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BioPharm International
July 09, 2019
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Top Stories


Pfizer Completes Acquisition of Clinical-Stage Biotech

Pfizer has successfully completed its acquisition of Therachon, a privately held clinical-stage biotechnology company.
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Gilead, Carna Biosciences in R&D Collaboration

The companies will join forces to develop new immuno-oncology therapies in a deal worth up to $470 million.
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Industry News


Proposed Rule Designed to Open Biosimilar Competition

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.
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Industry Continues to Invest Significantly in UK R&D

New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.
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Biopharma News


Bristol-Myers Squibb, Draper to Develop Liver Tissue Model

The companies will work to develop a liver tissue model for screening the toxicity of drugs.
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Catalent Biologics Acquires Vaccine Manufacturing Facilities

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent's expanding gene therapy footprint.
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Supplier News


Fujifilm Irvine Scientific Plans to Open New Manufacturing Site in Europe

Fujifilm Irvine Scientific has announced plans to open a third manufacturing facility in Tilburg, The Netherlands.
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Lonza Announces Acquisition of Novartis Drug Product Facility

Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.
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Regulatory News


FDA Announces Draft Guidance for Bioanalytical Method Validation

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.
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FDA Revamps Biosimilar Quality Requirements

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
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Process Development Forum
Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com.
Click here to access the site »


FEATURED TOPICS

MANUFACTURING

Thinking Flexibly in Biomanufacturing

Single-use systems may offer a suitably flexible solution to the biomanufacturing challenges of cost and time-to-market.
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OUTSOURCING

The Importance of Single-Use Components for Bioprocessing

Simple components help maintain physical integrity throughout a bioprocess setup, and single-use components play a role in ensuring a closed system for aseptic processing.
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DRUG DEVELOPMENT

Taking Therapeutic Antibodies to the Next Level

This article explores the challenges and potential of next-generation therapeutic antibodies.
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SINGLE-USE SYSTEMS

Extractables and Leachables: Determining Risk in Single-Use Systems

As SUS become prevalent in the biologics industry, the question of safety becomes increasingly important.
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UPCOMING WEBCASTS

The Versatility of High Throughput Dynamic Light Scattering in Protein Characterization and Formulation Development
Tuesday, August 20, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Improving Confidence and Productivity in Released Glycan Analysis for Biotherapeutic Development
Wednesday, July 17, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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ON Demand WEBCAST

Empowering HCP Identification with Antibody Affinity Extraction (AAE) and Mass Spectrometry
On Demand
Learn More

Events

BioManufacturing Conference

September 3–4, 2019

PDA/FDA Joint Regulatory Conference

September 16–18, 2019

PDA Data Integrity Workshop

September 18–19, 2019

more events

eBook

Single-Use Systems 2019 eBook

The editors examine the technology, practices, and regulatory approval questions facing companies employing single-use technologies for commercial manufacturing.

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