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.
Opinion on Wall Street said the matter could have gone either way, but in the end Akebia Therapeutics Inc.’s vadadustat, a HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease (CKD), garnered a complete response letter (CRL) instead of approval from the FDA. The news slammed Akebia shares (NASDAQ:AKBA), which closed at 82 cents, down $1.61, or 66%. Specifically, the agency said that the data in the NDA do not support a favorable benefit-risk assessment of vadadustat in dialysis-dependent (DD) and non-DDs patients.
Neogenomics Inc. stunned investors, reporting that Mark Mallon would step down as CEO and board member, effectively immediately. Tuesday’s unexpected announcement – coupled with news that first-quarter revenue could miss prior guidance – sent Neogenomics stock (Nasdaq: NEO) down 29.8% to close at $12.49, and triggered a 52-week low of $11.00 earlier in the day.
Unless the U.S. FDA once again overrides its Peripheral and Central Nervous System Drugs Advisory Committee, it looks like the ALS community will have a longer wait for an additional tool against the fatal, degenerative disease. After hearing from both Amylyx Pharmaceuticals Inc. and FDA reviewers, along with 26 people testifying during the open public hearing, the committee voted March 30 against approval of AMX-0035, a fixed-dose combination of sodium phenylbutyrate and taurursodiol, as a much-needed treatment for amyotrophic lateral sclerosis (ALS).
RSS
