Generics drugmakers have been consolidating for years, as low prices and market volatility have made it harder to do business. Dunn presided over the controversial approval. Adam Feuerstein is STATs national biotech columnist, reporting on the intersection of biotech and Wall Street. This decision is a disastrous blow to the agencys credibility, public health and the financial sustainability of the Medicare program. The latter point refers to the fact that Aduhelms developer, Biogen, set the drugs list price at $56,000 for a years supply. FDA neurosciences chief Billy Dunn to leave immediately - Reuters But in order to review that new data, the FDA needed three more months. Why Reata Pharmaceuticals Shares Are Falling Monday? - Yahoo Finance by Zachary Brennan: The FDA's top neuroscience expert Billy Dunn, who was embroiled in controversy over his close ties with industry ahead of two key Alzheimer's drug approvals, has decided to leave the agency effective immediately, according to an internal email obtained by Endpoints News. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. Unlock this article along with other benefits by subscribing to one of our paid plans. Writing for the Harvard Business Review, Sanyin Siang and Michael Canning outline the three most effective team coaching methods to help leaders foster "accelerated learning and successful outcomes.". Syfovre will be available as an injection and can slow the progression of the disease, although it will not reverse it. If youre nominating, I ask that you actually know the person. MeSH terms Alzheimer Disease* / diagnosis . The apparent disregard of the FDA advisers who voted against approval and the FDAs decision not to seek their input on the use of the surrogate endpoint. FDA neurosciences chief Billy Dunn to leave immediately, analysts raise Sign up for our daily newsletter covering global breaking news around the world. The deal for NJOY, one of the few e-cigarette makers whose products have clearance from federal regulators, could be announced as soon as this week, the people said, though the talks could still fall apart. As we have outlined previously (Have We Seen This Movie Before? Approving aducanumab despite the lack of evidence of effectiveness has raised false hope for millions of Alzheimers disease patients and their families and will impede for years the development of other experimental treatments for this devastating disease, Carome wrote. Billy Dunn, head of the FDA's neuroscience office, has been with the agency for around 18 years, during which he was involved in several high-profile drug approvals. The deal will look at the delivery of Rallybios C5 inhibitor using EyePoints tech for intraocular drug delivery, dubbed Durasert. Jefferies analyst Maury Raycroft said in a research note that while Dunn's departure may have already been in the works, his immediate exit ahead of the agency's decision on the Reata drug raised suspicion about the timing. Teams must consider how they iteratively test human-centric digital therapeutic solutions and scale promising aspects in the same way they would with a non-digital therapy. "Billy has decided to retire from the FDA and . Beth Mole / Beth is Ars Technicas Senior Health Reporter. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. More than half of physicians report frequently or occasionally changing their perception of a treatment after viewing content on social media, according to a new joint survey from Sermo and LiveWorld. 2029 Becker Drive; Lawrence, Kansas 66047 USA Privacy and deletion: Digital therapeutics support increased access to safe and effective therapies, providing an untapped opportunity for biopharmaceutical companies to maximize the value of medicinal assets and drive differentiation, When developed in combination with a medicinal asset, digital therapeutics enable significant market differentiation and significant benefits for stakeholdersfrom optimizing patient outcomes to supporting more efficient generation of compelling real-world data, Integrating digital therapeutics early in the asset development process will allow for gathering of clinical data to drive a clearer value proposition that maximizes the potential of both products, Early market entry is fundamental, and manufacturers must plan strategically to consider how digital therapeutics (DTx) are best incorporated into the launch and go-to-market strategy. Start your single-user one-year subscription (250 issues) FDAnews for only $1,895. It makes sense of everything successful drug and device manufacturers must know and do, delivering the news, analysis and interpretation of industry changes you need to stay in compliance and thrive. Shares of the now penny stock player