The Senate Health, Education, Labor and Pensions (HELP) Committee met April 5 to review the user fee agreements for the drug and device centers, but one member of the committee was quite vocal about the ever-growing volume of user fees. Sen. Richard Burr (R-N.C.) said the pace with which user fees are increasing suggests that the FDA is growing increasingly independent of Congress.
As part of an investigation into the international provisions of the U.S. 2017 tax law, Sen. Ron Wyden (D-Ore.) is zeroing in on how Merck & Co. Inc. was able to report 14% of its pre-tax income in the U.S. when nearly half of its global sales were in the country.
Even as many in the U.S. are looking for the end of the COVID-19 public health emergency, Health and Human Services (HHS) Secretary Xavier Becerra reinforced expectations April 5 that he will continue the emergency declaration into the summer, if not beyond. When asked during a Senate Finance Committee budget hearing if he saw the emergency ending this summer, Becerra declined to give a date, but reiterated his commitment to give stakeholders at least 60 days’ notice.
Ascensia Diabetes Care Holdings AG aims to reduce the pain associated with continuous glucose monitoring (CGM) just a bit with a new cost structure for Senseonics Holdings Inc.’ Eversense E3 CGM. The system, which lasts a ground-breaking six months without replacement, received FDA clearance in February.
3Spine Inc. has raised $33 million in an oversubscribed series C private offering for a phase II clinical study to assess what it calls “the first total joint replacement” for the lower back. This brings total private investment in the Balancedback total joint replacement to $50.3 million, largely due, said 3Spine CEO Marc Peterman, to “tremendous clinical outcomes and a mountain of benchtop research.”
Bringing a new medical device or diagnostic to market has never been a small feat for small companies, and regulatory review is still one of the largest hurdles facing device makers. However, a new report by Boston Consulting Group (BCG) and the UCLA Biodesign program shows that the twin issues of coverage and reimbursement still combine to present the most difficult hurdle to overcome for med-tech companies.
T2 Biosystems Inc. is accelerating development of its T2biothreat and T2resistance panels, direct-from-blood panels that detect the six pathogens most likely to be weaponized and 13 common antibiotic resistance genes, respectively. A $4.4 million Biomedical Advanced Research and Development Authority (BARDA) cost-sharing contract will be used to advance clinical trials for the tests. The total potential funding from BARDA under the contract is $69 million.
Executives of Spero Therapeutics Inc. evaded analysts’ attempts to clarify “deficiencies” noted by the U.S. FDA in its ongoing review of the company’s NDA seeking approval of oral carbapenem antibiotic tebipenem HBr for complicated urinary tract infections (cUTIs), emphasizing instead that they have three months to work with the regulator ahead of a June 27 PDUFA date assigned to the application.
The company conference call related to Akebia Therapeutics Inc.’s complete response letter (CRL) for vadadustat, an HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease, brought on the ongoing and perhaps inevitable comparisons with a similar product from Fibrogen Inc., rejected by the agency last August.
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