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 is $364.55...
07:00 , Jun 22, 2015 |  BC Week In Review  |  Company News

Besins Healthcare, Atossa Genetics deal

Besins granted Atossa exclusive, worldwide rights to develop and commercialize afimoxifene gel to treat and prevent hyperplasia of the breast. Besins is eligible to receive 8-9% royalties for 15 years after commercialization. Atossa also received...
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 9, 2013 |  BC Week In Review  |  Clinical News

BHR-100: Completed Phase III enrollment

Besins' BHR Pharma LLC subsidiary completed enrollment of 1,180 patients in the double-blind, placebo-controlled, international Phase III SyNAPSe trial evaluating a 5-day continuous IV infusion of BHR-100 given within 8 hours of injury. BHR-100 has...
07:00 , Apr 29, 2013 |  BC Week In Review  |  Company News

Besins Healthcare, Shin Nippon Biomedical Laboratories deal

Besins received rights to use Shin Nippon's Muco intranasal delivery technology to develop Besins' BHR-310 to treat mild to moderate traumatic brain injury. BHR-310 is an intranasal progesterone powder in preclinical testing, with a Phase...
08:00 , Feb 25, 2013 |  BC Week In Review  |  Clinical News

BHR-100 regulatory update

Besins' BHR Pharma LLC subsidiary said the European Commission granted Orphan Drug designation for BHR-100 to treat moderate and severe traumatic brain injury (TBI). The IV progesterone formulation is in the Phase III SyNAPSe trial...
08:00 , Jan 28, 2013 |  BC Week In Review  |  Clinical News

BHR-100: Phase III ongoing

Besins' BHR Pharma LLC subsidiary said a DSMB recommended continuation of the double-blind, placebo-controlled, international Phase III SyNAPSe trial of BHR-100 based on safety data from 803 patients. Based on an interim analysis of the...
08:00 , Dec 14, 2009 |  BC Week In Review  |  Clinical News

BHR-100 progesterone: Phase III start

Early next year, Besins' BHR Pharma LLC unit will begin the international Phase III SyNAPSe trial to compare a 5-day continuing IV infusion of BHR-100 vs. placebo given in 1,200 patients. Study treatment must begin...
08:00 , Dec 14, 2009 |  BC Week In Review  |  Clinical News

BHR-100 progesterone regulatory update

FDA granted Orphan Drug designation for BHR-100 to treat moderate to severe traumatic brain injury (TBI). BHR Pharma LLC, a subsidiary of Besins, plans to begin a Phase III trial of the intravenous progesterone product...