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Ousted FDA vaccine chief Vinay Prasad is returning to the agency

Ousted FDA vaccine chief Vinay Prasad is returning to the agency

Boston Globe2 days ago
Vinay Prasad smiles for a portrait.
Uncredited/Associated Press
A longtime a critic of FDA's standards for approving medicines, Prasad briefly ordered the maker of a gene therapy for Duchenne's muscular dystrophy to halt shipments after two patient deaths. But that action triggered pushback from the families of boys with the fatal condition and libertarian supporters of increased access to experimental medicines.
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Prasad's decision to pause the therapy was criticized by The Wall Street Journal editorial board, former Republican Sen. Rick Santorum and others. The FDA swiftly reversed its decision suspending the therapy's use.
But Prasad has had the backing of FDA Commissioner Marty Makary and health secretary Robert F. Kennedy Jr., who have both called for scrutinizing the use of COVID-19 vaccines. Under Prasad, the FDA restricted the approval of two new COVID-19 shots from vaccine makers Novavax and Moderna and set stricter testing requirements for future approvals.
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Alzheimer's DMT Market to Grow at 67.8% CAGR Through 2030
Alzheimer's DMT Market to Grow at 67.8% CAGR Through 2030

Yahoo

time8 minutes ago

  • Yahoo

Alzheimer's DMT Market to Grow at 67.8% CAGR Through 2030

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The report analyzes the market by target type (anti-amyloid and emerging targets), drug (Leqembi, Kisunla, and others), molecule type (large and small), and region (Asia-Pacific, North America, Europe, South America, and the Middle East and Africa). This report is particularly relevant today because the Alzheimer's disease (AD) DMT market is in its early stage of development, with several therapies currently in late-stage clinical trials. If these therapies are approved, they could significantly expand the market and reshape treatment options. In this context, studying the AD DMTs market is both timely and crucial for pharmaceutical companies and industry stakeholders. The report offers essential market and business insights, helping participants in the AD drugs industry make informed decisions and prepare for upcoming opportunities. The factors driving the market's growth include: High Unmet Need in AD Treatment: Alzheimer's disease currently lacks effective long-term treatments, with existing options only offering temporary symptom relief. This creates a strong demand for therapies that can slow or halt disease progression, encouraging investment, innovation, and regulatory support for disease-modifying therapies. Use of Biomarkers to Accelerate Approvals of AD DMTs: Biomarkers like amyloid-beta and tau proteins help detect Alzheimer's early and track its progression. Their use in clinical trials allows faster and more precise evaluation of new therapies, enabling quicker regulatory approvals and more targeted treatment development. Request a sample copy of the global and regional markets for disease-modifying therapies for Alzheimer's disease report. Report Synopsis Report Metric Details Base year considered 2024 Forecast period considered 2025-2030 Base year market size $235.8 million Market size forecast $13.1 billion Growth rate CAGR of 67.8% for the forecast period of 2025-2030 Segments covered Target Type, Drug Type, Drug Molecule Type, and Region Regions covered North America, Europe, Asia-Pacific, South America, Middle East and Africa Market drivers • High unmet need in AD treatment. • Use of biomarkers to accelerate AD DMTs approval. Interesting facts: As of May 2025, over half of the AD therapeutic candidates in phase 3 trials are disease modifying small molecules ( There are very few DMTs targeting the moderate to advanced stages of AD. Emerging startups: AgeneBio Inc.: The company is investigating AGB101 (levetiracetam) in phase 2 and 3 clinical trials for the treatment of hippocampal overactivity and to assess its ability to control progression to Alzheimer's dementia. 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More than 20 GOP attorneys general call on RFK Jr, FDA to reinstate safeguards for abortion drugs
More than 20 GOP attorneys general call on RFK Jr, FDA to reinstate safeguards for abortion drugs

Fox News

time12 minutes ago

  • Fox News

More than 20 GOP attorneys general call on RFK Jr, FDA to reinstate safeguards for abortion drugs

