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PharmTech Europe
16 October 2018

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Top Stories

Sandoz Humira Biosimilar Patent Dispute Resolved

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).
/ read more /


Janssen, Arrowhead Enter Partnership to Treat Hep B

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection, in a deal worth EUR 3.2 billion (US$3.7 billion).
/ read more /

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 College London and Pall Biotech Open Research and Training Center

The UCL-Pall Biotech Centre of Excellence will address industry challenges and provide workforce training.
/ read more /


Meet the 2018 CPhI Pharma Awards Winners

This year’s awards attracted more than 250 entries, which included innovations in products and service offerings from across the bio/pharmaceutical supply chain and honored companies and individuals driving the industry forward.
/ read more /


More Industry News
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Evonik sets new standard for enteric coatings: EUDRAGIT® FL 30 D-55 is an advanced, new combination polymer solution for enteric coatings that integrates the respective benefits of two existing, well-accepted monographs. It is highly flexible, plasticizer-free, and can be sprayed with a smooth, fast and no-stick process. As a single product, preparation times can be reduced by up to 70%. Visit Evonik at AAPS (booth 2127) or email healthcare@evonik.com
Learn more


Regulatory News

MHRA Seeks Views on ‘No-Deal’ Brexit Legislation and Procedural Changes

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario.
/ read more /


Congressional Action Alters FDA Policies, Pharma Practices

Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.
/ read more /


More Regulatory News

Bio/Pharma News

GSK, Hitachi Chemical in T-Cell Manufacturing Pact

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.
/ read more /


Roche Acquires Tusk Therapeutics

Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).
/ read more /


More Bio/Pharma News

Supplier News

Catalent Invests in Aprilia, Italy Facility

The US$7.3-million (EUR 6.3-million) investment includes an upgrade and expansion of the company's packaging and softgel encapsulation capabilities at its facility in Aprilia, Italy.
/ read more /

 

AGC Biologics Adds Mammalian Production Capacity in Japan

The new facility will include comprehensive mammalian process development and manufacturing capabilities.
/ read more /


More Supplier News

FEATURED TOPICS

VACCINES

Modern Manufacturing Key to More Effective Vaccines

Accelerated development of new preventives raises challenges for CMC evaluation and production.
/ read more /

 

FACILITIES

Modular Facility Design Maximizes Space Flexibly

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.
/ read more /

MANUFACTURING

Planning a Successful MES Deployment

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.
/ read more /

FINISHED PRODUCT ANALYSIS

PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 1

In this three-part podcast series, Rob Thomas, principal consultant at Scientific Solutions, discusses the impetus behind his book, Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide.
/ read more /


Product Profiles

Shimadzu

Nexera Mikros - New Micro-Flow LC-MS solution Shimadzu has released the Nexera
Mikros, a micro flowrate-compatible liquid chromatograph mass spectrometer. The Nexera Mikros maintains the durability and operability of LC-MS systems while providing at least ten times more sensitivity.
/ Read more/

Veltek Associates, Inc.

SMA MicroParticle ICSTM
VAI is pleased to announce the addition of the SMA MicroParticle ICS line of non-viable particle counters that utilize the latest innovation in particle counting technology, to our contamination control portfolio.
/ Read more/

Events

PDA Europe Pharmaceutical Microbiology

Berlin, Germany

15–16 October 2018

Orphan Drugs and Rare Diseases

London, UK

17–18 October 2018

Visual Inspection Forum

Berlin, Germany

23–24 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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