Sage soars on success of postpartum depression drug

Analysts noted the new data, as well as previous clinical victories, bode well not only for SAGE-217, but also for Sage's lead candidate, brexanolone.

By Jacob Bell • Jan. 8, 2019

Blockbuster … or lackluster? Four steps to a winning label

Do you have enough data to back-up how your product is better than others? Following these four steps can help you prepare for competition in the marketplace.

Jan. 8, 2019

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

Novartis' cell therapy ambitions outpace early returns

Vas Narasimhan, the Swiss pharma's CEO, sees cell therapy's potential stretching beyond oncology, while acknowledging struggles with scaling manufacturing.

By Ned Pagliarulo • Jan. 7, 2019

Sanofi zeroes in on bispecifics in reworked Regeneron deal

Seeking flexibility in its immuno-oncology research, Sanofi will narrow a 2015 partnership with the antibody specialist but keep opt-in rights to two bispecifics.

By Ned Pagliarulo • Jan. 7, 2019

Bristol-Myers' gamble on Celgene pipeline prospects

Five Celgene drugs could launch in the next few years, a key factor in attracting the big pharma. But predictions of more than $15 billion in peak sales may prove rosy.

By Ned Pagliarulo • Jan. 4, 2019

Acorda wins FDA nod for Parkinson's drug

An OK for Inbrija may help Acorda rebound from a damaging court ruling that opened the door for generic competition to the biotech's only marketed drug.

By Ned Pagliarulo • Dec. 24, 2018

Our 10 best stories of 2018

Pharma boards, cell therapy, AI and cancer drug ads feature in BioPharma Dive's top articles of the past 12 months.

By Ned Pagliarulo • Dec. 21, 2018

Pharma returns on R&D ebb to new low, Deloitte finds

Bringing a molecule to market is costlier and less lucrative than in years past, a Deloitte report found, even as new drug approvals hit record highs in the U.S.

By Ned Pagliarulo • Dec. 20, 2018

Aduro inks deal with Lilly, driving shares higher

Lilly gets exclusive rights to compounds designed to inhibit the STING pathway, which it hopes have potential in treating autoimmune diseases.

By Kristin Jensen • Dec. 19, 2018

Vertex chalks up another win for pain drug

Following two other mid-stage trial wins, new data showed VX-150 significantly reduced pain caused by small fiber neuropathy.

By Jacob Bell • Dec. 18, 2018

AstraZeneca's China push boosted by anemia drug OK

China's approval of AstraZeneca and Fibrogen's roxadustat flips the script on the usual path to market for new drugs, which almost always hit in Western countries first.

By Ned Pagliarulo • Dec. 18, 2018

Taltz waltzes ahead of Humira in psoriatic arthritis study

Lilly is battling for market share against Novartis' rival IL-17 inhibitor Cosentyx, and hopes a study pitting Taltz against Humira can help.

By Suzanne Elvidge • Dec. 18, 2018

Biogen backs away from AGTC after gene therapy failure

The smaller biotech lost a main revenue source and about half its market cap as one of its candidates proved safe but ineffective in a rare eye disorder.

By Jacob Bell • Dec. 13, 2018

J&J's Tremfya beats out Novartis' Cosentyx in psoriasis study

Tremfya's success could boost J&J as both drugmakers jockey to carve out a leading position in the hotly competitive market for psoriasis drugs.

By Andrew Dunn • Dec. 12, 2018

Need to accelerate study execution in the face of trial complexity? Consider a unified data strategy

Need to accelerate study execution in the face of trial complexity? Consider a unified data strategy. 

Dec. 12, 2018

Axovant drops small molecule development after dementia drug failure

The company will shift its focus to gene therapies after a Phase 2 trial setback for nelotanserin in patients with Lewy body dementia.

By Suzanne Elvidge • Dec. 11, 2018

Replacement of in vivo Draize test with alternative in vitro methods

Regulatory pressure and technological advancements have led to ethical in vitro-based evaluations of skin irritants and corrosives.   

Dec. 10, 2018

Roche's Tecentriq gets first-line lung cancer approval

While a positive step for Roche's I/O ambitions, it will likely run into trouble differentiating Tecentriq from the first-line regimen of Keytruda plus chemo.

By Andrew Dunn • Dec. 7, 2018

Novartis sheds light on liquid biopsies with SOLAR-1 analysis

Tying together a targeted drug and a companion diagnostic could give Novartis an edge in advanced breast cancer.

By Suzanne Elvidge • Dec. 7, 2018

Supernus ADHD data doesn't win back investor optimism

An "odd data point" may have overshadowed otherwise positive Phase 3 readouts. Still, analysts see potential in SPN-812.

By Suzanne Elvidge • Dec. 7, 2018

Six practices of high performing clinical research sites

How are high-performing clinical research sites getting sponsors to return to them again and again?

Dec. 7, 2018

Conatus unsuccessful in spinning NASH failure

The pharma's share value almost halved Thursday morning despite what it described as "clinically meaningful" results for its drug, emricasan.

By Jacob Bell • Dec. 6, 2018

ASH successes set to lift Imbruvica in CLL

Positive data from three studies might be a commercial boon for AbbVie and J&J's drug. Yet high expectations could leave room for investor disappointment.

By Ned Pagliarulo • Dec. 6, 2018

AbbVie's Rova-T hits yet another setback

The cancer drug's prospects look dim after its latest clinical failure, casting further negative light on AbbVie's nearly $6 billion Stemcentrx acquisition.

By Suzanne Elvidge • Dec. 6, 2018

3 questions leaving ASH

Like many a medical meeting, ASH showcased data that — while promising — also offers as many questions as answers.

By Jacob Bell • Dec. 5, 2018