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Drug Discovery and Development
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Trials & Filings
Ultragenyx Posts HIBM Topline Results
Positive results against muscle-wasting disease
Gil Roth
12.20.13
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GSK, Theravance COPD Treatment Approved
Approval triggers $30 million payment from Theravance, with another $30 mil. due to GSK at launch
Gil Roth
12.19.13
Bio News
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Biologics, Proteins, Vaccines
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Sandoz Begins Global Testing of Humira Biosimilar
Adds to anti-inflammatory biosimilar portfolio
Gil Roth
12.19.13
Bio News
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Pfizer Completes Enrollment in MultiStem Colitis Trial
Trial springs from 2009 collaboration with Aethersys
Gil Roth
12.19.13
Clinical Trials
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Inspections
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Daiichi Submits sNDA for Lixiana
Seeks Japanese approval for AF, VTE
Gil Roth
12.19.13
Bio News
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NewLink Begins Renal Immunotherapy Trial
Dose-escalation study uses two allogeneic renal cell cancer lines
Gil Roth
12.19.13
Bio News
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Biologics, Proteins, Vaccines
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Genzyme MS Treatment Approved in Australia
Follows approvals in Canada, EU
Gil Roth
12.19.13
Clinical Trials
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Trials & Filings
Galectin Posts Positive Preclinical NASH Data
Ph I trial of galectin-3 inhibitor is ongoing
Gil Roth
12.19.13
Clinical Trials
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Inspections
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Vertex CF Treatment Misses Endpoint
Subset shows significant improvement in lung function
Gil Roth
12.19.13
Bio News
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Biologics, Proteins, Vaccines
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Arzerra sBLA for CLL Gets Priority Review status
GSK, Genmab biologic gets PDUFA date of April 19, 2014
Gil Roth
12.18.13
Bio News
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Biologics, Proteins, Vaccines
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Ipsen To Resupply EU with Increlex
CMO issues apparently resolved
Gil Roth
12.18.13
Bio News
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Octapharma Begins Enrolling MS Patients
Looks for lower annualized relapse rate in patient subset
Gil Roth
12.18.13
Bio News
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Omeros Gets Orphan Designation for TMA Treatment
MASP-2 targeter to begin Ph II in 1Q14
Gil Roth
12.18.13
Bio News
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Biologics, Proteins, Vaccines
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Eylea sBLA Accepted for Standard Review
Followup application covers DME indication
Gil Roth
12.18.13
Bio News
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Biologics, Proteins, Vaccines
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Clinical Trials
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Versartis GHD Treatment Gets Orphan Status
Monthly rhGH currently in safety/efficacy trials for pediatric patients
Gil Roth
12.18.13
Capsules
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Mylan, Banner To Market Generic Targretin
Reach settlement with Eisai, Valeant
Gil Roth
12.18.13
Clinical Trials
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GMPs/GCPs
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Inspections
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Regulatory Affairs
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Trials & Filings
Gilead Posts SOF/LDV SVR12 Results
Fixed-dose combo wallops HCV-1 infection
Gil Roth
12.18.13
Clinical Trials
|
GMPs/GCPs
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Trials & Filings
Andromeda Begins Dosing in Diabetes Extension Study
Testing DiaPep277 on two-year patients of DIA-AID 2 trial
Gil Roth
12.18.13
Bio News
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Biologics, Proteins, Vaccines
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Clinical Trials
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ArGEN-X Antibody Hits Dose Escalation Goals
Will expand Ph Ib trial to hematology, solid tumor cohorts
Gil Roth
12.17.13
Bio News
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Biologics, Proteins, Vaccines
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Clinical Trials
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Trials & Filings
Good Results for Dysport in Spasticity Trial
Ipsen botulinum toxin performs well against Adult Upper Limb spasticity
Gil Roth
12.17.13
Breaking News
Ascend Taps Scott Law as COO
FibroBiologics Discusses Opportunities to Work with Charles River
Lilly Acquires Manufacturing Facility from Nexus Pharmaceuticals
Kühne Holding AG Agrees to Acquire Aenova Group
BigHat Biosciences Partners with Janssen Biotech to Guide Antibody Discovery & Design
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April 2024
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Industry Experts Weigh in on Oral Solid Dosage
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