, 2019

Gilead forges closer ties with Galapagos in $5.1B deal

Eschewing a buyout, Gilead head Daniel O'Day instead opted for a partnership approach in his first major development deal as the biotech's CEO.

By Ned Pagliarulo • Updated July 15, 2019

Amgen and Novartis halt Alzheimer's studies as faith in amyloid hypothesis dims

The setback in high-risk pre-symptomatic patients raises questions over use of anti-beta amyloid agents, even in a preventive setting.

By Jonathan Gardner • July 12, 2019

Amgen's KRAS success has other drugmakers eager to follow

Novartis, for one, will partner on a combination study with Mirati Therapeutics, which awaits the first clinical readout for its closely watched KRAS inhibitor.

By Ned Pagliarulo • July 10, 2019

New GSK data raises threat to Gilead's star HIV drug

Dovato, GSK's two-drug HIV treatment, maintained viral suppression about as well as three-drug regimens with a similar makeup to Gilead's Biktarvy.

By Jacob Bell • July 10, 2019

Intra-Cellular's depression drug goes 1 for 2 in Phase 3 studies

The biotech's stock dropped more than 20% on news of a failed study in bipolar disorder, which company execs attributed to a high placebo rate.

By Andrew Dunn • July 8, 2019

Sangamo backs up early success for hemophilia gene therapy

Updated results show the highest dose of Sangamo's gene therapy boosted blood-clotting protein levels for hemophilia A patients to normal levels.

By Andrew Dunn • July 5, 2019

BioPharma Dive's 10 biggest stories of the spring

Developments in gene therapy, cancer treatments, drug pricing and dealmaking kept the industry in the headlines.

By Jacob Bell • July 3, 2019

Gilead firms up path to market for key arthritis drug

Filing filgotinib with the FDA this year, as Gilead now plans to do, would shorten the lead held by competitor AbbVie.

By Ned Pagliarulo • July 2, 2019

Once 'bodies for hire,' CROs are finding a new role as data specialists

Drugmakers and regulators are paying more attention to what real-world data can prove — driving demand for CROs to help keep up.

By Jacob Bell • June 28, 2019

Digital is bringing the change clinical trials need, DIA head says

Barbara Kunz, DIA's global chief executive, noted that when it comes to new technology, "there's a pretty big mountain that we'll be climbing. Some of the early successes will seem trivial a year from now."

By Jacob Bell • June 28, 2019

Pfizer muscular dystrophy gene therapy stumbles on safety

Study results presented Friday, which were the first significant look at Pfizer's DMD candidate, spurred shares in rival Sarepta to climb higher.

By Jonathan Gardner • June 28, 2019

Zogenix boosted on FDA about-face for seizure drug application

The regulator agreed to permit resubmission of Zogenix's drug with a corrected dataset, while waving off a potentially time-consuming toxicology study.

By Jonathan Gardner • June 27, 2019

AstraZeneca gets immuno-oncology win in a disease that Merck doesn't rule

Imfinzi's success in small-cell lung cancer pits it against Roche's Tecentriq, as both are now ahead of Merck's Keytruda.

By Jonathan Gardner • June 27, 2019

FDA officials see 'missed opportunity' with patient outcomes in clinical trials

The information is viewed as a valuable tool for improving trial design, guiding drug approvals and supporting label decisions, but its reach has been limited.

By Jacob Bell • June 26, 2019

FDA lifts hold on AbbVie multiple myeloma study

However, nine other studies for Venclexta remain suspended for safety concerns.

By Andrew Dunn • June 24, 2019

Beating Keytruda a big task, Exelixis and Roche find

A combination of Cotellic and Tecentriq didn't beat Merck's immunotherapy as a single agent in melanoma.

By Jonathan Gardner • June 21, 2019

Regeneron, Sanofi antibody works in asthma, but not as well as Dupixent

Phase 2 data fueled analyst speculation over how the companies' drug, REGN3500, as well as one from AnaptysBio, would stack up to Dupixent.

By Andrew Dunn • June 21, 2019

Despite late-stage win, investors not sold on Global Blood sickle cell drug

Patients taking voxelotor​ had significant increases in hemoglobin, but a miss on a "very important" secondary endpoint may hinder the drug down the line.

By Jacob Bell • June 14, 2019

Savara lung disease trial misses, but execs vow to press on

Patients did show a quality of life improvement, however, which the company hopes will be met favorably by the FDA.

By Jonathan Gardner • June 13, 2019

NASH trial miss halves CymaBay's market value

None of the three doses CymaBay tested performed better than placebo in cutting liver fat, a result that dims prospects for the biotech's drug.

By Jacob Bell • June 11, 2019

Novo Nordisk goes for broke on semaglutide heart data

The diabetes giant is asking the FDA for permission to market cardiovascular claims before a long-term outcomes study is complete.

By Jonathan Gardner • June 11, 2019

Experimental drug delays Type 1 diabetes in research first

The findings suggest progression of the chronic condition could be slowed with therapy, and sent shares in the drug's biotech owner soaring. 

By Ned Pagliarulo • June 10, 2019