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...
07:00 , Sep 21, 2015 |  BC Week In Review  |  Company News

Par Pharmaceutical sales and marketing update

Par launched its testosterone gel 1%, a generic version of AndroGel 1% from AbbVie Inc. (NYSE:ABBV, Chicago, Ill.). AndroGel is marketed as testosterone replacement therapy. The wholesale acquisition cost (WAC) of the gel...
07:00 , Sep 29, 2014 |  BC Week In Review  |  Clinical News

Enclomiphene: Phase III data

Top-line data from the double-blind, double-dummy, U.S. Phase III ZA-304 trial in 114 evaluable men with secondary hypogonadism showed that Androxal was superior to AndroGel 1.62% testosterone gel on the co-primary endpoints of the...
07:00 , Sep 29, 2014 |  BC Week In Review  |  Clinical News

LPCN 1021: Phase III data

Top-line data from the efficacy population in the open-label, U.S. Phase III SOAR trial in 315 patients with hypogonadism showed that twice-daily oral LPCN 1021 met the primary endpoint of >=75% of patients on active...
02:44 , Sep 19, 2014 |  BC Extra  |  Company News

FDA panel rebuffs Clarus' testosterone

FDA's Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees voted against approval of Rextoro oral testosterone from Clarus Therapeutics Inc. (Northbrook, Ill.). The committees voted 18-3 that Rextoro's overall risk/benefit...
07:00 , Sep 15, 2014 |  BC Week In Review  |  Company News

AbbVie, Besins Healthcare, Teva, U.S. Federal Trade Commission generics, endocrine/metabolic news

FTC filed a suit in the U.S. District Court for the Eastern District of Pennsylvania alleging that AbbVie, Besins' Besins Healthcare Inc. subsidiary and Teva engaged in anticompetitive activity to delay the availability of generic...
02:52 , Sep 10, 2014 |  BC Extra  |  Politics & Policy

FTC files antitrust suit on Androgel deal

The U.S. Federal Trade Commission (FTC) filed a suit alleging several drug makers engaged in anticompetitive behavior by striking a deal to delay the availability of generic versions of AndroGel testosterone gel. FTC's suit, filed...
07:00 , Sep 1, 2014 |  BC Week In Review  |  Clinical News

Androxal enclomiphene: Phase III data

Top-line data from the double-blind, double-dummy, U.S. Phase III ZA-305 trial in 117 evaluable men with secondary hypogonadism showed that Androxal was superior to AndroGel 1.62% testosterone gel on the co-primary endpoints of the...
07:00 , Sep 1, 2014 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Alkermes plc (NASDAQ:ALKS) gained $1.49 to $44.73 last week after submitting an NDA to FDA for aripiprazole lauroxil to treat schizophrenia. The product is a once-monthly, injectable formulation of aripiprazole that uses Alkermes' LinkeRx technology. Amgen...