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).
While the Medicare Coverage of Innovative Technologies (MCIT) program has been formally abandoned, the U.S. CMS has resurrected those policy underpinnings in the form of the Transitional Coverage for Emerging Technologies (TCET) concept. Several speakers on a recent webinar said the TCET paradigm should allow CMS to promptly rescind coverage in the event of a safety signal, including Mark McClellan, who has served as both FDA commissioner and CMS administrator.
The ongoing tension between manufacturers of imaging systems and entities that perform extensive servicing activities has prompted activity on Capitol Hill in the form of H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act.
After more than 10 years on the market in Europe, Staar Surgical Co. can finally see a brighter future for its newest lenses in the U.S. This week, the company received FDA premarket supplement approval of its Evo/Evo+ Visian implantable lens for the correction of myopia and myopia with astigmatism in patients aged 21 to 45. Made of a proprietary poly(2-hydroxyethyl methacrylate)-based collagen co-polymer the company calls Collamer, the lens is inserted behind the iris in a quick procedure and can be removed, if needed. Unlike laser-assisted in situ keratomileusis (LASIK), the Evo procedure does not remove corneal tissue.
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA.
Policymakers shouldn’t look to march-in rights as a simple solution to make medical products more affordable, according to experts speaking at an Information Technology & Innovation Foundation discussion on how using the march-in provisions of the Bayh-Dole Act as price controls would threaten America’s research universities.
Medtronic plc reported its tibial neuromodulation device was implanted in the first patient with overactive bladder as part of its Titan 2 pivotal study. The device stimulates the posterior tibial nerve near the ankle to assist in regulation of bladder function. Medtronic expects to enroll 130 patients in the study.
The Biden administration has floated a budget proposal for fiscal year 2023, which includes $49 billion for the National Institutes of Health (NIH) and an additional FDA budget authority of $356 million over the current fiscal year. However, the budget also includes legislative proposals, such as a virtual inspection requirement for device manufacturing facilities and compulsory studies of drug shelf life to evaluate finished drug stability beyond the labeled expiration.
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