BioSpace News Archive

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• Policy

  Kyowa Hakko Kirin Announces Marketing Authorisation Application for Mogamulizumab Validated by the EMA

  Kyowa Hakko Kirin announces that its MAA for mogamulizumab, for the treatment of cutaneous T-cell lymphoma in adults who have received at least one prior systemic therapy.

  October 27, 2017

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  2 min read
• Orexo Announces Conditional Total Redemption of its Senior Unsecured Bonds

  Orexo announces today that the Company will issue a notice of conditional early total redemption of its outstanding SEK 342,000,000 senior unsecured callable floating rate bonds due 2018 with ISIN SE0005932159 in accordance with the terms and conditions of the Bonds.

  October 27, 2017

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  3 min read
• Business

  Hoya Reports Second Quarter Results; Record Half Year Results

  Hoya Corporation today announced financial results for the second quarter ended September 30, 2017.

  October 27, 2017

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  2 min read
• 

  Drug Development

  AbbVie Receives FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

  AbbVie expects the PDUFA date for the FDA to complete its review will be in Q2 2018.

  October 27, 2017

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  5 min read
• 

  FDA

  Butterfly Network’s First Ultrasound-on-a-Chip Receives Broadest FDA 510(k) Clearance

  The clearance covers 13 clinical applications, the broadest ever for a single ultrasound transducer.

  October 27, 2017

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  4 min read
• Business

  ICON and the International Consortium for Health Outcomes Measurement Unveil the World’s First Global Patient Outcomes Benchmarking Platform

  ICON, and the International Consortium for Health Outcomes Measurement (ICHOM) shared the findings of a global patient outcomes benchmarking platform at this week’s ICHOM’s annual conference in Washington DC.

  October 27, 2017

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  6 min read
• Biotech Beach

  Ionis Pharma Announces Plans to Open Expanded Access Program to Provide Inotersen to Patients With Hereditary TTR Amyloidosis in the U.S.

  Ionis Pharma announced today that it plans to open an expanded access program for eligible patients with hereditary transthyretin amyloidosis with polyneuropathy in the coming months.

  October 27, 2017

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  6 min read
• Microbix Completes Second Tranche of Brokered Private Placement

  Microbix has now closed a second tranche of private placement financing for further gross proceeds of $1.17 million, resulting in the issue of 3,882,133 more Units at a price of $0.30 per Unit.

  October 27, 2017

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  4 min read
• Pharm Country

  Relmada Therapeutics Announces Notice of Acceptance of Key Patent in Australia Covering NMDA Receptor Antagonist d-Methadone for Treatment of Psychiatric Symptoms

  Relmada Therapeutics announced today that IP Australia has issued a notice of acceptance for patent application number 2013323645 for “D-methadone for the treatment of psychiatric symptoms.""

  October 27, 2017

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  4 min read
• Drug Development

  CureVac Initiates Phase I Clinical Trial of RNAdjuvant Candidate As Intratumoral Therapy for Solid Tumors

  CureVac today announced it has initiated a Phase I study assessing the intratumoral application of its novel RNAdjuvant technology in patients with superficial solid tumors that are easily accessible for repeated intratumoral injections.

  October 27, 2017

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  3 min read