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

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

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

Roche blood cancer drug falls short in late-stage study

Gazyva, an heir apparent to Roche's aging Rituxan, failed to meet its primary endpoint in patients with diffuse large B-cell lymphoma. 

By Ned Pagliarulo • July 18, 2016

Late-stage study confirms efficacy of AstraZeneca's Tagrisso

The positive results help cement Tagrisso's status as a second-line treatment for a type of lung cancer. 

By Edwin Lopez • July 18, 2016

Patient dies in clinical testing of Ziopharm gene therapy

The brain cancer patient died from intracranial hemorrhage 15 days after Ziopharm's gene therapy injection. 

By Edwin Lopez • July 15, 2016

FDA staff raises safety concerns for Valeant psoriasis drug

Six suicides occurred during clinical testing of the drug, which Valeant had licensed from AstraZeneca last year. 

By Ned Pagliarulo • July 15, 2016

Why Allergan thinks an 'open science' approach can help it develop new antibiotics

BioPharma Dive spoke with David Nicholson, head of R&D at Allergan, about his company’s continued efforts to develop novel antibiotics, even as other companies have dropped out of R&D. 

By Ned Pagliarulo • July 14, 2016

Lilly, Boehringer enter R&D pact to test breast cancer combo

The companies have a proven track record with Jardiance, but can they extrapolate their success in metabolics to oncology?

By Nicole Gray • July 14, 2016

Sage soars after small study of postpartum depression drug shows benefit

Seven out of 10 women in the mid-stage trial experienced remission from depression after receiving Sage's drug. 

By Ned Pagliarulo • July 12, 2016

Cancer drug could benefit Parkinson's patients, study shows

Researchers at Georgetown University believe a leukemia drug helped boost dopamine production in 11 patients and have plans for further study. 

By Ned Pagliarulo • July 11, 2016

Hours after Juno tragedy, Kite announces full-enrollment in CAR-T trial

The company's ZUMA-1 trial involves a similar pre-conditioning regimen as was present in Juno's ROCKET trial, which led to three patient deaths last week. 

By Edwin Lopez • July 11, 2016

Pfizer, German Merck to test new combo against ovarian cancer

The two companies are aggressively developing the checkpoint inhibitor avelumab in hopes of catching early leaders in immuno-oncology. 

By Nicole Gray • July 7, 2016

AbbVie bet on Ablynx gets boost after arthritis drug shows promise

Belgium-based Ablynx said its experimental drug matched Roche's Actemra in improving symptoms of rheumatoid arthritis. 

By Ned Pagliarulo • July 7, 2016

Pfizer's PCSK9 drug notches two Phase 3 wins

Bococizumab would be the third PCSK9 drug to hit U.S. markets, but Pfizer hopes to distinguish it with stronger clinical data. 

By Nicole Gray • June 30, 2016

Shire's adult ADHD drug shows promise in late-stage study

But another drug for a rare eye condition failed to meet its primary goal in a mid-stage study, somewhat offsetting the positive news for Shires' ADHD drug.

By Nicole Gray • June 30, 2016

Cancer Moonshot summit adds new partnerships to lofty goals

At the summit, FDA commissioner Robert Califf said the agency would consolidate clinical review of cancer products into a new Oncology Center of Excellence. 

By Nicole Gray • June 30, 2016

Tesaro soars after ovarian cancer drug meets Phase 3 goal

Results showed Tesaro's drug, niraparib, extended progression-free survival times by 16 months for certain patients, compared to a placebo. 

By Ned Pagliarulo • June 29, 2016

GW Pharma shares jump on Phase 3 data for cannabis-based drug

Based in London, the company has been developing Epidiolex for treatment of a number of rare childhood seizure disorders.

By Ned Pagliarulo • June 27, 2016