17:10 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

FDA approves Antares' Xyosted testosterone replacement therapy

FDA approved in October Xyosted from Antares Pharma Inc. (NASDAQ:ATRS) as a testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Antares expects launch the drug by...
17:26 , Aug 17, 2018 |  BC Week In Review  |  Company News

Perrigo to separate its generics business

Perrigo Co. plc (NYSE:PRGO; Tel Aviv:PRGO) said it plans to separate its prescription generics business to focus on its consumer healthcare products. The company expects the transaction -- which could include a separation to shareholders,...
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...
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...
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...