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CP Wire Articles

FDA Releases Six New Draft Guidances on Gene Therapy

On 7/11/2018 FDA Commissioner, Scott Gottlieb, announced the release of six new draft guidance documents related to gene therapy development. In the announcement, Gottlieb acknowledged the... read more

Thu, 07/12/18 - 09:51 am
Landos Biopharma Initiates Ph I Trial of First-in-class Oral Treatment for IBD
  • BT-11 is a first-in-class, oral, locally-acting small molecule
  • BT-11 has demonstrated a 90% reduction of inflammation by acting locally in the gut mucosa in 4 validated mouse models... read more
Thu, 07/12/18 - 09:17 am
Seattle Genetics Doses First Patient In Ph II Trial of Antibody-drug Conjugate in Multiple Solid Tumors
  • Trial is Enrolling Patients with Colorectal, Non-Small Cell Lung, Pancreatic or Head and Neck Cancers
  • Earlier study demonstrated an encouraging response rate in patients with... read more
Thu, 07/12/18 - 08:58 am
Opdivo Gains New Approval in Combination with Yervoy
  • Approved in patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a... read more
Wed, 07/11/18 - 10:11 am
Takeda's Ninlaro Met Primary Endpoint in Ph III Trial In Patients with Multiple Myeloma Post Stem Cell Transplant



  • Ninlaro maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo.
  • Ninlaro has orphan drug status in... read more
Wed, 07/11/18 - 09:56 am

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