Print Close By Landon Mion Published August 13, 2025 EXCLUSIVE: More than 20 Republican attorneys general are demanding that the Trump administration reinstate safety protocols for the abortion drug mifepristone, saying it poses "serious risks to women." In a letter obtained by Fox News Digital, 22 attorneys general called on Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drugs Administration head Martin Makary to bring back safeguards for the pills that were scrapped by the Obama and Biden administrations. "Recent comprehensive studies of the real-world effects of the chemical abortion drug mifepristone report that serious adverse events occur 22 times more often than stated on the drug's label, while the drug is less than half as effective as claimed. These facts directly contradict the drug's primary marketing message of 'safe' and 'effective,'" the letter reads, citing studies published earlier this year by the Ethics and Public Policy Center (EPPA), a Washington, D.C.-based advocacy group. The EPPA report claims the pill presents harm to women, causing 1 in 10 patients to experience a "serious adverse event," including hemorrhage, emergency room visits and ectopic pregnancy. FDA CHIEF HAS 'NO PLANS' FOR ABORTION PILL POLICY CHANGES BUT CONTINUES SAFETY REVIEW The letter, led by Kansas Attorney General Kris Kobach, comes after Kennedy Jr. asked Makary to review the latest data on mifepristone and its safety. "Based on that review, the FDA should consider reinstating safety protocols that it identified as necessary as recently as 2011 in its issuance of a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, but which were removed by the Obama and Biden administrations," the letter reads, adding that the drug should be taken off the market if safeguards cannot be put in place. "Alternatively, in light of the serious risks to women who are presently being prescribed this drug without crucial safeguards, and in the event the FDA is unable to reinstate the 2011 safety protocols for mifepristone, the FDA should consider withdrawing mifepristone from the market until it completes its review and can decide on a course of action based on objective safety and efficacy criteria," the attorneys general wrote. Sen. Josh Hawley, R-Mo., also sent a letter to Kennedy Jr. last month urging him to take immediate action to reinstate safety guardrails on mifepristone following the secretary's commitment to conducting a safety review of the drug. Makary had previously said that he had no plans to modify policies surrounding mifepristone but that the FDA would act if the data suggested there was a safety issue. Mifepristone, which is taken with another drug called misoprostol to end an early pregnancy, was first approved by the FDA in 2000 after "a thorough and comprehensive review" found it was safe and effective, according to the agency's website, which noted that periodic reviews since its approval have not identified new safety concerns. Last year, the Supreme Court rejected a challenge targeting the drug's availability. The plaintiffs had sought to restrict access to mifepristone across the country, including in Democrat-led states where abortion remains legal. The court did not rule on whether the FDA acted lawfully when it moved during the Obama and Biden administrations to ease the rules for mifepristone's use that had been established during the Clinton administration. Medication abortions made up more than half of all abortions in the U.S. health care system in 2023, according to a study by the Guttmacher Institute. MEDICAL GROUPS URGE FDA, KENNEDY TO REEXAMINE BROAD APPROVAL OF ABORTION DRUGS CLICK HERE TO GET THE FOX NEWS APP "Currently, a woman can obtain a mifepristone abortion by participating in only one telehealth visit with any approved healthcare provider (not necessarily a physician), ordering the drugs through a mail-order pharmacy, and self-administering them," the attorneys general wrote. "And the prescriber is only required to report an adverse event if he or she becomes aware that the patient has died." "The FDA's removal of these crucial safety protocols in 2016 (and in 2023) that only five years before the FDA considered necessary begs the question of whether the removal was motivated by considerations other than the safety of patients … The current FDA's dedication to the health and wellbeing of all Americans is encouraging, as is the much-needed review of mifepristone that Secretary Kennedy has promised," the letter concludes. Print Close URL

State Senate Minority Leader John Braun announces bid for Congress
State Senate Minority Leader John Braun announces bid for Congress

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timean hour ago

  • Yahoo

State Senate Minority Leader John Braun announces bid for Congress

Aug. 12—The top Republican in the Washington state Senate has announced a bid to represent southwest Washington in the U.S. House of Representatives. State Sen. John Braun will challenge Democratic Rep. Marie Gluesenkamp Perez, of Skamania, to represent Washington's 3rd Congressional District. Braun enters the race with the backing of Republican Rep. Michael Baumgartner, Braun's former colleague in the state Legislature. Braun, who has served in Olympia since 2013, was selected as Senate minority leader in 2020. Braun is a U.S. Navy veteran and president of Braun Northwest, a family-owned manufacturer of emergency vehicles based in Lewis County. "Whether in the Navy, running a small business, or serving in the state legislature, I've always focused on solving tough problems, clearing roadblocks, and helping others succeed," Braun said in a statement Tuesday. "In Congress, I'll bring that same approach — working to lower costs for families, support American manufacturing, and expand opportunities for family-wage jobs here at home." In his announcement, Braun cited his 31 years of service in the U.S. Navy, which included serving as the director of the U.S. Navy Submarine Force Reserve Component. "Members of Congress take an oath to defend our country against all enemies, foreign and domestic. I take that oath seriously. I'll work to secure our borders and maintain a strong national defense — because peace is best preserved through strength," Braun said in a statement. Braun represents the 20th Legislative District, which includes Lewis County and parts of Thurston, Cowlitz and Clark counties. Braun's announcement Tuesday gives Republicans a high-profile candidate in a district that is one of their top targets in the 2026 midterms. Gluesenkamp Perez was a political newcomer when she won the seat in 2022 by 2,629 votes over Republican nominee Joe Kent, and subsequently defeated Kent again in her 2024 re-election bid. Kent has since been confirmed as the director of the National Counterterrorism Center in the Trump administration. While in Congress, Gluesenkamp Perez has repeatedly earned national headlines for her success in a red-leaning district, particularly with Republicans finding success on the top of the ticket. Despite Gluesenkamp Perez's re-election, the district has continued to lean Republican, with voters supporting Donald Trump in each of his three presidential campaigns. Following the announcement, Democratic Congressional Campaign Committee spokesperson Lindsay Reilly said that Braun "has proven time and again that he's out for himself and his donor friends. "Voters know Braun is nothing more than a suit in Olympia who works for special interests like Big Pharma, not for working people," Reilly said. "He's a swamp creature who will be more of the same in D.C., championing the status quo that's left too many Southwest Washington families behind." Before Gluesenkamp Perez, the district was represented for 12 years by Republican Jaime Herrera Beutler. The Cook Political Report rates the district as one of 18 "toss-up districts" in the country, which they classify as those where "either party has a good chance of winning."

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