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98 articles with PharmaMar S.A.
Although August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar for PDUFA dates, this week’s dates were almost all approved ahead of schedule. Here’s a look.
The approval was based on monotherapy clinical data from a trial in 105 adults with SCLC whose disease progressed after platinum-based chemotherapy.
TGA has granted provisional designation for new drug Lurbinectedin based on encouraging Phase 2 results and high unmet medical need
5/4/2020There’s plenty of news related to clinical trials related to COVID-19, but it does seem to be drowning out non-COVID-19-related clinical trials. Here’s a look.
4/30/2020Biopharma companies from across the globe provide updates on their business and pipelines.
PharmaMar Has Announced That the Spanish Medicines Agency Has Authorized the APLICOV-PC Clinical Trial With Aplidin® (Plitidepsin) for the Treatment of Patients With COVID-19
The objective of the trial is to evaluate the efficacy and safety of plitidepsin in patients with COVID-19 requiring hospital admission
PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer
PharmaMar and Jazz Pharmaceuticals plc announce that the U.S. Food and Drug Administration accepted for filing with Priority Review the New Drug Application seeking accelerated approval for lurbinectedin for the treatment of patients with Small Cell Lung Cancer who have progressed after prior platinum-containing therapy.
The U.S. Food and Drug Administration accepted the companies’ New Drug Application for lurbinectedin under Priority Review.
GENOMICA, a wholly owned company of PharmaMar Group, is developing a kit to reliably detect and identify the new virus known as "Wuhan pneumonia".
PharmaMar and Bionical Emas launch Expanded Access Program for lurbinectedin in relapsed Small Cell Lung Cancer in the U.S.
PharmaMar and Bionical Emas, a global specialist Clinical Research Organization have announced the launch of an Expanded Access Program for lurbinectedin to treat patients in the United States with relapsed Small Cell Lung Cancer, who are unable to enter clinical trials and there are no appropriate alternative treatments.
PharmaMar and Jazz Pharmaceuticals Announce the U.S. License Agreement for Lurbinectedin is Effective with the Expiration of the HSR Waiting Period
PharmaMar and Jazz signed an exclusive license agreement on 19 December 2019 for lurbinectedin in the United States
This is a Phase I-II study to determine the recommended dose and efficacy of lurbinectedin in combination with atezolizumab (Roche) in patients with advanced Small Cell Lung Cancer (SCLC).
Madrid, January 9th, 2020- PharmaMar management will be meeting with institutional investors in San Francisco during the JP Morgan Annual Healthcare Conference next week.
Collaboration emphasizes Jazz and PharmaMar's commitments to providing differentiated medicines to patients in areas of high unmet need
12/19/2019Companies from across the globe provide updates on their business and product pipelines.
PharmaMar has filed New Drug Application for lurbinectedin with the FDA for the treatment of relapsed small cell lung cancer
The Company has filed the New Drug Application (NDA) for lurbinectedin, in monotherapy, for the treatment of relapsed Small Cell Lung Cancer (SCLC), under the “accelerated approval” regulations.
PharmaMar shall receive an upfront payment and is eligible for additional remunerations, including regulatory milestone payments.
PharmaMar has presented results of its antitumor compounds trabectedin and plocabulin at the CTOS Congress
PharmaMar had a notable presence at CTOS with two oral presentations and six posters on trabectedin and two posters on plocabulin.
The Company reaffirms that it will file for the lurbinectedin NDA to the FDA under accelerated approval regulations for the treatment of relapsed Small Cell Lung Cancer (SCLC) during the fourth quarter (Q4) of 2019.
PharmaMar has presented data from the Phase IV NIMES-ROC clinical trial with its marine-derived anti-tumor compound, Yondelis®, at the European Congress of Oncological Gynecology, being held from 2-5 November in Athens, Greece..