Latest news with #CNPV
Business Wire
14-07-2025
- Business
- Business Wire
Kaizen Biosciences Announces Multiple Abstract Acceptances and Presents Pediatric Antibiotic PK Data to ISOM; Targets FDA's New CNPV Pathway Ahead of September NDA Filing
PHILADELPHIA--(BUSINESS WIRE)-- Kaizen Biosciences, Co., a biopharmaceutical company, today announced the acceptance of its abstract for presentation at IDWeek 2025, which serves as a premier forum for infectious disease (ID) professionals to knowledge-sharing around improving patient care and overall public health. The acceptance of our work at major clinical meetings, along with our anticipated engagement with the FDA's new CNPV program, underscores the significance and urgency of our approach In addition, the company recently presented new pharmacokinetic data at the International Society of Pharmacometrics (ISoP/ISOM) a biennially meeting, spotlighting a novel amoxicillin-reduced clavulanate formulation for use in children aged 3-24 months. The data, presented by Dr. Carl Peck, former Director of the FDA Center for Drug Evaluation and Research (CDER), compared the pharmacokinetics of Augmentin ES-600 with the amoxicillin-reduced clavulanate formulation. The study revealed that Augmentin ES-600 delivered elevated clavulanic acid exposures—exceeding the amount found in adult approved Augmentin formulations, suggesting a need to revisit clavulanate dosing found in the current pediatric approved oral suspension formulations. Dr. Peck further highlighted that the proposed formulation, while containing less clavulanate, still provided the AUC/MIC required for bacterial killing or net bacterial stasis when tested against 5 different H. influenzae strains. Kaizen Biosciences is preparing to submit a New Drug Application (NDA) in September 2025 for its novel amoxicillin-reduced clavulanate formulation. The company is also actively pursuing the FDA's recently announced Commissioner's National Priority Voucher (CNPV) Program, which is designed to accelerate review periods. Kaizen intends to formally request consideration under this pathway, highlighting the public health need for an optimized antibiotic and beta-lactamase inhibitor for children aged 3–24 months, while also supporting increased domestic drug manufacturing—a hallmark of national security. 'We're excited to share this important data with the medical and regulatory communities and we remain committed to pursuing our company philosophy of 'Change, For the Better,'' said Keith-Harrison Dewedoff, Co-Founder & Executive Chair. 'The acceptance of our work at major clinical meetings, along with our anticipated engagement with the FDA's new CNPV program, underscores the significance and urgency of our approach.' About Kaizen Biosciences Kaizen Biosciences is a clinical-stage biotechnology company focused on serving patients in a variety of therapeutic areas where big, traditional pharmaceutical companies often overlook. The company's lead program is an improved amoxicillin-clavulanate formulation which reduced the unnecessary quantities of clavulanic acid in children aged 3–24 months while remaining efficacious against S. pneumoniae, H. influenzae, or M. catarrhalis pathogens.
Yahoo
30-06-2025
- Business
- Yahoo
FDA's new mission to speed drug reviews
This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter. Between a 20% reduction in workforce in April and the departure of several top officials across departments, the FDA is undergoing a major transition. The job cuts have heightened concerns about potential delays and raised questions about how the federal regulator will keep up with its workload. But Commissioner Dr. Marty Makary has vowed to keep the review wheels churning, and the FDA recently launched its AI tool, Elsa, to help. So far, the overall rate of drug approvals appears to be on track (or better) for the year. And the FDA is looking at other new initiatives to speed up drug reviews. While some of the proposed programs are still short on details, the FDA is expected to release more information about their plans in the coming months. Here's a look at some of the new programs and tools at the FDA aimed at streamlining reviews. The FDA announced plans to launch a new voucher program last month, with the lofty goal of reducing drug review times from as long as a year to as little as a month for select candidates. Dubbed the Commissioner's National Priority Voucher program, the concept replaces the standard review with a team-based approach in which 'a multidisciplinary team of physicians and scientists' will review submitted information in one day. Makary, a surgical oncologist, said the review process will be similar to how teams of doctors make decisions on 'major life-and-death questions for patients' in a 'one-day tumor board-style discussion.' The agency also stated it would issue a 'limited number of vouchers' in the first year, designated for companies 'aligned with U.S. national priorities.' The vouchers operate via four criteria, including if a drug or program addresses a health crisis in the U.S., delivers innovative cures, addresses an unmet public need or increases domestic manufacturing. Drugmakers can be granted a voucher for a specific drug candidate that meets the criteria or as an undesignated voucher that can be used at the company's discretion. Based on the design, drugmakers would use their voucher to submit the chemistry, manufacturing and controls portion of their application for pre-review 60 days before submitting the final application. 