Alnylam pauses clinical trials of hemophilia drug after patient death

A fatal thrombotic event in a Phase 2 study of fitusiran has reignited investor worries over the company's RNAi platform.

By Jacob Bell • Sept. 7, 2017

Verastem bet on blood cancer drug pays off with trial success

The Boston biotech plans to file for U.S. approval of duvelisib early next year based on positive data from its Phase 3 DUO study. 

By Ned Pagliarulo • Sept. 6, 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

Sobi orphan drug approved for simpler dosing

Approval of a once-daily regimen for the rare disease cuts the treatment burden for patients and caregivers.

By Suzanne Elvidge • Sept. 6, 2017

Insmed soars on strong results for inhaled antibiotic

A quick filing for approval is expected now that the biotech has positive late-stage results in hand. 

By Lisa LaMotta • Sept. 5, 2017

Cell and gene therapies: From clinical to commercial

There is a natural flow from clinical trial logistics to commercial logistics. Proactive planning during the early stages is vital for a product's commercial success.

Sept. 5, 2017

Death in Cellectis CAR-T trial leads to clinical hold

Another patient death in CAR-T trials pushed the Food and Drug Administration to place two early trials on clinical hold. 

By Lisa LaMotta • Sept. 5, 2017

Industry Pulse: 10 charts on M&A, I/O and biosimilar threats

While Gilead's acquisition of Kite lifted the biotech sector, major dealmaking has been few and far between this year. Elsewhere, copycat biologics pose a growing threat to industry top-sellers. 

By Ned Pagliarulo • Sept. 1, 2017

Prescribed Reading: Get ready for CAR-T clash

The biggest deal of the year and a major approval were both based around CAR-T technology, setting up the market for a price war in the space. 

By Lisa LaMotta • Sept. 1, 2017

Incyte, Merck build case for skin cancer combo

Data from a Phase 1/2 study of Incyte's IDO1 inhibitor and Merck's Keytruda continued to look positive, building momentum for the closely watched pairing. 

By Ned Pagliarulo • Aug. 31, 2017

Otonomy stock crumbles as the company sidelines a key pipeline asset

Otividex failed to meet all primary and key secondary endpoints of a late-stage study, leading the company to suspend the drug's development.

By Jacob Bell • Aug. 30, 2017

Merck's REVEAL results could spell end to CETP class

While mildly positive, the cardiovascular outcomes study for the CETP inhibitor was underwhelming, leaving Merck uncertain of whether to file for approval.

By Lisa LaMotta • Aug. 29, 2017

Bristol-Myers, Pfizer continue to build case for Eliquis

The pharmas have been conducting follow-up study and real-world analyses of the anticoagulant in a bid to boost market uptake.

By Ned Pagliarulo • Aug. 28, 2017

Novartis rare disease drug opens up new way to treat heart disease

A large study of canakinumab, currently marketed as Ilaris, showed targeting inflammation could lower cardiovascular risk and possibly help prevent lung cancer.

By Ned Pagliarulo • Aug. 27, 2017

Prescribed Reading: Biosimilars or biologics? Why not both?

A few small deals, plenty of stock movement on clinical trial results and several new therapies inch closer to market. 

By Lisa LaMotta • Aug. 25, 2017

Genmab's Darzalex heading for first-line in multiple myeloma

A data monitoring committee recommended unblinding the study after positive data for Darzalex in first-line treatment of multiple myeloma. 

By Suzanne Elvidge • Aug. 25, 2017

Flush with cash, Apellis trumpets positive Phase 2 AMD results

Apellis is moving forward into Soliris territory with some interesting early data in untreated and refractory patients.

By Suzanne Elvidge • Aug. 25, 2017

AstraZeneca touts Brilinta CV benefit with new analysis

Days before the European Society of Cardiology's 2017 Congress, the British pharma said an analysis of a prior study showed the drug lowered risk of cardiovascular death.

By Jacob Bell • Aug. 24, 2017

Ultragenyx shelves genetic disease drug after trial failure

Extended release aceneuramic acid missed the primary and secondary endpoints of a Phase 3 study.

By Jacob Bell • Aug. 23, 2017

Novogen irons out Phase 2 plans for brain cancer candidate

Contract research organization Chiltern will help the company conduct a mid-stage study slated for the fourth quarter.

By Jacob Bell • Aug. 22, 2017

Pop quiz: What's your patient centricity IQ?

Patients are quickly becoming the center of clinical trials. Take the same quiz that was given to attendees at DIA 2017 and see how well you align with the thinking of potential study participants. 

By Gabriela Feldberg, Head of Feasibility, Recruitment and Engagement • Aug. 22, 2017

Novo bests Lilly in diabetes trial, but will that lead to market advantage?

With the diabetes space already crowded, some investors are questioning whether the Danish drugmaker's semaglutide can secure market share.

By Jacob Bell • Aug. 17, 2017

Bristol-Myers' Opdivo comes up short in kidney cancer study

In another setback for the drugmaker's flagship immunotherapy franchise, Opdivo plus Yervoy failed to cleanly beat out Sutent in renal cell carcinoma.

By Ned Pagliarulo • Aug. 16, 2017

Lexicon's diabetes drug continues to deliver in the clinic

Fresh results show sotagliflozin met all the secondary endpoints of the pivotal inTandem2 study.

By Jacob Bell • Aug. 15, 2017

Regeneron dumps RSV drug after trial failure

Cutting its losses, the big biotech is abandoning an infant respiratory drug after poor trial results. 

By Lisa LaMotta • Aug. 14, 2017

Opthotech's Fovista crashes out in wet AMD

Negative results from a third Phase 3 study of Fovista further cloud the future for Opthotech, which has seen its fortunes reverse in the past few quarters.

By Suzanne Elvidge • Aug. 14, 2017