18:17 , Aug 17, 2018 |  BC Extra  |  Company News

FDA approves 12-week Eylea regimen after short delay

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA approved an sBLA for an every 12-week dosing schedule of Eylea aflibercept in wet age-related macular degeneration (AMD). The agency's green light comes just days after Regeneron revealed a complete...
03:31 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

FDA gives green light for Regeneron's 12-week Eylea regimen

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA approved an sBLA for an every 12-week dosing schedule of Eylea aflibercept to treat wet age-related macular degeneration (AMD). Eylea's updated label says patients may be treated with every 12-week...
16:45 , Aug 13, 2018 |  BC Extra  |  Company News

Delay for Regeneron’s 12-week Eylea regimen

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA issued a complete response letter to an sBLA for an every 12-week dosing schedule of Eylea aflibercept to treat wet age-related macular degeneration (AMD). The company said the delay is...
18:57 , Jul 13, 2018 |  BC Week In Review  |  Company News

Novartis to spin out Alcon unit

Novartis AG (NYSE:NVS; SIX:NOVN) said it intends to spin out its Alcon eye care business, while retaining the pharma’s ophthalmology pharmaceuticals portfolio. The spinout will include Alcon’s surgical and vision care assets, which yielded $6.7 billion...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate of...
20:52 , Jun 29, 2018 |  BC Extra  |  Company News

Novartis to spin out Alcon unit

Novartis AG (NYSE:NVS; SIX:NOVN) said it intends to spin out its Alcon eye care business, while retaining the pharma’s ophthalmology pharmaceuticals portfolio. The spinout will include Alcon’s surgical and vision care assets, which yielded $6.7 billion...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
20:42 , Nov 17, 2017 |  BC Week In Review  |  Clinical News

Novartis details brolucizumab wet AMD data

In a media briefing, Novartis AG (NYSE:NVS; SIX:NOVN) detailed secondary endpoint data from the Phase III HAWK and HARRIER trials of brolucizumab (RTH258) to treat wet age-related macular degeneration (AMD) and touted the candidate's potential...
23:36 , Nov 10, 2017 |  BC Extra  |  Clinical News

Novartis details brolucizumab wet AMD data

In a media briefing Friday, Novartis AG (NYSE:NVS; SIX:NOVN) detailed secondary endpoint data from the Phase III HAWK and HARRIER trials of brolucizumab (RTH258) to treat wet age-related macular degeneration (AMD) and touted the candidate's...
23:10 , Oct 6, 2017 |  BioCentury  |  Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...