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PharmTech Europe
7 July 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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Global Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.
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Industry News

CPhI Worldwide Supports Industry with Digital 2020 Experience

As a result of disruptions caused by COVID-19, CPhI Worldwide 2020 in-person event will not be taking place in Milan, Italy, but instead will be a unique digital experience to connect the global pharma industry.
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EIB and EC Pledge Billions More to Ensure Equitable Access to COVID-19 Treatments

The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds.
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Regulatory News

CHMP Recommends Marketing Authorization for Triple Combination Therapy for Cystic Fibrosis

EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union.
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Europe and Korea to Share Confidential COVID-19 Information

The European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have announced an agreement that will enable the parties to share confidential information on COVID-19 medicines.
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Bio/Pharma News

Genomics England Launches Next-Generation Genomics Research Platform

Genomics England (GEL) has announced the launch of a next-generation genomics research platform, supported by Lifebit—a deep tech company—and Amazon Web Services (AWS), which will be primarily dedicated for COVID-19 research.
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Vaxart’s Oral COVID-19 Vaccine Chosen for Operation Warp Speed

The company’s oral COVID-19 vaccine has been chosen to participate in a non-human primate challenge study organized and funded by Operation Warp Speed.
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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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Cambrex Expands Flexible Manufacturing Capacity in Sweden

Cambrex has invested in an expansion of its flexible manufacturing facility in Sweden, which will increase the company’s flexible drug substance manufacturing capacity.
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FEATURED TOPICS

VIEWPOINTS

Are We All In This Together?

Achieving herd immunity will require testing, data, a vaccine, and public support.
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QUALITY/REGULATIONS

Following Guidelines During a Crisis

Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic.
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SUPPLY CHAIN

Finding New Efficiencies in Clinical Trial Logistics

The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks.
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US REGULATORY WATCH

Generic Drugs in Spotlight as Pandemic Creates Shortages

FDA and the US Congress support innovation and access to cheaper medicines.
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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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