APGN went down 3% after the morning bell Monday to $1.25 a share. by Damian Garde covers biotech, is a co-writer of The Readout newsletter, and a co-host of "The Readout LOUD" podcast. The call for fresh FDA leadership comes atop a chorus of harsh criticism over the decision, which outside researchers and industry experts have called disgraceful and dangerous, among other things. This mindset ensures truly synergistic development, overcoming barriers, and maximizing potential. For Cytokinetics, FDA Rejection Of Heart Drug Would Help, Not Hinder Dunns retirement could impact the agencys stance on neurological drug decisions in the near term. Billy Dunn, director of the FDA's Office of Neuroscience (ON) and a key figure in the FDA's controversial June 2021 approval of Biogen's Alzheimer's drug Aduhelm (aducanumab), is officially leaving the agency after nearly two decades. Strong collaborations and partnerships will ensure that the overall ToPP provides a compelling offering. Those four problems echo the criticisms brought up by other experts and the FDAs advisory committee before and after the approval. This enables the gathering of evidence of clinically significant outcomes, which are integral to the digital therapy approval processes. (Reuters) - The U.S. Food and Drug Administration neurosciences head Billy Dunn will retire from his role effective immediately, the health regulator told Reuters on Tuesday. Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters, Bioscience & Technology Business CenterThe University of KansasLawrence, Kansas. Proactively integrating digital therapeutics into your early global commercial asset strategy can increase the chances of a successful launch and commercialization, ensuring assets are positively differentiated from the competition and offer benefits beyond the drug for all stakeholders, including: For biopharmaceutical manufacturers, the benefits are far reaching and include the ability to differentiate assets positively in crowded markets with multiple competing modes of action and where several generations of a product are on the market simultaneously. On Wednesday, advocacy group Public Citizen only increased the din of criticism, calling the FDAs approval reckless. The FDAs decision showed a stunning disregard for science, eviscerated the agencys standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency, Michael Carome, director of Public Citizens Health Research Group, said in a statement. This means digital therapeutics are held to the same standards of evidence and regulatory requirements as conventional pharmacological treatments, requiring approval from regulatory bodies to support product claims of risk, efficacy, and intended use.2, Figure 1: The key differences between digital health, digital medicine, and digital therapeutics2. It is with regret that I announce the departure of Dr. Billy Dunn, director of the office of neuroscience, Peter Stein, head of the FDAs office of new drugs, wrote in an email to colleagues. The acquisition of Seagen would build out Pfizers oncology program as the company looks for new growth after its blockbuster Covid-19 vaccine sales begin to moderate. Representatives for Seagen didn't immediately respond to requests for comment. You can support KHN by making a contribution to KFF, a non-profit charitable organization that is not associated with Kaiser Permanente. Mayne has been working to revamp its portfolio and to support the launch of Nextstellis, a brand-name birth control pill. For decades, top drug and device manufacturers have relied on FDAnews insightful coverage with two of the industrys most-trusted publications: Drug Industry Daily and Device Daily Bulletin Premium. (Maloney, Chung and Thomas, 2/27), The New York Times: The FDA declined to comment on the speculation, which hit the stocks of some neurological drugmakers on Monday - Biogen had fallen marginally and Amylyx Pharmaceuticals declined 2.5% in the previous session. Jazz Pharmaceuticals has figured out a way to push the boundaries even further a feat that demonstrates the lengths to which drug makers go to eke out extra profits and that two federal courts have now ruled was improper. Newly appointed deputy director Teresa Buracchio will also serve in Dunn's role on an interim basis at the Office of Neuroscience, the agency told Reuters. Bringing teams on this transformation journey will require new processes and structures. Dunn was integral in the FDA's controversial decision to approve Biogen Inc and Eisai Co's Alzheimer's drug Aduhelm last year despite a lack of evidence that it worked at slowing the effects of the disease. A leading consumer advocacy group on Wednesday demanded the immediate resignation or removal