Lilly sweetens its position in diabetes with positive 'twincretin' data

Researchers found LY3298176, which targets both GLP-1 and GIP, significantly outperformed placebo on measures of glucose control and weight loss.

By Suzanne Elvidge • Oct. 5, 2018

Roche's flu drug strongly beat placebo. But could one data miss be critical?

Baloxavir marboxil fell short of showing a statistical edge over Roche's older Tamiflu in the overall study population, although it did so in a subgroup. 

By Andrew Dunn • Oct. 4, 2018

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

Sarepta gene therapy for DMD takes another step forward

Updated results, including data from a fourth boy with Duchenne muscular dystrophy, help to firm up the prospects for the biotech's gene therapy.

By Ned Pagliarulo • Oct. 4, 2018

Gilead's Biktarvy matches GSK's Triumeq in Phase 3 study

Biktarvy is a key drug for Gilead in its battle with GSK for HIV market share. New Phase 3 data could help Gilead make its case. 

By Suzanne Elvidge • Oct. 4, 2018

Roche drug shows benefit in spinal muscular atrophy

Yet attention remains focused on a gene therapy in development by Novartis, which could reshape treatment of the genetic neuromuscular disorder.

By Ned Pagliarulo • Oct. 3, 2018

Seattle Genetics' Adcetris tops chemo in Phase 3 lymphoma trial

An unexpected hit on overall survival could be a boost for the biotech and partner Takeda as they seek to expand the market for Adcetris. 

By Suzanne Elvidge • Oct. 2, 2018

10 biotechs set to shake up the industry's top ranks

Analysts at Cowen picked 10 midsized biotechs that might be next to catch the market's eye as pipeline setbacks and missed financial targets have frustrated investors of larger drugmakers.

By Ned Pagliarulo , Andrew Dunn • Oct. 1, 2018

Alnylam puts its chips on speedy OK for rare disease drug

An early look at late-stage data showed the RNAi drug givosiran significantly cut levels of a key disease biomarker. But will that be enough for the FDA?

By Ned Pagliarulo • Sept. 28, 2018

Aldeyra has positive dry eye data — for now

Though its lead candidate beat vehicle in a Phase 2 study, Aldeyra's presentation of the results raised questions about the trial readout.

By Jacob Bell • Sept. 26, 2018

Takeda's dream of a first-line ALK inhibitor supported by late-stage data

Pfizer, Roche and Novartis all have first-line drugs for ALK-positive lung cancer, putting pressure on Takeda to keep up in the increasingly competitive market.

By Jacob Bell • Sept. 25, 2018

AstraZeneca's Imfinzi shows its strength in Stage 3 lung cancer

Results released at World Lung spell out the cancer immunotherapy's survival benefit, bolstering AstraZeneca's place in the earlier, locally advanced setting.

By Ned Pagliarulo • Sept. 25, 2018

Tecentriq sets the bar in small-cell lung cancer

Roche owns the first successful Phase 3 study of an immunotherapy in the less-common lung cancer type. But others are closing in.

By Ned Pagliarulo • Sept. 25, 2018

AstraZeneca heart study delivers mixed results for diabetes drug

The pharma hopes the results will help Farxiga compete with Eli Lilly and Boehringer Ingelheim's rival Jardiance, which has carved out a leading position on the strength of its heart claims.

By Andrew Dunn • Sept. 24, 2018

Vascepa's big heart benefit pumps up Amarin's value by $2B

Amarin's CEO called it "the single most significant advance in preventative cardiovascular drug therapy since the advent of statin therapy."

By Andrew Dunn • Sept. 24, 2018

One bottle of hope for one amazing kid

How Fisher Clinical Services, by Thermo Fisher Scientific worked with a drug company to create a special clinical trial to save a patient with late stage brain cancer.

Sept. 24, 2018

What cheap data means for understanding the patient experience in clinical trials

More nuanced, dynamic insights into patient experience can decrease the burden on patients by extrapolating from objective data sources and reducing the number of questionnaires being asked.

By Paul O'Donohoe Medidata Solutions Scientific Lead, eCOA and Mobile Health • Sept. 24, 2018

Narcan developer secures grant for counter to opioid weaponization

BARDA is concerned that repeat doses of naloxone would not be available in a large-scale terrorist attack involving weaponized opioids. So it's tapped Opiant to develop a long-acting opioid overdose agent. 

By Suzanne Elvidge • Sept. 21, 2018

How do doctors feel about robots in the exam room?

ZS’s 2018 research finds that only 25% of doctors are comfortable letting AI help with diagnosis.

By Paul Darling • Sept. 21, 2018

Phase 3 win underscores that Astellas is more than Xtandi

Though better known for the prostate cancer med, Astellas gets considerable revenue from bladder drugs and reported positive data Thursday for an experimental chronic kidney disease therapy.

By Jacob Bell • Sept. 20, 2018

Pharming knocked back with CRL from FDA

Regulators are looking for more data from Pharming to support an expanded approval of the company's HAE drug Ruconest. 

By Suzanne Elvidge • Sept. 20, 2018

Does your brand need behavioral science?

Does your brand need a behavioral science solution? Find the right solution to meet your needs.

By Meredith Terry, PHD, Lead Behaviorist, Innovation and Practice MicroMass Communications, Inc. • Sept. 19, 2018

Clovis, execs pay up to settle charges of misleading investors

The SEC had accused Clovis, along with its CEO and former CFO, of knowingly misrepresenting the efficacy of its cancer candidate rociletinib.

By Suzanne Elvidge • Sept. 19, 2018

Viking shares soar as NASH drug impresses

Positive results from a small study suggested the San Diego-based biotech could compete in the race to develop therapies for the liver disease.

By Ned Pagliarulo • Sept. 18, 2018

Argenx's auto-immune drug headed for Phase 3 in ITP

Data from a proof-of-concept study showed "clinically meaningful" platelet count improvements for a variety of primary immune thrombocytopenia patients.

By Suzanne Elvidge • Sept. 18, 2018

FDA lifts clinical hold on Mersana study, but shares slide

Mersana will soon restart the paused trial of a cancer candidate with modified dosing and tweaked protocols. Markets, though, didn't seem all that relieved.

By Suzanne Elvidge • Sept. 18, 2018