Top Stories
The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.
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The $4.3-billion acquisition is expected to strengthen Roche's gene therapy pipeline.
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Solving Difficult Compounds with Sophisticated Formulations
Ascendia Pharmaceuticals is a specialty CDMO dedicated to delivering sophisticated formulations to meet your drug development needs. Our advanced approach incorporates a suite of three technologies – AmorSol, EmulSol, and NanoSol – that allow us to meet stringent timelines and solve difficult compounds in a shorter time window and improve the success rate, so clients achieve their goals.
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Industry News
Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.
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The collaboration will target the acceleration of the development of automated microfluidic systems for rapid and high-throughput gene editing in mammalian cell lines.
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Supplier News
The companies will collaborate to accelerate of discovery and development of biologic drugs and advanced cell therapies.
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ACG Group highlighted its expanded footprint in Brazil through the launch of a new capsules manufacturing plant in Pouso Alegre-Minas Gerais.
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Exclusive Interview from AAPS
Developing New Technologies in Controlled Release
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Bio/Pharma News
The company will invest $60 million to expand its manufacturing facility in Durham County, NC.
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India's Bharat Biotech is set to acquire GlaxoSmithKline's Chiron Behring Vaccines, a World Health Organization-prequalified global manufacturer of rabies vaccines.
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Regulatory News
In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.
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A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.
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Exclusive Interview from AAPS 2018
Cutting Edge Formulations in Topic Drug Development
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SCALE UP
Only careful planning can prevent problems that stem from differences between a sponsor's and a CDMO's equipment, practices, and culture. This article highlights best practices and case studies.
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ANALYTICS
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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