of the acting head of the Food and Drug Administration as well as other U.S. government officials involved in the recent approval of Biogen's aducanumab, a purported Alzheimer's treatment whose effectiveness has been widely questioned by independent expe. A Drug Company Exploited A Safety Requirement To Make Money. "Billy has decided to retire from the FDA and explore other opportunities while continuing his focus on improving the lives of patients with neurological diseases," Peter Stein, head of the Office of New Drugs, said in the email. Last months congressional report on Aduhelms approval found that the FDA and Biogen engaged in at least 45 collaborative workstream meetings that Dunn and Samantha Budd Haeberlein, Biogens head of clinical development, attended and that were outside the normal scope of FDA-sponsor meetings. You should direct the next Acting FDA Commissioner to consider whether the agencys approval of Biogens BLA for aducanumab should be withdrawn.. Billy Dunn departs FDAChutes & Ladders - fiercebiotech.com Theravance could not be reached for comment at time of publication. The FDAs top neuroscience expert Billy Dunn, who was embroiled in controversy over his close ties with industry ahead of two key Alzheimers drug approvals, has decided to leave the agency effective immediately, according to an internal email obtained by Endpoints News. Drew Armstrong on Twitter: " FDA's head of neuro drugs, Billy Dunn, is Stat reports that Billy Dunn, who presided over the controversial approval of the Alzheimer's drug Aduhelm, will retire to pursue other opportunities. 1 Thanks you! Office of Neuroscience | FDA FDA on Monday announced the departure of Billy Dunn, director of the office of neuroscience, who is leaving the agency to "explore other opportunities," in today's bite-sized hospital and health industry news from Maryland, New York, and Ohio.. Maryland: FDA on Monday announced the departure of Billy Dunn, director of the office of neuroscience, who is leaving the agency after more than 15 years. There was a problem with your request. But, upon approval, the regulator said that it did use the surrogate and claimed that the reduction of amyloid-beta is. The needs of your stakeholders are key to creating a product that provides value to an area of unmet need for all stakeholder groups. Dunns departure likely means a more stringent FDA, and in its Q2 report, Reata noted that the FDA was concerned about the efficacy of omaveloxolone. According to various reports, the FDA's neuroscience expert Billy Dunn is leaving the agency after more than 15 years, effective immediately. His departure was announced in an email to FDA staff sent by Peter Stein, head of the regulator's Office of New Drugs. All Rights Reserved. Mondays news comes after nirogacestat passed a Phase III test in May 2022, achieving a 71% reduction in the risk of disease progression as a monotherapy. Billy Dunn, who presided over the polarizing approval of the Alzheimer's disease treatment Aduhelm, is leaving the Food and Drug Administration after more than 15 years at the agency, STAT has learned. Advancing the Development of Treatments for Neurological Disorders | FDA With the prediction that digital therapeutics markets will intensify due to both biopharmaceutical and tech companies entering this space, it is critical the narrative is shaped proactively, highlighting the importance of early market entry. Axsome Therapeutics said the FDA wants safety information from the biotech's third Phase III study of its drug candidate for Alzheimers disease agitation before submitting a label expansion request. The pharmaceutical industry is rife with tales of companies dreaming up ways to prolong their monopolies on lucrative drugs. Cytokinetics was founded 26 years ago but has not yet developed a drug successfully to approval. SVB Securities analysts wrote in a note on the Reata situation on Monday: We view the timing of Dunns departure as curious; however, we also note that given the proximity to the PDUFA, the decision for omav has likely already been made. Welcome to this week's Chutes & Ladders, o | Dunn-zo would be an apt term to summarize the top employment move this week. Dunn's departure follows several high-profile drug approvals that raised questions about the agency's coziness with Biogen regarding its approval of the amyloid-targeted drug Aduhelm and led to a highly critical congressional report. Billy Dunn, the neurosciences head of U.S. Food and Drug Administration will retire from his role effective immediately, the health regulator said. Where Design Control Meets Risk Management: A Lifecycle Approach for Medical Devices, Reliability Assessment for Medical Devices and Combination Products: Meeting