In recent years, the U.S. Congress has come to rely unduly on continuing budget resolutions to fund government operations, and fiscal year 2024 is no exception. The current continuing resolution (CR) for the FDA budget is set to expire March 1, but there is concern that Congress will resort yet again to a CR to cover the balance of fiscal 2024, a predicament which suggests that the FDA’s appropriations may be flat relative to fiscal year 2023.
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
The good news is that the U.S. FDA’s complete response letter (CRL) for Venatorx Pharmaceuticals Inc.’s intravenous antibiotic combination, cefepime-taniborbactam, in complicated urinary tract infections (cUTIs) requested no additional clinical testing. The bad news is the inevitable delay for a drug Venatorx and partner Melinta Therapeutics Inc. are aiming to position as a much-needed option for the fight against drug-resistant gram-negative infections.
Chief executives of U.K. medical research charities have issued a call for speedier uptake and more equitable access to new drugs that have received a cost-effectiveness seal of approval from the National Institute for Health and Care Excellence. In a joint report with the Association of the British Pharmaceutical Industry, the heads of eight charities examined a number of cases where access has been limited and set out recommendations to address the challenges of equity, uptake and health inequalities.
Seven new therapies, including two influenza vaccines, were recommended for approval by the EMA’s Committee for Medicinal Products for Human Use during its February 2024 meeting. One of these was sparsentan by CSL Vifor Pharma Inc. and Travere Therapeutics Inc. for the treatment of IgA nephropathy (IgAN), for which the committee has awarded conditional marketing authorization.
The new director of the U.S. NIH, Monica Bertagnolli, has set out the prospectus for her tenure, saying she intends to apply the agency’s $47 billion per annum budget to reverse the decline in health and life expectancy in the U.S.
The U.S. FDA issued an update to a previous advisory to doctors regarding the use of electromyogram endotracheal tubes made by Dublin-based Medtronic plc., but there is still some noise in the agency’s communications regarding this matter.
Zimmer Biomet Holdings Inc.’s Rosa robotics surgical assistant snapped up its fourth application with the U.S. FDA’s 510(k) clearance for use in shoulder replacement surgery. Over the past five years, the system has built a portfolio that includes partial and total knee replacement and total hip replacement.
Clearmind Medicine Inc. has received approval from Israel’s Ministry of Health to initiate a phase I/IIa trial of CMND-100 oral capsules for alcohol use disorder (AUD). The multinational trial in healthy volunteers and AUD subjects will be conducted in Israel and the U.S.
As chronic drug shortages continue in the U.S., yet another congressional investigation into the problem has been launched. But instead of a wholistic search for the root causes, this one, launched by the Democratic members of the House Oversight Committee, focuses on three drug companies – Pfizer Inc., Sandoz Inc. U.S. and Teva Pharmaceuticals USA Inc.
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