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PharmTech Europe
21 August 2018

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Top Stories

GSK Plans to Close Facility in Ireland

GSK will close the Sligo, Ireland skincare product
manufacturing site by 2021.
/ read more /


Boehringer Ingelheim Licenses Global Rights to Cystic Fibrosis Gene Therapy

Boehringer Ingelheim joins Oxford BioMedica, UK
Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.
/ read more /


Regeneron, bluebird bio Partner on Cell Therapy Development

The companies will collaborate on the discovery,
development, and commercialization of cell therapies for cancer.
/ read more /

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Check out the PharmTech Europe Supplement on APIs,
Excipients, and Manufacturing,
includes the CPhI Worldwide
Planning Guide.

August Supplement 2018
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Industry News

University of Warwick Develops New Method for Screening Polymeric Antimicrobials

Researchers from the Department of Chemistry and Warwick Medical School developed a way to synthesize polymers to accelerate antimicrobial activity screening.
/ read more /


Import Alert Spurs Recall of Levothyroxine and Liothyronine

Westminster Pharmaceuticals, LLC is voluntarily
recalling levothyroxine and liothyronine after FDA issues import alert affecting the active ingredient.
/ read more /


More Industry News

Regulatory News

FDA Approves First-of-its-Kind RNA Therapy

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA)
treatment.
/ read more /


FDA Issues Warning Letter to Canadian API Manufacturer

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
/ read more /


More Regulatory News

Bio/Pharma News

Pfizer, BioNTech to Develop mRNA-based Flu Vaccines

The companies entered a multi-year R&D collaboration to develop mRNA-based flu vaccines.
/ read more /


First Generic Version of EpiPen Gets Approval

FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
/ read more /


More Bio/Pharma News

Supplier News

FDA Approves Drug Product Manufacturing for Samsung BioLogics

Drug product approval from FDA follows previous approvals from European and Japanese authorities.
/ read more /


Avalon GloboCare Partners with Weill
Cornell Medical College for CAR-T Production Technologies

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.
/ read more /


More Supplier News

FEATURED TOPICS

BIOLOGICS

The Challenge of Building Better Biologic Drugs

Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.
/ read more /

 

FORMULATION

Key Considerations in Multilayer Tableting

Jean-Yves Balfin, product manager at Korsch AG, speaks to Pharmaceutical Technology Europe about the ins and outs of multilayer tableting.
/ read more /

MANUFACTURING

Modular Manufacturing Can Ease Bioprocessing Woes

Modular manufacturing systems offer a less costly way to increase capacity while reducing time-to-market.
/ read more /

QUALITY

Risk-Based Predictive Stability for
Pharmaceutical Development—A Proposed Regulatory Template

A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
/ read more /


Product Profiles

DIOSNA Dierks & Söhne GmbH

CCS 10-80 RC
The Granulating Line CCS 10-80 RC by DIOSNA, a granulation line for pilot scale with a highly flexible range of batch sizes.
/ Read more/

Veltek Associates, Inc.-

Cleanroom Documentation Systems
VAI has solved the challenges surrounding particulate and fiber contamination in controlled areas by developing CleanPrint 10, the Core2Print, and Core2Write and has addressed cleanroom traceability via our Core2Scan System.
/ Read more/


Events

SMi's 9th Annual Biosimilars & Biobetters Conference

London, United Kingdom

26–27 September 2018

CPhI 2018

Madrid, Spain

9–11 October 2018

Cell & Gene Therapy 2018

London, United Kingdom

10–11 October 2018

PDA Europe Pharmaceutical Microbiology

Berlin, Germany

15–16 October 2018


more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2018

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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