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Top Stories
The acquisition will expand Pfizer's rare disease portfolio with an early pipeline candidate for treating dwarfism.
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Novartis will acquire assets associated with Takeda Pharmaceuticals' Xiidra (lifitegrast ophthalmic solution) 5%, an eye-care drug.
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Industry News
Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.
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The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), awarded grants totaling $41.6 million to establish four cooperative research centers focused on developing vaccines to prevent sexually transmitted infections (STIs).
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Supplier News
Lonza will provide development and manufacturing services to two of Alector's neurodegeneration drug candidates.
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Research Point Global and WuXi Clinical Development Services have revealed that they are to combine and rebrand as a new CRO, WuXi Clinical.
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Bio/Pharma News
The acquisition provides Valby, Denmark-based Lundbeck with a discovery platform and a US-based research hub.
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The new 40,000-ft2 facility will support Bayer's growing biologics portfolio in oncology, cardiology, and additional therapeutic areas.
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Regulatory News
The new guidance document discusses reproductive toxicity testing and labeling recommendations.
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The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.
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Advanced HDX-MS and Native-MS for Improved Biologic Candidate Selection and Development
• Strategic use of advanced mass spectrometry to guide biologic drug development decisions
• Improve selection of biologic drug candidates
• De-risk development, CMC and clinical designs through earlier understanding of critical molecular attributes
• Better understand target engagement by using HDX and Native MS approaches
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MANUFACTURING
Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.
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EQUIPMENT
Isolators, robotics, and other new technologies are ready to modernize aseptic pharmaceutical filling and packaging.
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FORMULATION
Particle morphology of magnesium stearate, added as an anti-caking agent in a high water soluble drug substance, has an influence on the dissolution rate of compressed tablets.
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The new RA816 Biological Analyser
The Renishaw RA816 Biological Analyser is a compact benchtop Raman imaging system, designed exclusively for biological and clinical research. Use the RA816 Biological Analyser to identify and assess biochemical changes associated with disease formation and progression. There is little to no sample preparation, and no contrast agents or tags are needed.
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UPCOMING WEBCASTs
Overcoming Challenges in Ophthalmic Drug Delivery Including Bioavailability and Sterility
Wednesday, June 19, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Impact of New FDA Guidance on Bioanalytical Testing on Drug Development
Thursday, May 30, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
Two Live Events: Tuesday, May 28, 2019, at 10am JST | 9pm EDT | 6pm PDT
Tuesday, May 28, 2019, at 5pm JST | 10am CEST
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Designing Amorphous Dispersion Formulations for Poorly Soluble Drugs
Thursday, May 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Technologies to De-Risk Biologic Candidates to Successfully Transition from Research to Clinic
Wednesday, May 22, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Events
June 3–6, 2019
June 12–13, 2019
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eBOOKS
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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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