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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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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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Why Amgen's Bone Builder Drug Evenity Will Be Delayed Approval in Spite of Superior Efficacy Results

Amgen’s (AMGN) and UCB's drug Evenity ( romosozumab) , which, in long and large 24 months of clinical investigation has demonstrated superior results in reducing new vertebral, non vertebral and clinical bone fractures, has demonstrated a heart-related side effects. At the weekend...

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May 23, 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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Amgen, Rhythm Pharmaceuticals and an important story to know

Amgen Higher Dividends For those who invest in top-tier biotech firms for dividend payments, in addition to the firms’ continued growth, Amgen (AMGN) announced last Friday that its Board of Directors declared a  $1.45 per share dividend for the first quarter...

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December 12, 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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Great biotech news in a bizarre market. Incyte has two consecutive good news

During the departed week, outstanding advancements and improvements in various clinical disciplines filled the media. What’s bad is that all the accomplishments could not bring joy to the deserving investors. The reason is the unpersuasive crazy market behavior. We believe...

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December 17, 2018

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Proteostasis: Its $100 million agreement with Genentech seems not enough to motivate investors to buy into the stock

Proteostasis (PTI) signed a worldwide, exclusive license agreement with Genentech  about licensing rights to potential therapeutic small molecule modulators of an undisclosed target within the proteostasis network . The agreement does not include cystic fibrosis (CF)  transmembrane conductance regulator (CFTR)...

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December 18, 2018

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