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Category: News & Comments

Portola: The FDA Approves Bevyxxa

After years of spending efforts in creating and developing its pipeline products,  Portola (PTLA)  has just been granted a U.S. Food and Drug Administration’s (FDA) approval of its Prior Approval Supplement (PAS) for the anticoagulant product  Bevyxxa® (betrixaban) . The product is...

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December 19, 2017

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The Market Reaction Towards the FDA Complete Response Letter Offers a Unique Investment Opportunity In Incyte

Eli Lilly (LLY) and Incyte (INCY) announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of baricitinib for moderate-to-severe rheumatoid arthritis (RA). The FDA letter indicated that additional clinical data are required to...

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April 17, 2017

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Exelixis Has Good News About CABO

EXELIXIS Good News about CABO The FDA has determined that  Exelixis’ (EXEL ) cabozantinib New Drug Application (NDA) for advanced renal cell carcinoma (RCC) to  be sufficiently complete  to permit a substantive review. The NDA will be considered officially filed...

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January 28, 2016

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Who Skipped the Bloody Market? Why Gilead Embarked on Galapagos NV Drug Filgotonib?

The market looks like angry, probably very angry, as stocks are in a severe selloff mood. There will be many explanations like usual, but it is difficult for us to speculate this time over the correctness of the offered explanations,...

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January 4, 2016

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The FDA Grants Fast Track Status to DelMar Pharmaceuticals’ Product VAL-083

The FDA Grants Fast Track Status to DelMar Pharmaceuticals’ Product VAL-083 Dec.26, 2017 –  DelMar Pharmaceuticals (DMPI)  announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s lead product candidate,  VAL-083 , in...

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December 27, 2017

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ImmunoGen: What About Now?

ImmunoGen is one of two firms Prohost selected for investment on February 2011 based on the promises of its novel antibody-drug conjugate (ADC). An ADC drug is an antibody that carries highly potent cancer-killing agent attached to the antibody by...

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April 28, 2017

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What Makes Merck and Array Shareholders Edgy

MERCK Merck (MRK) has beaten analysts’ expectations generating $9.4 billion for revenues in the first quarter of 2017. Its GAAP EPS was $0.56 for the first quarter of 2017 and the Non-GAAP EPS $0.88 for the first quarter of 2017....

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May 3, 2017

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The FDA Approved Aerie Pharmaceuticals’ Glaucoma Eye Drops Rhopressa. What’s Next?

Two months ahead of the PDUFA date scheduled for February 28, 2018, the Food and Drug Administration (FDA) approved  Aerie Pharmaceuticals’ (AERI)   ophthalmic solution) 0.02% Rhopressa ®  (netarsudil for the lowering of elevated intraocular pressure (IOP) in open-angle glaucoma....

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December 22, 2017

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Why Epizyme's Upcoming Presentation Is More Than Exciting

EPIZYME Many oncologists, we believe, must be impatient to learn about the outcome of a first-in-class cancer drug based on epigenetics in upcoming oncology conventions. The drug tazemetostat was created and is being developed by Epizyme. Epizyme (EPZM) is a...

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May 8, 2017

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Cellectis: Offering Proof of Concept is What Led to the Stock Rally

UCART19 UCART19  is one of the  Cellectis’ (CLLS)  lead  allogeneic anti-CD19 CAR T-cell products . The word  allogeneic  is important as it makes the difference between Cellectis’ CAR T products and the two approved chimeric antigen receptor (CAR T) products...

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December 14, 2017

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