Posts Tagged ‘Biopharma’
How Could the 21st Century Cures Act Aid Innovation?
There’s more to the 21st Century Cures Act, which passed the full House of Representatives with overwhelming bipartisan support, than $9 billion in new funding for the National Institutes of Health (NIH) to pick up the pace of medical research. The legislation also includes a number of provisions that would speed up the Food and…
Read MoreYear 1: What OIS Podcasts Were Most Popular? Part Two
[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 051″] We’re thrilled to be celebrating the one-year anniversary of the OIS Podcast. We hope you enjoyed these tales of innovation as much as we have. To celebrate milestone we reveal and review the interviews that most resonated with our listeners. We reviewed numbers Six through Ten in our last episode.…
Read MoreYear 1: What OIS Podcasts Were Most Popular? Part One
[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 050″] We’re thrilled to be celebrating the one-year anniversary of the OIS Podcast. We hope you enjoyed these tales of innovation as much as we have. To celebrate milestone we reveal and review the interviews that most resonated with our listeners. Transcripts Tom Salemi: Hello, everyone, welcome back to the OIS…
Read MoreFirst Lucentis Biosimilar Launches in India, but Path in US not so Clear
The first biosimilar agent for Lucentis (ranibizumab, Genentech) has come to market in India with the launch of Intas Pharmaceuticals’’ Razumab in June. But whether biosimilar agents gain any traction in the United States remains to be seen as they must overcome myriad regulatory and competitive hurdles. Biosimilars are to branded biologic agents like Lucentis…
Read MoreA favorite From The OIS Podcast Stack
[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 049″] Oculeve’s stunning acquisition by Allergan last week led us back to a conversation we had with Mark S. Blumenkranz, MD, Professor & Chairman of the Department of Ophthalmology, Stanford University. Mark S. Blumenkranz is the H.J. Smead Professor and Chairman of the Department of Ophthalmology at Stanford University. He received…
Read MoreAllergan’s Oculeve Acquisition Bolsters Dry Eye, Medtech
The dry eye space has taken a few hits lately with disappointing clinical news on the biopharmaceutical front. But investors and entrepreneurs developing new treatments have to be bolstered by Allergan’s agreeing to purchase early-stage company Oculeve. According to a press release on the deal, Allergan would pay $125 million up front for Oculeve, which…
Read MoreOculeve Open Ups, Just A Little, On OD-01
[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 047″] In this week’s OIS Podcast, we talk with Oculeve CEO Michael Ackermann about the start-up company that caught the eye of Dry Eye Leader Allergan. The dry eye space has taken a few hits lately with disappointing clinical news on the biopharmaceutical front. But the news that Allergan would pay…
Read MoreAerie Pharmaceuticals
Rhopressa is a Rho-kinase and norepinephrine transporter inhibitor and lowers episcleral venous pressure, with phase 3 efficacy data expected mid-Q2 2015, and an FDA filing in mid-2016. The Rhopressa “Rocket 1” registration trial is designed to evaluate non-inferiority to timolol BID. Entry criteria included pressures in the 20-27 mmHg range. (A phase 2b study comparing…
Read MoreSpotlight on Pressure Reduction
Participants: Kuldev Singh, MD, MPH Dr. Kuldev Singh is Professor of Ophthalmology and Director of the Glaucoma Service at the Stanford University School of Medicine. View Full Profile Thomas A. Mitro Thomas A. Mitro has served as our President and COO since August 2013. From November 2012 to August 2013, Mr. Mitro served as Vice…
Read MoreSpotlight on Drug Delivery
“It’s becoming more like cage fighting than company building.” The Drug Delivery market is increasingly competitive. CEOs from the sector’s leading innovators Ocular Therapeutix, Kala Pharmaceuticals, Envisia Therapeutics and Icon Bioscience join in a discussion led by OIS Co-chair Emmett Cunningham, MD and K. Angela MacFarlane for ForSight Labs. Topics discussed including battling generics, protecting…
Read MoreOcular Therapeutix
The company is evaluating sustained-release injectable anti-VEGF drug depots along with using its proprietary hydrogel platform technology for anterior segment disorders (specifically pain and inflammation). The company’s OTX drug-eluting punctal plug is a non-invasive procedure that will eliminate drops (and the potential non-compliance). Two phase 3 studies have been completed on inflammation, with 39.4% absence…
Read MoreIcon Bioscience
The company’s proprietary Verisome drug delivery technology is being used as the base for IBI-10090, for post-cataract surgery inflammation. The dexamethasone compound completed a pivotal phase 3 study (n=394), and based on these results, Icon plans to file an NDA by late 2015/early 2016. Phase 3 results builds on the phase 2b data, which showed…
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