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Top Stories
Right-to-Try bill sent to White House for President's signature after passage by Congress.
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The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.
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Industry News
Internationalization and regulatory reform are driving growth and investment China.
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Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
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Biopharma News
The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.
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WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.
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Supplier News
Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.
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Regulatory News
The agency approved Amgen and Novartis' Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.
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The FDA commissioner released a statement expressing the agency's plan to address tactics used by pharma companies to delay generic-drug competition.
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IVT's Stability Testing Europe allows attendees to review core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing. Don't miss the chance to participate in hands-on training for small molecules, biologics and medical devices to harmonize global systems and enhance stability programmes.
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FEATURED TOPICS
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QUALITY SYSTEMS
A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to biopharmaceutical processes and systems.
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As the landscape continues to face an influx of regulations surrounding the reliability, consistency and accuracy of analytical methods and data, it is critical for the biopharmaceutical industry to adhere to new regulatory expectations.
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USP is a global leader in the development of quality standards for biologics that assist manufacturers by increasing predictability and reliability, and preserving the integrity of the global supply chain.
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Events
June 4–7, 2018
June 7–8, 2018
June 14–15, 2018
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eBook
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How are contract development and manufacturing contract service organizations meeting the development and manufacturing needs of innovator biopharmaceuticals and biosimilars companies? In this BioPharm International ebook, the editors examine trends, partnerships, manufacturing capacity, regulatory, supply chain, and technical expertise issues.
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