FDA Authorizes Emergency Use of Tamiflu and Relenza to Treat Swine Flu
In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration has authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu.
In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration has authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu. The FDA is empowered to make such Emergency Use Authorizations (EUAs) under Project BioShield, which became law in July 2004.
Tamiflu, made by Roche, is approved for the treatment and prevention of influenza in patients one year and older, but the new authorization allows the drug to be used in children under one year, and to provide alternate dosing recommendations for children older than one year.
In addition, under the new authorizations, both Tamiflu and GlaxoSmithKline’s Relenza, approved for children five and older, may now be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs. They also may be distributed by a broader range of healthcare workers, including some public health officials and volunteers, in accordance with applicable state and local laws or public health emergency responses.
The EUA authority allows the FDA to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Filter Sizing for Process Optimization in Life Sciences Sterile Filtration
April 24th 2025Bench-scale filterability studies play a critical role in optimizing sterile filtration in biopharmaceutical manufacturing. By guiding the selection and sizing of filters, these studies help streamline processes, improve scalability, and reduce costs. Through data-driven case studies, this paper highlights how the strategic use of pre-filters and membrane materials can maximize throughput and minimize filter fouling.
VERAXA and Voyager to Create Combined Business for Advancing Pipeline of Next-Gen Cancer Therapies
April 23rd 2025The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.
