21:36 , Sep 17, 2018 |  BC Extra  |  Company News

Roivant launches respiratory vant, announces other vant news

Roivant Sciences GmbH (Basel, Switzerland) had a busy Monday announcing the launch of a new respiratory disease subsidiary, a real-world evidence partnership between its Datavant Inc. (San Francisco, Calif.) subsidiary and CRO Parexel International Corp....
03:32 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

FDA accepts applications for Circassia COPD products Duaklir, Tudorza

Circassia Pharmaceuticals plc (LSE:CIR) said FDA accepted for review an NDA for Duaklir Pressair aclidinium bromide/formoterol fumarate to treat chronic obstructive pulmonary disease (COPD). The company also said the agency accepted an sNDA for Tudorza...
16:58 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Tonix stops Phase III of PTSD candidate on lack of separation from placebo

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) said it will stop the Phase III HONOR trial of Tonmya (Sublingual TNX-102) to treat military-related post-traumatic stress disorder (PTSD) after the candidate showed "inadequate separation" from placebo at an...
16:56 , Jul 20, 2018 |  BC Week In Review  |  Financial News

Roivant’s urology subsidiary files for $150M IPO

Urovant Sciences Ltd. (London, U.K) proposed on July 13 to raise up to $150 million in an IPO on NASDAQ underwritten by J.P. Morgan, Jefferies and Cowen. The urology play is a wholly owned subsidiary...
23:51 , Jul 13, 2018 |  BC Extra  |  Financial News

Roivant’s urology subsidiary files for $150M IPO

Urovant Sciences Ltd. (London, U.K) proposed Friday to raise up to $150 million in an IPO on NASDAQ underwritten by J.P. Morgan, Jefferies and Cowen. The urology play is a wholly owned subsidiary of Roivant...
19:58 , Jun 15, 2018 |  BC Week In Review  |  Clinical News

Mylan expecting another delay for generic Advair

Mylan N.V. (NASDAQ:MYL) said it expects to receive a second complete response letter from FDA for an ANDA of a generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK). Any delay would be a reprieve...
22:40 , Jun 14, 2018 |  BC Extra  |  Company News

Mylan expecting another delay for generic Advair

Mylan N.V. (NASDAQ:MYL) said it expects to receive a second complete response letter from FDA for an ANDA of a generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK). Any delay would be a reprieve...
02:31 , May 18, 2018 |  BC Week In Review  |  Clinical News

FDA approves US WorldMeds' Lucemyra for opioid withdrawal

FDA approved Lucemyra lofexidine from US WorldMeds LLC (Louisville, Ky.) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. According to the agency, Lucemyra is the first non-opioid drug approved...
23:41 , May 16, 2018 |  BC Extra  |  Company News

FDA approves US WorldMeds' Lucemyra for opioid withdrawal

FDA approved Lucemyra lofexidine from US WorldMeds LLC (Louisville, Ky.) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. According to the agency, Lucemyra is the first non-opioid drug approved...
18:25 , May 11, 2018 |  BC Week In Review  |  Clinical News

Boehringer's Stiolto Respimat misses in Phase III for COPD

In March, Boehringer Ingelheim GmbH (Ingelheim, Germany) reported data from the Phase III DYNAGITO trial in 7,880 patients with chronic obstructive pulmonary disease (COPD) showing that Stiolto Respimat tiotropium/olodaterol (Inspiolto Respimat, Spiolto Respimat) missed the...