18:30 , Jan 11, 2019 |  BC Week In Review  |  Company News

Former Insys CEO pleads guilty to opioid prescription kickbacks

Michael Babich, former president and CEO of Insys Therapeutics Inc. (NASDAQ:INSY), pleaded guilty on Jan. 9 in conspiring to bribe physicians to unnecessarily prescribe Subsys fentanyl sublingual spray and defraud insurance companies. The opioid is...
20:07 , Oct 11, 2018 |  BC Extra  |  Company News

Management tracks: Former Baxalta exec joins VisionGate; Carrick names Golumbeski chair

Cancer company VisionGate Inc. (Phoenix, Ariz.) hired John Glasspool as chief operating and strategy officer, a newly created position. He was EVP and head of corporate strategy and customer operations at Baxalta Inc., which Shire...
01:14 , Oct 6, 2018 |  BioCentury  |  Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
18:41 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Fast Track for Insys' nasal epinephrine

Insys Therapeutics Inc. (NASDAQ:INSY) jumped $2.71 (34%) to $10.67 on Aug. 30 after it said FDA granted Fast Track designation to its epinephrine nasal spray to treat anaphylaxis. A spokesperson for Insys told BioCentury that...
18:32 , Aug 10, 2018 |  BC Week In Review  |  Company News

FDA reviewers say data are lacking on TIRF drug use

FDA reviewers pointed to significant data gaps for evaluating the REMS program for transmucosal immediate-release fentanyl (TIRF) drugs at a joint advisory committee meeting Aug. 3. Participants gave "important feedback" that insufficient data exists to...
17:43 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

FDA issues CRL for Insys' analgesic

Insys Therapeutics Inc. (NASDAQ:INSY) said FDA issued a complete response letter for buprenorphine sublingual spray to treat acute pain. Insys was seeking the candidate's approval for the management of acute pain severe enough to require...
22:21 , Jul 27, 2018 |  BC Extra  |  Company News

FDA issues CRL for Insys' analgesic

Insys Therapeutics Inc. (NASDAQ:INSY) said FDA issued a complete response letter for buprenorphine sublingual spray to treat acute pain. Insys was seeking the candidate's approval for the management of acute pain severe enough to require...
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...
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...