billy dunn leaving fda

1 FDAnews delivers what you need to know each business day. ': The Long Road to Reining In Short-Term Plans. Email me at klahucik@endpointsnews.com. Please try again. Building the required capabilities and expertise within technology, data science, and analytics is critical and takes planning and timing. FDA neurosciences chief Billy Dunn to leave immediately - Reuters 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. Never miss out on the latest innovative health care content tailored to you. He also backed the approval of Amylyx Pharmaceuticals Inc's Relyvrio last year, telling a panel of outside advisers that the amyotrophic lateral sclerosis drug could be pulled from the market if it failed in a larger trial underway. The FDAs decision deadline for expanding Ayvakits label to adults with indolent SM is May 22. The FDA will make a decision by Aug. 27, SpringWorks said in a press release. Drew Armstrong on Twitter: " FDA's head of neuro drugs, Billy Dunn, is Adam Feuerstein is STATs national biotech columnist, reporting on the intersection of biotech and Wall Street. Billy Dunn, former FDA neuroscience head, joins Prothena board PMID: 34254984 DOI: 10.1001/jamainternmed.2021.4607 No abstract available. Beth Mole It is imperative that your target stakeholders can see the significant value that your digital therapy can provide. Take the data with a grain of salt: The sample size is 66 companies that replied to a BIO survey. 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. Jacqueline Corrigan-Curay, J.D., M.D., is the Principal Deputy Center Director in FDA's Center for Drug Evaluation and Research (CDER). The deal will look at the delivery of Rallybios C5 inhibitor using EyePoints tech for intraocular drug delivery, dubbed Durasert. We have two nomination forms currently open for our 20 Under 40 and LGBTQ+ biopharma leaders. By continuing to browse the site you are agreeing to our use of cookies in accordance with our. With Apexigen only having 20 employees at the end of 2022, according to an SEC filing, that translates to 11 staffers. ON Director Billy Dunn, M.D., supervised the FDA team conducting this review and likely played a key role in the close FDA-Biogen collaboration. His departure was announced in an email to FDA staff sent by Peter Stein, head of the regulator's Office of New Drugs. 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. CDER Leadership Bios | FDA - U.S. Food and Drug Administration With a global news desk that operates in over 200 markets, BNN provides up-to-the-minute breaking news, sophisticated data analysis, and thorough research, to keep audiences informed and engaged. Copyright 2021 NXT.financial media, Reatas regulatory concerns turn into three-month delay on FDA decision for Friedreichs ataxia drug. Press Esc to cancel. by Billy Dunn, the neurosciences head of U.S. Food and Drug Administration will retire from his role effective immediately, the health regulator said. That makes Tuesdays Food and Drug Administration decision on its treatment for heart failure a big deal except nearly everyone, even investors who own Cytokinetics hopes the agency rules against it. It fell nearly 6% on Tuesday before reversing losses. While many critics of the FDAs decision have expressed concern for the precedent the approval sets for future drugs, Public Citizen and others also worry about the impacts on patients and their families. 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. Texas-based Reata is expecting FDA's decision by Tuesday on its drug to treat a rare neuromuscular disorder called Friedreich's ataxia. Along with the 45 on-market products, it also includes about 40 drugs that aren't currently being sold. Expose Showing 'Inappropriately Close' FDA, Biogen Collaboration All Rights Reserved. Shares of Pfizer$PFE were down 1% today to $41.34. You have remaining this month. Thank you for your interest in supporting Kaiser Health News (KHN), the nations leading nonprofit newsroom focused on health and health policy. The Wall Street Journal: By piling up patents, drug companies delay the day when competitors can introduce similar, cheaper products. (Reporting by Sriparna Roy in Bengaluru; editing by Caroline Humer and Shinjini Ganguli), Asia stocks set for best week of 2023, dollar reels on dovish Fed bets, Tumbling US dollar a boon to risk assets across the globe, Lifco AB Reports Earnings Results for the Second Quarter and Six Months Ended June 30, 2023, India to reject call for anti-subsidy tax on certain Chinese steel products, South Korea torrential rain triggers power cuts, flight cancellations, Nokia issues profit warning, rival Ericsson delivers 'lukewarm' results, Ericsson's operating profit down in Q2 results, U.S. banks point to resilient but slowing economy, flag risks ahead, MICROSOFT CORP : Upgraded to Buy by UBS, China invites global investors for rare meeting as economy sputters-sources. Embedding digital therapeutics into the overall downstream development process must complement existing processes without causing additional constraints. Reacting to the news of the departure of Dunn, the shares of Reata Pharmaceuticals fell 30% on Monday. Be sure to nominate them before the deadlines. Stat: 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. The Japanese pharma Shionogi is hoping to reap big sales for its Covid antiviral pill once it's approved in the US. The Phase III completion could come about a year sooner than previously anticipated, though, with the timeline for ADVANCE-2 moving from mid-2025 to the first half of next year, per a quarterly update Monday morning. Last week, Akorn Pharmaceuticals shut down a sterile drugs manufacturing site in Illinois, laying off 400 workers; the company had filed for bankruptcy in 2020 after failing to find a buyer. The pharmaceutical industry is rife with tales of companies dreaming up ways to prolong their monopolies on lucrative drugs. 