Clinical Trials
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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
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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
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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
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Deep DiveAt 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
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Deep DiveHunting 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
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SponsoredBlockbuster … 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.
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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. 08, 2019
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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. 07, 2019
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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. 07, 2019
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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. 04, 2019
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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
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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
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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
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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
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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
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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
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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
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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
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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
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SponsoredNeed 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.
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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
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SponsoredReplacement 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.
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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. 07, 2018
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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. 07, 2018
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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. 07, 2018