BioSpace News Archive

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  Drug Development

  Kura Sees Quick Resolution as FDA Lifts AML Study Hold

  The FDA has lifted the partial hold on Kura Oncology’s KOMET-001 Phase IB trial on a potential treatment for acute myeloid leukemia.

  January 21, 2022

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Bio NC

  SPONSORED | BioCryst’s First Rare Disease Drug Exceeds Expectations One Year into Launch

  When presented with ORLADEYO, both patients and physicians recognized immediately the freedom gained with the once-daily prophylactic therapy and indicated a high willingness to use.

  January 21, 2022

   · 

  7 min read
• 

  BioCapital

  BIO Report Outlines Economic Impact of Booming Life Sciences Industry

  The Biotechnology Innovation Organization provides a glimpse of economic development in the biosciences ecosystem at the state and regional levels.

  January 21, 2022

   · 

  3 min read

   · 

  Alex Keown
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  Drug Development

  FDA Action Alert: Bristol Myers Squibb and Azurity

  January has been a largely quiet month for PDUFA dates on the U.S. Food and Drug Administration (FDA)’s calendar. There were two dates for the entire month, and one of those has been moved back to April. Here’s a look.

  January 21, 2022

   · 

  3 min read

   · 

  Mark Terry
• 

  Policy

  Defining “Hospitalized For or With COVID”, and Lions and Pumas, Oh My

  Public health officials churn out a lot of statistics related to COVID-19, but it can often be difficult to determine just how accurate they are because there are just so many unreported test results.

  January 21, 2022

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  5 min read

   · 

  Mark Terry
• 

  BioCapital

  Pig Heart Transplant Recipient Reaches 2-Week Milestone, Hope for Kidney Patients

  Xenotransplantation company United Therapeutics Corporation is making significant headway in using genetically modified animal organs as a replacement for failing organs in humans.

  January 21, 2022

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  3 min read

   · 

  Alex Keown
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  Drug Development

  Elon Musk’s Brain Implants Move Toward In-Human Trials

  Visionary tech magnate Elon Musk is taking his neurotech company to the next step toward in-human trials of his implantable brain-machine interface.

  January 21, 2022

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  2 min read

   · 

  Kate Goodwin
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  FDA

  Early Immunotherapy for Peanut Allergies Shows Potential in Toddlers

  After receiving daily doses of the therapeutic, 71% of the children could tolerate the equivalent of 16 peanuts and six months later, 21% of them still could.

  January 21, 2022

   · 

  2 min read

   · 

  Hayley Shasteen
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  Biotech Beach

  Sorrento’s Covishield Demonstrating Serious Game Against Omicron

  Sorrento Therapeutics announced its COVID-19 treatment, Covishield, shows major progress in neutralizing Omicron and Omicron (+R346K) variants of SARS-COV-2.

  January 21, 2022

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  2 min read

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  Alvin Clavines
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  Drug Development

  Yvonne Greenstreet Aims to Take Alnylam to the Top 5 by ’25

  The data is coming in right away for Alnylam in one of its primary indications, transthyretin-mediated (ATTR) amyloidosis.

  January 21, 2022

   · 

  6 min read

   · 

  Heather McKenzie