BioSpace News Archive

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• Policy

  Amicus Therapeutics Submits New Drug Application to U.S. FDA for Migalastat for Treatment of Fabry Disease

  Migalastat previously received both Orphan Drug Designation and Fast Track designation from the U.S. FDA.

  December 14, 2017

   · 

  9 min read
• Drug Development

  Akcea Initiates Phase II Study of AKCEA-ANGPTL3-LRx in Patients With Hypertriglyceridemia, Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease (NAFLD)

  The primary goal of the study is to determine the dose level and frequency for use of AKCEA-ANGPTL3-LRx in future registration studies.

  December 14, 2017

   · 

  5 min read
• Genetown

  HSS and pSivida Report Positive Phase I Knee Osteoarthritis Pain Study Data

  The implant was designed to deliver a continuous-low dose of dexamethasone into the knee joint for several months.

  December 14, 2017

   · 

  8 min read
• Business

  Axsome Therapeutics Collaborates With World-Leading Nicotine Addiction Research Center for Phase II Trial of AXS-05 in Smoking Cessation

  This collaboration builds upon preclinical research conducted at Duke demonstrating positive effects of the dextromethorphan component of AXS-05.

  December 14, 2017

   · 

  8 min read
• Genetown

  Jounce Therapeutics Added to NASDAQ Biotechnology Index

  The addition will take effect prior to the open of the U.S. markets on Monday, December 18, 2017.

  December 14, 2017

   · 

  1 min read
• Singapore Institutes Collaborate With Samsung Medical Center to Improve Treatment of Liver Cancer

  Scientists and doctors from Singapore institutes are collaborating with SMC to develop the world’s first clinically reliable and robust platform that will significantly improve the treatment of hepatocellular carcinoma or liver cancer.

  December 14, 2017

   · 

  4 min read
• Business

  Kraig Biocraft Laboratories Begins Operations in New Laboratory

  The Company expects to begin the testing of existing spider silk formulations and the construction of new formulations before Christmas.

  December 14, 2017

   · 

  2 min read
• Galectin Therapeutics Provides Corporate Update at Annual Meeting

  The NASH-CX trial was a randomized, double-blind, placebo-controlled Phase 2b clinical trial which enrolled 162 NASH cirrhosis patients into the treatment phase.

  December 14, 2017

   · 

  7 min read
• Business

  Cinfa Biotech Begins U.S. Partnering and Prepares U.S. Development for B12019, a Proposed Biosimilar to Neulasta (Pegfilgrastim)

  Cinfa Biotech S.L. today announced the start of US partnering and the preparation of US development for its drug candidate B12019, a biosimilar of Neulasta to treat chemotherapy-induced neutropenia.

  December 14, 2017

   · 

  2 min read
• Drug Development

  BTG Release: Centers Commence Enrollment in KNOCOUT PE Study to Measure the Impact of Shorter, Even Safer EKOS Therapy Protocols for Pulmonary Embolism

  At full enrollment, KNOCOUT PE is expected to include up to 100 centers internationally.

  December 14, 2017

   · 

  4 min read