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

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

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

Prescribed Reading: No such thing as unicorns

Both closely watched Axovant and Intarcia had major setbacks this week, despite high hopes that their therapies would be game-changers. 

By Lisa LaMotta • Sept. 29, 2017

A drug 15 years in the making: Alnylam's quest to prove RNAi

This month's success from the APOLLO study puts the biotech on the brink of making the technology a medical reality for patients.

By Ned Pagliarulo • Sept. 29, 2017

Zynerba shares up on rare disease trial success

Cannabis-based company's Phase 2 trial met its primary endpoint in Fragile X, shooting its shares up over 50%.

By Suzanne Elvidge • Sept. 29, 2017

Pharma tackles the ever-present problem of unmet need

Industry executives are focused on targeting what they see as the largest untapped markets. 

By Lisa LaMotta • Sept. 27, 2017

Mateon shuts down lead trial due to bad data

The small biotech will lay off 60% of its staff after halting its most advanced clinical study due to lack of efficacy. 

By Lisa LaMotta • Sept. 27, 2017

PureTech's Gelesis touts obesity drug's success in study

But a miss on one of the study's co-primary endpoints could complicate the company's pitch to the FDA.

By Suzanne Elvidge • Sept. 26, 2017

Arbutus' hepatitis B drug shows Phase 2 promise

Fresh data in hand, Arbutus plans to advance its lead RNAi therapeutic into a new study later this year. 

By Suzanne Elvidge • Sept. 26, 2017

Axovant's closely watched Alzheimer's drug fails late-stage trial

Intepirdine failed to meet either of the study's endpoints, sending shares in the unorthodox biotech down more than 70%.

By Ned Pagliarulo • Sept. 26, 2017

Acer jumps on 7-year-old data

The rare disease drugmaker's stock rose nearly 10% after announcing it had confirmed results from a 2010 study of celiprolol.

By Jacob Bell • Sept. 25, 2017

Allergan touts new data from failed NASH study

Cenicriviroc didn't meet the CENTAUR study's primary endpoint, but did show benefit in liver fibrosis.

By Jacob Bell • Sept. 22, 2017

Versartis crashes after Phase 3 miss

Friday's setback throws the biotech's plans to bring a long-acting human growth hormone to market into doubt.

By Ned Pagliarulo • Sept. 22, 2017

Prescribed Reading: Consolidation, clinical holds and landmark results

The FDA continues its clinical hold spree for PD-1/L1s, consolidation is rampant in the CDMO space and RNAi may become a reality very soon. 

By Lisa LaMotta • Sept. 22, 2017

Intercept shares plummet on FDA warning

A FDA safety alert for Ocaliva, following a 'Dear Dr.' letter last week, knocked 25% off Intercept's stock.

By Suzanne Elvidge • Sept. 22, 2017

Alzheimer's drug development just as challenging as ever

While biotech holds its breath for results from Axovant, a report from PhRMA showcases how hard it is to bring a new treatment to market.

By Lisa LaMotta • Sept. 21, 2017