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BioPharm International
December 11, 2018
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Top Stories

Opposition Demands Protection for Part D "Protected Classes"

The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.
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Pfizer Gets Global Patent License for AbbVie's Humira

AbbVie will grant Pfizer license to launch a biosimilar to AbbVie's Humira worldwide.
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Industry News

Quality Manufacturing Key to Reducing Drug Shortages

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.
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UK Government Announces Huge Investment Through Second Life-Sciences Sector Deal

The UK's government has revealed the details of the second Life Sciences sector deal, forming part of the Industrial Strategy.
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Process Development Forum

Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com
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Biopharma News

FDA Approves Celltrion and Teva's Biosimilar to Rituxan

FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche's anti-cancer biologic, Rituxan (rituximab).
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BMS Partners with TARGET PharmaSolutions for Inflammatory Bowel Disease Research

The companies aim to advance research into inflammatory bowel disease.
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Supplier News

Catalent Expands Biologics Packaging Capabilities at Indiana Site

The company is investing approximately $14 million to expand biologics packaging capabilities and capacity at its biologics manufacturing facility in Bloomington, IN.
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Tosoh Bioscience Moves to Acquire Semba Biosciences

The investment builds on a collaboration the companies entered into in 2007 for various biomanufacturing projects.
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Regulatory News

FDA Introduces Framework for Health Data Evaluation

The agency is looking to leverage real-world health data to support drug development.
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Shire Gains EU Approval for its Preventive Treatment of Hereditary Angioedema

Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.
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More Regulatory News

FEATURE TOPICS

QUALITY SYSTEMS

How FDA's 21st Century Goals Can Be Realized by Using a Multi-Purpose Manufacturing Facility

FDA's 21st Century goals can be realized by using a multi-purpose manufacturing facility with a flexible design that provides reliable production without extensive regulatory oversight.
/ read more /

 

MANUFACTURING

Separation and Purification of a Tissue-Type Plasminogen Activator from Trichoderma reesei

Recent equipment and updated product options offer improvement to a range of biopharmaceutical manufacturing tasks.
/ read more /


ANALYTICAL METHODS

Microbial Identification Strategies for Bioburden Control

Microbial identity data can be critical for determining contamination sources.
/ read more /

DRUG DEVELOPMENT

Overcoming Challenges in ADC Bioconjugation at Commercial Scale

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.
/ read more /


UPCOMING WEBCAST

Understanding Absolute Stoichiometry of Oligomeric Protein Complexes using SEC-MALS
Tuesday, January 29, 2019 at 11am EST| 8am PST| 4pm GMT| 5pm CET
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ONDEMAND WEBCASTS

Optimizing SEC for Analysis of Antibodies and Antibody–Drug Conjugates
On Demand
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Screen Hundreds of N-Glycans per Day: More Samples – Better Decisions – Faster
On Demand
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Events

2018 ISPE Biopharmaceutical Manufacturing Conference

December 10–12, 2018

Pharmaceutical Microbiology UK 2019

January 21–23, 2019

more events

eBook

Biopharma Laboratory Best Practices 2018 eBook

This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.

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