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.
Astellas Pharma Inc. and Seagen Inc. received approval through a priority review from Japan's Ministry of Health, Labour and Welfare for Padcev (enfortumab vedotin) to treat radically unresectable urothelial carcinoma that has progressed after chemotherapy. The green light for the antibody-drug conjugate is based on the global phase III EV-301 clinical trial, which included sites in Japan.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astellas, Atara, BMS, Eisai, Genetx, Immunoforge, JW, Kintor, Lipidor, Moderna, Opko, Takeda, Transcenta, Ultragenyx, Vifor.
The FDA posted an advisory for health care professionals regarding a “potential for differences” between men and women in connection with the use of left atrial appendage (LAA) closure devices. The agency said that differences in procedural outcomes as described in a new medical journal article included a procedure-associated death rate of 0.3% among women undergoing the procedure, triple the rate of 0.1% in men.
The issue of FDA regulation of lab-developed tests (LDTs) has been percolating for a number of years, but the Verifying Leading-edge IVCT development (VALID) Act of 2021 appears to offer the solution. Several stakeholders, including Jeff Allen, president and CEO of Friends of Cancer Research, are eager to see the reforms come through quickly, given the increasingly vital role that tests such as companion diagnostics play in the care of patients facing potentially deadly diseases.
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