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 research partnership will focus on advancing regenerative medicine using porcine bioproducts
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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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Biopharma News
Merck & Co. has acquired oncology-focused biopharmaceutical company Viralytics to strengthen Merck's oncology pipeline.
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Fluarix Tetra has been approved for use in children aged six months and above.
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Supplier News
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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The agreement follows the recent opening of WuXi STA's oligonucleotide R&D labs in China and the US.
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Regulatory News
The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.
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FEATURED TOPICS
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MANUFACTURING
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
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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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