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...
22:36 , May 8, 2018 |  BC Extra  |  Preclinical News

SNS nerve loss drives hematopoietic stem cell aging

A paper published in Nature Medicine showed that the loss of sympathetic nervous system (SNS)nerves in bone marrow is a driver of hematopoietic stem cell (HSC) aging, suggesting that agonizing the receptors targeted by SNS-delivered...
17:59 , Apr 13, 2018 |  BC Week In Review  |  Clinical News

Ocugen reports Phase II data for dry eye disease candidate

Ocugen Inc. (Malvern, Pa.) reported data from a Phase II trial showing that dry eye disease candidate OCU310 met the primary endpoint of tolerability over a 12-week period. The company said the trial was not...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...