Decentralized clinical trials: Are we ready to make the leap?

Is the biopharma industry ready to take the next step and fully implement the ultimate in patient-centricity: "decentralized,” or virtual, clinical trials that allow patients to participate while almost never visiting a clinical site?

Jan. 29, 2019

Alexion's follow-on to Soliris succeeds in late-stage trial

The positive data support a U.S. submission of ravulizumab in the first half of 2019 for a rare blood clotting disorder known as aHUS.

By Jacob Bell • Jan. 28, 2019

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

Advaxis hit with clinical hold for cervical cancer drug

The FDA flagged issues with Advaxis' chemistry, manufacturing and controls, handing the biotech another setback. 

By Suzanne Elvidge • Jan. 24, 2019

Opdivo questions hang over Bristol-Myers amid sales miss

The pharma wants to focus on the drug pipeline it gains by buying Celgene. But withdrawal of a key application for Opdivo has analysts wondering about the immunotherapy's future.

By Ned Pagliarulo • Jan. 24, 2019

Potential Restasis rival falls short in head-to-head study

While Aurinia Pharma believes it has a dry eye drug to take on Allergan's top-selling treatment, new clinical data shade that notion with some doubt.

By Andrew Dunn • Jan. 22, 2019

AbbVie, J&J's Imbruvica falls short in pancreatic cancer

Combining the top-selling drug with chemo failed to improve survival in a Phase 3 study, illustrating the challenges presented by the tough-to-treat tumor type. 

By Suzanne Elvidge • Jan. 22, 2019

Lilly suspends Lartruvo promotion after Phase 3 failure

A miss on overall survival in the pharma's ANNOUNCE study calls into question the cancer drug's earlier accelerated approval.

By Jacob Bell • Jan. 18, 2019

Aptinyx stung by pain drug's mid-stage miss

The biotech's shares fell roughly 70% Wednesday morning as investors questioned the outlook for its lead candidate.

By Jacob Bell • Jan. 16, 2019

FDA to bulk up cell and gene therapy staff, growing with the field

Two FDA leaders said the development of cell and gene therapies has reached  "a turning point," leading to new agency plans to keep pace with research.

By Andrew Dunn • Jan. 16, 2019

At JPM, the NASH flood gates start to crack

Multiple late-stage results are slated for 2019, bringing to the forefront a question of how battle lines will be drawn across the market.

By Jacob Bell • Jan. 11, 2019

Hunting productivity, drugmakers pitch new 'pillars' of R&D

By some measures, returns on R&D have fallen to decade lows. Pharmas and biotechs, however, argue new technologies could open faster paths to market. 

By Ned Pagliarulo • Jan. 11, 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

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

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