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HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.

HMA and EMA Release Joint Statement on the Approval of Vaccines

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.

Johnson & Johnson Starts Second Global Phase III Clinical Trial of Janssen COVID-19 Vaccine

Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.

Interim Results Show Strong Immune Responses and Better Tolerability in Older Adults for AZD1222

Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.

EMA Starts Rolling Review of Moderna’s COVID-19 Vaccine Candidate

Interim efficacy data suggests the Pfizer/BioNTech  has an efficacy rate above 90%.

Pfizer: COVID-19 Vaccine Shows High Efficacy	

Editor of Pharmaceutical Technology Europe

Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.

Improving Solubility with Amorphous Solid Dispersions

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

An optimal engineering design is crucial for aseptic operation and cleaning.

Understanding the Impact of Annex 1 on Isolator Design

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

RCPE Awarded FDA Funding to Develop Next-Generation Technology

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

Novavax COVID-19 Vaccine Trial Expands Enrollment

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19. 

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