Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
Anatomical model of human kidney. BK polyomavirus is a common infection in patients with kidney transplants. Credit: Peakstock via Shutterstock Memo Therapeutics has announced that the FDA has awarded a fast track designation for its BK polyomavirus (BKV) drug AntiBKV (MTX-005). How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success.
Source: Pharmaceutical Technology
Antigua & Barbuda (+1268)
Bosnia Herzegovina (+387)
Cape Verde Islands (+238)
Central African Republic (+236)
Dominican Republic (+1809)
Sao Tome & Principe (+239)
Trinidad & Tobago (+1868)
Turks & Caicos Islands (+1649)
United Arab Emirates (+971)
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Virgin Islands - US (+1340)
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Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
View allCompanies IntelligenceOno Pharmaceutical Co LtdMemo Therapeutics AGB+K GmbH & Co. KGMemo ASView all Submit
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This FDA decision was based on data from the Phase I Safe Kidney I clinical study (NCT05358106). This drug is the Swiss biotech’s lead antibody therapy and is currently being evaluated in a Phase II/III trial that is being run in the US.
In a Phase I partially randomised placebo-controlled Safe Kidney I trial, no relevant adverse events occurred up to the highest given dose, and the drug’s pharmacokinetics were deemed standard, as per a January 24 release. The FDA gave the company clearance to study the drug further in the currently recruiting Phase II/III SAFE Kidney II clinical study (NCT05769582), which will enroll approximately 180 patients.
Memo screened several BKV-infected kidney transplant patients to then identify antibodies that affected the viral response, eventually homing in on AntiBKV. This screening platform was also the center of Memo’s November 2022 partnership with the Japanese company Ono Pharmaceutical. In a May 2 press release, Memo Therapeutics’ CEO Dr. Karsten Fischer said, “Receiving Fast Track designation from the FDA is a significant achievement for Memo, validating the potential of AntiBKV and expediting its development. We believe AntiBKV could be a first- and best-in-class treatment option for kidney transplant patients suffering from BKV infection”. How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success.
Source: Pharmaceutical Technology
Antigua & Barbuda (+1268)
Bosnia Herzegovina (+387)
Cape Verde Islands (+238)
Central African Republic (+236)
Dominican Republic (+1809)
Sao Tome & Principe (+239)
Trinidad & Tobago (+1868)
Turks & Caicos Islands (+1649)
United Arab Emirates (+971)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Bonaire, Sint Eustatius and Saba
British Indian Ocean Territory
French Southern Territories
Heard Island and McDonald Islands
Saint Helena, Ascension and Tristan da Cunha
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
South Georgia and The South
US Minor Outlying Islands
By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy
Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
Please check your email to download the Report.