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Top Stories
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
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Guidances for regulatory changes, batch testing, and reporting address situations resulting from "no-deal" Brexit scenario.
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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.  Learn More |
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Industry News
The Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine manufacturer IDT Biologika will collaborate to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
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FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company's Yamaguchi, Japan facility.
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Supplier News
The company installed a ZSE-3D twin-screw extrusion system at its Somerville, NJ process laboratory.
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The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.
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Bio/Pharma News
The acquisition will support Novo Nordisk's development of glucose-responsive insulins.
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The European Commission (EC) has approved Novartis' chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
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Regulatory News
Dompé Farmaceutici's Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.
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FDA proposed in a Federal Register notice that bumetanide, nicardipine hydrochloride, and vasopressin should not be included on the list of bulk drug substances that outsourcing facilities may use in compounding.
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FORMULATION
API can be mixed with silicone and other polymers to create drug-delivery combination products.
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MANUFACTURING
Why shouldn't biopharmaceutical manufacturers be able to leverage standardized construction practices to improve time to market?
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QUALITY SYSTEMS
A year's worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
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Events
September 3–5, 2018
September 24–26, 2018
October 9–11, 2018
more events |
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eBOOKS
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This ebook covers 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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