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...
23:23 , Feb 13, 2019 |  BC Week In Review  |  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...
22:01 , Feb 1, 2019 |  BioCentury  |  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...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
03:55 , Dec 14, 2018 |  BC Innovations  |  Product R&D

Gene therapy’s make or buy choice

Whether or not to bring manufacturing in-house for gene therapy companies is becoming a critical choice, as contract manufacturers struggle to keep up with demand. The trade-off for the upfront investment risk is control over...
03:50 , Dec 1, 2018 |  BioCentury  |  Product Development

Cell therapy momentum at ASH

This year’s American Society of Hematology (ASH) meeting will showcase a surge in clinical CAR T cell presentations. But gene therapies are not following the same trajectory, despite both modalities being fresh off their first...