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FDA Approves Utility Therapeutics’ Pivya in UTIs
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[WEBINAR] Headspace Gas Ingress Methods - The Golden Tool for Container Closure Integrity Testing
[WEBINAR] Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model
Headspace Gas Ingress Methods - The Golden Tool for Container Closure Integrity Testing
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Aseptic Processing
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Inspections
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Trials & Filings
Kala Files IND for MPP Formulation
Seeks test in post-cataract patients
Gil Roth
01.06.14
Bio News
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Capsules
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Trials & Filings
Trials & Filings in Brief: Jan. 6, 2014
Alkermes, DiaVacs, Kala, Oxygen Biotherpeutics, Peregrine, TauRx
Gil Roth
01.06.14
Clinical Trials
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TauRx Expands Alzheimer's Programs
Adds 35 research centers in U.S. for LMTX studies
Gil Roth
01.06.14
Bio News
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Biologics, Proteins, Vaccines
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Peregrine Gets Fast Track Status for NSCLC Biologic
Bavituximab Phase III trial recently initiated
Gil Roth
01.06.14
Bio News
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Biologics, Proteins, Vaccines
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Trials & Filings
DiaVacs T1DM Immunotherapy Gets Orphan Status
Phase II diabetes trial begun
Gil Roth
01.06.14
Capsules
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Clinical Trials
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Formulation Development
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Solid Dosage/Semi-solids
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Alkermes Receives MMF Patent
Expects to begin trials of MS prodrug in mid-2014
Gil Roth
01.06.14
Bioassay Development
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Drug Development
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FDA Lifts Clinical Hold on Cell Therapeutics Drug
Phase II Tosedostat trials in blood cancer resume
Kristin Brooks
01.02.14
Bioassay Development
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Veloxis Gains Orphan Status for Envarsus
Once-daily formulation offers potential in kidney transplants
Kristin Brooks
12.30.13
Breaking News
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Vials
Trials & Filings in Brief: Dec. 20, 2013
Amarin, Bristol-Myers Squibb, Cellceutix, FibroGen, MicuRx, Pfizer, Ultragenyx
Gil Roth
12.20.13
Clinical Trials
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Trials & Filings
Cellceutix Files for Orphan Designation
Defensin mimetic treats oral mucositis in radiation and chemotherapy patients.
Gil Roth
12.20.13
Capsules
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Amarin sNDA To Miss PDUFA Date
FDA to review SPA for label expansion trial
Gil Roth
12.20.13
Clinical Trials
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FibroGen Begins IPF Trial Enrollment
Positive results from open-label study inspires new trial design
Gil Roth
12.20.13
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MicuRx Expands Antibiotic Program
Ph II goes global, Ph I begins in Australia, goal to file IND with FDA
Gil Roth
12.20.13
Clinical Trials
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Trials & Filings
FDA Accepts Eliquis sNDA
BMS, Pfizer seek new indications against DVT, PE
Gil Roth
12.20.13
Clinical Trials
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GMPs/GCPs
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Trials & Filings
Ultragenyx Posts HIBM Topline Results
Positive results against muscle-wasting disease
Gil Roth
12.20.13
Bio News
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Genzyme MS Treatment Approved in Australia
Follows approvals in Canada, EU
Gil Roth
12.19.13
Capsules
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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
Clinical Trials
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GMPs/GCPs
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Inspections
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Trials & Filings
Daiichi Submits sNDA for Lixiana
Seeks Japanese approval for AF, VTE
Gil Roth
12.19.13
Bio News
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Biosimilars
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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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Trials & Filings
Pfizer Completes Enrollment in MultiStem Colitis Trial
Trial springs from 2009 collaboration with Aethersys
Gil Roth
12.19.13
Breaking News
Regeneron & Mammoth Partner on CRISPR Therapies
FDA Approves Utility Therapeutics’ Pivya in UTIs
Actym Therapeutics Taps Industry Veteran as CEO
Multiply Labs and GenScript Partner to Automate Cell Isolation
Parexel, Palantir Expand AI Alliance
View Breaking News >
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April 2024
Anti-Counterfeiting Technology
Navigating Global CDMO Trends
Weight-loss Drug Packaging
Clinical Supply CDMOs
Industry Experts Weigh in on Oral Solid Dosage
Newsmakers Q&A: Almac Group
Economical Mobile Workstations for Lower-Grade Cleanrooms
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