OncoGenex scrambles after trial fail

A Phase 3 study of the small pharma's lead candidate failed to demonstrate a survival benefit in advanced prostate cancer. 

By Ned Pagliarulo • Aug. 16, 2016

Aurinia succeeds, but safety concerns loom

A high number of patient deaths in both treatment arms of the study overshadowed the positive efficacy findings, leading Aurinia stock to fall by more than half yesterday. 

By Nicole Gray , Ned Pagliarulo • Aug. 16, 2016

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

ICPE Booth A2 - ICON

Discover a convergence model driven by real-world intelligence and patient-centric innovation.

By Ramita Tandon, Executive Vice President
 Commercialisation & Outcomes, ICON plc • Aug. 16, 2016

AcelRx meets goal in Phase 3, but stock slips

The California biotech has partnered with the Department of Defense for development of its formulation of the powerful pain drug sufentanil. 

By Ned Pagliarulo • Aug. 15, 2016

Nymox readies FDA filing for prostate drug

Following strong Phase 3 results, Nymox plans to submit an application for approval sometime in the next three to six months. 

By Lisa LaMotta • Aug. 12, 2016

Spark Therapeutics on track to file gene therapy in 2017

The biotech reported positive results from a late-stage trial of its lead gene therapy candidate. 

By Nicole Gray • Aug. 11, 2016

NIH shuts down facility used to produce drugs for clinical trials

Inspections by the FDA last year revealed serious violations of proper manufacturing processes, prompting a sweeping review of all sterile production at the national medical research agency.

By Ned Pagliarulo • Aug. 10, 2016

Hopes of early end to Lilly breast cancer trial dashed

The big pharma's CDK 4/6 inhibitor will continue through its Phase 3 program as planned, but Lilly had hoped the trial would be stopped early.

By Lisa LaMotta • Aug. 10, 2016

AstraZeneca's lung cancer hopeful fails in Phase 3

Deevelopment of selumetinib for thyroid cancer and neurofibromatosis will continue, despite the setback. 

By Nicole Gray • Aug. 10, 2016

Kite steps up plans for leading CAR-T, putting pressure on Juno

After a recent trial tragedy, Juno pushed back its timeline for a potential U.S. approval of its lead therapy to 2018, likely ceding its lead position in the CAR-T race to Kite. 

By Ned Pagliarulo • Aug. 8, 2016

Allergan's Vraylar launch a success, despite trial failure

Allergan is making headway with its branded pharma business after divesting its generics and distribution businesses.  

By Lisa LaMotta • Aug. 8, 2016

Experimental asthma pill from Novartis posts encouraging results

Most current drugs for asthma are inhaled treatments. If proven effective in further study, Novartis' drug would be the first new pill for the condition in decades. 

By Nicole Gray • Aug. 8, 2016

Despite trial restart, Juno pushes back launch timeline for CAR-T therapy

The race to get the first CAR-T therapy on the market has a new leader now that a clinical hold has forced Juno to delay its filing timelines for its lead drug candidate. 

By Ned Pagliarulo • Aug. 5, 2016

Bristol-Myers' Opdivo fails key lung cancer study, stocks ricochet

Opdivo missed its primary endpoint in a Phase 3 study testing the drug for first-line use in non-small cell lung cancer, likely giving Merck's rival Keytruda a major, and much-needed, boost.

By Ned Pagliarulo • Aug. 5, 2016

Novartis creeps in on Pfizer's Ibrance

The Swiss giant's oncology strategy is coming together as a Breakthrough Therapy designation moves it closer to filing on one of its key growth drivers. 

By Lisa LaMotta • Aug. 4, 2016

FDA hits Adaptimmune with partial hold on T-cell therapy

The company said the trial halt was unrelated to any safety issues. 

By Nicole Gray • Aug. 4, 2016

Expansion on the horizon for Pfizer's Xeljanz

Pfizer bounced back from an earlier regulatory setback with strong Q2 results and new clinical data supporting two new indications for its rheumatoid arthritis drug.

By Edwin Lopez • Aug. 3, 2016

Lymphoma drug from Takeda, Seattle Genetics beats out existing meds in late-stage trial

The companies are jointly developing Adcetris for treatment of cutaneous T-cell lymphoma, a type of non-Hodgkin lymphoma. 

By Nicole Gray • Aug. 2, 2016

Biogen snaps up rights to neuromuscular disease drug after trial success

Shares in Ionis Pharmaceuticals, which had developed the drug until now, rose sharply on the positive results. Biogen stock climbed modestly. 

By Ned Pagliarulo • Aug. 1, 2016

Tokai cuts workforce by 60% after phase 3 failure with prostate cancer drug

Once the layoffs take effect, Tokai will have only 10 full-time employees. 

By Nicole Gray • Aug. 1, 2016

Microbiome biotech on edge after critical phase 2 failure

Seres Therapeutics' lead candidate failed to meet its trial endpoint, driving the company's stock down 75% this morning.

By Edwin Lopez • July 29, 2016

Phase 1 trial reveals high efficacy for hemophilia A gene therapy

BioMarin's pipeline candidate increased plasma factor VIII levels to 50% in two thirds of hemophilia patients.

By Nicole Gray • July 28, 2016

TauRx Alzheimer's drug flunks late-stage study

But the privately held company tried to salvage hopes for the experimental drug, pointing to a benefit seen in a small subgroup of patients. 

By Ned Pagliarulo • July 27, 2016

Tokai Pharma tumbles after Phase 3 failure

After Tokai said it would terminate a late-stage study of its prostate cancer drug, company stock plummeted nearly 80%. 

By Nicole Gray • July 27, 2016

Celgene abandons plans for new Revlimid indication after trial disappointment

The cancer drug failed to improve overall survival for patients with large B-cell lymphona in a phase 3 trial.

By Nicole Gray • July 26, 2016