BioSpace News Archive

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  Policy

  6 Biotechs Facing Make-or-Break FDA PDUFA Catalysts in November

  Here’s a closer look at six drugs facing FDA decisions in November.

  October 31, 2017

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  2 min read

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  Mark Terry
• New Analyses Reinforce Hemodynamic Benefits of Medtronic Evolut TAVR Platform in Intermediate Risk Aortic Stenosis Patients

  Data of the FORWARD ‘real-world’ study were presented at the Transcatheter Cardiovascular Therapeutics Annual Meeting.

  October 31, 2017

   · 

  3 min read
• 

  Drug Development

  Indivior Explodes After the FDA Panel Backs Opioid Addiction Drug

  The FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18 to 1 to recommend Indivior’s RBP-6000 to treat opioid use disorder.

  October 31, 2017

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  2 min read

   · 

  Mark Terry
• BioMidwest

  Grand River Aseptic Manufacturing Sponsoring Grand Rapids .1K to End Duchenne

  Proceeds from the 100-meter race on Nov. 4 will be donated to Parent Project Muscular Dystrophy (PPMD), the largest U.S. nonprofit organization focused on ending Duchenne muscular dystrophy.

  October 31, 2017

   · 

  1 min read
• Business

  Maxhealth to Distribute Legacy’s Hair Loss Treatment in China

  Maxhealth Medicine of Wuxi, China struck a deal with Switzerland’s Legacy Healthcare to commercialize Legacy’s CG 210 in Mainland China and Macao.

  October 31, 2017

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  1 min read
• Genetown

  NANOBIOTIX Launches Capital Increase by Means of an Accelerated Bookbuild Offering - Oct. 31, 2017

  The company intends to issue up to 1,941,789 new shares.

  October 31, 2017

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  8 min read
• Novo Nordisk A/S: Share Repurchase Programme - Oct. 13, 2017

  This programme is part of the overall share repurchase programme of up to DKK 16 billion to be executed during a 12-month period beginning 2 February 2017.

  October 31, 2017

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  2 min read
• Week in Review: China Resources Pharma Files for $369 Million China Life Science Investment Fund

  China Resources Pharma announced plans to raise $368.5 million for a China life science investment fund.

  October 31, 2017

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  1 min read
• 

  FDA

  FDA Clears Abbott’s Alinity ci-series Next-Generation Diagnostic System

  Abbott has secured FDA clearance for its Alinity ci-series instruments for clinical chemistry and immunoassay diagnostics.

  October 31, 2017

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  4 min read
• 

  FDA

  BRH Medical Snags FDA OK for its Patented BRH-A2 Combined Ultrasound and Electric Field Stimulation Device

  The BRH-A2 device is a non-invasive BRH-A2 System that can be used together with any treatment modality.

  October 31, 2017

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  2 min read