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PharmTech Europe
23 June 2020

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COVID-19 Update

Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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EMA Endorses ICMRA Statements on Value of Safe and Effective Vaccines

EMA has issued a press release on June 18, 2020, in which it endorses two statements from the International Coalition of Medicines Regulatory Authorities (ICMRA) about the importance of the safety and effectiveness of vaccines.
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Industry News

Takeda and Neurocrine to Collaborate on $2-Billion Deal for Pipeline Program Development

Neurocrine will develop and commercialize seven of Takeda’s pipeline programmes, including three clinical-stage assets for schizophrenia, treatment-resistant depression, and anhedonia.
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Catalent to Partner with AstraZeneca for COVID-19 Vaccine

Catalent will provide vial filling and packaging capacity to AstraZeneca at its manufacturing facility in Anagni, Italy, for the large-scale commercial manufacturing of the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate.
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Regulatory News

EDQM Offers Free Access to European Quality Standards for COVID-19 Vaccine Developers

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has opened up access to the texts of the European Pharmacopoeia (Ph. Eur.) to support developers of COVID-19 vaccines.
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MHRA Stops Recruitment of New Patients in COVID-19 Hydroxychloroquine Trials

An instruction has been issued to all those performing clinical trials using hydroxychloroquine to treat or prevent COVID-19 to stop recruitment of any new patients by the MHRA in the UK.
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Bio/Pharma News

Cobra Biologics to Manufacture AstraZeneca’s COVID-19 Vaccine Candidate

Cobra Biologics has signed a supply agreement to provide GMP manufacturing for AstraZeneca’s AZD1222 COVID-19 vaccine candidate.
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Siemens and Exyte Collaborate to Provide Modular Biopharma Facilities

Siemens and Exyte partner for fast-track construction of modular, automated, digitalized biopharmaceutical facilities.
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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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Cascade Chemistry Selected to Produce API for COVID-19 Treatment

The company has been selected to produce the active pharmaceutical ingredient for clinical trial supplies of RBT-9, an investigational therapy for the treatment of COVID-19 in patients at high risk of declining health due to age or comorbid conditions.
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FEATURED TOPICS

SUPPLY CHAIN

Securing the Supply Chain

The global COVID-19 pandemic has highlighted the need for the pharmaceutical industry to strengthen its supply chain.
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EUROPEAN REGULATORY WATCH

A Strategic Shake Up in Europe’s Medicines Sector

The EU’s pharmaceutical strategy has the potential to shake up the policies and regulations of the region’s medicines sector.
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PEER-REVIEW RESEARCH

Approaches to Alleviating Subcutaneous Injection-Site Pain for Citrate Formulations

The authors compare formulations containing citrate with other buffers in reducing subcutaneous injection-site pain and discuss a formulation and excipients selection strategy.
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FORMULATION

Reducing Risk with Abuse Deterrent Formulations

Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach to abuse-deterrent formulations.
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WEBCAST

Dry Powder Inhalers: Key Considerations for Combination Product Development

Wednesday June 24, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
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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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