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Category: News & Comments

AstraZeneca and Genentech Checkpoint Inhibitors improve survival in two different Lung Cancers

ASTRAZENECA AstraZeneca’s (AZN) Checkpoint Inhibitor Imfinzi significantly improved Overall Survival (OS) for  Stage III Non-Small Cell Cancer Imfinzi  (durvalumab) achieved positive overall survival (OS) results for the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung...

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May 29, 2018

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Amgen: The FDA approves Aimovig™. The first specific migraine drug

The U.S. Food and Drug Administration (FDA) approved  Amgen’s (AMGN)  new once a month drug Aimovig™ (erenumab-aooe) for the prevention and treatment of migraine in adults. Aimovig is the first and only FDA-approved treatment specifically developed to prevent migraine. The drug blocks calcitonin gene-related peptide...

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May 18, 2018

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The FDA Approves Compugen's IND for Its Oncology Product COM902

Compugen FDA Approval for COM902 Compugen Announces FDA Clearance of IND Application for COM902 Phase 1 clinical study in patients with advanced malignancies expected to begin in early 2020 Clinical development of COM902 will enable testing the combination treatment with...

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November 4, 2019

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The FDA Approves Keytruda for primary Mediastinal Large B-Cell Lymphoma (PMBCL)

–  Keytruda becomes the first anti-PD-1 therapy to be approved for PMBCL   – This is the 2nd indication for Keytruda for a hematologic malignancy. – The approval is based on tumor response rate and durability of response. The FDA...

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June 14, 2018

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Cara Therapeutics: More Positive Results from the Korsuva Product Trial for Hemodialysis Patients' Pruritis

Positive Results from Korsuva for Pruritis Cara Therapeutics Postive Results from Korsuva Trial On May 29, 2019 Cara Therapeutics ( CARA ) announced positive topline data from the KALM-1 pivotal Phase 3 trial of its Korsuva in hemodialysis patients with...

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May 30, 2019

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The Bad News That Might Save the Life of Halozyme Therapeutics

Halozyme Therapeutics is Focusing on ENHANZE® Technology Halozyme Therapeutics ( HALO ) decides to focus on its ENHANZE® drug delivery technology, halt the development activities for PEGPH20 and close its oncology operations. These decisions were made after the failure of ...

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November 6, 2019

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bluebird bio Announces a European Conditional Approval of Its Gene Therapy ZYNTEGLO™ for Transfusion-Dependent β-Thalassemia  

Zynteglo™ from bluebird bio Gets European Conditional Approval European marketing authorization for Zynteglo follows the fastest assessment of an advanced therapy medicinal product ( ATMP ) as part of the European Medicines Agency’s Priority Medicines ( PRIME ) program. Zynteglo...

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June 4, 2019

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Another Approval for Celgene and the First for Acceleron

FDA Approval for Celgene and Acceleron Drug REBLOZYL® The U.S. Food and Drug Administration ( FDA ) has approved Celgene’s ( CELG ) and Acceleron Pharma’s ( XLRN )  drug  REBLOZYL®  (luspatercept-aamt) for anemia only in adult patients with beta...

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November 12, 2019

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Why Vertex and CRISPR Rallied Today

Vertex Pharmaceuticals and CRISPR Therapeutics Rallied Today Vertex Pharmaceuticals ( VRTX )  and CRISPR Therapeutics ( CRSP ) announced positive, interim data from the first two patients with severe hemoglobinopathies treated with the investigational CRISPR/Cas9 gene-editing therapy CTX001 in ongoing...

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November 19, 2019

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Alnylam: Its Second RNAi Therapy Approval Boosted Savvy Investors' Trust

Alnylam Granted FDA Early Approval of GIVLAARI™ for AHP Alnylam’s ( ALNY ) stock outperformed as its subcutaneous injection GIVLAARI™ (givosiran) has been granted FDA early approval. GIVLAARI™ is created and developed for the treatment of adults with acute hepatic...

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November 22, 2019

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