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Top Stories
The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.
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The European Medicines Agency's detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.
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Industry News
The National Institute for Health and Care Excellence recently rejected National Health Service's funding of Kymriah for diffuse large B-cell lymphoma (DLBCL) despite recognizing that the drug has significant clinical benefits.
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Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 9, 2018.
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Biopharma News
The company's biosimiliar to Amgen's Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
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The company plans to lay off approximately 400 employees to support the restructuring of its R&D organization.
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Supplier News
The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.
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GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.
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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.
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Regulatory News
The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
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The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.
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FEATURE TOPICS |
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OUTSOURCING
Partnerships, mergers, and new services indicate that biologics are continuing to influence CMOs' and CDMOs' decisions to expand their biopharmaceutical services.
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REGULATORY
The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.
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UPCOMING WEBCASTS
Using High-Throughput Automation to Accelerate Biologic Drug Formulation
Thursday October 25, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Protein A Chromatography: Important Features in Purification to Reduce mAb Aggregation and Increase Recovery
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Make Better Decisions, Faster with Highly Reproducible, High-Throughput Glycan Screening
Europe Broadcast: Friday, October 12, 2018 at 3pm BST | 4pm CEST
US Broadcast: Friday, October 12, 2018 at 2pm EDT | 1pm CDT | 11am PDT
Asia Pacific Broadcast: Monday, October 15, 2018 at 11am CST | 12pm JST | 1pm AEST
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Screen Hundreds of N-Glycans per Day: More Samples – Better Decisions – Faster
Europe Broadcast: Thursday, October 4, 2018 at 2pm BST | 3pm CEST
US Broadcast: Thursday, October 4, 2018 at 11am EDT | 10am CDT | 8am PDT
Asia Pacific Broadcast: Friday, October 5, 2018 at 11am CST | 12pm JST | 1pm AEST
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The Multi-Attribute Method (MAM): Advancing Biopharmaceutical Discovery, Development, and Manufacturing
Wednesday, October 3, 2018 at 11am | 8am PDT | 4pm BST | 5pm CEST
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Events
October 9–11, 2018
October 9–11, 2018
October 14–17, 2018
more events
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eBook
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A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.
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