Brain Talk: How new approaches to clinical trials benefit mental health research

Every day, new research opens doors to the brain's inner workings. The first in this Brain Talk series zeroes in on brain research today for depression and bipolar disorders.

March 21, 2018

Zealand's rescue pen for hypoglycemia hits in Phase 3

Dasiglucagon showed positive results in the first of multiple late-stage studies.

By Suzanne Elvidge • March 21, 2018

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

Eylea positive in diabetic retinopathy, but analysts skeptical

Regeneron's blockbuster showed favorable results, but there's debate about how incremental the new indication could be for the drug. 

By Lisa LaMotta • March 20, 2018

Tecentriq combo success boosts Roche in lung cancer

Positive results from the Phase 3 IMpower 131 study could hand Roche an advantage in the first-line treatment setting for squamous NSCLC.

By Ned Pagliarulo • March 20, 2018

Arena keeps up comeback with positive UC data

The biotech is clawing its way back from obscurity as it produces a second round of positive clinical results. 

By Suzanne Elvidge • March 20, 2018

Novo takes aim at obesity with positive semaglutide results

The Danish drugmaker announced positive Phase 2 results for once-daily injectable semaglutide in obese patients without diabetes.

By Lisa LaMotta • March 19, 2018

Heron's non-opioid pain drug succeeds in Phase 3, lifting shares

Treatment with HTX-011 following surgery reduced both pain intensity and need for opioids — results Heron hopes can secure a broad label from the FDA.

By Ned Pagliarulo • March 19, 2018

Prescribed Reading: Neuro's comeback tour

Activity in the neuroscience space spiked higher, with a flurry of licensing deals highlighting BioPharma Dive's prediction the field is ready for a resurgence.

By Lisa LaMotta • March 16, 2018

Solid Biosciences reveals upgraded clinical hold for gene therapy

The newly public biotech lost more than 60% of its value after announcing an FDA hold for its DMD study. 

By Lisa LaMotta • March 15, 2018

Alexion's follow-on stacks up to Soliris

The biotech's successor candidate, ALXN1210, demonstrated non-inferiority to the blockbuster drug in a study of patients with PNH.

By Lisa LaMotta • March 15, 2018

Incyte study could bring lessons for cancer immunotherapy

Merck has bet on the potential of Incyte's IDO blocker as a partner for Keytruda across five different cancer types. A Phase 3 trial in melanoma is first up.

By Ned Pagliarulo • March 14, 2018

Right to Try fails amid warning from regulators, patient groups

Backers of the bill like President Trump and the Koch brothers faced off against major patient groups and some regulators.

By David Lim • March 14, 2018

Positive readout for AbbVie's second fibroids Phase 3

AbbVie's elagolix met its primary endpoints in its second late-stage study of women with uterine fibroids.

By Suzanne Elvidge • March 14, 2018

Anthera shares plunge as company drops failed CF drug

Shares in the biotech moved toward an all-time low on news of its Phase 3 miss in CF, which led the company to discontinue development of Sollpura.

By Suzanne Elvidge • March 13, 2018

Biogen snaps up Pfizer's schizophrenia candidate

Sale of the experimental drug to Biogen comes two months after Pfizer announced plans to end its early-stage neuroscience research.

By Randi Hernandez • March 12, 2018

AstraZeneca pushes back readout of key lung cancer study

The pharma is counting on overall survival results from its crucial MYSTIC study of Imfinzi plus tremelimumab to redeem a damaging setback last year.

By Ned Pagliarulo • March 12, 2018

J&J's CANVAS study positive, pitting Invokana against Jardiance

The SGLT-2 inhibitor improved cardiovascular outcomes for people who have type 2 diabetes, setting it up to better compete with Eli Lilly and Boehringer Ingelheim's rival drug.

By Suzanne Elvidge • March 12, 2018

Regeneron-Sanofi cholesterol drug cuts heart risk in major study

In an unusual step, the companies signaled willingness to lower the price of Praluent if insurers ease restrictions that have so far limited uptake.

By Ned Pagliarulo • March 10, 2018

Prescribed Reading: Bold comments from Gottlieb, PBMs get the spotlight

Against the backdrop of Cigna's planned deal to buy Express Scripts, the FDA chief sharply criticized bad behavior from players involved in drug pricing.

By Lisa LaMotta • March 9, 2018

Despite crowded I/O field, pharma, VCs still eager to invest

Surging biopharma investment into cancer has raised concerns about duplicative research. Industry execs, however, see the opportunities as too great to pass up.

By Ned Pagliarulo • March 9, 2018

VBL brain cancer drug flunks Phase 3

The Israeli biotech saw its stock drop more than 60% on the late-stage failure. 

By Lisa LaMotta • March 8, 2018

Merck partners with Eisai in sweeping bet on Keytruda combo

Eisai will receive a sizable $300 million upfront, but the real value of the deal will come if studies testing its drug Lenvima together with Keytruda bear fruit.

By Ned Pagliarulo • March 8, 2018

Merck KGaA's BTK drug hits in Phase 2 MS study

Treatment with evobrutinib significantly reduced lesions characteristic of the disease compared to placebo.

By Jacob Bell • March 8, 2018

Despite positive data, Esperion still has high hurdle to clear

The biotech reported strong results for its cholesterol-lowering drug, but faces a crowded market that isn't welcoming to new treatments.

By Jacob Bell • March 7, 2018

Gilead builds case for switching to its new HIV triplet

New data are demonstrating that HIV-positive women can swap Genvoya, Stribild and other therapies for Biktarvy and experience similar benefits.

By Jacob Bell • March 6, 2018