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Category: Today’s Highlights

Incyte’s promising trial results and its plans to accelerate its future growth

Incyte (INCY) announced positive topline results from its pivotal Phase 2 REACH1 trial evaluating ruxolitinib (Jakafi ® ) in combination with corticosteroids for patients with steroid-refractory acute graft-versus-host disease (GVHD). The study met its primary endpoint , with a 55%...

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June 21, 2018

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Congratulations: The FDA Approved Portola’s Anticoagulant Drug Bevyxxa (betrixaban). The Stock Rallied.

Portola (PTLA) announced that the U.S. Food and Drug Administration (FDA) has approved Bevyxxa (betrixaban), the first anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical...

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June 23, 2017

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The FDA committee voted 19 to 1 in favor of approving Amgen's & UCB's new osteoporosis product Evenity

On January 8, 2019 the osteoporosis monoclonal antibody Evenity (romosozumab) developed by Amgen and UCB was granted approval by the Japanese Ministry of Health, Labor and Welfare for osteoporosis in patients at high risk of bone fracture. Yesterday , Amgen (AMGN)   and...

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January 17, 2019

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Exploring two clinical-stage firms with new, different approaches to treatments

SOPHIRIS BIO AND NANOBIOTIX SOPHIRIS BIO  Sophiris Bio (SPHS) has a product called Topsalysin (PRX302) in Phase 2 clinical trial for the treatment of localized prostate. The product is in Phase 3 clinical trial for lower urinary tract symptoms of...

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June 27, 2018

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About Bellicum Pharmaceuticals' Product BPX-501

IMPRESSIVE RESULTS?  Bellicum Pharmaceuticals’ (BLCM) drug BPX-501 is described as a safe and effective product that can offer children with cancer and other serious diseases the opportunity to beat their intractable sicknesses. The drug enables the patients who are in...

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June 27, 2017

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Lipocine's product, LPCN-1144, has promising results in decreasing the risk of NASH in non-alcoholic fatty liver disease

Lipocine (LPCN) , a specialty pharmaceutical company, announced that an approximately eight-week top-line study using LPCN 1144 in subjects with non- alcoholic fatty liver disease (NAFLD) who might have the potential to develop NASH.  Treatment results showed an absolute mean...

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January 17, 2019

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Why Vertex added over $20 to its stock price today

Health Canada Approves PrSYMDEKO™ For People Ages 12 and Older With Certain CFTR Gene Mutations Vertex (VRTX) announced that Health Canada approved SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have...

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June 29, 2018

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Exelixis liver cancer results are gratifying, so do not worry if some pretend they do not like them

The New England Journal of Medicine ( NEJM ) published results from the CELESTIAL phase 3 pivotal trial of Exelixis (EXEL) product Cabometyx® ( cabozantinib) in previously treated patients with advanced hepatocellular carcinoma (HCC) . The data demonstrate that Cabometyx...

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July 5, 2018

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Amgen and UCB resubmit BLA to the FDA for the approval of Evenity™ to prevent or heal Osteoporosis bone fracture in post-menopausal women

The BLA Includes Data from More Than 11,000 Patients Amgen (AMGN) and UCB (Euronext Brussels: UCB) resubmitted a Biologics License Application (BLA) to the U.S. FDA for the approval of their osteoporosis investigational monoclonal antibody product Evenity™ (romosozumab). The product...

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July 13, 2018

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Halozyme's Approved Drug, Promising News and Ongoing Pancreatic Cancer Trials

On June 22, 2017, the U.S. Food and Drug Administration (FDA) has approved Genentech’s Rituxan Hycela™. This product is a combination of Genentech’s drug rituximab and Halozyme's hyaluronidase enzyme through Halozymes’s proprietary human ENHANZE® technology. The aim of the combination...

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June 30, 2017

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