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Category: News & Comments

Successful results were announced by uniQure for its gene therapy, AMT-061, on hemophilia B patients

The United States FDA granted Breakthrough Therapy Designation to AMT-061. The European Medicines Agency gave it access to the Priority Medicine (PRIME) regulatory initiative. Gene therapy firm,  uniQure ( QURE ),  announced updated clinical data in patients treated in the...

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February 11, 2019

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Outperforming Biotechs In a Bad Market Day

Outperforming Biotechs On August 27, 2019 we posted “ The Medicines Company Has Agreeable News ” under Today’s Highlights.  The Medicines Company We described The Medicines Company ( MDCO ) as a firm focused on cardiovascular diseases with a goal...

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September 3, 2019

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RegenxBio: An analyst and investor event focused on the firm’s ophthalmology program.

RegenxBio ( RGNX ) ,  a clinical-stage gene therapy firm with a proprietary NAV ®  Technology Platform, will host an analyst and investor event focused on its ophthalmology program;  including its lead product candidate RGX-314 , on Thursday, February 21, 2019, from 9:00...

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February 15, 2019

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Arena Pharmaceuticals: Positive Results on Ulcerative Colitis

Arena Pharmaceuticals (ARNA)   announced positive  Phase 2 results  from the  OASIS trial  for  etrasimod  in ulcerative colitis (UC). The Drug : Etrasimod is a selective  sphingosine 1-phosphate (S1P) receptor modulator.  Patients receiving the 2 mg dose of the drug...

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March 20, 2018

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Exelixis: Further Stretching Its Cabozantinib’s Market

Exelixis (EXEL)   completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Cabometyx® (cabozantinib) tablets for previously treated patients with advanced hepatocellular carcinoma (HCC). The sNDA submission is based on results from the CELESTIAL randomized...

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March 16, 2018

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Regeneron Discovers the Therapeutic Target for Non-Viral Chronic Liver Diseases. Alnylam is Assigned to Discover and Create the Targeted RNAi Therapeutic

Regeneron (REGN)   and   Alnylam (ALNY)  announced a collaborative agreement aimed at identifying RNAi therapeutics for the chronic liver disease nonalcoholic steatohepatitis (NASH) and potentially other related diseases. The agreement is not the first between the two firms, but...

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March 22, 2018

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Gilead Collaboration with Sangamo

Kite, a Gilead Company, and Sangamo Therapeutics Announce Collaboration to Develop Next-Generation Engineered Cell Therapies for Cancer Kite , a  Gilead (GILD)  company, and  Sangamo Therapeutics (SGMO)   announced a worldwide collaboration agreement for using Sangamo’s zinc finger nuclease (ZFN)...

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February 22, 2018

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Merck's product Keytruda and Exelixis' product Cabometyx are both winners

Keytruda and Cabometyx Are Both Winners Keytruda failed to meet co-primary endpoints in Pivotal Phase 3 trial The pivotal Phase 3 KEYNOTE-240 trial evaluating Keytruda, Merck’s ( MRK ) checkpoint inhibitor anti-PD-1 therapy plus best supportive care, for the treatment...

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February 21, 2019

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The FDA Approves AstraZeneca Checkpoint Inhibitor Imfinzi® for a Lung Cancer. A Probable Partnership Agreement Between Arbutus and Roivant

The Food and Drug Administration (FDA) approved  AstraZeneca (AZN)   Checkpoint inhibitor drug  Imfinzi ®  (durvalumab)  for patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT)....

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February 22, 2018

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Spark Therapeutics to be acquired by Roche at $113.47 UP $61.91 

We congratulate our subscribers who kept  Spark Therapeutics ( ONCE ) in spite of the stock’s kind of paralysis for no serious reasons. Spark, a fully integrated, commercial gene therapy company, announced today that it has entered into a definitive merger agreement...

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February 25, 2019

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