BioSpace News Archive

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• Pharm Country

  Acorda Announces Royalty Monetization Transactions for $53M

  In return for the payment to Acorda, HCR obtains the right to receive royalty revenue on FAMPYRA payable by Biogen, up to an agreed upon threshold of royalties.

  November 17, 2017

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  5 min read
• MiMedx Market Leadership Well Positioned in Light of FDA New Guidance Document

  In the final HCT/P Guidance document, FDA updated and clarified its previous draft Guidance documents regarding HCT/Ps.

  November 17, 2017

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  9 min read
• SenesTech Announces Pricing of Public Offering of Common Stock and Warrants to Purchase Common Stock

  The warrants will have an exercise price of $1.50 per share, are exercisable immediately and will expire five years from the date of issuance.

  November 17, 2017

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  4 min read
• Business

  BioDiscovery Forms Partnership With Be Creative Lab (Beijing) Co. Ltd. for Distribution of NxClinical Software

  The two companies inked the deal at the recent 2017 Clinical Application Conference in Beijing hosted by Be Creative.

  November 17, 2017

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  5 min read
• Successful First-in-Human Testing of Implandata’s Next Generation EYEMATE Micro-Sensor for Improved Monitoring of Glaucoma Patients

  Implandata now reports that its optimized next generation EYEMATE micro-sensor implant for intraocular placement has successfully passed first-in-human validation.

  November 17, 2017

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  3 min read
• Policy

  Statement by FDA Commissioner Scott Gottlieb, M.D., on Efforts to Address Impact of IV Fluid Shortages Following Hurricane Destruction and Resolve Manufacturing Shortfalls

  It’s been nine weeks since Hurricane Maria made landfall on Puerto Rico and the island continues to struggle to recover from the devastation brought by this storm, as well as Hurricane Irma.

  November 17, 2017

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  5 min read
• VBL Therapeutics Prices 2.5 Million Ordinary Share Offering

  The offering is subject to customary closing conditions and is expected to close on or about November 21, 2017.

  November 17, 2017

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  4 min read
• Drug Development

  Celldex Therapeutics Initiates Phase II Combination Study of CDX-3379 and Cetuximab in Head and Neck Squamous Cell Carcinoma

  The study will enroll approximately 30 patients with cetuximab-resistant, advanced HNSCC who have previously been treated with an anti-PD1 checkpoint inhibitor.

  November 17, 2017

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  6 min read
• 

  Policy

  FDA Extends Review for Lipocine’s TLANDO; Advisory Committee Meeting Date of January 10, 2018 Remains Unchanged

  The FDA has assigned a new Prescription Drug User Fee Act goal date of May 8, 2018.

  November 17, 2017

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  3 min read
• Business

  Ascendis Pharma Reports Third Quarter 2017 Financial Results

  For the third quarter, Ascendis reported a net loss of €33.9 million, or €1.04 per share (basic and diluted) compared to a net loss of €18.3 million, or €0.72 per share (basic and diluted) for the same period in 2016.

  November 17, 2017

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  8 min read