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. The departure of Dunn, 53, was announced in an internal message to the agencys employees on Monday. Billy Dunn is leaving his post leading the FDA's neuroscience team after an 18-year career that in recent years has included the controversial accelerated approval of Biogen's Alzheimer's . Integrating a digital therapeutic into the asset strategy can also help drive efficient clinical trials and support effective evidence generation, providing more compelling data to regulators and payers to achieve favorable access. March 1, 2023. By subscribing up, you agree to the our terms and agreement. In August of last year, the company said that the Covid-19 pandemic had left behind its goals for the Nextstellis launch. Manufacturers need to act quickly, before the tech giants shape this arena, to develop digital therapeutics that truly increase the value of products for all stakeholders. 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. The Reuters report also stated that sales of Xocova could be somewhere in the $1 billion to $1.5 billion in sales this year. Blueprint is hoping to expand Ayvakit's label into a less advanced form of systemic mastocytosis, a rare disease in which too many mast cells, a type of white blood cell, build up in the body. 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. Unlock this article along with other benefits by subscribing to one of our paid plans. Billy Dunn Email & Phone Number - U.S. Departme.. | ZoomInfo Contact Will Tuttle, Business Development Representative at wtuttle@fdanews.com or +1 612.216.2948 to receive a custom quote. FDA neurosciences chief Billy Dunn to leave immediately, analysts raise Teresa Buracchio, deputy of the Office of Neuroscience, will take over Dunns role as director on an acting basis. 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. Drugs Regulatory Affairs. (Reporting by Sriparna Roy in Bengaluru; editing by Caroline Humer and Shinjini Ganguli). The FDA did not immediately respond to Ars request for comment. Why Reata Pharmaceuticals Shares Are Falling Monday? - Yahoo Finance Representatives for Seagen didn't immediately respond to requests for comment. It's a pivotal moment for Reata, which has struggled to push drugs. Musings on Omavs Dance With the FDA), prior comments from Billy Dunn during the regulatory review for Albrioza [Relyvrio] suggested that the FDA is trying to be flexible for rare central nervous system/CNS diseases; however, it remains unclear if this also reads through to omaveloxolone/omav in Friedreichs ataxia/FA. Last August, Apexigen merged with Brookline Capital Acquisition Corp. and ended up going public at over $10 a share on Aug. 1 a substantial decline in less than seven months. FDA recently published five guidances for industry related to. FDA official behind Alzheimer's drug scandal steps down 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. Shares of Reata fell nearly 6% on Tuesday before reversing losses. Approval of Aducanumab for Alzheimer Disease-The FDA's Perspective But, upon approval, the regulator said that it did use the surrogate and claimed that the reduction of amyloid-beta is. It is estimated that the number of people using digital therapeutics will increase by 381% over the next four years.1. A Plan to Cut Montanas Medicaid Waiting List Was Met With Bipartisan Cheers. There was an error saving your display name. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. She specializes in covering infectious diseases, public health, and microbes. Digital and data science expertise and mindset. free members-only resources remaining this month, You've reached your limit of free monthly insights. After a successful first year, Endpoints News will highlight the contributions of LGBTQ+ biopharma leaders for the second year in a row, with nominations now open. 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. 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. magic link that lets you log in quickly without using a password. From: Billy Dunn, M.D. People who stopped taking semaglutide gained back, on average, two-thirds of the weight they lost within a year, according to a study published in August 2022 in the journal Diabetes, Obesity, and Metabolism. Should the drug win approval, it would be the companys first since being spun out of Pfizer five and a half years ago. Irenic said that since Theravance spun out Innoviva in 2014, its shareholders have lost significantly on their investment. CDC on Friday issued a public health advisory warning of a surge in serious gastrointestinal infections caused by Shigella bacteria that are highly resistant to antibiotics and pose a "serious public health threat. But the result has been occasional shortages, such as out-of-stock ADHD medicines reported across the US over the last year. A Drug Company Exploited A Safety Requirement To Make Money 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. