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PharmTech Europe
30 June 2020

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TOP STORIES

COVID-19 Update

Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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EU and US Discuss Regulatory Collaboration

Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.
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Industry News

Symbiosis, AstraZeneca Sign Supply Agreement for Sterile Vaccine Manufacture

Symbiosis Pharmaceutical Services has signed a supply agreement with AstraZeneca for the sterile manufacture of AZD1222, a COVID-19 recombinant adenovirus vaccine, to be used in clinical trials.
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Catalent and Moderna Collaborate on Fill/Finish Manufacturing of COVID-19 Vaccine Candidate

Catalent will offer vial filling, packaging capacity, and additional staffing at the site to support the production of the initial 100 million doses of the vaccine candidate to supply the US market beginning in the third quarter of 2020.
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Regulatory News

CHMP Recommends EU Authorization of Remdesivir for COVID-19

EMA’s Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.
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EMA to Give Free Advice to Academia Developing Treatments for Rare Diseases

The agency will be waiving fees for scientific advice for academia developing orphan drugs.
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Bio/Pharma News

Sanofi to Expand Collaboration with Translate Bio

The companies are expanding their existing collaboration and license agreement to develop mRNA vaccines for infectious diseases.
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ILC Therapeutics Enters Research Agreement with University of St Andrews

Biotechnology company, ILC Therapeutics, has revealed that it has entered into a research partnership with the University of St Andrews aimed at progressing a therapeutic drug that can treat COVID-19 to clinical trials.
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Supplier News

Supplier Operations Status Report

Suppliers to the bio/pharma industry are sharing news about the business operations during the global COVID-19 pandemic. To view current information about the company’s business operations, click the company name.
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Malvern Panalytical and Concept Life Sciences Launch Amplify Analytics

The partnership combines Malvern’s physicochemical characterization expertise and Concept Life Sciences’ chemistry and analytical services to provide services that focus on analytics, know-how, instrumentation, and expert support to customers.
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FEATURED TOPICS

OUTSOURCING

Pulling the Levers of Stability Testing

The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in development.
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QUALITY/REGULATIONS

USP Novel Excipients Survey: Stakeholders’ Views on the Current State of Excipient Innovation

Survey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.
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CLINICAL TRIAL SERVICES

What’s Next in Air Transportation for Clinical Trial Logistics

The future will bring changes for temperature-controlled container rental companies.
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VIEWPOINTS

A Little More Respect

Pharma’s reputation is being boosted in light of the current COVID-19 pandemic efforts.
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Events

Bioprocessing Summit Europe

Barcelona, Spain

21–23 July 2020

SMI Group's 3rd Annual Injectable Drug Delivery Conference

London, UK

2–3 September 2020

CPhI Worldwide

Milan, Italy

13–15 October 2020

more events

eBOOKS

Regulatory Sourcebook and Reference, December 2019

In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.

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