FDA Objectives and Requirements, GMP Quality Management vSummit 2023: Where Quality Meets Risk, WCG MAGI Clinical Research Conference 2023 West, FDAs New Quality System Regulation: Transitioning from QSR to ISO 13485, Selecting and Implementing Electronic Document Management Systems in the EU, 340B Hospitals Owed $9 Billion in Reimbursements CMS Proposed Rule Says, Icelandic Fish-Skin Wound Care Manufacturer Acquired by Coloplast for $1.3 Billion, Dietary Management Critical in IEM Drug Trials, FDA Guidance Says, Warning Letter to Outset Medical Cites Additional Observations, Best practices in regulatory compliance and the pathways to approval, Draft and final guidances from the FDA and other regulatory agencies, Company mergers and technology developments, FDA budgets and spending, including proposals and approvals by Congress and the President, Quality and GMP regulatory policies and developments, FDA inspection policies, practices and enforcement activities, Global enforcement and supply chain trends, Reports and perspective on Form 483s, warning letters, recalls, FDA policy notices and other reports, In-depth exposs that take a deep dive into essential pharmaceutical and device issues, Original columns from thought leaders and former FDA officials on trending topics, Daily posts of breaking headlines and premium stories throughout the day on. Type above and press Enter to search. The departure of Dunn, 53, was announced in an internal message to the agencys employees on Monday. Texas-based Reata was expecting FDAs decision by Tuesday on its drug to treat a rare neuromuscular disorder called Friedreichs ataxia. For Seagen, taking a deal with Pfizer would be a meaningful come-down: The Seagen-Merck deal broke down over price, Bloomberg reported at the time, that was about $10 billion higher than the current reported target under discussion with Pfizer. According to a report from Reuters, the pharma thinks the pill could net around $2 billion in annual sales once approved. This is a summary taken from Fishawack Healths new publication Digital therapeutics: The key to maximizing the potential of medicinal assets.. By signing up, you agree to the our terms and our our agreement. Building the required capabilities and expertise within technology, data science, and analytics is critical and takes planning and timing. The Food and Drug Administration headquarters in White Oak, Maryland. Digital therapeutics are a subcategory of digital medicine. advertisement The FDA's neuroscience office, led by Dunn, is expected to render its decision on omaveloxolone by Feb. 28. Billy Dunn, the director of the FDA's Office of Neuroscience, made it clear: "We're not using the amyloid as a surrogate for efficacy." That meant the panelists were not asked to consider. Theravances share price has dropped by 55% since it began trading in 2014 and is now at just over $10. FDA Is Petitioned To Boost Enforcement Of Trial Sponsors, The Wall Street Journal: SpringWorks is also running several other nirogacestat trials for pediatric desmoid tumors, ovarian granulosa cell tumors and relapsed or refractory multiple myeloma in combination with a variety of BCMA monoclonal antibodies, bispecifics and antibody-drug conjugates. Dunn with the FDA: Head of agency's neuroscience unit to depart It's a pivotal moment for Reata, which has struggled to push drugs. Dunn was integral in the FDA's controversial decision to approve Biogen Inc and Eisai Co's Alzheimer's drug Aduhelm last year despite a lack of evidence that it worked at slowing the effects of the disease. Error in form submission. FDA officials asked to step down after contentious Alzheimer's drug Texas-based Reata is expecting FDA's decision by Tuesday on its drug to treat a rare neuromuscular disorder called Friedreich's ataxia. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. Broad-based PR pitches will not be given priority. Billy Dunn, who presided over the polarizing approval of the Alzheimers disease treatment Aduhelm, is leaving the Food and Drug Administration after more than 15 years at the agency, STAT has learned. Before entering the market, manufacturers must plan strategically with a future-focused lens to maximize the value of the asset and portfolio, ensuring a clear vision and business case to support the commercialization of the digital therapeutic, which includes the following considerations: Digital therapeutics and asset development should not be seen as separate but of the same overall value proposition and total product profile (ToPP). Nirogacestat is an oral small molecule gamma secretase inhibitor, spun out of Pfizer in September 2017 with a handful of other early-stage programs and $103 million in backing, including from