20:32 , Jul 14, 2017 |  BC Week In Review  |  Clinical News

Immune begins Phase I/II of Ceplene in CMML

Immune Pharmaceuticals Inc. (NASDAQ:IMNP; SSE:IMNP) began a Phase I/II trial to evaluate twice-daily 0.5 mg subcutaneous Ceplene histamine dihydrochloride plus low-dose IL-2 in 15 patients with chronic myelomonocytic leukemia (CMML). Patients will receive Ceplene with...
08:00 , Nov 18, 2013 |  BC Week In Review  |  Clinical News

Ceplene histamine regulatory update

Germany's Federal Joint Committee (G-BA) said it plans to assess 12 drugs launched before drug pricing law AMNOG came into effect in January 2011, including Vidaza azacitidine from Celgene and Pfizer and Ceplene histamine from...
08:00 , Feb 11, 2013 |  BC Week In Review  |  Company News

ALK-Abello, Japan Tobacco, Torii deal

ALK-Abello granted Japan Tobacco and its Torii Pharmaceutical subsidiary exclusive rights to develop and commercialize ALK-Abello's histamine dihydrochloride preparation in Japan. ALK-Abello markets the product as Soluprick Positive control in Europe for use as a...
08:00 , Feb 11, 2013 |  BC Week In Review  |  Company News

Boehringer Ingelheim pharmaceuticals news

The U.S. District Court for the Northern District of Ohio approved a consent decree of permanent injunction restraining Boehringer's Ben Venue Laboratories Inc. company from manufacturing and distributing drugs from its Bedford, Ohio, facility until...
07:00 , Jun 25, 2012 |  BC Week In Review  |  Company News

EpiCept, Meda sales and marketing update

EpiCept made several moves to save cash and extend its projected operations into 4Q12. EpiCept will receive $2.6 million in cash from Meda in exchange for relinquishing future milestones and royalties under a 2010 deal...
07:00 , Mar 26, 2012 |  BC Week In Review  |  Clinical News

Caelyx regulatory update

EMA recommended that the manufacturing process for cancer drugs Caelyx doxorubicin from Johnson & Johnson and Ceplene histamine dihydrochloride from EpiCept be transferred to alternative facilities from the Ben Venue Laboratories Inc. facility. EMA's CHMP...
08:00 , Feb 27, 2012 |  BC Week In Review  |  Clinical News

Angiox regulatory update

EMA's CHMP issued final recommendations on a Good Manufacturing Practice Certificate issued to Ben Venue Laboratories Inc. preventing the third-party manufacturer from supplying 12 non-essential drugs. CHMP recommended removing Ben Venue's manufacturing site from the...
08:00 , Jan 2, 2012 |  BC Week In Review  |  Clinical News

Ceplene histamine dihydrochloride regulatory update

EpiCept said that "adequate" supplies of Ceplene histamine dihydrochloride are available despite the cancer drug's third-party manufacturer ceasing all manufacture and distribution of medicines from the drug's manufacturing site. The manufacturer, Ben Venue Laboratories Inc.,...
07:00 , Sep 19, 2011 |  BC Week In Review  |  Clinical News

Ceplene histamine dihydrochloride: FDA action

According to EpiCept, FDA indicated the biotech should compare Ceplene plus IL-2 vs. IL-2 monotherapy using OS as the primary endpoint as part of a registration trial in order to isolate the effect of Ceplene...
07:00 , Aug 1, 2011 |  BC Week In Review  |  Clinical News

Ceplene histamine dihydrochloride cancer data

A meta-analysis of data from 1,455 AML patients in first complete remission in 6 international trials showed that IL-2 alone did not significantly increase LFS or OS vs. standard of care (p=0.52 and p=0.46, respectively)....