Latest news with #Marks'
CNBC
06-05-2025
- Business
- CNBC
Watch CNBC's full interview with Oaktree's Howard Marks
Howard Marks, Oaktree Capital Management co-chairman, joins CNBC's Money Movers' to discuss how Marks' investing outlook has changed since Trump's tariffs announcements, what doesn't make sense to Marks, and more.
CNBC
06-05-2025
- Business
- CNBC
Oaktree's Howard Marks: Markets in 'limbo' waiting on finalization on tariffs
Howard Marks, Oaktree Capital Management co-chairman, joins CNBC's Money Movers' to discuss how Marks' investing outlook has changed since Trump's tariffs announcements, what doesn't make sense to Marks, and more.
CNN
01-04-2025
- Health
- CNN
Top vaccine official forced out of FDA
The head of the US Food and Drug Administration department responsible for assuring the safety and effectiveness of vaccines has resigned, according to a resignation letter obtained by CNN. Dr. Peter Marks, director of the agency's Center for Biologics Evaluation and Research, was given the choice to resign or be fired. Marks' resignation takes effect April 5. The news of Marks' forced resignation was first reported Friday by The Wall Street Journal. 'It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,' Marks wrote in his letter, referring to US Health and Human Services Secretary Robert F. Kennedy Jr. In an email, an HHS official told CNN, 'If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.' FDA's Center for Biologics Evaluation and Research is responsible for the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue and gene therapies. Marks was instrumental in carrying out Operation Warp Speed, the federal government's Covid-19 vaccine development program. He has overseen the approval of more recent vaccines, including the first influenza vaccine for self- or caregiver-administration, providing a new option for protection against seasonal flu. Marks' forced resignation and other recent moves by HHS drew a wave of warnings from health experts. 'This is what happens when you hire a 20 year virulent anti-vaccine activist who continues to deny the science that vaccines don't cause autism, and put him in a position of influence,' Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a vaccine adviser to the FDA, told CNN, referring to Kennedy. 'So what you're about to see is studies done, presumably under the imprimatur of the CDC, showing that vaccines cause autism. That's what you're about to see, because he will put in place people who will shoehorn data to make it look that way, which will create more fear, will create likely more people who will choose not to be vaccinated, and you'll just see more and more in the way of these outbreaks.' Earlier this month, HHS asked the CDC to study vaccines and autism, despite strong evidence that vaccines do not cause autism. Dr. Ashish Jha, dean of the Brown University School of Public Health and Covid-19 response coordinator during the Biden administration, said on X that Marks is a brilliant scientist who 'helped usher in scientific rigor and transparency into the FDA.' Pushing him out makes 'the FDA dramatically weaker, less effective,' Jha wrote. 'This is not how we make America healthy.'
Yahoo
31-03-2025
- Business
- Yahoo
Why Biotech Stocks Like Recursion Pharmaceuticals, CRISPR Therapeutics, and Summit Therapeutics Plunged Today
Shares of biotechnology stocks such as Recursion Pharmaceuticals (NASDAQ: RXRX), Summit Therapeutics (NASDAQ: SMMT), and CRISPR Therapeutics AG (NASDAQ: CRSP) plunged on Monday, down 9.4%, 5.6%, and 9.2%, respectively, as of 12:55 p.m. ET. All three companies are early-stage biotechnology companies working on next-generation therapeutics with advanced technologies. However, that means none of these companies actually makes much revenue today, let alone profit. So not only were these stocks slammed by the risk-off mentality in the markets ahead of tariffs coming on April 2, but a key resignation at the Federal Drug Administration (FDA) over the weekend raised questions about the speed and willingness of the agency to approve new drug technologies going forward. The double whammy sent these stocks down much more than the market today. Over the weekend, Dr. Peter Marks, who headed the FDA's Center for Biologics Evaluation and Research, as well as its vaccine division, resigned in protest. Of note, Dr. Marks was instrumental in "Operation Warp Speed" during President Trump's first term, which sped up the development and approval of the COVID-19 vaccine. But with the appointment of vaccine skeptic Robert F. Kennedy Jr. as Secretary of Health and Human Services, it appears Trump 2.0 will take a different path forward regarding the FDA. In his resignation letter to FDA Commissioner Sara Brenner over the weekend, Dr. Marks wrote: I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies. My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science. In an interview on CNBC this morning, former FDA Commissioner Scott Gottlieb cited other reporting that Dr. Marks had been forced to resign by Kennedy, or be fired. Both Marks' letter and Gottlieb's interview stressed Marks' role in the creation of more modern approval processes for new gene therapies, which was as consequential -- if not more so -- than his presiding over the nation's vaccine approval process. During Marks' tenure, the FDA approved 22 gene therapies, including new treatments across a range of diseases such as inherited blindness, sickle cell anemia, and child leukemia, among many others. Overall, Marks had been an advocate for newer, more flexible approval processes for new drugs, especially orphan diseases. Therefore, with his departure, it's possible the approval process for therapies with newer technologies could be slowed down. While we don't know who Marks' successor will be, his resignation certainly throws more uncertainty into the drug approval process, which could be significant for these three very forward-looking biotechs. Recursion Pharmaceuticals uses artificial intelligence (AI) in its proprietary operating system to match new compounds against a vast library of human genes in order to come up with new therapies. Currently, Recursion has trials underway for a variety of neurological diseases, as well as some cancers. Summit Therapeutics is much larger than the other two stocks, thanks to last year's promising Phase III results for its lung cancer monoclonal antibody drug