CAR-T race heats up as Kite, Novartis complete filings to FDA

Which company reaches market first may not matter much at first, but the coming quarters should see a flurry of activity in the emerging CAR-T field. 

By Ned Pagliarulo • April 2, 2017

Prescribed Reading: All the approvals

FDA goes on an approval spree, drug manufacturers toe the line on pricing, and Vertex has both good and bad news. 

By Lisa LaMotta • March 31, 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

J&J, Genmab abandon NHL indication for Darzalex

The companies chose not to move forward with a mid-stage study of Darzalex in non-Hodgkin's lymphoma after patients failed to reach the desired level of overall response rates. 

By Suzanne Elvidge • March 31, 2017

Karyopharm shakes off clinical hold for lead cancer med

The quick reversal of the FDA's partial clinical holds reaffirmed that administrative problems were the main culprit holding up the trials.

By Jacob Bell • March 30, 2017

Vertex boosted by strong trial data for next-gen CF drug

Success for the experimental treatment would bolster Vertex's cystic fibrosis portfolio and provide a foundation for future triple-combos. 

By Ned Pagliarulo • March 29, 2017

AACR preview: IDO1, CDK 4/6 and cancer combos

Biopharma dollars have been pouring into cancer research as new technologies make the leap to market. Next week's AACR conference will highlight some of what could come next. 

By Ned Pagliarulo • March 29, 2017

Investigator site portal reduces errors and improves communication for more efficient clinical trial management

CROs can reduce data discrepancies up to 80% by automating and streamlining routine tasks.

By Roni Robbins • March 28, 2017

Selecta shares surge on early positive signs for gout med

The company believes the design of SEL-212, its lead clinical candidate, should allow for repeat dosing and better control of the painful inflammatory condition. 

By Suzanne Elvidge • March 28, 2017

Allergan acne med shines in late-stage trials

The specialty drugmaker plans to file the treatment, developed through a collaboration with Paratek Pharmaceuticals, for approval in the latter half of 2017.

By Jacob Bell • March 27, 2017

Prescribed Reading: Avelumab OK'd, Ultragenyx fails trial

As Washington debates healthcare, pharma continues to make deals and Pfizer joins the checkpoint inhibitor race. 

By Lisa LaMotta • March 24, 2017

NEJM: Lyrica ineffective in sciatica

As Lyrica nears the end of its life cycle, a new study finds that the pain drug is not effective in treating sciatica. 

By Suzanne Elvidge • March 24, 2017

Ultragenyx's seizure med fails mid-stage trial

The rare disease drugmaker said the treatment failed to best a placebo in a Phase 2 trial, but will continue on in late-stage testing for another indication.

By Jacob Bell • March 23, 2017

Trial restart approval brings back DMD hope for Akashi

The biotech rejoins the ranks of companies following the rocky road of drug development for Duchenne muscular dystrophy.

By Suzanne Elvidge • March 23, 2017

Novartis heart drug fails in Phase 3

Serelaxin, one of 13 potential blockbuster drugs flagged by the Swiss pharma, did not meet the primary endpoint of a study testing it in patients with acute heart failure.

By Jacob Bell • March 22, 2017

Cosentyx could change the course of psoriasis, study suggests

The fast-growing drug from Novartis could be the first treatment to lead to long-term skin clearance in moderate to severe forms of the disease.

By Suzanne Elvidge • March 22, 2017

Empowering CRAs for clinical trials in rare disease

Environments that lead to a high CRA turnover can undermine productive partnerships, as instability and low employee empowerment begets preventable quality issues, delays, and cost overruns.

March 21, 2017

Nektar stock reaches new highs on pain drug results

The San Francisco biotech's opioid painkiller hit on primary and secondary endpoints in a Phase 3 trial, setting Nektar up to out-license the drug for a tidy sum. 

By Suzanne Elvidge • March 21, 2017

Bristol-Myers and Pfizer's Eliquis outperforms rivals versus warfarin

In a so-called real world study, the anti-coagulant did better in reducing the risk of strokes or major bleeds compared to warfarin than did competing NOACs. 

By Ned Pagliarulo • March 20, 2017

Phase 3 win moves Lilly's breast cancer drug closer to market

But the drug, abemaciclib, will face tough competition if approved: Novartis' Kisqali recently joined Pfizer's Ibrance as the second CDK 4/6 inhibitor on the market.

By Ned Pagliarulo • March 20, 2017

Real world study shows cardiovascular benefit to SGLT2 drugs

AstraZeneca, which sponsored the study, hopes the results will help boost earlier use of the newer class of diabetes drugs.

By Ned Pagliarulo • March 20, 2017

Medicines Co. hits mark in ORION, plans PCSK9 Phase 3

Inclisiran showed solid efficacy and safety in the mid-stage study, but Amgen’s FOURIER results spark questions on trial design.

By Ned Pagliarulo • March 17, 2017

Prescribed Reading: CRISPR, Trump and FOURIER. Oh my!

CRISPR technology is moving into new therapeutic areas; we finally know the skinny on Repatha's CV effects; and potential budget cuts could hammer the industry. 

By Lisa LaMotta • March 17, 2017

Seres rekindles once-failed microbiome study

Under the FDA’s direction, the microbiome pioneer hopes its redesigned trial for a therapeutic treating C. diff. qualifies as a pivotal study.

By Judy Packer-Tursman • March 17, 2017

Amgen's Repatha shows CV benefit, but falls short of expectations

Results from the hotly anticipated FOURIER trial showed the PCSK9 inhibitor cut the risk of heart attack and stroke, but will it be enough to buoy the drug to commercial success? 

By Ned Pagliarulo • March 17, 2017

Following failure, Proteon tweaks Phase 3 study

After FDA discussions, Proteon has changed the size and endpoints of its PATENCY-2 study.

By Suzanne Elvidge • March 17, 2017