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PharmTech Europe
20 June 2017

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Top Stories

Novartis Releases Interim Analysis of CAR-T Therapy

The company released an interim analysis from its JULIET study with CTL019.
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Basilea Announces Distribution Agreements with Pfizer and Avir Pharma Inc

Basilea has entered into a distribution and license agreement with Pfizer and Avir Pharma Inc. to distribute its antifungal treatments.
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Industry News

Europe, Japan, and US Align on Antibiotics

The three regulatory agencies have agreed to data requirements for development of new antibiotics.
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Teva Pharmaceuticals Recalls Paliperidone

The company has extended its voluntary recall of one lot of paliperidone extended-release tablets to the consumer level due to dissolution test failure.
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More Industry News

Bio/Pharma News

J&J to Complete Acquisition of Actelion

The company said it expects to transaction to close on June 16, 2017.
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Supreme Court Rules in Amgen v. Sandoz

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
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More Bio/Pharma News

Regulatory News

Compounding Facility Cited for Lack of Sterile Conditions

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
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EMA to Evaluate Liver Problems Linked to Zinbryta

In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.
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More Regulatory News

Supplier News

Baxter and Dorizoe Agree to Develop More Than 20 Generic Injectables

The companies announced an agreement where Dorizoe will work with Baxter to develop more than 20 generic injectable products.
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GE Healthcare and NIBRT Open New Training Center in Ireland

The new training center will feature technologies that boost biomanufacturing.
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More Supplier News

FEATURED TOPICS

OUTSOURCING

Update on Continuous Bioprocessing: From the Industry’s Perception to Reality

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.
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FACILITIES

Facility Design Issues for Single-Use Processes

Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities.
/ read more /

ANALYTICS

Extractables and Leachables Testing for Inhaled Medicines

Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.
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FORMULATION

Understanding Dissolution Testing

Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used.
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Product Profiles

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/

Rommelag AG

Bottelpack aseptic processing
Bottelpack machines allow primary packaging for a wide variety of formulations including inhalation solutions, ophthalmics and parenterals.
/ Read more/


ON DEMAND WEBCAST

Best Practices for Extractables and Leachables Testing for Primary Drug Product Packaging
On Demand
Learn more


Events

1st Seminar on Formulation Designs for Challenging Needs

London, United Kingdom

22 June 2017

Advanced Therapy Medicinal Products

Valencia, Spain

27–28 June 2017

Excipientfest Asia

Beijing, China

13–14 July 2017


more events

Reference Library

Pharmaceutical Technology Outsourcing Guide

Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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More Reference BookS

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.

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