19:15 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review during the beginning Feb. 18, according to company announcements. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib...
03:14 , Dec 8, 2018 |  BioCentury  |  Regulation

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...
17:51 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

Clearside discontinues combo therapy for retinal vein occlusion

Clearside Biomedical Inc. (NASDAQ:CLSD) discontinued development of Xipere (formerly CLS-TA) plus Eylea aflibercept to treat macular edema following retinal vein occlusion (RVO) after the combination missed the primary endpoint in the Phase III SAPPHIRE trial....
19:46 , Sep 12, 2018 |  BC Extra  |  Company News

Management tracks: Clearside, ImCheck

Clearside Biomedical Inc. (NASDAQ:CLSD) hired Leslie Zacks as general counsel and chief compliance officer. He was VP, general counsel and chief compliance officer at Arbor Pharmaceuticals Inc. (Atlanta, Ga.). Clearside plans to submit an NDA...
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...
18:17 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

Clearside reports Phase II DME data for CLS-TA

Clearside Biomedical Inc. (NASDAQ:CLSD) reported that suprachoroidal CLS-TA plus Eylea aflibercept led to a smaller gain in visual acuity and a greater incidence of both elevated intraocular pressure and cataracts compared with Eylea alone in...
21:35 , May 31, 2018 |  BC Extra  |  Clinical News

Clearside falls on Phase II DME data

Clearside Biomedical Inc. (NASDAQ:CLSD) lost $4.68 (32%) to $9.86 on Thursday after reporting that suprachoroidal CLS-TA plus Eylea aflibercept led to a smaller gain in visual acuity and a greater incidence of both elevated intraocular...
17:51 , May 3, 2018 |  BC Innovations  |  Translation in Brief

Hydrogels on demand

Alivio Therapeutics is using a hydrogel platform to develop controlled-release therapies for inflammatory diseases that respond to flare-ups as they occur. The approach, described in an April Nature Communications study, could avoid systemic toxicities associated...
16:02 , Apr 18, 2018 |  BC Innovations  |  Distillery Therapeutics

Autoimmune disease

INDICATION: Rheumatoid arthritis (RA) Patient sample and mouse studies suggest a hydrogel-based formulation of the GCCR agonist triamcinolone acetonide could help treat RA and other forms of inflammatory arthritis. The hydrogel contains injectable triglycerol monostearate...
17:03 , Mar 16, 2018 |  BC Week In Review  |  Financial News

Clearside, G1 price upsized follow-ons

Ophthalmology company Clearside Biomedical Inc. (NASDAQ:CLSD) and cancer company G1 Therapeutics Inc. (NASDAQ:GTHX) each priced bumped-up follow-ons on the back of positive data, raising a total of $199.8 million. Clearside raised $85 million on March...