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Imfinzi approved in the US for less-frequent, fixed-dose use

Nov 20, 2020
AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage…
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Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized…

Nov 20, 2020
Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the distribution and emergency use of…
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1 week to go Webinar on Cost-efficient and Green Manufacturing of Peptides thanks to Molecular…

Nov 20, 2020
SMi Reports: There is only one to go to join the online webinar taking place on Thursday 26th November 2020 on Cost-efficient and Green Manufacturing of Peptides thanks to Molecular…
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Zymeworks Receives Orphan Drug Designation From the European Commission for HER2-Targeted Bispecific…

Nov 19, 2020
Zymeworks Inc. announced that the European Commission (EC) has granted Orphan Drug designation for zanidatamab, the company’s investigational HER2-targeted bispecific antibody, in…
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Rilzabrutinib granted FDA Fast Track Designation for treatment of immune thrombocytopenia

Nov 19, 2020
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the oral investigational Bruton’s tyrosine kinase (BTK) inhibitor, rilzabrutinib, which has the…
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Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary…

Nov 19, 2020
Pfizer Inc. and BioNTech SE announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all…
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Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing…

Nov 19, 2020
Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application for SB11, a proposed…
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InMed Pharmaceuticals and BayMedica Announce Collaboration for Manufacturing and Testing of Novel…

Nov 18, 2020
InMed Pharmaceuticals Inc. a clinical-stage pharmaceutical company developing medications targeting diseases with high unmet medical need and leading the way in the clinical development…
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ViiV Healthcare receives FDA Breakthrough Therapy Designation for investigational, long-acting…

Nov 18, 2020
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi Limited as shareholders, announced that the US Food and Drug…
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EMA Begins Rolling Review of Moderna’s mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)

Nov 18, 2020
Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the…
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