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Top Stories
The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
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The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.
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Industry News
Only 54% of North Americans feel informed about the requirements of the general data protection regulation (GDPR), according to a report by GlobalData.
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Ebola vaccinations by the World Health Organization began in North Kivu, Democratic Republic of the Congo, one week after the country’s latest outbreak.
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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.  Learn More |
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Supplier News
The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.
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Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.
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Bio/Pharma News
Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.
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The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.
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Regulatory News
The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
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Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine after FDA issues import alert affecting the active ingredient.
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BIOLOGICS
Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.
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MANUFACTURING
A process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness in a Wurster coating process.
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SUPPLY CHAIN
Air transport continues to be the most secure way to ship valuable therapies, but it is also the riskiest. Standards are helping to improve service quality.
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QUALITY
A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
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Events
August 21–23, 2018
September 3–5, 2018
September 24–26, 2018
more events |
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eBOOKS
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics. |
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