Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenue, Biocryst, Estrella, Janssen, Novo Nordisk, Scisparc, Soligenix, Vertex.
While the U.S. is in an IPO drought, going public remains the only lifeline for many small life sciences companies facing a decade of development, R&D costs of $1 billion or more, and a hefty risk of failure, Susan Washer, former CEO of Applied Genetic Technologies Corp., testified in a March 9 hearing before the House Subcommittee on Capital Markets.
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antev, Biogen, Biomarin, Boehringer, Eli Lilly, Inhibikase, Mesoblast, Revive, Sage.
The Biden administration released a blueprint for the U.S. federal government’s fiscal 2024 budget year on March 9, which includes additional funding for pandemic preparedness. However, the White House has signaled its intent to drill down on drug prices with an increase in the scope of the number of drugs subject to Medicare price negotiations along with a 67% increase in the Advanced Research Projects Agency–Health (ARPA-H) to $2.5 billion, a boost that is sure to draw cheers from companies in the life sciences.
The FDA’s device center just released three performance reports related to the fourth and fifth device user fee agreements, including a financial report that shows the agency collected far more in user fees than it spent for fiscal year 2022, yielding a carryover amount of more than $142 million. One of the more interesting aspects of the report is that because the taxpayer dollars used for FDA’s device inspections did not meet a pre-specified amount for two consecutive years, third-party inspections for FDA compliance purposes have been disallowed for fiscal year 2023, making hash of a program sought by domestic manufacturers who distribute their products to other nations as well as in the U.S.
Noting that the FDA had rejected its previous proposal last year to voluntarily withdraw Makena from the U.S. market, Covis Pharma BV is again offering to voluntarily withdraw the drug, which is the only drug approved to reduce the risk of preterm birth. Along with its offer, the company asked the agency “to allow for an orderly wind-down that would best serve the interests of the patients,” according to a March 6 letter from Covis’ attorney to FDA Commissioner Robert Califf and Namandjé Bumpus, the agency’s chief scientist.
After placing a temporary hold on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd., citing “unresolved national security risks,” the Committee on Foreign Investment in the United States (CFIUS) has finally cleared the merger to proceed.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Genethon, Ionis, Novan, Regeneron, Sanofi, Shorla, Siga, Takeda.
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