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AIVITA Biomedical Receives IND Clearance for Phase 1B Melanoma Trial

Jan 17, 2019
AIVITA Biomedical announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1B clinical trial investigating the…
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Nexus Pharmaceuticals announces FDA approval of Busulfan Injection

Jan 17, 2019
Nexus Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approval of Busulfan Injection, the company's AP-rated therapeutic equivalent for Busulfex 60 mg/10…
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Luye Pharma Reaches Strategic Partnership with AstraZeneca

Jan 17, 2019
Luye Pharma has announced it has entered an agreement with AstraZeneca China, the terms of which grant AstraZeneca China exclusive rights to promote Luye Pharma's Xuezhikang Capsules in…
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Phoenix Molecular Designs Announces Collaboration To Develop Diagnostic for Triple-Negative Breast…

Jan 17, 2019
Phoenix Molecular Designs announced that it has entered into a collaboration with Roche to develop a diagnostic (CDx) in triple-negative breast cancer (TNBC). The Roche CDx identifies…
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FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients…

Jan 16, 2019
The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an…
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Abbott To Acquire Cephea Valve Technologies

Jan 16, 2019
Abbott announced that it has exercised its option to purchase Cephea Valve Technologies, Inc., a privately held medical device company developing a less-invasive heart valve replacement…
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Tom Parke to lead a workshop on the new FDA draft guidance on Adaptive designs during the 11th…

Jan 16, 2019
SMi Group are delighted to have industry expert Tom Parke to lead the post-conference workshop during Adaptive Designs in Clinical Trials 2019. The 11th Annual Adaptive Designs in…
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Pharmaceutical Microbiology UK CONFEX takes place in less than a week!

Jan 16, 2019
SMi reports: Registration will close in less than week, as the countdown begins for the 8th Annual Pharmaceutical Microbiology UK Conference. The 8th Annual Pharmaceutical…
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SLN124 granted Orphan Drug Designation by EMA for the treatment of β-Thalassemia

Jan 16, 2019
Silence Therapeutics announces that its lead medicine candidate SLN124 has been granted Orphan Drug Designation by the Committee for Orphan Medicinal Products (COMP), the European…
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Cobra Biologics appoints Dr Darrell Sleep as Director of Innovation

Jan 16, 2019
Cobra Biologics announced the appointment of Dr Darrell Sleep as Director of Innovation. The appointment is part of on-going strategic expansion activities currently underway at Cobra’s…
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