ivonescimab, which received "fast-track" designation by the FDA late last year. But with the change of leadership at the FDA, the timeline for final approval could be pushed out later than it otherwise would be. Finally, CRISPR is at the forefront of revolutionary gene-editing therapies for a variety of blood and cardiovascular diseases, as well as certain cancers. Should these new and novel therapies get rejected or their approval timeline get extended, it could affect the future revenue and profit outlook for these companies. In addition, since none of these stocks are profitable, each may have to raise more money at some point to fund their research. With a potentially longer path to approval and equity valuations currently plunging broadly, that could mean more shareholder dilution. Therefore, it's no surprise to see these stocks sell off hard today. But as with most of the market's current issues, whether it be tariff policies, geopolitical issues, or the change of leadership at HHS and the FDA, right now there is just profound uncertainty. Investors have to hope that a sensible replacement for Marks will move new therapies along in a timely manner. Before you buy stock in Recursion Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Recursion Pharmaceuticals wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $672,177!* Now, it's worth noting Stock Advisor's total average return is 815% — a market-crushing outperformance compared to 162% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of March 24, 2025 Billy Duberstein and/or his clients have no position in any of the stocks mentioned. The Motley Fool has positions in and recommends CRISPR Therapeutics and Summit Therapeutics. The Motley Fool has a disclosure policy. Why Biotech Stocks Like Recursion Pharmaceuticals, CRISPR Therapeutics, and Summit Therapeutics Plunged Today was originally published by The Motley Fool Sign in to access your portfolio
Yahoo
29-03-2025
- Health
- Yahoo
Peter Marks, FDA's top vaccine official, resigns
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Peter Marks, the Food and Drug Administration's top vaccine official, abruptly resigned from the agency on Friday, citing disagreement with Health and Human Services Secretary Robert F. Kennedy Jr. Marks, who helped lead the successful advancement of COVID-19 vaccines during the first Trump administration, said he had tried to address Kennedy's concerns around vaccine safety and transparency. 'However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,' Marks wrote in a letter to acting FDA Commissioner Sara Brenner, a copy of which was obtained by BioPharma Dive. 'My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science,' he continued. Marks' resignation is effective April 5. His departure will leave both of the FDA's principal drug review offices without a permanent leader. Patrizia Cavazzoni, who was formerly head of the other office, stepped down from her role on January 18. In addition to Marks and Cavazzoni, several other agency leaders have either departed or been fired in recent months. The Wall Street Journal first reported news of Marks' resignation. Both HHS and FDA did not respond to multiple requests by BioPharma Dive for comment. Marks, a physician and hematologist, has led the Center for Biologics Evaluation and Research since 2016, overseeing the agency's review of vaccines, blood products and some genetic medicines. He helped come up with the idea for Operation Warp Speed, a cross-government initiative that helped the U.S. quickly develop, review and produce several safe and effective vaccines for COVID-19. He's also championed the development of cell and gene therapies, pushing the agency to be more flexible and move faster — sometimes controversially so. 'I had the chance to work closely with [Marks],' Robert Califf, a former FDA commissioner under Presidents Barack Obama and Joe Biden, wrote on Bluesky. 'While many people disagreed with one or another decision he made, I can assert that his interest was always with the combination of public health and the special needs of patients in this rapidly evolving world of technology.' Marks' ouster could spark concerns within the biopharmaceutical industry, which has been cautious in opposing Trump administration actions at HHS and the FDA. "We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people," John Crowley, head of the biotech lobbying group BIO, said in a statement. 'Marks will be sorely missed,' John Maraganore, a biotechnology leader and former CEO of Alnylam Pharmaceuticals, wrote on X. In his letter, Marks directly cited the current measles outbreak that has sickened at least 483 people across 20 states through Thursday and led to the first U.S. death from the disease in 10 years. Kennedy, who for years pushed unproven claims about the safety of many vaccines, has been criticized for his handling of the outbreak. While he recommended parents discuss vaccination with their child's physicians, he has also touted ineffective treatments like cod liver oil, which can cause injury if overdosed. 'Undermining confidence in well-established vaccines that have met the high standards for quality, safety, and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation's health, safety and security,' Marks wrote in his letter. Two doses of the measles vaccine available in the U.S. are 97% effective at preventing the disease and side effects are mild in the vast majority of cases. It has not been linked to autism, as Kennedy has long claimed. Other actions by Kennedy since he became health secretary have also raised alarms. A meeting of advisers to the Centers for Disease Control and Prevention was postponed soon after Kennedy was sworn in, although it has since been rescheduled. According to reporting by Politico, Kennedy is also considering forcing out some of the advisers on the panel, and is scrutinizing other vaccine advisory committees. Most significantly, Kennedy on Thursday unveiled plans to dramatically shrink HHS, including by cutting some 2,400 employees at the CDC and 3,500 at FDA. The layoffs follow a number of moves by the Trump administration to force government workers to leave or retire early, as well as to reduce funding for scientific research. Martin Makary, President Donald Trump's pick to run the FDA, was confirmed by the Senate Tuesday, but it's not clear if he has been sworn in yet as commissioner.