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! Pfizer declined to comment. As the news of Dunns departure hit the markets, Reata Pharmaceuticals saw its stock price $RETA fall by more than 34% at one point on Monday afternoon. But in order to review that new data, the FDA needed three more months. We appreciate all forms of engagement from our readers and listeners, and welcome your support. 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. Altria In Talks To Buy Vaping Startup NJOY For At Least $2.75 Billion, Divest Its Stake In Juul Billy Dunn, head of the Office of Neuroscience at the FDA, is leaving . Advisory Board's Solomon Banjo outlines three potential reasons driving this trend and explores whether the rise in online clinician communities will improve clinical decision-making or compound existing challenges. A Drug Company Exploited A Safety Requirement To Make Money. Dunns retirement could impact the agencys stance on neurological drug decisions in the near term. This is a summary taken from Fishawack Healths new publication Digital therapeutics: The key to maximizing the potential of medicinal assets.. Leaders are tasked with supporting their team by "providing guidance, setting routines and practices, and creating constant opportunities for group learning." Steins email to staff on Monday didnt say where Dunn is headed. As we have conveyed during our months of private engagement, the substantial disconnect between Theravances intrinsic value and its trading price reflects an absence of investor confidence in management and the Board, the activist investor wrote in its letter. . Our digital archive gives you access to our entire innovative history of insights. Theravance could not be reached for comment at time of publication. The on-market drugs brought in $111 million in the last reported year of results, Dr. Reddy's said. Dunns departure follows several high-profile drug approvals that raised questions about the agencys coziness with Biogen regarding its approval of the amyloid-targeted drug Aduhelm and led to a highly critical congressional report. Watchdog Demands FDA Chief Resign Over 'Reckless' Approval of Biogen An organization that promotes and studies clinical trial disclosure has petitioned the Food and Drug Administration to take several steps to boost its enforcement of wayward trial sponsors and investigators that fail to register studies and report results. "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. Billy Dunn, FDA's top neuroscience official to depart agency Shares of other neurological drugmakers Biogen and Amylyx Pharmaceuticals also had fallen on Monday. 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. Billy Dunn, the FDA's controversial neuroscience head, is stepping down from his post to "explore other opportunities," according to an internal FDA e-mail. advertisement The FDA's neuroscience office, led by Dunn, is expected to render its decision on omaveloxolone by Feb. 28. 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). 2. Dunn, 53, is retiring from the agency to "explore other opportunities," according to an internal FDA email sent Monday. FDA's Billy Dunn, Key Figure In Aduhelm Approval, To Leave Agency, CBS News: While it was a difficult but prudent decision to reduce our workforce to focus on critical areas as we conduct this comprehensive review of strategic alternatives, we strongly believe this process will maximize stockholder value and the likelihood of sotigalimabs successful development, Apexigen CEO and founder Xiaodong Yang said in a statement. We distribute our journalism for free and without advertising through media partners of all sizes and in communities large and small. The letter was first reported by Reuters. However, no financial details have been given yet. Generic drugs giant Dr. Reddy's Laboratories has made a deal to acquire Mayne Pharma's US generics portfolio for at least $90 million. Much of the industry has shifted overseas, with lower-cost manufacturers such as Dr. Reddy's benefiting. 2 min read FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland (Reuters) - The U.S. Food and Drug Administration neurosciences head. For Cytokinetics, FDA Rejection Of Heart Drug Would Help, Not Hinder, Stat: Talking with Billy Dunn, M.D., who is the director of the Division of Neurology Products in CDER's Office of New Drugs. Nominate them for Endpoints annual report, Activist investor pushes for management overhaul, strategic review at Theravance, Axsome says FDA wants more data for Alzheimers agitation label expansion, but readout to come sooner, Pfizer spinout SpringWorks gets FDA priority review for lead drug, Ahead of FDA decision, Blueprint puts out full data for expanded Ayvakit label, Glenmark's biotech company Ichnos Sciences lays off 50, Dr. Reddy's to buy Mayne Pharmas US generics drug list for at least $90M, EyePoint and Rallybio shake hands on collaboration; Shionogi expects billions for Covid antiviral pill report, Novartis retreat from NASH takes down $80M alliance with Pliant Therapeutics, Breaking: FDA neuroscience chief Billy Dunn, who led Aduhelm approval, will leave agency, Pfizer makes moves to acquire Seagen in potential $30B+ deal, Tiny Apexigen to lay off majority of workers after SPAC deal, Hemolytic Anemia Sales Specialist, Rare Genetic Diseases, General Catalyst Life Sciences Investment Fellowship, Whos charting paths for LGBTQ+ leaders in biopharma? He has provided thoughtful direction for individual IND development programs and has also moved the field more broadly through innovations in trial designs and endpoints, clarifying how drugs targeting particular disorders can be more efficiently developed, Stein said. The drug was approved for the advanced form of the disease in 2021. We'll e-mail you a link to set a new password. Billy Dunn departs FDAChutes & Ladders - fiercebiotech.com Novo Nordisk funded the trial. 