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...
17:01 , May 25, 2018 |  BC Week In Review  |  Clinical News

FDA panel votes no for Insys' analgesic

An FDA panel voted 18-1 that the benefits of Buvaya buprenorphine sublingual spray from Insys Therapeutics Inc. (NASDAQ:INSY) do not outweigh its risks, and thus recommended against the analgesic’s approval. The vote came at a...
22:45 , May 22, 2018 |  BC Extra  |  Company News

FDA panel rebuffs Insys' analgesic

An FDA panel voted 18-1 that the benefits of Buvaya buprenorphine sublingual spray from Insys Therapeutics Inc. (NASDAQ:INSY) do not outweigh its risks, and thus recommended against the analgesic’s approval. The vote came at a...
19:21 , May 18, 2018 |  BC Extra  |  Company News

FDA reviewers cast doubt on Insys analgesic's utility, safety

FDA reviewers said data from an NDA of Buvaya buprenorphine sublingual spray from Insys Therapeutics Inc. (NASDAQ:INSY) do not support its usage to treat acute pain. The remarks came in briefing documents issued ahead of...
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...
04:20 , Dec 8, 2017 |  BC Week In Review  |  Clinical News

FDA accepts NDA for Insys' buprenorphine sublingual spray

Insys Therapeutics Inc. (NASDAQ:INSY) said FDA accepted for review an NDA for the company’s buprenorphine sublingual spray to manage moderate to severe acute pain. The PDUFA date is July 28, 2018. Next quarter, Insys said it...
18:04 , Dec 6, 2017 |  BC Extra  |  Company News

FDA accepts Insys' NDA for buprenorphine sublingual spray

Insys Therapeutics Inc. (NASDAQ:INSY) said FDA accepted for review an NDA for the company’s buprenorphine sublingual spray to manage moderate to severe acute pain. The PDUFA date is July 28, 2018. Next quarter, Insys said it...
15:18 , Oct 6, 2017 |  BC Week In Review  |  Clinical News

Insys submits NDA for Buprenorphine Sublingual Spray

Insys Therapeutics Inc. (NASDAQ:INSY) submitted an NDA to FDA for Buprenorphine Sublingual Spray for the management of moderate to severe acute pain. The product has met the primary endpoint in a Phase III trial to...
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Clinical News

Buprenorphine Sublingual Spray: Phase III data

Top-line data from a double-blind, U.S. Phase III trial in 322 patients with moderate to severe postoperative pain after a bunionectomy showed that thrice-daily 0.125, 0.25 and 0.5 mg Buprenorphine Sublingual Spray all met the...