Food and Drug Administration (FDA)
NEWS
The U.S. FDA greenlit China-based Triastek’s IND Application for its 3D printed drug product, T20, for cardiovascular and clotting disorders.
In a regulatory filing, the Cambridge, Massachusetts-based company indicated that it plans to “refocus its strategic priorities” and lay off 42% of its workforce.
AstraZeneca has penned a deal with Harbour Biomed for its bispecific antibody HBM7022, which is intended to eliminate tumors in oncological patients.
Galen Robotics will further benefit from Robert Langer’s extensive experience in biotech startups and hands-on laboratory work.
With the accelerated approval from the U.S. Food and Drug Administration, Vijoice becomes the first treatment approved in the United States for PROS
The FDA has stated that GSK and Vir’s COVID-19 treatment sotrovimab is no longer authorized to be used for the condition because of its low efficacy against Omicron sub-variant BA.2.
The U.S. Food and Drug Administration (FDA) has approved BioXcel Therapeutics’ Igalmi, a drug designed to reduce agitation episodes in bipolar disorder and schizophrenia patients.
Following the ongoing trend in the pharmaceutical industry, approximately 30% of bluebird’s staff will be let go in an effort to reduce operational costs to under $340 million by the end of 2022.
The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the FDA’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture.
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