22:56 , Dec 17, 2018 |  BioCentury  |  Politics, Policy & Law

When drugs can’t go generic: Honoring our end of the contract with 'synthetic genericization'

The biopharma industry’s social contract with society relies on the idea that drugs eventually go generic and thereafter remain inexpensive. When that can’t happen, the contract breaks down - but there are ways to fix...
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...
15:27 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

FDA approves AbbVie's Orilissa for endometriosis pain

FDA approved Orilissa elagolix from AbbVie Inc. (NYSE:ABBV) for the management of moderate to severe pain associated with endometriosis. AbbVie expects to launch the drug early next month at a wholesale acquisition cost (WAC) of...
16:43 , Jul 24, 2018 |  BC Extra  |  Company News

FDA approves AbbVie's Orilissa for endometriosis pain

FDA approved Orilissa elagolix from AbbVie Inc. (NYSE:ABBV) for the management of moderate to severe pain associated with endometriosis. AbbVie expects to launch the drug early next month at a wholesale acquisition cost (WAC) of...
17:47 , Jul 20, 2018 |  BC Week In Review  |  Financial News

Myovant raises $75M

Myovant Sciences Ltd. (NYSE:MYOV) raised $75 million through the sale of 3.3 million shares at $22.50 in a follow-on underwritten by J.P. Morgan, Goldman Sachs, Barclays, JMP Securities and Baird. The price is a 7%...
18:14 , Jul 13, 2018 |  BC Extra  |  Financial News

Follow-on roundup: Myovant, CytomX, Spero

Myovant Sciences Ltd. (NYSE:MYOV), CytomX Therapeutics Inc. (NASDAQ:CTMX) and Spero Therapeutics Inc. (NASDAQ:SPRO) each priced follow-ons late Thursday, raising a total of $275 million. Myovant raised $75 million through the sale of 3.3 million shares...
22:53 , Jul 12, 2018 |  BC Extra  |  Politics & Policy

ICER panel votes against elagolix for endometriosis

An ICER panel showed little confidence in the clinical effectiveness of elagolix (ABT-620) from AbbVie Inc. (NYSE:ABBV) to treat endometriosis, voting Thursday that evidence is not adequate to support a net health benefit over other...
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...
20:44 , Jun 22, 2018 |  BC Week In Review  |  Clinical News

ObsEva's linzagolix meets in Phase IIb for endometriosis-associated pain

ObsEva S.A. (NASDAQ:OBSV) said three of four doses of linzagolix (OBE2109, KLH-2109) met the primary endpoint in the Phase IIb EDELWEISS trial to treat moderate to severe endometriosis-associated pain. The company plans to present additional...
19:03 , Jun 22, 2018 |  BC Week In Review  |  Financial News

ObsEva raises $73M follow-on

Reproductive health company ObsEva S.A. (NASDAQ:OBSV) raised $73.1 million through the sale of 4.8 million shares at $15.39 in a follow-on underwritten by J.P. Morgan, Credit Suisse Securities (USA), Jefferies, Wedbush Securities and H.C. Wainwright....