18:21 , Jan 12, 2018 |  BC Week In Review  |  Clinical News

PharmaMar reports OS data from Phase III of Aplidin for MM

PharmaMar S.A. (Madrid:PHM) reported data for the secondary overall survival (OS) endpoint from the Phase III ADMYRE trial in 255 patients with relapsed or refractory multiple myeloma (MM) evaluating Aplidin plitidepsin plus dexamethasone vs. dexamethasone...
00:13 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

CHMP recommends against PharmaMar's Aplidin for MM

EMA's CHMP recommended against approval of Aplidin plitidepsin from PharmaMar S.A. (Madrid:PHM) to treat relapsed or refractory multiple myeloma. The committee said it will publish more information on the opinion "shortly." Chugai Pharmaceutical Co. Ltd. (Tokyo:4519)...
23:22 , Dec 15, 2017 |  BC Extra  |  Company News

CHMP recommends basket of therapies

EMA's CHMP recommended approval of a host of therapies, including Alofisel darvadstrocel (Cx601) to treat Crohn's disease, Ozempic semaglutide (NN9924, OG217SC) to treat Type II diabetes, Herzuma biosimilar trastuzumab to treat breast and gastric cancer...
21:10 , Dec 22, 2016 |  BC Extra  |  Company News

PharmaMar, Chugai in second cancer deal

PharmaMar S.A. (Madrid:PHM) said it granted Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) rights in Japan to lurbinectedin (PM1183). The candidate is in Phase III studies to treat two forms of cancer. PharmaMar added EUR 0.27 (10%)...
17:50 , Nov 2, 2016 |  BC Week In Review  |  Clinical News

Aplidin regulatory update

EMA accepted for review an MAA for Aplidin plitidepsin from PharmaMar to treat relapsed or refractory multiple myeloma (MM) in combination with dexamethasone. The company said it expects a decision in 2Q17. Chugai Pharmaceutical Co....
07:00 , Sep 26, 2016 |  BC Week In Review  |  Clinical News

Aplidin plitidepsin regulatory update

PharmaMar submitted an MAA to EMA for Aplidin plitidepsin in combination with dexamethasone to treat relapsed or refractory multiple myeloma (MM). The submission is based on data from the Phase III ADMYRE trial of the...
07:00 , Sep 22, 2016 |  BC Extra  |  Company News

PharmaMar submits Aplidin MAA

PharmaMar S.A. (Madrid:PHM) submitted an MAA to EMA for Aplidin plitidepsin in combination with dexamethasone to treat relapsed or refractory multiple myeloma (MM). In March, the company said the candidate significantly improved progression-free survival (PFS)...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Rethinking risk

Steve Edelson, Senior Editor   The second half does not contain the high-impact, sector-moving milestones seen in the first six months of the year, but investors still have at least 90 late-stage milestones from which to...
07:00 , Apr 4, 2016 |  BC Week In Review  |  Clinical News

Aplidin plitidepsin: Phase III data

Top-line data from the open-label, international Phase III ADMYRE trial in 255 patients with relapsed or relapsed MM after 3-6 prior therapies showed that 5 mg/m 2 IV Aplidin on days 1 and 15 of...
01:23 , Apr 1, 2016 |  BC Extra  |  Clinical News

PharmaMar's Aplidin passes Phase III MM test

PharmaMar S.A. (Madrid:PHM) said Aplidin plitidepsin met the primary endpoint of improved progression free survival (PFS) in the Phase III ADMYRE study to treat relapsed or refractory multiple myeloma. The company plans to submit an...