As the number of drug shortages continues to grow in the U.S. and globally, the FDA is issuing a draft guidance spelling out drug and API manufacturers’ responsibility to give the agency a timely, informative heads-up about changes in their production that could lead to a shortage.
Positive results from Limflow SA’s PROMISE II U.S. pivotal trial show its Limflow system for transcatheter arterialization of deep veins (TADV) led to sustained amputation-free survival and wound healing in patients with chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease. According to the Paris-based company, 76% of CLTI patients who received Limflow therapy were able to avoid an otherwise life-saving major amputation.
The granting of breakthrough device designation from the U.S. FDA to Pixium Vision SA for its Prima system was a boon for the company as its share price jumped more than 300% following the news. The price increase was “validation from the public market and investors” that the Prima system, for dry age-related macular degeneration (AMD), has the potential to get regulatory approval, Lloyd Diamond, CEO of Pixium, told BioWorld.
The U.S. NIH once again faces questions about its oversight of certain research. In the latest round, the U.S. Government Accountability Office called on the agency to do more to ensure that foreign facilities conducting NIH-funded animal research are compliant with U.S. standards and policy regarding animal care and use, as well as international standards.
The U.S. Centers for Medicare & Medicaid Services (CMS) has scaled back the list of Medicare Part B drugs facing the new inflation rebate under the Inflation Reduction Act for the first quarter of 2023.
Philips RS North America LLC, formerly known as Respironics Inc., has agreed to pay more than $24 million to settle allegations that the company violated the False Claims Act in relation to CPAP equipment, another hit on the company which has been dealing with a stream of FDA recalls for these products. The allegations include that Philips RS provided durable medical equipment suppliers physician prescribing data to help these suppliers market their inventory, an unusual vector for violation of the FCA.
Masimo Corp.’s Opioid Halo, an opioid overdose prevention and alert system, was granted de novo status by the U.S. FDA. The device detects opioid-induced respiratory depression, the primary cause of opioid deaths. The de novo authorizes the company to make Halo available over the counter and by prescription for use on individuals aged 15 and up.
The U.S. Federal Trade Commission (FTC) issued a final order in connection with the proposed reacquisition of Grail Inc. by Illumina Inc., in an action that might seem to finally conclude a matter that has stretched over several years. However, the FTC acknowledged that Illumina has 60 days to petition the order, which Illumina said it intends to do in conjunction with an effort to overturn a similarly adverse outcome in the EU.
A frustrating lack of detail left analysts with little to do but speculate on the odds for a 2023 U.S. FDA approval of Ascendis Pharma A/S’s Transcon PTH (palopegteriparatide), a parathyroid hormone prodrug for hypoparathyroidism, after the company disclosed a letter from the agency citing unspecified deficiencies that preclude further discussions about labeling and postmarketing requirements.
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