The supply chain for Seres Therapeutics Inc.’s oral microbiome therapeutic Vowst, formerly known as SER-109, to prevent recurrent Clostridium difficile infection (rCDI) is “well-established,” said David Arkowitz, the firm’s chief financial officer and head of business development. “It’s the same supply chain that we used for phase III [trials], and we’ve been manufacturing product for launch for some time.” Arkowitz spoke during a conference call with investors April 27, regarding the previous day’s U.S. FDA go-ahead for Vowst, cleared for adults with rCDI, including first recurrence following antibacterial therapy.
The legislative pile-on continues as the U.S. Congress considers more ways to take down health care costs while defending innovation. The House Energy and Commerce Subcommittee on Health met April 26 to consider 17 draft discussion bills offered as bipartisan solutions to lower costs by increasing transparency and competition across the health care playing field.
The U.S. FDA’s Oncologic Drugs Advisory Committee meets April 28 to discuss the future of Astrazeneca plc and Merck & Co. Inc.’s supplemental NDA for Lynparza (olaparib) for an expanded label to treat prostate cancer. It has a few bones to pick. The FDA said it is concerned that the efficacy and safety have not been demonstrated outside of the small population of patients with tumor BRCA mutations and that the addition of olaparib to abiraterone may cause harm in patients who are definitively negative for tumor BRCA mutations.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Biogen, Cormedix, Direct, Inhibrx, Inovio.
As expected, Seres Therapeutics Inc. gained U.S. FDA approval of the BLA for the oral microbiome therapeutic Vowst, formerly known as SER-109, for prevention of recurrent Clostridium difficile infection (rCDI), accepted for priority review in October of 2022 without an advisory committee meeting.
Four U.S. government agencies have issued an advisory regarding bias in the use of artificial intelligence (AI) and other automated systems, the scope of which includes software products that “make decisions.” The four agencies have pledged to use their enforcement powers to “protect individuals’ rights regardless of whether legal violations occur through traditional means or advanced technologies,” all of which sends a signal to developers of medical software that the FDA is not the only federal government agency that will be looking over their shoulder to evaluate the risk of bias in those algorithms.
Dublin-based Medtronic plc, and the U.S. FDA have wrapped up their discussion of the December 2021 warning letter for the company’s manufacture of continuous glucose monitors, clearing a hurdle that was critical in restoring the company’s footprint in the U.S. market. Left unanswered from the resolution of the warning letter is whether the FDA believes that device makers need to track the number of devices in distribution vs. those in actual use in order to properly calculate the risk of device failure based on postmarket surveillance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avinger, Cardiex, Galderma, Ultromics, Vyspine.
U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure made her first appearance April 26 before the House Energy and Commerce’s Subcommittee on Health, ostensibly to discuss legislative solutions to increase transparency and competition in health care. But member after member, regardless of political party, demanded answers about why CMS continues to severely restrict access to Eisai Co. Ltd.’s Alzheimer’s drug, Leqembi (lecanemab), especially since another government agency is covering it for all veterans that meet the labeling requirements.
The industry has hit out at the European Commission’s proposals for new pharmaceuticals regulations, saying they risk “sabotaging” life sciences in Europe. “Today’s proposals manage to undermine research and development in Europe while failing to address access to medicines for patients,” said Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations.
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