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Category: News & Comments

The EU CHMP Recommends Approving Alnylam’s RNAi Therapeutic, ONPATTRO™

The Committee for Medicinal Products for Human Use (CHMP) announced a Positive Opinion recommending marketing authorization of Alnylam’s (ALNY) RNAi product Onpattro ™ (patisiran). The product is designed to treat hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy....

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July 27, 2018

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A new European approval for Bristol-Myers’ immunotherapy opdivo. The future is starting now

The Future is Starting Now Recognizing that the future has already started now is important as it makes analysts use different criteria for the fair evaluation of the future growth of biotechnology startups and revenue-generating companies. This is our main...

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July 31, 2018

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A Promising Strategic Agreement Between a Large and a Small Biotech Firms

When plenty of news comes out of the biotech sector, we are left with no option but prioritizing. Connecting the dots also might serve some purpose, including smelling take-over possibilities that make sense or contribute to improvements of the treatments...

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October 13, 2016

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Senator Sanders and Ariad

Shares of Ariad Pharmaceuticals declined following Senator Bernie Sanders’ criticism of the high price of the firm’s drug Iclusig (ponatinib) on Twitter. Ariad said, "our pricing reflects our significant investment in R&D, our commitment to the very small, ultra orphan...

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October 17, 2016

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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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Why We Are Ignoring the Temporary Selling of NKTR. See Also: Agenus Adjuvant in GSK Successful Shingles Vaccine

There is nothing wrong with Nektar Therapeutics (NKTR) . The stock is temporarily underperforming as traders are practicing their conviction that they must sell when a firm finances through dilution. The traders practice this law of thumb regardless of whether...

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October 19, 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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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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Regeneron and Sanofi Rheumatoid Arthritis Drug is Still Extremely Promising

Regeneron (REGN) and Sanofi informed that the FDA has issued a Complete Response Letter ( CRL ) regarding the Biologics License Application (BLA) for sarilumab. The drug  is an investigational interleukin-6 receptor (IL-6R) antibody for adult patients with moderately to...

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October 31, 2016

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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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