DRA Consulting Oy

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DRA Consulting Oy is an independent employee-owned Finnish consultancy in the pharmaceutical regulatory affairs. We are in co-operation with over 250 pharmaceutical companies. Our personnel’s high-quality education and many years of experience allow us to offer our clients expertise and professional services even on tight deadlines. Our size ensures that we always have qualified personnel available to meet client needs.

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Pharmacy Market

SANOFI'S HOPES FOR RARE BLOOD DISEASE CANDIDATE SUTIMLIMAB ON HOLD AFTER FDA BLASTS 3RD-PARTY MANUFACTURER

Sanofi | November 17, 2020

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When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn't happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer's plant. The FDA blasted a third-party manufacturer of Sanofi's rare blood disease drug sutimlimab in a complete response letter, citing "certain deficiencies" at...

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Business Insights

ICECURE SUBMITS REGULATORY FILING IN VIETNAM FOR APPROVAL OF PROSENSE®

IceCure Medical Ltd | August 30, 2022

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IceCure Medical Ltd. developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing as an alternative to surgical tumor removal, announced it has submitted a regulatory filing with the Department of Medical Equipment and Construction of Vietnam's Ministry of Health for the ProSense System and accessories. The application covers indications including benign and malignant breast tumors, benign and malignant lung tumors, benign ...

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INOVIO PHARMACEUTICALS KICKS OFF PHASE 1 CLINICAL TRIAL FOR EXPERIMENTAL COVID-19 VACCINE

The Motley Fool | April 06, 2020

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Inovio Pharmaceuticals (NASDAQ:INO) has been moving fast in the race to develop a vaccine for COVID-19. The company claimed it had created a potential vaccine for the rapidly spreading coronavirus on Jan. 10, just three hours after Chinese researchers publicly released the genetic sequence of SARS-CoV-2 the virus that causes the illness. Now, it's starting human clinical trials for that potential vaccine, INO-4800. The trial will involve up to 40 healthy adult volunteers, each of whom ...

Read More

Business Insights

ILLUCCIX® AVAILABLE ON HIGH ACTIVITY GALLIUM GENERATOR TECHNOLOGY TO MEET HIGH DEMAND

Telix Pharmaceuticals Limited | November 23, 2022

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Telix Pharmaceuticals Limited announces Illuccix® with up to 50mCi for radiolabeling is available for use on 100mCi gallium generators, an important development in radioisotope production. High activity generators from Eckert & Ziegler Strahlen- und Medizintechnik AG increase activity from 50mCi to 100mCi and will be integral to expanding patient access to gallium-based radiopharmaceuticals as demand for PSMA-PET imaging in the United States continues to grow. This technol...

Read More
news image

Pharmacy Market

SANOFI'S HOPES FOR RARE BLOOD DISEASE CANDIDATE SUTIMLIMAB ON HOLD AFTER FDA BLASTS 3RD-PARTY MANUFACTURER

Sanofi | November 17, 2020

When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn't happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer's plant. The FDA blasted a third-party manufacturer of Sanofi's rare blood disease drug sutimlimab in a complete response letter, citing "certain deficiencies" at...

Read More
news image

Business Insights

ICECURE SUBMITS REGULATORY FILING IN VIETNAM FOR APPROVAL OF PROSENSE®

IceCure Medical Ltd | August 30, 2022

IceCure Medical Ltd. developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing as an alternative to surgical tumor removal, announced it has submitted a regulatory filing with the Department of Medical Equipment and Construction of Vietnam's Ministry of Health for the ProSense System and accessories. The application covers indications including benign and malignant breast tumors, benign and malignant lung tumors, benign ...

Read More
news image

INOVIO PHARMACEUTICALS KICKS OFF PHASE 1 CLINICAL TRIAL FOR EXPERIMENTAL COVID-19 VACCINE

The Motley Fool | April 06, 2020

Inovio Pharmaceuticals (NASDAQ:INO) has been moving fast in the race to develop a vaccine for COVID-19. The company claimed it had created a potential vaccine for the rapidly spreading coronavirus on Jan. 10, just three hours after Chinese researchers publicly released the genetic sequence of SARS-CoV-2 the virus that causes the illness. Now, it's starting human clinical trials for that potential vaccine, INO-4800. The trial will involve up to 40 healthy adult volunteers, each of whom ...

Read More
news image

Business Insights

ILLUCCIX® AVAILABLE ON HIGH ACTIVITY GALLIUM GENERATOR TECHNOLOGY TO MEET HIGH DEMAND

Telix Pharmaceuticals Limited | November 23, 2022

Telix Pharmaceuticals Limited announces Illuccix® with up to 50mCi for radiolabeling is available for use on 100mCi gallium generators, an important development in radioisotope production. High activity generators from Eckert & Ziegler Strahlen- und Medizintechnik AG increase activity from 50mCi to 100mCi and will be integral to expanding patient access to gallium-based radiopharmaceuticals as demand for PSMA-PET imaging in the United States continues to grow. This technol...

Read More