BioSpace News Archive

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• Drug Development

  MEI Pharma Announces Study of Clinical Stage Oral CDK Inhibitor Voruciclib Published in Nature Scientific Reports

  Researchers found that voruciclib when combined with the BCL-2 inhibitor Venclexta was capable of inhibiting two master regulators of drug resistance, MCL-1 and BCL-2.

  December 21, 2017

   · 

  5 min read
• Drug Development

  CANbridge Life Sciences Submits Investigational NDA for CAN017 Trial in Esophageal Squamous Cell Cancer (ESCC) in China

  CANBridge Life Sciences announced that it has submitted an IND application to the CFDA for a Phase Ib/III clinical study of CAN017 in ESCC.

  December 21, 2017

   · 

  4 min read
• 

  Policy

  Gynesonics Announces Submission of FDA 510k for Incision-Free Treatment of Symptomatic Uterine Fibroids

  The Sonata System is designed to treat fibroids transcervically with radiofrequency energy guided by an integrated intrauterine ultrasound probe.

  December 21, 2017

   · 

  2 min read
• Biotech Bay

  CancerVX, an OncoEpigenetic DNA Immuno Therapy From World Cancer Institute Targets Female Hormonal Cancers, 5 Other Solid Tumor and 4 Hematological Malignancies and May Become the First Bioactive Personalized Universal Cancer Vaccine

  World Cancer Institute Inc., today announced the evolutionary platform of cancer clinical protocols originating initially in 2008 /2009 based on molecular cancer genetics and DNA programmable pharmaceutics to inhibit the growth, replication and proliferation of human cancer cells.

  December 21, 2017

   · 

  2 min read
• Business

  Transgene Announces Financial Calendar for 2018

  Transgene today announced its financial reporting dates for 2018: March 21, 2017 Fiscal Year Results.

  December 21, 2017

   · 

  1 min read
• FDA

  Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency

  AEterna Zentaris announced today that the FDA has granted marketing approval for Macrilen, an orally available ghrelin agonist, to be used in the diagnosis of patients with AGHD.

  December 21, 2017

   · 

  5 min read
• 

  Business

  TRACON Pharma, Ambrx Ink Deal Up to $143.5M for TRC105

  TRACON will receive an upfront payment of $3M, and is eligible to receive development and regulatory milestones of up to $10.5M, and commercial sales milestones of up to $130M.

  December 21, 2017

   · 

  5 min read
• Drug Development

  FDA Grants RMAT Designation For Mesoblast’s Cell Therapy in Heart Failure Patients With LVADs

  The RMAT designation under the 21st Century Cures Act aims to expedite the development of regenerative medicine therapies intended for the treatment of serious diseases and life-threatening conditions.

  December 21, 2017

   · 

  8 min read
• Nemaura Announces Completion of SugarBEAT European Clinical Trial Programme and Positive Interim Results

  Nemaura announced the completion of its sugarBEAT European clinical trial programme and positive interim accuracy data.

  December 21, 2017

   · 

  3 min read
• Business

  Aetna Joins SAFE-BioPharma Association

  It is the first health care benefits company to join the association.

  December 21, 2017

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  2 min read