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...

Catalent to buy Paragon for $1.2B as gene therapy demand grows

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 Drug...

Bluebird sets $1.8M price tag for blood-disease gene therapy

Bluebird declined to release the Zynteglo price when the agent received European Commission conditional approval last week. The price announcement Friday coincided with a data...

The gene therapy era has arrived. So have the challenges.

A landmark regulatory approval has vaulted the cell and gene therapy space to the front of the drug industry's mind. But speedy progress has...
Approval of Inrebic, which was previously known as fedratinib, is the first domino to fall in Bristol-Myers bet on Celgene's product pipeline. 
The U.S. opioid crisis breathed new life into clinical development of the nerve-growth factor (NGF) inhibitors tanezumab and fasinumab. The drug class had been...
Takeda, on the cusp of closing its deal to acquire Shire, is also working to ramp up its efforts in emerging fields of cancer...

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Roche acknowledges the obvious, extends Spark buyout deadline

The Securities and Exchange Commission filings that Spark released Monday confirm what became apparent when the FTC announced it was subjecting the Roche buyout...

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...

Rival accuses Kaleo of cybersquatting in ‘elaborate scheme’

Cybersquatting was most common in the 1990s and early 2000s, with someone snatching a domain and then selling it to the trademark holder for...

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

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...

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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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