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Category: Today’s Highlights

On CRISPR Therapeutics’ news

CRISPR Therapeutics (CRSP)  and  Vertex Pharmaceuticals (VRTX)  announced that The U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug Application (IND) for CTX001 for the treatment of sickle cell disease pending the resolution of certain questions...

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May 31, 2018

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Coming from AstraZeneca and Juno: News That Makes a Big Difference

Important news is the news that informs about successful achievements that make a difference in treating life-threatening diseases, chronic diseases and diseases with no available treatments. Sometime you might not have a personal interest in one, or another or even...

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July 18, 2016

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The FDA accepted Exelixis’ supplemental new drug application of Cabometyx® for previously treated advanced Hepatocellular Carcinoma. The FDA approved Imdexxy developed by TherapeuticsMD for moderate to severe Dyspareunia

The U.S. Food and Drug Administration (FDA) has accepted for filing  Exelixis’ (EXEL)   supplemental New Drug Application (sNDA) for  Cabometyx® (cabozantinib)  tablets for patients with previously  treated advanced hepatocellular carcinoma (HCC).  The FDA has determined that the application is sufficiently complete to...

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May 30, 2018

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Motif Bio Has Good News. Amicus Therapeutics Has a Series of Good News

MOTIF BIO Antibiotic Motif Bio’s (MTFB ) antibiotic drug  Iclaprim met the Phase 3 Revive-2 trial’s primary endpoints of non-inferiority against the current standard of care antibiotic, vancomycin in acute bacterial skin and skin structure infections (ABSSSI). The drug demonstrated a...

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October 5, 2017

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About Nektar’s product NKTR- 214 at ASCO

The real news coming from the presentation at ASCO related to the combination of   Nektar Therapeutics (NKTR)  and   Bristol-Myers Squibb (BMY)  was viewed as positive by many analysts and investor until a sell-side negative article led to an unwarranted...

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June 4, 2018

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More promising news for Array from its melanoma combination clinical trial

Array BioPharma (ARRY)  announced updated results from the Phase 3 COLUMBUS trial in  BRAF -mutant advanced melanoma. The results showed that the median overall survival (mOS ) was 33.6 months  for patients treated with the combination of encorafenib and binimetinib compared...

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June 5, 2018

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CRISPR Editing and the two published studies

Slashing of the CRISPR gene editing companies’ stocks, including  CRISPR Therapeutics (CRSP), Editas (EDIT) and   Intellia (NTLA)  is caused by two studies published in Nature Medicine, which revealed that cells whose genes are edited by  CRISPR/ Cas9 could develop...

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June 12, 2018

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Why FDA approval of Agilent Technologies’ Assay is important to cervical cancer patients

The U.S. Food and Drug Administration (FDA) has approved  Agilent Technologies’ (NYSE: A)   Dako PD-L1 IHC 22C3 pharmDx assay  for an expanded use. The expended use is expected to help physicians to identify cervical cancer patients who are most...

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June 15, 2018

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Ardelyx's Exciting News. Spark Therapeutics: Facing the Moment of Thrilling Truth

Good news emanating from late phase trials by development-stage firms is always refreshing for Prohost, especially when the news brings hope for the suffering patients whose diseases are not adequately responding to existing treatments. Today GOOD news is coming from...

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October 12, 2017

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Array: Selumetinib Negative Results Are No Match to Its Binimetinib Positive Results

We do expect some selling of Array today after AstraZeneca’s announced negative results from Phase 3 SELECT-1 trial of the MEK inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment for KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell...

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August 9, 2016

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