Mixed results in NASH for Gilead

While the higher dose showed a clinical effect, GS-0976 didn't hit the mark at its lowest dose, and the study missed its additional endpoints.

By Suzanne Elvidge • Oct. 25, 2017

Global Blood abandons IPF indication after multiple trial letdowns

Focus now turns to the Phase 3 HOPE study, which is testing oral GBT440 in patients with sickle cell disease.

By Jacob Bell • Oct. 23, 2017

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

Immuno-oncology: Am I choosing the right biomarker?

Learn how to choose the right biomarker for your immuno-oncology trial in this Q&A.

By Mario Rocci Jr., Senior Vice President at ICON Laboratories • Oct. 23, 2017

DBV forges ahead with peanut allergy treatment despite study miss

Trial results, which fell just shy of goal, won't stop DBV from filing its treatment for U.S. approval. 

By Suzanne Elvidge • Oct. 22, 2017

UniQure shares jump on trial plans for revamped hemophilia gene therapy

Shaking off recent setbacks, the Dutch biotech will advance a reworked version of its hemophilia B candidate into a pivotal study next year.

By Suzanne Elvidge • Oct. 20, 2017

Prescribed Reading: Blockbuster potential thwarted; generics consolidate

The past week saw multiple companies discontinue development of potential blockbusters, while a tightening generics market prompted a new merger.

By Lisa LaMotta • Oct. 20, 2017

Celgene calls it quits on expensive Crohn's drug

The big biotech is discontinuing development of a potential blockbuster, putting pressure on its pipeline product ozanimod to outperform.

By Jacob Bell • Oct. 20, 2017

Ignyta lifts off on cancer drug's best-in-class potential

Shares in the biotech rose more than 20% after entrectinib showed strong objective response rates in a subset of lung cancer patients.

By Jacob Bell • Oct. 18, 2017

FDA go-ahead shoots Diffusion shares up by a fifth

The regulator cleared the biotech's Phase 3 trial in inoperable brain cancer.

By Suzanne Elvidge • Oct. 18, 2017

MassBio: Massachusetts edges out California as #1 biotech hub

A recent report shows there are now more biopharma jobs in the Boston area than any other place in the U.S., while funding to the area continues to flow.

By Jacob Bell • Oct. 17, 2017

Pfizer next-gen ALK inhibitor could ease lung cancer burden

Lorlatinib could help the big pharma bolster its position in the NSCLC market as Xalkori faces increased competition. 

By Suzanne Elvidge • Oct. 17, 2017

TG stumbles on FDA feedback for cancer combo

The regulator informed TG Therapeutics that changes made to its GENUINE study would impact a potential accelerated approval, sending company shares sliding.

By Suzanne Elvidge • Oct. 17, 2017

Exelixis continues to gain momentum with positive data

Cabometyx's success in a liver cancer study could support an expanded label for the drug, boosting its commercial prospects. 

By Ned Pagliarulo • Oct. 16, 2017

More positive ozanimod data bolsters the drug's profile

Celgene's ozanimod, which is edging closer to the market for MS, has shown benefit in ulcerative colitis and Crohn's, setting up blockbuster prospects.

By Suzanne Elvidge • Oct. 16, 2017

Prescribed Reading: A week of game-changers in pharma

A new gene therapy is poised to hit the market; one dose of Anaptysbio's drug is all it took to clear some patients' skin; and a late-stage failure is hurting Lilly's oncology prospects.

By Lisa LaMotta • Oct. 13, 2017

Spark's gene therapy for blindness takes major step toward approval

If OK'd in January, Spark's Luxturna would be the first gene therapy approved for an inherited disease, a major milestone for the field but one that will test how such drugs are covered and paid for. 

By Ned Pagliarulo • Oct. 12, 2017

CETP class shelved as Merck pulls out

Development of the last major CETP inhibitor has now ceased, ending a decade of pharma setbacks. 

By Lisa LaMotta • Oct. 12, 2017

Ardelyx IBS drug edges closer to the market

Positive Phase 3 trial results prompt submission plans for the irritable bowel syndrome with constipation remedy.

By Suzanne Elvidge • Oct. 12, 2017

Generon moving ahead with Phase 3 trial following SPA

The FDA has agreed to the study protocol, which will test the Chinese biotech's lead candidate as a treatment for chemotherapy-induced neutropenia.

By Jacob Bell • Oct. 11, 2017

AnaptysBio has game-changing results in atopic dermatitis

Topline proof-of-concept data sent the biotech's share price skyrocketing.

By Suzanne Elvidge • Oct. 11, 2017

Lilly's plans for abemaciclib dented by lung trial miss

Failure of the CDK 4/6 inhibitor to improve survival in certain lung cancer patients could raise questions for the drug's potential outside of breast cancer.

By Ned Pagliarulo • Oct. 10, 2017

Paratek data bodes well for new antibiotic class

Positive Phase 3 clinical results presented for Paratek's potential blockbuster bring it closer to filing.

By Suzanne Elvidge • Oct. 9, 2017

Bayer, J&J pull the plug on large Xarelto study

Following a DMC review, the companies stopped a late-stage trial testing the drug against aspirin in patients who had an embolic stroke of undetermined source.

By Jacob Bell • Oct. 9, 2017

Prescribed Reading: DMD, MS and other acronyms

Another DMD drug struggles to get closer to market, a blockbuster MS drug now faces multiple generic competitors, and a deal is inked to increase competition in the Tyk2 inhibitor space. 

By Lisa LaMotta • Oct. 6, 2017

Bluebird bio unveils positive, albeit early, data for gene therapy

Interim data on the company's Lenti-D treatment raises a flutter of hope for patients, yet markets barely seemed to notice.

By Suzanne Elvidge • Oct. 6, 2017