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Pharma Press Releases

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Made-in-Singapore Cancer Drug ETC-159 Advances Further in Clinical Trials

Thursday, July 30, 2020

MadeinSingapore cancer drug ETC has achieved a new developmental milestone in achieving First Patient First Visit in Phase B The first dose of ETC has been administered to patients in this new phase of clinical testing which for the first time will l...

Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS)

Thursday, July 30, 2020

Takeda Pharmaceutical Company Limited announced that the US Food and Drug Administration FDA granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higherrisk myelodysplastic syndromes HR...

Merck Announces Two US Regulatory Milestones for KEYTRUDA® (pembrolizumab) in Triple-Negative Breast Cancer (TNBC)

Thursday, July 30, 2020

Merck known as MSD outside the United States and Canada today announced that the US Food and Drug Administration FDA has accepted two new supplemental Biologics License Applications sBLAs for KEYTRUDA Mercks antiPD therapy The FDA has accepted and gr...

Tagrisso granted Breakthrough Therapy Designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR-mutated lung cancer

Thursday, July 30, 2020

AstraZenecas Tagrisso osimertinib has been granted Breakthrough Therapy Designation BTD in the US for the adjuvant treatment of patients with earlystage IB II and IIIA epidermal growth factor receptormutated EGFRm nonsmall cell lung cancer NSCLC afte...

FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma

Friday, July 31, 2020

Roche announced that the US Food and Drug Administration FDA approved Tecentriq atezolizumab plus Cotellic cobimetinib and Zelboraf vemurafenib for the treatment of BRAF V mutationpositive advanced melanoma patients The safety profile observed in th...

Eisai: Application for Additional Indication of Anti Cancer Agent Lenvima for Unresectable Thymic Carcinoma Submitted in Japan

Friday, July 31, 2020

Eisai Co Ltd and MSD KK a subsidiary of Merck Co Inc Kenilworth NJ USA announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase...

Pelican BioThermal Survey Reveals Biopharma Companies’ Focus on Sustainability in Cold Chain Partnerships

Friday, July 31, 2020

Pelican BioThermal the global name in temperaturecontrolled packaging today released results of its Biopharma Cold Chain Logistics Sustainability Survey According to key opinion leaders in biopharma cold chain the biopharma industry is increasing it...

Celltrion receives MHRA approval to initiate Phase I trial of potential COVID-19 antiviral antibody treatment, CT-P59, in the UK

Friday, July 31, 2020

Celltrion Group announced that the UK Medicines and Healthcare products Regulatory Agency MHRA has approved the companys Clinical Trial Authorisation CTA application for a Phase I clinical trial with CTP a COVID antiviral antibody treatment candidate...

Imara Announces IMR-687 Granted Fast Track Designation and Rare Pediatric Disease Designation for Treatment of Beta-Thalassemia

Friday, July 31, 2020

IMARA Inc a clinicalstage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin today announced the US Food and Drug Administration FDA...

FDA Grants Breakthrough Therapy Designation to Merck’s Novel HIF-2α Inhibitor MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma

Wednesday, July 29, 2020

Merck known as MSD outside the United States and Canada announced today that the US Food and Drug Administration FDA has granted Breakthrough Therapy designation to the hypoxiainducible factor alpha HIF inhibitor MK a novel investigational candidate...