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PharmTech Europe
10 October 2017

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Top Stories

Amgen to Develop Four Biosimilars in China

Amgen will collaborate with China's Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.
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Pharma Gives Update on Puerto Rico Manufacturing Operations

AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.
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Industry News

UK's Cell and Gene Therapy Catapult Partners with Japan

The Cell and Gene Therapy Catapult, one of UK's centers of excellence, has partnered with Japan's Forum for Innovative Regenerative Medicine to boost their respective stances in the global cell and gene therapy landscape.
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FDA Increases REMS Requirements for Opioids

The agency will require training for healthcare providers who prescribe immediate-release opioids.
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Regulatory News

Data Integrity and Quality Issues Found at China Facility

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
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FDA Publishes ANDA Guidance Documents

The agency published four guidance documents regarding ANDAs and amendments to ANDAs.
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More Regulatory News

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Bio/Pharma News

Celgene and Nimbus Partner for Autoimmune Disorders

The alliance gives Celgene an option to acquire programs run by Nimbus Therapeutics for developing therapeutics to treat autoimmune disorders.
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PnuVax Receives Grant to Advance Pneumonia Vaccine

A grant from the Bill & Melinda Gates Foundation will advance PnuVax's pneumonia vaccine's clinical development and biomanufacturing scale-up using a low-cost manufacturing approach.
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More Bio/Pharma News

Supplier News

Eurofins Opens New UK Analytical Testing Facility

Eurofins Scientific has opened a £4-million pharmaceutical chemistry and microbiology facility in Livingston, Scotland, to support the company's product and water testing businesses in the UK.
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Lonza to Acquire Manufacturing Facility from Shire

Lonza has announced plans to acquire a clinical-stage mammalian manufacturing facility in the United States from Shire.
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More Supplier News

FEATURED TOPICS

Outsourcing

How to Get the Most from Regulatory Outsourcing

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
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Standards/Regulations

Regulation of Companion Diagnostics

EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.
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Biologics

The Role of Quality Standards for Biomanufacturing Raw Materials

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
/ read more /

Quality

Using QbD in Topical Drug Manufacturing

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
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Product Profiles

AbbVie

AbbVie's Contract Manufacturing Business has been serving our partners globally for more than 35 years.
/ Read more/

Capsugel

Vcaps® Enteric Encapsulation Technology
Vcaps® Enteric Capsule is a fully compliant capsule technology that simplifies drug enteric delivery implementation from early-stage development to commercial manufacturing.
/ Read more/

Shimadzu

Nexera UC/s enables Liquid and Supercritical Fluid Chromatography with a single System
Shimadzu's Nexera UC/s (SFC/UHPLC switching system) allows measurements by liquid chromatography (LC) and supercritical fluid chromatography (SFC) on a single system.
/ Read more/


Event Profile

CPhI Worldwide 2017

Date: 24-26 October 2017
Venue: Messe Frankfurt, Germany
CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, hosts more than 42,000 visiting pharma professionals over three days. 2,500+ exhibitors from 153 countries gather at the event to network and take advantage of more than 150 free industry seminars. The exhibition covers every sector of the pharmaceutical market under one roof.
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UPCOMING WEBCASTS

From Candidate to Clinic: Strategies to Select, Assess, Formulate, and Deliver the Right Drug Candidate in the Early Phase
Live Webcast: Tuesday, October 10 at 2:00pm EDT
Register now


Enteric Capsule Technologies to Help Fast-Track Pharmaceutical Drug Development
Live Webcast: Thursday, October 17 at 9am EDT
Register now


Excipient Selection to Enable the Performance of Skin Delivery Dosage Forms
Live Webcast: Wednesday, Oct. 18, 2017 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


ON DEMAND WEBCAST

No-Fuss Continued Process Verification: Automating Process and Product Monitoring
On Demand
Learn more


Events

CPhI Worldwide

Messe Frankfurt, Germany

24–26 October 2017


more events

eBOOKS

Biologics and Sterile Manufacturing

New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.

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