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PharmTech Europe
4 December 2018

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Top Stories

Bayer Announces R&D and Manufacturing Cuts

In a strategic move to strengthen its core life science businesses, Bayer announces 900 R&D and 350 manufacturing job cuts.
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GE Healthcare Opens Biotechnology Manufacturing Center in UK

GE's new facility, which will be operational in 2019, will produce a fiber-based chromatography platform for more efficient biopharmaceutical purification.
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Industry News

Five Additional EU Member States Able to Perform GMP Inspections Equivalent to US Level

Five additional European Union member states have been confirmed by the US Food and Drug Administration (FDA) as capable of performing good manufacturing practice inspections at a level equivalent to that of the United States.
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Yposkesi Announces Agreement in Principle with Axovant to Expand Gene Therapy Manufacturing Capacity

Contract development and manufacturing organization (CDMO), Yposkesi, has entered into an agreement in principle with Axovant Sciences.
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Regulatory News

Immuno Biotech Owner Imprisoned for 15 Months

Owner of Immuno Biotech, David Noakes, has been sentenced to 15 months in prison over charges of manufacturing, selling, and supplying an unlicensed medicine, as well as money laundering.
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FDA Issues Warning Letter to Mylan for Pharma Manufacturing Facility

FDA has issued a warning letter to Mylan citing GMP violations of finished pharmaceutical products manufactured at the company's Morgantown, WV, facility.
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Bio/Pharma News

Lonza Opens New Biomanufacturing Center in Israel

The new collaborative center aims to serve as a hub for innovations in drug development and manufacturing.
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FDA Approves New Cancer Drugs from Pfizer and Loxo Oncology

The agency has approved two new chemical entities, Daurismo (glasdegib) from Pfizer, and Vitrakvi (larotrectinib) from Loxo Oncology, for treating cancers.
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Supplier News

Catalent Expands Clinical Packaging Capabilities in Shanghai, China

Catalent will expand primary packaging capabilities and commission an automated, high-speed bottling line for clinical packaging of capsules and tablets.
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Cobra, Pall, and Partner Receive $1.9 million to Study Continuous Manufacturing of Adeno Associated Virus Vectors for Gene Therapy

Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.
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FEATURED TOPICS

PEER-REVIEWED RESEARCH

Uniformity of Dosage Units, Part 1: Acceptance Value

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.
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REGULATIONS

Guidelines on Integral Drug-Device Combinations

Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.
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QUALITY

User Requirements Specifications–How Difficult Can It Be?

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.
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VIEWPOINTS

Fasten Your Seatbelts ...

... Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.
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Product Profiles

Shimadzu

New i-Series Plus integrated HPLC
Significantly improved analytical productivity with automated pretreatment operations
This year celebrating the 50th anniversary of its presence in Europe, Shimadzu emphasizes its Excellence in Science approach through the release of the new i-Series Plus integrated HPLC.
/ Read more/

Wickham Laboratories Ltd

Microbiology & toxicology testing services for the medical device and pharmaceutical industries
Wickham Laboratories Ltd is a trusted name in the pharmaceutical and medical device industries with over 50 years of experience in contract testing, research and consultancy.
/ Read more/


Events

Cold Chain Distribution 2018

London, UK

10–11 December 2018

Pharmaceutical Microbiology UK 2019

London, UK

21–23 January 2019


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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