Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caretaker Medical, Wyss Center.
As part of its real-world evidence (RWE) program, the U.S. FDA is issuing a draft guidance on using electronic health records and medical claims data in clinical trials to support a drug’s safety and effectiveness.
Thanks to a drop in the cost of conducting U.S. FDA reviews, it’s getting even cheaper to use a priority review voucher (PRV) to shave four months off the agency’s standard 10-month drug review.
When the White House COVID-19 Response Team announced its booster program in August, it justified the broad use of a third vaccine dose with antibody studies and real-world data from Israel.
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim Immunotech, Astrazeneca, Eisai, Gilead, Humanigen, I-Mab, Iterum, Lipocine, MRM, Pfizer, Regeneron, Revelation, Sanofi, Viiv, Zogenix.
Nonagen Bioscience Corp. received FDA breakthrough device designation for its liquid biopsy assay designed to predict response to treatment for bladder cancer. The test, Oncuria, measures 10 protein biomarkers in a urine sample and uses an algorithm to predict whether patients will respond to Bacillus Calmette-Guerin (BCG), the first-line treatment for bladder cancer, or should proceed to another treatment option.
The FDA’s device center has been nudging electronic device submissions along for several years and has now posted a draft guidance related to the contents of those submissions. The agency said it will notify industry by Sept. 30, 2022, of the date upon which electronic submissions will be compulsory, although it will offer a one-year grace period for companies that have not yet gone fully electronic with their premarket submissions.
Selux Diagnostics Inc. has received breakthrough device designation from the FDA for its Next Generation Phenotyping (NGP) platform for positive blood culture and sterile body fluid samples. The NGP technology is a diagnostic platform designed to help with the delivery of personalized antimicrobial therapies within 24 hours. The Boston-based company is hoping the technology can tackle the global antibiotic resistance crisis. According to the World Health Organization, antimicrobial resistance is one of the top 10 global public health threats facing humanity.
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