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The new CMO combines SK Biotek in Korea, SK Biotek in Ireland, and AMPAC Fine Chemicals in the US to form SK Pharmteco.
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States oppose the company's plans for a Chapter 11 settlement, which would restructure the company as a trust and cap funding to plaintiffs, Reuters and other news outlets report.
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Industry News
Procarta Biosystems has received an award from CARB-X, potentially worth $9.2 million, for the development of antibiotic precision medicines.
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The new board will assume their positions at the 2019 ISPE Annual Meeting & Expo on Oct. 27–30, 2019 in Las Vegas, NV.
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Supplier News
The companies will focus on identifying peptides applicable to the affinity chromatography process used in the purification of biopharmaceuticals.
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Novo Nordisk has revealed the findings from an exploratory analysis of Phase IIIa clinical development program, demonstrating improved glycemic control with oral semaglutide.
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Bio/Pharma News
The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion recommending marketing authorization for Bavencio (avelumab) in combination with axitinib for treating kidney cancer.
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The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca's Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.
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Regulatory News
FDA has approved Novo Nordisk’s Rybelsus (semaglutide), a glucagon-like peptide receptor protein treatment in oral tablet form for type 2 diabetes.
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In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.
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SCALE UP
Front-end focus and new approaches are speeding scale-up and reducing costs, while scale-down and scale-out become increasingly important.
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SUPPLY CHAIN
Recent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.
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REGULATORY
Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.
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MANUFACTURING
New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.
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UPCOMING WEBCASTS
Data Integrity and the Next Level of Connectivity in a Modern Lab
Tuesday, October 29, 2019 at 11am EDT | 8am PDT| 3pm GMT| 4pm CET
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Workflow Breakthroughs that Are Improving Data Quality and Efficiency and Changing Pharmaceutical Analysis
Europe: Wednesday, October 16, 2019 at 9am EDT | 2pm BST | 3pm CEST
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APIs and ADCs: A Journey Through High Potency
Friday, September 27, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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The editors explore novel technologies for the formulation, manufacture,
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