Another late-stage miss knocks Gilead from its leading NASH position

Gilead is part of a small group of drugmakers with late-stage NASH assets. But misfires in the STELLAR program have dimmed the prospects of...

Sangamo hemophilia A progress boosts shares

While BioMarin and Spark remain out in front, Sangamo's data appear strong enough to warrant consideration of the biotech's therapy in the discussion of potential...

Once ‘bodies for hire,’ CROs are finding a new role as data specialists

Drugmakers want better designed, less expensive clinical trials. The demand is so great that contract research providers, often called CROs, are building out their business...

FTC demands could mean months-long delay for Roche-Spark deal

Roche's $4.8 billion takeout of gene therapy specialist Spark Therapeutics looked like a typical biopharma transaction — that is, until the Federal Trade Commission...
Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the biotech industry mature from the early days of...
Drugmakers want better designed, less expensive clinical trials. The demand is so great that contract research providers, often called CROs, are building out their...
Hemophilia has become one of the most competitive battlegrounds in the emerging field of gene therapy. While BioMarin remains the frontrunner to market, a...

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Celgene wins approval for drug key to Bristol buyout

Approval of Inrebic, which was previously known as fedratinib, is the first domino to fall in Bristol-Myers bet on Celgene's product pipeline. 

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

Deloitte's annual report on R&D productivity, while limited in scope, is an indicator of the challenges faced by large pharmaceutical firms in bringing new...

Biogen points to M&A power as Wall Street presses...

Dive Insight: Biogen took the most severe blow in its history last month, losing more than $20 billion in market capitalization on the announcement that...

Nonprofit under pressure to make new TB drug affordable

Authorities warn that antibiotic-resistant infections rank high, if not at the top, of public and global health concerns. TB offers a prime...

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CMS chief declines to provide details on Trump healthcare plan

The administration faces increasing pressure to release a concrete healthcare plan as Democratic presidential candidates are eager to keep the national conversation focused...

Roche cancer drug the 3rd approved for pan-tumor use

Aimed at the molecular catalysts of tumor growth, targeted therapies are treatment mainstays across a wide range of cancer types. 

Novo faces shareholder suit over insulin sales disclosures

Novo is best known for its insulin products like Levemir (insulin detemir) and Tresiba (insulin degludec), as well as other diabetes treatments like...

Celgene wins approval for drug key to Bristol buyout

Approval of Inrebic, which was previously known as fedratinib, is the first domino to fall in Bristol-Myers bet on Celgene's product pipeline. 

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