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Category: Today’s Highlights

The Amgen/Novartis story. A Little Curiosity About Alder Biopharmaceuticals.

The Amgen/Novartis Story In May 2018 Amgen ( AMGN ) & Novartis ( NVS ) announced that their novel migraine drug Aimovig™ was granted FDA approval for adults. Aimovig is the first and only FDA-approved migraine treatment designed to specifically...

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April 8, 2019

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Encouraging News About the COVID-19 Outbreak. See Also: Important News from Gilead

COVID-19 at Its Peak? The number of deaths from the COVID-19 outbreak in NYC are expected to peak soon. This expectation is coming from a prestigious trustworthy Washington University. The news also stated that Italy is turning the corner if...

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April 8, 2020

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Amgen and UCB granted FDA approval of Evenity for osteoporosis in menopausal women at risk of bone fracture

Amgen and UDB Granted FDA Approval of Evenity™ Amgen ( AMGN ) and U CB Pharmaceuticals ( UCB ) announced that the U.S. Food and Drug Administration (FDA) has granted approval of Evenity™(romosozumab-aqqg) for osteoporosis in postmenopausal women at high risk...

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April 10, 2019

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Gilead Sciences: An FDA Complete Response Letter Will Not Stop This Firm from Rallying

Gilead Sciences Was Issued a CLR from the FDA for Filgotinib Gilead Sciences ( GILD ) is in receipt of a complete response letter ( CRL ) from the U.S. Food and Drug Administration ( FDA ) for the New...

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August 19, 2020

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Learning More About Moderna's Virtual Vaccine Day

Moderna Therapeutics Virtual Vaccine Day On April 7, 2020 Moderna Therapeutics ( MRNA ) announced that it will host its virtual Vaccine Day for analysts and investors at 8:00 a.m. EST on Tuesday, April 14th. Moderna informed that during its...

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April 14, 2020

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Novartis: More promising data from a Phase 3 trial with AveXis' gene therapy Zolgensma® for Spinal Muscular Atrophy Type 1

Novartis Has More Promising Data from Their Phase 3 Gene Therapy Trial with AveXis AveXis Inc., a Novartis ( NVS ) company, announced positive interim data from its Phase 3 STR1VE trial of Zolgensma ®  ( onasemnogene abeparvovec - xio...

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April 17, 2019

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Novartis Gene Therapy Zolgensma Will Be Approved. The FDA Approves a Merck Combination for First-Line Renal cell Carcinoma. Regenxbio and Exelixis Are in Great Shape.

Zolgensma Findings The FDA submission of the gene therapy product Zolgensma was based on positive findings from a trial of 15 babies treated with it. Recently; however, at the Orlando meeting of the Muscular Dystrophy Association Novartis ( NVS )...

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April 22, 2019

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Exelixis is Rallying Today from CheckMate-9ER Trial Results

Exelixis Rallying from CheckMate-9ER Trial Results Exelixis ( EXEL ) and Bristol-Myers Squibb ( BMY ) announced results from CheckMate-9ER , a Phase 3 pivotal trial evaluating Opdivo® (nivolumab) in combination with Cabometyx® (cabozantinib) compared to sunitinib in previously untreated...

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April 20, 2020

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Exelixis Announces Submission of sNDA to U.S. FDA for Cabozantinib in Combination with Nivolumab for Advanced RCC

Exelixis Announces Submission of sNDA to US FDA for CABOMETYX® Exelixis ( EXEL ) announced the submission of a supplemental New Drug Application ( sNDA ) to the U.S. FDA for CABOMETYX® ( cabozantinib ) in combination with Opdivo® (nivolumab)...

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August 25, 2020

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Trovagene's News Is Encouraging

About Trovagene Trovagene ( TROV )  is still a clinical-stage company.  The p recision cancer medicine approach is practicing what it preaches right now in order to develop drugs that target cell division (mitosis) for: leukemias, lymphomas and solid tumor...

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April 24, 2019

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