two Bain funds. PMID: 34254984 DOI: 10.1001/jamainternmed.2021.4607 No abstract available. The consumer advocacy group has singled out Billy Dunn and his crew of neuro specialists at the FDA for an "inappropriate close collaboration with Biogen" in the way they. The FDA will make a decision by Aug. 27, SpringWorks said in a press release. Wall Street analysts said Dunn's departure could impact the regulator's stance on neurological drug decisions in the near term, sending down shares of Reata Pharmaceuticals Inc 30% on Monday when media reports on the exit surfaced. "Based on the current global economic climate and volatility in the financial markets and the biotechnology sector, Ichnos is in the process of a reorganization," a spokesperson told Endpoints News in an emailed statement. The company did not immediately respond to a request for an interview from Endpoints News. There is even more uncertainty now that Billy Dunn is leaving the agency, especially as he was a major pillar to the bull thesis, with investors assuming that the FDA was going to continue with the flexible stance and acquiesce with omav. The news comes after the agency said no to Eli Lilly's accelerated pitch for an Alzheimer's drug last month, citing its request for data on 100 patients for 12 months. The research will focus on geographic atrophy, an advanced form of macular degeneration that can eventually lead to vision loss. Since Aduhelms approval was announced June 7, three expert advisers to the FDA have resigned in protest, with one calling the decision probably the worst drug-approval decision in recent US history. The three experts were part of an 11-member advisory committee thatreviewed the clinical data for the Alzheimers drug last November and voted nearly unanimously against approval (10 voted against, 1 voted uncertain). Seagen $SGEN was up almost 12% at $180.07 with a market cap of $33.6 billion. Previously, Billy was Read More View Contact Info for Free Billy Dunn's Phone Number and Email Last Update 3/8/2023 8:20 PM Email b***@fda.hhs.gov Engage via Email Contact Number (301) ***-**** Engage via Phone Mobile Number ", 2 free members-only resources remaining this month, free members-only resources remaining this month, Unlimited access to research and resources, Member-only access to events and trainings, The latest content delivered to your inbox. The Reuters report also stated that sales of Xocova could be somewhere in the $1 billion to $1.5 billion in sales this year. Deborah Birx enters new phase as biotech CEO; Verastem chief announces his retirement, Frequency to hand Nasdaq spot to Korro Bio as Atlas-founded RNA editing startup nabs $117M, Roivant discussing sale of its Pfizer-partnered UC drug to Roche for $7B, according to report, Lilly bets up to $1.9B on Versanis' PhIIb weight loss drug alone and in combo with Novo Nordisk's Wegovy, Caribous off-the-shelf CAR-T therapy shows hints of durability in early cut of data. Much of the industry has shifted overseas, with lower-cost manufacturers such as Dr. Reddy's benefiting. Its other late-stage candidate, a MEK inhibitor known as mirdametinib, could be submitted for approval in the first half of next year, analysts say. FDA indicated it wants data on at least 300 patients treated for six months and 100 patients on the drug for one year, the New York biotech said. The FDAs top neuroscience expert Billy Dunn, who was embroiled in controversy over his close ties with industry ahead of two key Alzheimers drug. Written and reported by FDAnews team of experienced industry journalists and subject matter experts, each issue delivers coverage of the regulatory, legislative and business changes affecting the global drug and device industry. FDA's Billy Dunn, Key Figure In Aduhelm Approval, To Leave Agency, CBS News: KHN is an editorially independent program of KFF (Kaiser Family Foundation). Reata is due for a decision from the FDA before tomorrow on its omaveloxolone for the treatment of Friedreichs ataxia. free members-only resources remaining this month, You've reached your limit of free monthly insights. Billy Dunn. Dunn, 53, is retiring from the agency to explore other opportunities, according to an internal FDA email sent Monday. The biotechs history includes a $123 million Series C round back in March 2020, right as the Covid-19 pandemic hit the world stage. Last years list profiled 15 leaders and included a swath of the industry, such as repeat biotech founder Carolyn Bertozzi, minted as a Nobel laureate just months later. She specializes in covering infectious diseases, public health, and microbes. Axsome's combination drug received regulatory clearance for treating major depressive disorder last August and is marketed as Auvelity.