'Using a common-sense approach, the national priority review program will allow companies to submit the lion's share of the drug application before a clinical trial is complete so that we can reduce inefficiencies,' Makary said in the statement. The FDA already has voucher programs for drug approvals that incentivize new treatments in certain disease areas, including priority review for rare pediatric disease, tropical disease and medical countermeasures. Unlike the CNPV program, these priority review vouchers can be bought and sold by pharma companies, and they're sometimes worth over $100 million. The CNPV program does not have congressional approval, and the FDA hasn't yet clarified the program's jurisdiction nor how the agency will implement new regulations, according to legal experts. The CNPV program appears to borrow from established voucher programs, allowing drugmakers to pre-submit some information prior to a final new drug application. New vouchers will begin this year. Not all research experts believe the idea will benefit patients at a time when the FDA is operating on a shoe-string staff, and some have questioned the potential dangers of a faster timeline and the potential for the process to become politicized. '[T]he commissioner is forcing the FDA to use its limited resources to rush through reviews of new drugs for unclear reasons,' Dr. Reshma Ramachandran, a member of the board of directors of Doctors for America, said in a statement. 'Corners are likely to be cut.' There's also potential for increased litigation as some drugmakers will experience 'enormous value of a shortened review period' and there's little transparency so far as to how companies will be selected, according to legal experts at Hogan Lovells. Prior to announcing the voucher program, Makary proposed greasing the approval wheels for ultra-rare diseases with a new conditional approval pathway. In his plan, drugs could receive conditional approval based on a 'scientifically plausible mechanism' rather than randomized clinical trial data. Makary announced his idea for the pathway during an interview with Megyn Kelly in April, in line with his policy-from-the-podium approach to regulating, and no further details on the program have since been released. Currently, the FDA grants some drugs accelerated approval on the condition that drugmakers complete confirmatory trials. If these later-stage trials fail, drugs could be pulled from the market. The agency has other mechanisms to speed reviews as well, including fast track and breakthrough therapy designations. So far, based on the few details about the proposed idea, rare disease leaders aren't sure another pathway is needed. 'I would say that the FDA already has sufficient pathways to approve what they need to,' Ultragenyx Pharmaceutical CEO Dr. Emil Kakkis said during a panel at BIO this month in Boston, BioSpace reported. Ultragenyx is a California-based biopharma developing gene therapies for rare and ultra-rare diseases. However, past FDA officials, including Dr. Janet Woodcock, former acting commissioner, and former director of CBER Dr. Peter Marks, have pushed for a revamp of rare disease regulations. Recommended Reading FDA's Elsa AI is here, and the industry has questions Sign in to access your portfolio
Yahoo
24-06-2025
- Health
- Yahoo
FDA's Accelerated Drug Review Plan Praised by Former Senior Trump Health Official
Brett P. Giroir M.D., Former Acting FDA Commissioner and Assistant Secretary for Health, Says New Commissioner's National Priority Voucher Program (CNPV) Can Help Speed Innovative "Upstream" Therapies to Patients ATLANTA, June 23, 2025 /PRNewswire/ -- The former Acting Commissioner of the Food and Drug Administration (FDA) and Assistant Secretary for Health in the first Trump Administration, Brett P. Giroir M.D., today said the new expedited drug review proposal announced by FDA last week could help speed new, innovative therapies to patients and boost smaller drug innovators' ability to better address unmet public health needs. Giroir, CEO of Altesa BioSciences, said: "FDA Commissioner Makary's timely initiative can better enable smaller biotech innovators with breakthrough 'upstream' therapies to compete with Big Pharma's fixation on costly 'downstream' chronic care," said Giroir. "I plan to discuss this 'upstream' versus 'downstream' dynamic frequently moving forward." The Commissioner's National Priority Voucher (CNPV) program provides drug developers the opportunity to redeem a voucher to participate in a novel priority FDA program. This would shorten its review time from approximately 10-12 months to 1-2 months, following a sponsor's final drug application submission. Giroir, who also served as Admiral in the US Public Health Service Commissioned Corps and the national Covid "testing czar" during the 2020 pandemic, noted that by building on the investments made by the federal government during COVID, home tests for the majority of viruses that can be debilitating to vulnerable populations will soon be available -- including people living with chronic lung diseases like COPD or asthma. "We seek to lay the foundation for a new paradigm of prevention and treatment that moves us 'upstream' to intervene before health crises occur," continued Giroir. "The general thrust and intent of FDA's expedited drug review plan aligns perfectly with our mission to deliver transformative respiratory therapeutics at a time when they can be most effective." About Altesa BioSciences, BioSciences is a clinical-stage pharmaceutical company dedicated to developing new treatments for age-old threats to human health: high-consequence viral infections. These infections are particularly severe in vulnerable people, including those with chronic health conditions, like lung diseases, as well as the elderly and many people in underserved communities. Media Inquiries: Mia Heck Cellular (210) 284-0388 MHeck@ View original content to download multimedia: SOURCE Altesa Biosciences Inc. Sign in to access your portfolio
Reuters
17-06-2025
- Business
- Reuters
US FDA to shorten review time for drug developers under new voucher program
June 17 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it is launching a program under which its commissioner can issue vouchers to companies to shorten their review time for a drug application to 1-2 months from the typical timeline of about 10-12 months. The new Commissioner's National Priority Voucher (CNPV) program convenes experts from the regulator's offices for a team-based review, instead of using the standard review system, where a drug application is sent to numerous FDA offices, the agency said. The FDA plans to give a limited number of vouchers to companies aligned with U.S. national priorities in the first year of the program. The new program aims to accelerate the drug review process while maintaining the FDA's rigorous standards for safety, efficacy and quality, the regulator said.
