07:00 , Jun 16, 2014 |  BC Week In Review  |  Clinical News

Relistor methylnaltrexone regulatory update

The majority of panelists on FDA's Anesthetic and Analgesic Drug Products Advisory Committee felt cardiovascular outcomes trials weren't warranted for peripheral mu opioid receptor ( OPRM1; MOR) antagonists to treat opioid-induced constipation (OIC) in...
07:00 , Jun 16, 2014 |  BC Week In Review  |  Clinical News

Entereg alvimopan regulatory update

The majority of panelists on FDA's Anesthetic and Analgesic Drug Products Advisory Committee felt cardiovascular outcomes trials weren't warranted for peripheral mu opioid receptor ( OPRM1; MOR) antagonists to treat opioid-induced constipation (OIC) in...
07:00 , Oct 28, 2013 |  BC Week In Review  |  Clinical News

Entereg alvimopan regulatory update

Cubist said FDA approved an sNDA for Entereg alvimopan to accelerate upper and lower GI recovery following any surgery that includes a partial bowel resection with primary anastomosis. The mu opioid receptor ( OPRM1;...
07:00 , Jul 22, 2013 |  BC Week In Review  |  Clinical News

Bevenopran: Phase III started

Cubist began 3 identical, double-blind, placebo-controlled, U.S. Phase III trials to evaluate 0.25 mg oral bevenopran twice daily for 12 weeks each in about 600 patients receiving opioid therapy for chronic non-cancer pain. The trials...
08:00 , Jan 28, 2013 |  BioCentury  |  Finance

Oleg's asymmetry

Longtime BVF Partners portfolio manager Oleg Nodelman is betting there's room for a new fund focused on what he calls "asymmetric opportunities." Last October, Nodelman left the hedge fund after about 11 years to launch EcoR1...
08:00 , Jan 7, 2013 |  BC Week In Review  |  Clinical News

Entereg alvimopan regulatory update

On Dec. 21, 2012, Cubist said it submitted an sNDA to FDA for Entereg alvimopan to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis. The mu opioid receptor...
08:00 , Nov 5, 2012 |  BC Week In Review  |  Clinical News

CB-5945: Phase III started

Cubist began a double-blind, placebo-controlled, North American Phase III trial to evaluate 0.25 mg oral CB-5945 twice daily for 1 year in about 1,400 patients receiving opioid therapy for chronic non-cancer pain. The long-term safety...
07:00 , Oct 22, 2012 |  BioCentury  |  Finance

Abbott's wild ride

Abbott Laboratories (NYSE:ABT) had a rollercoaster ride last week, gaining $4.3 billion in market cap on positive HCV data before losing more than $8.6 billion on details of its AbbVie pharmaceutical spinout and safety signals...
01:14 , Sep 5, 2012 |  BC Extra  |  Company News

Kalidex debuts

Kalidex Pharmaceuticals Inc. (Menlo Park, Calif.) made its public debut on Tuesday and said it raised $45 million in a series A round in February 2011. Frazier Healthcare Ventures; Domain Associates; Canaan Partners; New Leaf...
07:00 , Jul 23, 2012 |  BioCentury  |  Finance

In like a lion . . .

Human Genome Sciences Inc. (NASDAQ:HGSI) roared into biotech in the early 1990s with its genomics database. But it's going out like a lamb after GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) agreed to acquire the biotech last week...