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

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

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

Motif delivers more strong data on its antibiotic

In another late-stage study, the company's iclaprim demonstrated non-inferiority to standard-of-care in treating bacterial skin infections. 

By Jacob Bell • Oct. 5, 2017

Catabasis climbs despite mixed results in DMD

Despite negative results in an earlier portion of the trial, an open-label extension has given the company the boost it needs to move into Phase 3.   

By Suzanne Elvidge • Oct. 5, 2017

With solid results in hand, Gilead inks manufacturing deal for HIV med

A combination including bictegravir showed non-inferiority in a late-stage trial of HIV patients, prompting Gilead to set contracts that allow the drug to be generically manufactured for low-income countries once approved.

By Lisa LaMotta • Oct. 4, 2017

Strong data for Pompe therapy boosts Amicus

Encouraging early-stage results for Amicus' enzyme replacement therapy gave the biotech a shot in the arm after a disappointing trial setback last month.

By Ned Pagliarulo • Oct. 3, 2017

RedHill reports positive Bekinda data, but investors wary

The biotech's shares took a double-digit drop Tuesday even though its drug for irritable bowel syndrome met the primary endpoint of a Phase 2 study.

By Jacob Bell • Oct. 3, 2017

Rigel blood drug hits mark in mid-stage study

On top of the solid results, investor hopes for fostamatinib were also buoyed by news the FDA won't hold an advisory panel meeting for Rigel's pending NDA.    

By Ned Pagliarulo • Oct. 3, 2017

10 Topics pharma execs were talking about in Q3

With the third quarter coming to a close, BioPharma Dive revisits the stories that sparked the most reader interest during the July-to-September period. 

By Lisa LaMotta • Oct. 3, 2017

Ablynx prepares path for lead drug after positive late-stage results

Caplacizumab met primary and key secondary goals of the HERCULES study, which evaluated the drug in patients with a rare blood disorder.

By Jacob Bell • Oct. 2, 2017

Merck drops hep C programs in 'strategic decision'

Mirroring a growing trend, Merck is tightening its focus to projects with greater possibilities of commercial success.

By Suzanne Elvidge • Oct. 2, 2017

AveXis gets FDA nod to start pivotal gene therapy trial

Following a change to GMP manufacturing, AveXis secured the regulator's go-ahead for an immediate initiation of its SMA gene therapy trial.

By Suzanne Elvidge • Oct. 2, 2017

Zogenix looks to filing after epilepsy trial success

The biotech hopes to submit ZX008 for approval in the latter half of next year, if a second study of the drug goes well. 

By Ned Pagliarulo • Sept. 29, 2017