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PharmTech Europe

2 February 2016

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Top Stories

NICE Announces Plans to Back Remicade Biosimilars

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.
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Novartis Announces Plans to Accelerate Growth of Vision Care Division

Novartis announced the companies plan to boost growth at Alcon, the company’s vision care division.
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Industry News

Baxter Recalls IV Solutions

Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.
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Novartis Announces Cloud Technology in
Development for Inhalers

Novartis announced that the company is collaborating with Qualcomm to develop cloud-based technology for COPD patients.
/ read more /


More Industry News

Regulatory News

FDA Seeking Feedback on Generic Drug Recommendations

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.
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European Pharmacopoeia Publishes Chemometrics Chapter

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.
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More Regulatory News

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Bio/Pharma News

FDA Accepts Amgen’s ABP 501 Biosimilar for Review

Amgen announces FDA will review the company’s BLA for ABP 501.
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FDA Will Review BLA for Merck’s Bezlotoxumab

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.
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Supplier News

Novasep Adds Small-Scale Manufacturing Capability to US Facility

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.
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Hermes Pharma Adds Hot Melt Coating Capability

Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.
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More Supplier News

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Next Generation HPMC Capsules
Bioequivalence and Functional Performance

On Demand
New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules.
Read more



FEATURED TOPICS

API SYNTHESIS AND MANUFACTURING

Nanotechnology Shows Promise for API Synthesis and Delivery

Nanoscale catalysts and engineered nanoparticles may have a big impact on small-molecule pharmaceuticals.
/ read more /

OUTSOURCING

The Market Consolidates for Better Service

Industry experts discuss what the outsourcing market holds for 2016.
/ read more /

DOSAGE FORMS

EMA Guideline on Setting Health-Based Exposure Limits

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
/ read more /

MANUFACTURING

Reducing the Environmental Impact of Manufacturing

Sustainable manufacturing practices at GSK aim to reduce waste, energy, and water use across the value chain.
/ read more /


Product/Service Profile

Catalent

OptiForm® Solution Suite to Enhance Bioavailability and Accelerate Development
Catalent’s OptiForm® Solution Suite platform integrates four technologies to match the best drug delivery methodologies to developmental API molecules, with the goal of providing optimal animal PK prototypes in just twelve weeks.
/ Read more /


Webcasts

Addressing Formulation Needs With a Different Technology: Say "Hello" to Ion Exchange Resins

On Demand

Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
Sponsored by Dow


Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Fragments

On Demand
Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by Tosoh Bioscience LLC


more webcasts

on pharmtech tv

PharmTech TV

A Conversation with AAPS Executive Director, Walt Marlowe

Addressing Pharma Industry Issues

The Transition from Paper Records to Electronic Batch Records

Events

Pharmapack Europe

10-11 February, 2016 | Paris, France

BIO Europe Spring 2016

4-6 April, 2016 | Stockholm, Sweden

Global Drug Delivery and Formulation Summit

23-25 May, 2016 | Berlin, Germany


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.
/ Click here /


More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.

more ebooks
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