23:13 , Jun 14, 2019 |  BC Extra  |  Company News

bluebird prices β thalassemia gene therapy, first to put majority of revenues at risk

bluebird bio could be the first company to test an outcomes-based pricing model for a gene therapy where the vast majority of the price is at risk. On Friday, bluebird bio Inc. (NASDAQ:BLUE) announced the...
21:21 , Jun 14, 2019 |  BioCentury  |  Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
00:21 , Jun 1, 2019 |  BioCentury  |  Product Development

SMA drug Zolgensma’s label more surprising than its price

FDA surprised Novartis, patient advocates and physicians by approving a label for the pharma’s gene therapy that creates hope that newborns diagnosed with spinal muscular atrophy can be treated before symptoms appear -- in time...
02:23 , May 18, 2019 |  BioCentury  |  Product Development

AAVs on the brink: Charting the clinical landscape of in vivo gene therapies

Gene therapy is finally teetering on the edge of becoming a drug development mainstay, with at least nine AAV-based therapies in Phase III or II/III testing. An analysis of the AAV therapies in the clinic...
23:29 , May 3, 2019 |  BioCentury  |  Product Development

Independents’ day: after their first solo launch, biotechs look to new partnering strategies

Having taken their first products to market alone, the new class of independent biotechs face decisions for what to keep and what to change as they seek to build sustainable value as end-to-end companies. One...
21:58 , Apr 26, 2019 |  BioCentury  |  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...
00:52 , Mar 7, 2019 |  BioCentury  |  Regulation

Gottlieb’s durable reforms

While most of the changes Scott Gottlieb has set in motion in just under two years as FDA commissioner are works in progress, and some may falter in his absence, an important number are well...
01:10 , Mar 2, 2019 |  BioCentury  |  Product Development

Roche broadens its BD scope

Roche’s proposed acquisition of Spark Therapeutics Inc. is the pharma’s first major deal since James Sabry took over partnering, and could be a glimpse of what’s to come as the pharma broadens its horizons on...
20:03 , Mar 1, 2019 |  BC Week In Review  |  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...
07:11 , Feb 25, 2019 |  BC Extra  |  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...