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

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

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

Regulators to expedite review of Merck's Ebola vaccine

Merck plans to submit its Ebola vaccine to regulatory authorities on both sides of the Atlantic next year, aiming to win approval and launch V920 by the end of 2017. 

By Nicole Gray • July 26, 2016

Alzheon readies Phase 3 study of Alzheimer's drug

Two Phase 1b studies showed a favorable pharmacokinetic profile, clearing the way for the planned pivotal trial to begin early next year. 

By Ned Pagliarulo • July 25, 2016

AbbVie partners with Bristol-Myers in combo study of cancer drugs

The early-stage trial will test AbbVie's experimental Rova-T with Bristol-Myers' two approved immunotherapies. 

By Ned Pagliarulo • July 25, 2016

Amgen, Allergan get biosimilar lift with positive data on Herceptin copy

Trial results showed "no clinically meaningful differences" between the biosim and Herceptin, company executives said. 

By Nicole Gray • July 22, 2016

Chinese team to test CRISPR in humans, jumping ahead of planned US study

Led by a scientist from Sichuan University, the Chinese study will seek to genetically engineer the T-cells of patients with lung cancer. 

By Ned Pagliarulo • July 22, 2016

Valeant wins backing of FDA panel for psoriasis drug

While the recommendation is welcome news for a company still struggling to remake its image, Valeant could face significant competition for brodalumab. 

By Ned Pagliarulo • July 20, 2016

Ziopharm says patient death unrelated to gene therapy

The patient had died two weeks after receiving treatment with the company's experimental drug, sparking safety concerns. 

By Ned Pagliarulo • July 19, 2016

The art and science of forecasting with clinical informatics

New informatics technology is improving forecasting and site selection efforts to advance studies and reduce overall costs.

July 19, 2016

After phase 2 success, Brainstorm sees promise for ALS drug

Brainstorm's drug, called NurOwn, met its primary endpoint for safety and tolerability. 

By Nicole Gray • July 19, 2016