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Top Stories
Roche will acquire oncology-focused healthcare technology and services company Flatiron Health for $1.9 billion to further its personalized oncological healthcare strategy.
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A jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead's Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), two best-selling hepatitis C drugs, has been overturned.
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Industry News
The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.
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The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.
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Supplier News
The company aims to add the additional analytical services in the European Union throughout 2018.
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The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.
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Bio/Pharma News
Merck & Co. has acquired oncology-focused biopharmaceutical company Viralytics to strengthen Merck's oncology pipeline.
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GlaxoSmithKline has issued a voluntary recall of three lots of respiratory inhalers in the United Kingdom, including preventer and emergency relief inhalers.
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Regulatory News
The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.
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The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.
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2018 PDA Annual Meeting
The 2018 PDA Annual Meeting will deliver the same high-quality content attendees expect in a NEW meeting format that starts on Monday afternoon. Delve into the future of bio/pharmaceutical manufacturing with the latest updates on the end user/patient perspective, innovative manufacturing strategies, and disruptive technologies. The industry's increased use of big data, artificial intelligence and robotics will also be explored.  Learn more and register today. |
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Analytics
Successful outsourcing in early phase drug-development analytics is driven by partnership.
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Quality Systems
Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.
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Dosage Forms
This article describes how to improve the regulatory journey from classification to market clearance for sponsors of medical device combination products.
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Drug Development
Mark Egerton, PhD, chief executive officer of Quotient Sciences, shares insights on a new approach to accelerate drug development, which integrates formulation development, real-time adaptive GMP manufacturing, and clinical research within a single platform.
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Events
March 6–7, 2018
March 12–14, 2018
March 12–14, 2018
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eBOOKS
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible. |
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