Zolgensma set a new drug pricing bar. Insurers show some signs of pushback

Zolgensma (onasemnogene abeparvovec) wasn't the first gene therapy approved in the U.S. That milestone belongs to Spark Therapeutics' Luxturna (voretigene neparvovec), a treatment for...

BioMarin confirms timeline for hemophilia gene therapy, putting pressure on rivals

Hemophilia has become one of the most competitive battlegrounds in the emerging field of gene therapy. While BioMarin remains the frontrunner to market, a key...

FDA’s Woodcock defends accelerated approvals and talks of culture shift in clinical trials

Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the biotech industry mature from the early days of biologics...

Audentes lays down marker in muscular dystrophy

Audentes Therapeutics is trying to show Sarepta isn't the only game in town when it comes to DMD. The collaboration with Nationwide's Children Hospital...
Wednesday's settlement follows last month's conviction of five former Insys executives, including the company's founder John Kapoor, for their involvement in bribing physicians to...
Biopharma companies wanting to treat rare diseases are increasingly pressed to be invested in gene therapy. Novartis and Roche have recognized this with their...
As Humira (adalimiumab) goes, so goes AbbVie. And it may require quite a few new products to replace the rheumatoid arthritis giant, which earned...

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Audentes lays down marker in muscular dystrophy

Audentes Therapeutics is trying to show Sarepta isn't the only game in town when it comes to DMD. The collaboration with Nationwide's Children Hospital...

Catalent to buy Paragon for $1.2B as gene therapy...

Biologics have been a business boon to contract manufacturers, Catalent included. Large-molecule drugs are such a focus, in fact, that last year Catalent split its...

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...

Aducanumab’s failure puts pressure on field to look beyond...

The plaques are considered hallmarks of Alzheimer's disease, formed in the brain from sticky clusters of a misfolded protein fragment called beta-amyloid. For the past...

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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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