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. 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. Buracchio joined FDA in 2013 as a reviewer in the division of gastroenterology and inborn error products, before moving in 2014 to the division of neurology products. To achieve this, biopharmaceutical companies will need deep knowledge of the existing processes and systems, using design thinking and deeper insight methodologies to drive integration. We help leaders and future leaders in the healthcare industry work smarter and faster by providing provocative insights, actionable strategies, and practical tools to support execution. 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. Meanwhile, CBS News says the FDA has recently approved the first drug that can slow the vision-loss illness geographic atrophy. Digital therapeutics are a subcategory of digital medicine. The layoffs include research and general and administrative positions. Design, CMS, Hosting & Web Development :: ePublishing, We use cookies to provide you with a better experience. A former Biogen employee told STAT that "It was clear that Billy Dunn was an ally, so the job for Biogen became figuring out how to support his efforts within the FDA." "FDA's decision to approve aducanumab is a disastrous blow to the agency's credibility, public health and the financial stability of the Medicare program," said Carome. For Cytokinetics, FDA Rejection Of Heart Drug Would Help, Not Hinder You should direct the next Acting FDA Commissioner to consider whether the agencys approval of Biogens BLA for aducanumab should be withdrawn.. Ichnos Science is another recent example of companies that have had to cut back on personnel as part of a February freeze across the industry. These two publications have recently merged to become FDAnews, a trusted one-stop destination for drug and device insights. Dunn, 53, is retiring from the agency to explore other opportunities, according to an internal FDA email sent Monday. Start your single-user one-year subscription (250 issues) FDAnews for only $1,895. The regulator wants long-term safety data from patients in that indication, which the company has previously said affects up to 70% of patients with Alzheimers. Internal digital and data science expertise is critical to developing a united value proposition that aligns the benefits of the digital and medicinal product, Improved outcomes, access, and experience for patients, Healthcare professionals can improve care for patients through additional monitoring, alongside leveraging applications that support patient adherence, Scalable and cost-effective interventions for payers, including improved clinical and health economic outcomes, reduced cost of medical interventions, and the ability to collect real-world data. Farmers Fight Health Advocates Over the Creamy Whole Variety, KFF Health News' 'What the Health? The biotech industrys leading organization called it a hopeful trend that may indicate progress toward a more equitable culture for LGBTQ staff.. They tweak dosing. Editors note: The spelling of Teresa Buracchios name was incorrect in a previous version of this story and has been corrected. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. 2 free members-only resources remaining this month Theravances share price has dropped by 55% since it began trading in 2014 and is now at just over $10. The drug is expected to be on the market in early March. Alzheimer's drug Aduhelm: What one ex-FDA adviser called - CNN 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. The Food and Drug Administration recently approved the first drug to treat geographic atrophy, a form of macular degeneration, which affects a person's central vision. (Lapook, Ann Winick and Novak, 2/27), Stat: Mayne Pharma sells about 45 different generics products in the US, Dr. Reddy's said in a release announcing the sale, including generics in women's health. In Wake of Stunning New Revelations of Unprecedented FDA-Biogen Reporting from the frontiers of health and medicine, You've been selected! 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. Please note this link is one-time use only and is valid for only 24 hours. FDA neurosciences chief Billy Dunn to leave immediately, analysts raise FDA says neurosciences chief Billy Dunn to leave immediately New FDA-Approved Drug Can Slow Vision Loss For Those With Age-Related Eye Disease Geographic Atrophy, A Form Of Macular Degeneration Generics drugmakers have been consolidating for years, as low prices and market volatility have made it harder to do business.
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