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Implementing an Automated DOE in Twin Screw Wet Granulation
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Parexel Announces CEO Transition
DifGen Acquires FDA-Registered Manufacturing Facility
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Plenaries Discuss AI and Next-Gen Modality Development at AAPS NBC
SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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Trials & Filings
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Drug Discovery and Development
Contract Manufacturing
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Compliance
Amgen’s Phase III Evolocumab Trial Meets Endpoints
Reduces LDL-C in statin intolerant patients
Kristin Brooks
01.23.14
Drug Delivery
Merrimack Initiates Phase I MM-398 Trial
To evaluate cyclophosphamide combination in pediatric tumors
Kristin Brooks
01.23.14
Capsules
Pfizer's Phase III ALO-02 Trial Meets Endpoint
Demonstrates statistically significant benefit
Kristin Brooks
01.23.14
Trials & Filings
Gilead's Sovaldi Gains EU Approval
Authorization follows accelerated EMA assessment
Kristin Brooks
01.17.14
Capsules
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Dosing Begins in Elite Bioequivalence Study
Camargo conducts abuse-deterrence study under 505(b)2
Gil Roth
01.15.14
Clinical Trials
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Galectin Drug in Early Test Against Melanoma
EACRI to test galectin-3 inhibitor with Yervoy in metastatic melanoma
Gil Roth
01.15.14
Clinical Trials
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GMPs/GCPs
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La Jolla Launches Extension Study
12-week program continues with CKD patients
Gil Roth
01.15.14
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Antarex MTX Auto-Injector Reaches Market
Otrexup approved in October 2013 for RA, pJIA
Gil Roth
01.15.14
Clinical Trials
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GMPs/GCPs
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AbbVie Begins Triple-Negative Breast Cancer Trial
Veliparib to be added to carboplatin in Ph III trial
Gil Roth
01.15.14
Chemistry
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Clinical Trials
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MediciNova Posts Strong NASH Results
Preclinical tests in mice lead to Ph II plans
Gil Roth
01.14.14
Clinical Trials
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Nektar Doses First Patients in Neuropathic Pain Study
Testing pharmacokinetics of novel pain-blocker
Gil Roth
01.14.14
Clinical Trials
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GSK NSCLC Drug Wins Breakthrough Status
FDA recognizes need for dabrafenib treatment
Gil Roth
01.14.14
Clinical Trials
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MEI Doses First MDS Patient
Tests pracinostat in patients failing HMA therapy
Gil Roth
01.14.14
Clinical Trials
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BioMarin Begins Dwarfism Trial
Tests CNP analog against achondoplasia in children
Gil Roth
01.14.14
Clinical Trials
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D-Pharm Recruits First Pancreatitis Patient
Ph II study to involve 30 patients
Gil Roth
01.14.14
Bio News
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Generex Completes Cancer Immunotherapy Enrollment
Ph II trial in breast cancer to include 300+ patients
Gil Roth
01.13.14
Clinical Trials
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Gilead iNHL Drug Gets PDUFA Date
Idelalisib has Breakthrough designation for CLL
Gil Roth
01.13.14
Clinical Trials
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Ampio Begins Dosing in Pivotal Trial
Ampion to test against OAK
Gil Roth
01.13.14
Bio News
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Merck Files Rolling BLA for anti-PD-1 Treatment
Filing covers advanced melanoma, expected to be complete in 1H14
Gil Roth
01.13.14
Clinical Trials
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GMPs/GCPs
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Trials & Filings
Galectin Enrolls First NASH Cohort
Begins first-in-man study of GR-MD-02
Gil Roth
01.13.14
Breaking News
Parexel Announces CEO Transition
DifGen Acquires FDA-Registered Manufacturing Facility
Quotient Sciences Makes Executive Leadership Team Appointments
Plenaries Discuss AI and Next-Gen Modality Development at AAPS NBC
SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
View Breaking News >
CURRENT ISSUE
March 2024
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Multi-particulate Formulations – Tablets or Capsules?
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