Source: Pharmaceutical Technology
The FDA’s pilot programme is set to accelerate the development of novel drug and biological products for rare diseases. Credit: Tada Images via Shutterstock. Recommended Buyer's Guides
Source: Pharmaceutical Technology
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Free ReportHow 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.
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Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
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Source: Pharmaceutical Technology
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Announced in September 2023, the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) programme aims to expedite new drug development by providing sponsors with frequent advice and regular communication with the FDA to advance their programme as quickly as possible. The gene therapy is a new vector from a class of recombinant adeno-associated viruses (rAAVs) that selectively target oligodendrocytes, the cells in the brain that produce myelin.
See Also:The tiny pills that may send shockwaves across immunology
Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
It is being evaluated in a Phase l/ll clinical trial (NCT04833907) enrolling 24 patients with CD. It involves administering the gene therapy to patients using neurosurgical procedures, which involves direct administration of gene therapy to affected regions of the brain. Outcome measures for the open-label clinical trial include longitudinal clinical assessments and brain imaging.
In the announcement accompanying the acceptance, Myrtelle global regulatory affairs senior vice president Nancy Barone Kribbssaid: “Opening the lines of communications beyond traditional meeting pathways provides the opportunity to quickly address development issues that would otherwise delay progression to market application.” Free ReportHow 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.
Thank you.You will receive an email shortly. Please check your inbox to download the Report.
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
Tick here to opt out of curated industry news, reports, and event updates
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.