BioSpace News Archive

Year

• 2005
• 2006
• 2007
• 2008
• 2009
• 2010
• 2011
• 2012
• 2013
• 2014
• 2015
• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

Month

• January
• February
• March
• April
• May
• June
• July
• August
• September
• October
• November
• December

Day

• 1
• 2
• 4
• 5
• 6
• 7
• 8
• 9
• 10
• 11
• 12
• 13
• 14
• 15
• 17
• 18
• 19
• 20
• 21
• 22
• 24
• 25
• 26
• 27
• 28
• 29
• 30

• Policy

  BioMarin Receives Anticipated Notification of PDUFA Extension for Pegvaliase BLA to May 28, 2018

  In a notice received from the FDA, the PDUFA Goal Date for pegvaliase has been extended by three months to May 28, 2018.

  December 22, 2017

   · 

  5 min read
• Drug Development

  Clover Biopharmaceuticals Receives CFDA Approval to Initiate Clinical Trials in China with Etanercept Biosimilar Candidate SCB-808

  A phase I clinical trial is planned to initiate in China in mid-2018.

  December 22, 2017

   · 

  2 min read
• Viemed Commences Trading on the TSXV

  The common shares of Viemed (the “Viemed Shares”) will commence trading on the TSX Venture Exchange (the “TSXV”) on December 22, 2017 under the stock symbol “VMD”.

  December 22, 2017

   · 

  8 min read
• Policy

  Antares Pharma Provides XYOSTED Regulatory Update

  Antares Pharma today announced that a written request for a Type A meeting, along with a comprehensive briefing document, have been submitted to the FDA, in response to the CRL received by Antares.

  December 22, 2017

   · 

  5 min read
• FDA

  La Jolla Pharmaceutical Company Announces FDA Approval of Giapreza (angiotensin II)

  La Jolla announced that the FDA has approved Giapreza to increase blood pressure in adults with septic or other distributive shock.

  December 22, 2017

   · 

  5 min read
• Biotech Bay

  Fluidigm Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

  Fluidigm today announced that the Compensation Committee of its Board of Directors, which is comprised entirely of independent directors, granted an equity award on December 15, 2017.

  December 22, 2017

   · 

  2 min read
• Business

  Humanigen Signs Definitive Agreements to Exchange Loan Obligations for Equity

  The transactions are expected to close in the first quarter of 2018 subject to the satisfaction of certain conditions contained in the definitive agreements.

  December 22, 2017

   · 

  7 min read
• Genetown

  Proteostasis Therapeutics Announces Completion of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

  Net proceeds from this offering were approximately $42.9M, after deducting underwriting discounts and commissions and estimated offering expenses.

  December 22, 2017

   · 

  4 min read
• Forward Pharma Files Final Brief in its Appeal of the U.S. Patent Interference to the Federal Circuit

  Forward Pharma today announced the filing of its reply brief to the U.S. Court of Appeals for the Federal Circuit in the appeal of the PTAB’s decision in the interference proceeding between the Forward 11/576,871 patent application and an issued Biogen patent.

  December 22, 2017

   · 

  3 min read
• BioMidwest

  DiaMedica Therapeutics Announces Results of Annual General and Special Meeting of Shareholders

  DiaMedica today announced that at its Annual General and Special Meeting of shareholders held on December 21, 2017.

  December 22, 2017

   · 

  2 min read