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Top Stories
Under a collaboration potentially worth more than $1.5 billion, the companies aim to develop the antisense therapy to treat patients with certain cardiovascular and metabolic diseases
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The new joint venture, named Oerth Bio, will use Arvinas’ Protac technology to develop innovative new agricultural products. As part of its collaboration with Arvinas, Bayer is also using this technology to develop human therapeutics.
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Industry News
Data from BIA and Informa Pharma Intelligence have shown that, despite investment slowing across all sectors, the biotech sector of the UK is still managing to raise significant funds.
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Data showed that the drug candidate activated T regulatory cells, believed to serve a crucial role in protecting the body from uncontrolled inflammation or autoimmunity.
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Supplier News
When the injector design is finalized, Stevanato Group will produce it at one of its manufacturing facilities using extensive tooling, molding, and assembly expertise.
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The companies are working together with Japanese clients to outline projects from early clinical stage up to commercial launch.
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A Global Perspective on PSS Insourcing Solutions
Read a recent interview with Beth DiPaolo, Global Head and President of Eurofins PSS Insourcing Solutions, to learn more about the global offering, quality of service and unique features. Eurofins PSS Insourcing Solutions provides managed laboratory testing services at clients’ facilities using our management personnel and scientists that we hire, train and engage to provide high‑quality laboratory services.
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Bio/Pharma News
The new facility raises production capacity by an additional 19,100 m2 and creates 200 new full-time jobs.
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GSK invested $139 million to its Rockville, MD site to support demand for Benlysta.
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Regulatory News
The tables can be used for new drug applications, biologics license applications, and supplements to these applications.
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The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.
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REGULATORY/GMP COMPLIANCE
A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.
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QUALITY
Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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UPCOMING WEBCASTS
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eBOOKS
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Biologics and Sterile Drug Manufacturing 2019
The editors explore 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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