23:16 , Jun 22, 2018 |  BC Extra  |  Company News

FDA cracks down on missing postmarket trial

FDA determined the Perrigo Israel Pharmaceuticals Ltd. unit of Perrigo Co. plc (NYSE:PRGO; Tel Aviv:PRGO) has failed to comply with a postmarketing trial requirement to assess the risk of major cardiovascular events (MACE) associated with...
16:20 , May 23, 2018 |  BC Innovations  |  Distillery Techniques

Disease models

TECHNOLOGY: Animal models Mice treated prenatally with AMH could be used to screen therapies to treat polycystic ovary syndrome, a partially heritable disease. In blood samples from 66 pregnant patients with PCOS, AMH levels were higher...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
17:17 , Mar 23, 2018 |  BC Week In Review  |  Clinical News

Mereo's BGS-649 meets in Phase IIb for hypogonadism

Mereo BioPharma Group plc (LSE:MPH) reported top-line data from a Phase IIb trial in 271 obese men with hypogonadotropic hypogonadism showing that all three doses of once-weekly oral BGS-649 met the primary endpoint of normalizing...
16:24 , Jan 12, 2018 |  BC Week In Review  |  Clinical News

Lipocine receives negative panel vote

Lipocine Inc. (NASDAQ:LPCN) said FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 13-6 that the benefit-risk profile of Tlando testosterone undecanoate is not acceptable to support its approval to treat hypogonadism. Its PDUFA date...
23:43 , Jan 10, 2018 |  BC Extra  |  Company News

Lipocine takes after-hours hit on negative panel vote

Lipocine Inc. (NASDAQ:LPCN) fell $1.88 (54%) to $1.58 in after-hours trading Wednesday on news that FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 13-6 that the benefit-risk profile of Tlando testosterone undecanoate is not...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
16:51 , Dec 21, 2017 |  BC Innovations  |  Translation in Brief

Replacing the replacements

A Wake Forest team has developed a cell-based hormone replacement therapy that can control the hypothalamic-pituitary-ovarian axis with lower levels of estrogen than standard therapies, and could provide a solution to the side effects of...
21:43 , Dec 1, 2017 |  BC Week In Review  |  Clinical News

FDA prolongs review of Lipocine's Tlando

Lipocine Inc. (NASDAQ:LPCN) said FDA extended by 3 months its review of Tlando testosterone undecanoate (LPCN 1021) to treat hypogonadism. The candidate’s new PDUFA date is May 8. Lipocine said the agency lengthened the review period...
20:22 , Nov 17, 2017 |  BC Extra  |  Company News

FDA prolongs review of Lipocine's Tlando

Lipocine Inc. (NASDAQ:LPCN) said FDA extended by three months its review of Tlando testosterone undecanoate (LPCN 1021) to treat hypogonadism. The candidate’s new PDUFA date is May 8, 2018. Lipocine said the agency lengthened the review...