BioSpace News Archive

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• 

  Genetown

  Sarepta Shares Plunge Temporarily After Serious Side Effect Mistakenly Reported

  It was reported that a boy in Sarepta Therapeutics clinical trial for its micro-dystrophin gene therapy for Duchenne muscular dystrophy had a serious adverse event. However, the company indicates the adverse event report was submitted erroneously.

  August 9, 2019

   · 

  3 min read

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  Mark Terry
• 

  Policy

  Canadian Government Takes U.S. and Switzerland Off Drug Pricing Comparison List, Pushes for More Transparency

  This is an area where the U.S. is considering changes as well. Earlier this year, the U.S. Department of Health and Human Services proposed a new policy called the International Pricing Index.

  August 9, 2019

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  Lexicon Posts Positive 52-Week Pooled Zynquista Data in Type 1 Diabetes

  The pooled data results came five months after the FDA rejected Zynquista following a split advisory committee vote.

  August 9, 2019

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  2 min read

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  Alex Keown
• 

  Drug Development

  Clinical Catch-up for August 5-9

  Last week was a particularly busy week for biopharma companies to release information about ongoing clinical trials. Here’s a look.

  August 9, 2019

   · 

  9 min read

   · 

  Mark Terry
• 

  Policy

  FDA Action Alert: Regeneron, Kala and Vanda

  Now that July has come and gone, the U.S. Food and Drug Administration is back to work approving drugs. This week marks three PDUFA target action dates, although one has already been rejected and another hit a snag that doesn’t appear to affect the decision date.

  August 9, 2019

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  AstraZeneca’s Tagrisso Hits the OS Mark in Phase III Lung Cancer Trial

  Tagrisso improved overall survival in lung cancer patients.

  August 9, 2019

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  2 min read

   · 

  Alex Keown
• 

  Policy

  FDA Issues Draft Guidance for Fabry Disease Drugmakers

  Before it finalizes the guidance, the FDA is seeking comment from drugmakers about the proposed plans.

  August 9, 2019

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  2 min read

   · 

  Alex Keown
• 

  Immunoglobulin Shortages Pressure Hospitals and Manufacturers While Patients Suffer

  The shortage isn’t new, although it appears to be hitting more of a crisis point.

  August 9, 2019

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  4 min read

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  Mark Terry
• Policy

  OssDsign AB (publ) Initiates Commercial Preparations for Launch in Japan Following Regulatory Filing for OssDsign Cranial

  OssDsign AB, the Swedish designer and manufacturer of innovative implants for bone regeneration, has filed for a Japanese regulatory approval of OssDsign Cranial.

  August 9, 2019

   · 

  3 min read
• Deals

  Innovus Pharmaceuticals to Release Second Quarter 2019 Financial Results and Provide Corporate Update on Tuesday, August 13, 2019

  Innovus Pharmaceuticals, Inc. announced that the Company will release its second quarter 2019 financial results and provide a corporate update on Tuesday, August 13, 2019, after the close of the U.S. financial markets.

  August 9, 2019

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  3 min read