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The FDA’s device center has been nudging electronic device submissions along for several years and has now posted a draft guidance related to the contents of those submissions.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.
PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ANP Technologies, Breathesuite, Koya Medical, Medtronic, Nanowear, Nonagen, Seaspine, Selux Diagnostics.
The PDUFA commitment letter negotiated between industry and the U.S FDA every five years provides an inside look at the future of drug development. The PDUFA VII letter, which is to be presented to Congress by Jan. 15, is no exception.
Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind.
Just months after the controversial FDA approval of Alzheimer’s disease drug Aduhelm (aducanumab), partners on that medicine, Eisai Co. Ltd. and Biogen Inc., are advancing a BLA for another possible AD therapy, lecanemab. Formerly known as BAN-2401, the Bioarctic AB-originated antibody is designed to neutralize and eliminate soluble, toxic amyloid beta for the treatment of early AD. The rolling submission, in pursuit of an accelerated approval, was primarily based on data from a phase IIb trial in people with early AD and confirmed amyloid pathology.
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