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Category: News & Comments

Reata Pharmaceuticals’ Product Omaveloxolone Met the Trial Primary Endpoints in Treating Friedreich’s Ataxia

Reata Pharmaceuticals Omaveloxolone for Friedreich's Ataxia On October 14, 2019  Reata Pharmaceuticals ( RETA ) announced the Part 2 portion of its Phase 2 MOXIe trial, with its product omaveloxolone, met its primary endpoint in modifying Friedreich’s ataxia ( FA...

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October 16, 2019

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The FDA granted Paratek two important product approvals. One is for acne

The U.S. Food and Drug Administration (FDA) has approved Paratek Pharmaceuticals' (PRTK)  product Seysara™ (sarecycline)  for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Paratek has exclusively licensed U.S. development and commercialization rights...

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October 3, 2018

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Exelixis initiates phase 3 trial with Cabometyx in radioiodine-refractory differentiated thyroid cancer (DTC) patients

Exelixis (EXEL) announced its initiation of a phase 3 pivotal trial (COSMIC-311) of Cabometyx (cabozantinib) in patients with radioiodine-refractory differentiated thyroid cancer (DTC) who have progressed after two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies . The co-primary endpoints for...

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October 9, 2018

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Can the Combination of Inarigivir from Spring Bank Pharmaceuticals and Vemlidy from Gilead Sciences Succeed in Treating Chronic Hepatitis B Viral Infection

Spring Bank Pharmaceuticals, Gilead Sciences and HBV If Spring Bank Pharmaceuticals' ( SBPH ) product inarigivir in combination with Gilead Sciences' ( GILD ) Vemlidy® could validate the current encouraging results of the ongoing trials on chronic hepatitis B virus...

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October 24, 2019

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Its All About Coronavirus

Coronavirus: The Possible Treatments While Moderna’s ( MRNA ) vaccine is being tested and its stock price continued to rise in the worst market performance day; other companies demonstrated readiness to bring their vaccines against the life-threatening virus into human...

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March 19, 2020

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Amgen's product Amgevita, a biosimilar to adalimumab, will be launched in the European market today.

Amgen (AMGN) announced that Amgevita TM , a biosimilar to adalimumab , will launch in markets across Europe  beginning on October 16, 2018 . According to Amgen’s press release, Amgevita TM  is the first adalimumab biosimilar to be approved by the European Commission ...

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October 16, 2018

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When Negative Reactions to Biotechnology News Mislead. The Case of Regenxbio.

Regenxbio Misleading Selloff A selloff of Regenxbio ( RGNX ) stock, following the FDA’s partial hold on the intrathecal administration of AVXS-101, is unwarranted and totally misleading.   Why? Because the selloff of RGNX gave the impression that the gene...

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October 31, 2019

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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 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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Alleviating osteoarthritis pain without the need for opioid drugs

Tanezumab , an investigational humanized monoclonal antibody developed by Pfizer (PFE) and Eli Lilly (LLY), met all three co-primary endpoints in patients with osteoarthritis (OA) . The 16-week Phase 3 study, which evaluated subcutaneous administration of tanezumab in patients with...

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October 25, 2018

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