Lilly strengthens Trulicity's leading position with REWIND results

Wall Street analysts note data from the cardiovascular outcomes study could help differentiate the diabetes drug in the crowded GLP-1 market.

By Jacob Bell • Nov. 5, 2018

Alkermes depression drug approval odds slim after negative FDA panel vote

An agency advisory panel voted 21-2 against recommending approval for ALKS-5461, sending shares in the company sliding. 

By Ned Pagliarulo • Nov. 2, 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

GSK's once-monthly HIV therapy shows promise, hitting goal

Positive Phase 3 results lend further support to the long-acting therapy, part of the British drugmaker's push to reinvigorate its HIV business.

By Suzanne Elvidge • Oct. 31, 2018

Roche touts eye drug pipeline progress

Swiss rival Novartis, however, is advancing its own experimental eye drug that it hopes can compete in the market for macular degeneration therapies. 

By Suzanne Elvidge • Oct. 30, 2018

Shares slump as Ultragenyx drops rare disease study

Missed endpoints in a Phase 3 study mean Ultragenyx will halt some research with UX007, one of three experimental drugs in the biotech's pipeline.

By Suzanne Elvidge • Oct. 29, 2018

How can pharma foster patient habits that will have an impact on your brand?

While there is a place for incorporating external motivators to influence behavior, behavioral science tells us that this is only part of the solution.

By Neala Havener Senior Behaviorist MicroMass Communications Inc. • Oct. 29, 2018

Esperion clears final trial hurdle in bid to shake up cholesterol market

Investors have awaited results from a fifth study of bempedoic acid to judge whether Esperion might outflank pricey PCSK9 inhibitors.

By Ned Pagliarulo • Oct. 28, 2018

FDA hits Regeneron with CRL for Eylea syringe

The biotech still expects, however, to launch the pre-filled syringe version of its blockbuster eye drug sometime next year.   

By Suzanne Elvidge • Oct. 26, 2018

Biogen dips as BAN2401 data bring more questions than answers

Whether BAN2401 is an effective drug for treating early Alzheimer's remains as divisive a question as before, despite updated results from Biogen and Eisai.

By Ned Pagliarulo , Jacob Bell • Oct. 25, 2018

Pfizer, Lilly avoid safety red flags in late-stage tanezumab trial

A key test, however, will come next year, when the companies report data from a large long-term safety study.

By Ned Pagliarulo • Oct. 24, 2018

How embracing flexibility creates success for all

When your internal processes aren't meeting the needs of your clients, considering new methods can go a long way.

Oct. 24, 2018

GSK arthritis drug comes up short in Phase 2

A negative result on the study's primary endpoint is a disappointing outcome for the British pharma, which had highlighted the candidate as a pipeline leader.

By Suzanne Elvidge • Oct. 23, 2018

ESMO 2018: What you missed over the weekend

Pfizer and Merck KGaA detailed Bavencio's success in kidney cancer, while data for Merck's STING agonist raised questions for its future potential. 

By Ned Pagliarulo • Oct. 22, 2018

Lynparza hits a 'home run,' putting pressure on other PARP inhibitors

Data from SOLO-1 showed first-line maintenance therapy with Lynparza cut risk of death or disease progression 70% for certain ovarian cancer patients.

By Jacob Bell • Oct. 22, 2018

FDA delays decision on Bristol-Myers' lung cancer combo

A longer review for the pharma's pairing of Opdivo and Yervoy in first-line non-small cell lung cancer appeared to trigger a 5% stock drop Monday.

By Suzanne Elvidge • Oct. 22, 2018

Loxo's targeted therapy holds up to Roche challenge

Entrectinib, which Roche snagged in last year's buyout of Ignyta, showed strong data in TRK fusion tumors. But are they enough to worry Loxo? 

By Ned Pagliarulo • Oct. 20, 2018

Benefit of Roche's Tecentriq looks limited in breast cancer

Positive Phase 3 results in triple-negative breast cancer put Tecentriq out in front of the immunotherapy field. But a modest benefit in all-comers could mean use is limited to PD-L1 positive patients.

By Ned Pagliarulo • Oct. 20, 2018

Merrimack lung cancer study flops, sending stock sliding

The Cambridge biotech will shutter a trial of its lead pipeline asset in lung cancer after a review panel judged further study to be futile.

By Andrew Dunn • Oct. 19, 2018

Clovis aims at new market for cancer drug Rubraca

Rubraca has fallen behind rival PARP inhibitors in ovarian cancer. But new data unveiled Friday suggests the drug could have promise in prostate cancer.

By Ned Pagliarulo • Oct. 19, 2018

Fresh data expands Pfizer's options for treating first-line kidney cancer

Pfizer's Inlyta, when paired with Keytruda, improved OS in advanced renal cell carcinoma. Yet a different combo of Inlyta plus Bavencio also looks promising.

By Jacob Bell • Oct. 18, 2018

Clean safety data sets up Allergan for 2019 filing of migraine drug

Ubrogepant is aimed at acute treatment of migraine, giving Allergan hope the drug can find a niche in a market newly flooded with preventive therapy.

By Suzanne Elvidge • Oct. 18, 2018

Roche's Kadcyla beats out Herceptin in Phase 3

The data should help to advance the Swiss pharma's plans to reinforce its breast cancer franchise as biosimilar competition to Herceptin creeps in.

By Suzanne Elvidge • Oct. 16, 2018

Alnylam nixes accelerated approval plans for givosiran, pushing back timeline

The biotech will begin a rolling filing to the FDA this year, but doesn't anticipate completing submission of the RNAi therapy until the middle of next year.

By Andrew Dunn • Oct. 15, 2018

Opdivo misses survival goal in small-cell lung cancer study

The clinical setback could weigh on Bristol-Myers' chances of staying competitive in the less common lung cancer type.

By Ned Pagliarulo • Oct. 12, 2018

Trevena's opioid gets thumbs down from FDA adcomm

While the FDA doesn't have to follow the advice of the panel, the negative vote doesn't bode well for the fate of oliceridine. 

By Suzanne Elvidge • Oct. 12, 2018