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Top Stories
Merger cites combined strengths in oncology, immunology and inflammation, and cardiovascular disease.
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AbbVie and immunotherapy company Tizona Therapeutics will join forces to develop and commercialize CD39-targeted therapeutics to treat cancer.
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Industry News
In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.
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Drug pricing and reimbursement concerns will continue to hinder industry growth in 2019, according to data and analytics company GlobalData.
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Biopharma News
The companies will work together to discover and develop new treatments for neurological conditions such as Alzheimer's and Parkinson's disease.
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The partnership provides Sarepta with capacity and manufacturing slots for GMP-grade plasmid production for its micro-dystrophin Duchenne muscular dystrophy gene therapy program, as well as plasmid capacity for future gene therapy programs.
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Supplier News
The company has brought a second stream of high-throughput GMP peptide manufacturing online.
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The Massachusetts site, formerly associated with an affiliate of Shire, is Rentschler Biopharma's first facility in the US.
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Regulatory News
The agency sent a warning letter to Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.
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FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company's Ahmedabad, Gujarat, India facility.
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FEATURE TOPICS |
QUALITY SYSTEMS
Innovation may capture headlines, but quality programs are the foundation to biopharma success.
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BIOPHARMACEUTICAL ANALYSIS
Fluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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Events
January 28–31, 2019
February 6–7, 2019
March 3–6, 2019
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eBook
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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