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PharmTech Europe
24 September 2019

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TOP STORIES

Regulators Tackle Nitrosamine Contamination in Prescription and OTC Ulcer and Heartburn Medications

US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.
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Colorcon Launches $50 Million Venture Capital Fund

Colorcon Ventures looks to fund promising startups in drug manufacturing, delivery, and supply chain.
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Industry News

UK Biotech Receives CARB-X Award Worth $9.2 Million

Procarta Biosystems has received an award from CARB-X, potentially worth $9.2 million, for the development of antibiotic precision medicines.
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Sanofi, Abbott Partner to Advance Diabetes Management

The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.
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Regulatory News

EMA Provides Guidance on How to Avoid Nitrosamines in Human Medicines

A request has been made to the CHMP by the executive director of EMA to provide guidance on how to avoid the presence of nitrosamine impurities in human medicines.
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GSK Announces First Biologic for the Treatment of Eosinophilic Asthma in Pediatric Patients

FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.
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Bio/Pharma News

Lundbeck to Acquire Alder BioPharmaceuticals in Deal Worth Up to $1.95 Billion

The acquisition will enhance Lundbeck's brain disease therapy portfolio as well as its antibody process and development capabilities.
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Grünenthal, Mesoblast Partner on Innovative Cell Therapy for Chronic Low Back Pain

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.
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Supplier News

Exploratory Analysis Findings Show Glycemic Control Improvements with Oral Semaglutide

Novo Nordisk has revealed the findings from an exploratory analysis of Phase IIIa clinical development program, demonstrating improved glycemic control with oral semaglutide.
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Acura and Catalent Team Up for LTX-03 Advancement

The companies have engaged in a manufacturing scale-up of LTX-03 tablets for clinical testing using LIMITx Technology.
/ read more /


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FEATURED TOPICS

PEER-REVIEWED RESEARCH

Inhalation Drug Delivery: The Impact of Particle Size Reduction

Research compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
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QUALITY

Stability Indicating Methods for Aluminium Adsorbed Vaccine Products

The authors provide an introduction to aluminium adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminium vaccine release and stability analysis.
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EU REGULATORY WATCH

EMA's Regulatory Impact: Not Yet in its PRIME

EMA is seeking ways to improve the effectiveness of its PRIME scheme, so that scientific innovations and new technologies more readily lead to novel medicines.
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OUTSOURCING

Biologics Continue to Grow and Create Outsourcing Opportunities

CDMOs are adding facilities and services to their portfolios in anticipation of the biologics industry's continued growth.
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UPCOMING WEBCAST

How Can You Transform the Patient Experience through Digital Transformation?
Wednesday, September 25, 2019 at 9am EDT | 2pm BST | 3pm CEST
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ON DEMAND WEBCAST

Implantable Systems and Microparticle Depots: Meeting the Formulation and Manufacturing Challenges of Long-Acting Drug Delivery"
On Demand
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Events

Particles in Injectables Conference

Berlin, Germany

24–25 September 2019

#PharmaGlass – free workshop: introduction to the use, analysis and verification of glass primary packaging

Sheffield, UK

9 October 2019

Wearable Injectors and Connected Devices Conference 2019

London, UK

9–10 October 2019

more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2019

The editors explore 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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