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PharmTech Europe
16 July 2019

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Top Stories

GSK Announces Opening of Singapore Manufacturing Facilities

GSK announced the opening of its new manufacturing facilities in Singapore after a $130-million investment.
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Industry Responds to New Payment System for Antibiotics in UK

Industry has responded positively to the United Kingdom government's new pharmaceutical payment system to incentivize development of new drugs to tackle AMR.
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Industry News

Certara Forms a New Practice Area with a Focus on Global Health

Certara has unveiled the formation of a new product development innovation practice area that will be focused on global health.
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Guidance on the Harmonization of Compendial Standards Published

FDA released draft guidance on using the USP pending monograph process in the drug application process.
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Regulatory News

CHMP Issues Positive Opinion for Self-Administration of Fasenra

AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).
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Dual Aspects of Informed vs. Explicit Consent in R&D

Patient consent is potentially tricky for pharma R&D to navigate as a result of new data protection rules in Europe.
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Bio/Pharma News

Amicus Partners with Catalent on Lysosomal Disease Gene Therapy Programs

Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent's Paragon Gene Therapy unit for gene therapy manufacturing.
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ADC Therapeutics Closes Series E Financing Expansion

Oncology drug discovery and development company, ADC Therapeutics, has closed its Series E financing expansion, in which it raised $103 million.
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Supplier News

The Native Antigen Company Appoints Biozol and Shanghai Bioleaf as Distributors

The Native Antigen Company has revealed its appointment of Biozol and Shanghai Bioleaf as its distributors in Germany, Switzerland, Austria, and China.
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CatSci Receives National Recognition for Contributions to Welsh Economy

CatSci has received two accolades from Welsh organizations, demonstrating its contributions to the Welsh economy in the field of process R&D.
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FEATURED TOPICS

REGULATORY/GMP COMPLIANCE

Clarifying Industry's Concerns Over Regulation of Drug Device Combinations

Will EMA's draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?
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PEER-REVIEWED RESEARCH

Improving Prospective Product Development Methods Derived from Management-Based Regulatory Guidelines

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.
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FILL-FINISH

Considerations for Sterile Filtration of Biologic Drugs

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.
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ANALYTICS

Putting Endotoxins to the Test

This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.
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Product Profile


Veltek Associates, Inc.

SMA MicroParticle ICS™
VAI is pleased to announce the addition of the SMA MicroParticle ICS line of non-viable particle counters that utilize the latest innovation in particle counting technology, to our contamination control portfolio.
/ Read more/


ON DEMAND WEBCASTS

Science or Hype? Navigating the Questions about Titanium Dioxide Safety
On Demand
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Overcoming Challenges in Ophthalmic Drug Delivery Including Bioavailability and Sterility
On Demand
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Events

CRS Annual Meeting & Exposition

Valencia, Spain

21–24 July 2019

BioManufacturing Conference

Munich, Germany

3–4 September 2019

Project Management in the Pharmaceutical Industry Conference

Munich, Germany

5 September 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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