BC Extra | Sep 4, 2019
Company News

Novartis’ early collaboration with NICE key to rapid response on Luxturna

In one of NICE’s fastest draft recommendations for a new therapy on the NHS, the HTA found gene therapy Luxturna from Novartis to be cost-effective to treat a rare genetic retinal disorder. Novartis’ offer of...
BC Extra | Jun 17, 2019
Company News

Trial data suggest 80% of Zynteglo patients could meet milestones in outcomes-based pricing model

The most recent long-term data for bluebird bio's Zynteglo β thalassemia gene therapy show that about 80% of patients could hit payment milestones based on details the biotech disclosed about its outcomes-based pricing model on...
BioCentury | Apr 26, 2019
Product Development

Rise of the independents, biotechs go to market

While product launch and commercialization has largely been the province of big biotech and big pharma, with smaller companies partnering to get their products over the finish line, BioCentury’s analysis of recent FDA approvals finds...
BC Week In Review | Mar 1, 2019
Company News

Spark gives Roche beachhead in gene therapy

Roche (SIX:ROG; OTCQX:RHHBY) will acquire Spark Therapeutics Inc. (NASDAQ:ONCE) for $4.8 billion in a deal that marks the Swiss pharma's first major move into gene therapy. The deal announced early Feb. 25 was the first...
BC Extra | Feb 25, 2019
Company News

Spark gives Roche beachhead in gene therapy

Roche (SIX:ROG; OTCQX:RHHBY) will acquire Spark Therapeutics Inc. (NASDAQ:ONCE) for $4.8 billion in a deal that marks the Swiss pharma's first major move into gene therapy. The deal announced early Monday was the first major...
BC Week In Review | Feb 13, 2019
Company News

Spark elaborates on proposed Luxturna value-based pricing model

Spark Therapeutics Inc. (NASDAQ:ONCE) Chief Commercial Officer Ron Philip disclosed additional details on the company's value-based pricing proposal to CMS for Luxturna voretigene neparvovec-rzyl during the BIO CEO and Investor Conference in New York on...
BioCentury | Feb 1, 2019
Politics, Policy & Law

Focusing on cures

A Massachusetts Institute of Technology-led consortium is finalizing pilot programs that are intended to serve as models for overcoming two major hurdles to implementing performance-based contracts for curative therapies in the United States. The goal...
BC Week In Review | Nov 30, 2018
Clinical News

Luxturna gets EU approval

The European Commission approved Luxturna voretigene neparvovec to treat patients with vision loss due to genetic mutation in both copies of the retinal pigment epithelium-specific protein 65kDa (RPE65) gene and who have enough viable retinal...
BC Week In Review | Sep 28, 2018
Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta...
BC Extra | Sep 21, 2018
Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT)...
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