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

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

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

Optimizing clinical trials: What you need to know

BioPharma Dive takes a closer look at the technology, trial design and site selection tools that pharma companies are using to speed up the clinical trial process. 

By Lisa LaMotta • March 16, 2017

Immunomedics results bolster case for efficacy in aggressive breast cancer

Results published in the Journal of Clinical Oncology give a boost to Immunomedics' lead candidate amid a turbulent time for the biotech. 

By Suzanne Elvidge • March 16, 2017

AstraZeneca staves off Tesaro threat to PARP crown

Impressive results from Lynparza as maintenance therapy for ovarian cancer dampened hopes Tesaro's niraparib might be a best-in-class PARP inhibitor.

By Ned Pagliarulo • March 14, 2017

Actionable consent data helps avoid wasted trials: One story of an estimated $100M saved

How one company brought together diverse data and gained meaningful insights that helped avoid a costly trial that had a low probability of success.

March 14, 2017

Good Repatha data for Amgen ahead of FOURIER

Positive news expected later this week from a key cardiovascular outcomes trial could help open up the PCSK9 market. 

By Suzanne Elvidge • March 14, 2017

Argos axes over a third of staff in retrench

The staff cutbacks followed disappointing Phase 3 results for Argos' cancer immunotherapy last month.

By Suzanne Elvidge • March 14, 2017

Investors have high expectations for cannabinoids

The pipeline is moving forward for cannabis-mimicking pharmaceuticals as investors' interest grows and new clinical data spark approval hopes. 

By Jacob Bell • March 13, 2017

FDA puts partial hold on Karyopharm's cancer drug

The pharma stresses that the FDA’s hold, while halting new patient enrollment until it’s lifted, is due to errors on written materials, not safety problems.

By Judy Packer-Tursman • March 12, 2017

Prescribed Reading: More backlash to drug pricing

Negotiating Medicare prices is now on the table, lawmakers are not happy with Marathon, and PTC is pushing back at the FDA. 

By Lisa LaMotta • March 10, 2017

Ocera touts liver drug prospects despite earlier failure

Shares in the biotech rose yesterday after Ocera announced new data it hopes to discuss with the FDA later this year.

By Judy Packer-Tursman • March 9, 2017

FDA lifts trial holds for Seattle Genetics' cancer med

The agency is allowing two early-stage trials testing the treatment in patients with AML to continue, but the company is not continuing a Phase 1/2 study.

By Jacob Bell • March 7, 2017