BioCentury | Jul 14, 2017
Clinical News

Immune begins Phase I/II of Ceplene in CMML

...Inc. (NASDAQ:IMNP; SSE:IMNP) began a Phase I/II trial to evaluate twice-daily 0.5 mg subcutaneous Ceplene histamine dihydrochloride...
...histamine dihydrochloride plus low-dose IL-2 in 15 patients with chronic myelomonocytic leukemia (CMML). Patients will receive Ceplene...
...relapse in patients with AML. Immune Pharmaceuticals Inc. (NASDAQ:IMNP; SSE:IMNP), New York, N.Y. Product: Ceplene histamine dihydrochloride...
BioCentury | Nov 18, 2013
Clinical News

Ceplene histamine regulatory update

...AMNOG came into effect in January 2011, including Vidaza azacitidine from Celgene and Pfizer and Ceplene...
...2007). Nippon Shinyaku Co. Ltd. (Tokyo:4516, Kyoto, Japan) has Japanese rights to Vidaza for MDS. Ceplene...
...Summit, N.J. EpiCept Corp. (OTCQX:EPCT; SSE:EPCT), Tarrytown, N.Y. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Ceplene...
BioCentury | Feb 11, 2013
Company News

ALK-Abello, Japan Tobacco, Torii deal

...granted Japan Tobacco and its Torii Pharmaceutical subsidiary exclusive rights to develop and commercialize ALK-Abello's histamine dihydrochloride...
BioCentury | Feb 11, 2013
Company News

Boehringer Ingelheim pharmaceuticals news

...for cancer drugs Caelyx doxorubicin from Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) and Ceplene histamine dihydrochloride...
BioCentury | Jun 25, 2012
Company News

EpiCept, Meda sales and marketing update

...deal for acute myelogenous leukemia (AML) drug Ceplene histamine dihydrochloride. Meda, which has rights to market Ceplene...
...and certain Pacific Rim countries including Japan, China and Australia, will assume responsibility for manufacturing Ceplene...
...territories not licensed to Meda or MegaPharm Ltd. (Raanana, Israel), which has rights in Israel. Ceplene...
BioCentury | Mar 26, 2012
Clinical News

Caelyx regulatory update

...that the manufacturing process for cancer drugs Caelyx doxorubicin from Johnson & Johnson and Ceplene histamine dihydrochloride...
...drugs for the EU. EMA expects to complete the transfer of the manufacturing process for Ceplene...
...Johnson (NYSE:JNJ), New Brunswick, N.J. Business: Cancer Product: Caelyx ( Doxil - U.S.) doxorubicin, Ceplene histamine dihydrochloride WIR...
BioCentury | Feb 27, 2012
Clinical News

Angiox regulatory update

...of 2 other cancer drugs, Caelyx pegylated liposomal doxorubicin from Johnson & Johnson and Ceplene histamine dihydrochloride...
...U.S.) bivalirudin, Busilvex busulfan injection, Caelyx ( Doxil - U.S.) doxorubicin, Cayston aztreonam lysine, Ceplene histamine dihydrochloride...
BioCentury | Jan 2, 2012
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...
...GMP "shortcomings" were identified last year at the site. EpiCept said no immediate shortage of Ceplene...
...subsidiary of Boehringer Ingelheim GmbH (Ingelheim, Germany). EpiCept Corp. (OTCQX:EPCT; SSE:EPCT), Tarrytown, N.Y. Product: Ceplene histamine dihydrochloride...
BioCentury | Sep 19, 2011
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...
...primary endpoint as part of a registration trial in order to isolate the effect of Ceplene...
...the EU and Israel for the indication. EpiCept Corp. (NASDAQ:EPCT; SSE:EPCT), Tarrytown, N.Y. Product: Ceplene histamine dihydrochloride...
BioCentury | Aug 1, 2011
Clinical News

Ceplene histamine dihydrochloride cancer data

...discuss the request and the SPA. Last August, FDA refused to file an NDA for Ceplene...
...not demonstrate the compound's "therapeutic contribution" in combination with IL-2 (see BioCentury, Aug. 30, 2010). Ceplene...
...the EU and Israel for the indication. EpiCept Corp. (NASDAQ:EPCT; SSE:EPCT), Tarrytown, N.Y. Product: Ceplene histamine dihydrochloride...
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