Latest news with #MartinMakary
Japan Today
a day ago
- Health
- Japan Today
U.S. ice cream makers to scoop out synthetic dyes under RFK Jr. push
(L/R) Food and Drug Administration Commissioner (FDA) Martin Makary and Secretary of Health and Human Services Robert F. Kennedy Jr., eat ice cream at the end of a news conference at the USDA headquarters building in Washington, DC, on July 14, 2025 By Issam AHMED Major U.S. ice cream makers on Monday announced plans to phase out their use of artificial dyes following pressure from Health Secretary Robert F. Kennedy Jr to eliminate unnecessary additives from the American diet. The International Dairy Foods Association (IDFA), which includes over 40 top ice cream brands, said its members would stop using petroleum-derived synthetic colorings by the end of 2027. These chemicals have been linked in studies to conditions including attention deficit hyperactivity disorder (ADHD), cancer, diabetes, gastrointestinal issues, and genomic disruption, yet serve no nutritional or functional purpose beyond cosmetic coloring, health advocates have long argued. "I'm particularly happy to be here today because this is relevant to my favorite food, which is ice cream," Kennedy said at a press event, lauding the dairy industry for its actions. "This is a great day for dairy and it's a great day for Make America Healthy Again," added the IDFA's President and CEO Michael Dykes, referencing Kennedy's MAHA slogan that is a play on President Donald Trump's "Make America Great Again" or MAGA. Andy Jacobs, CEO of Turkey Hill, said many commercial ice cream manufacturers had already phased out artificial colors or were in the process of doing so. "By taking this step now, ice cream manufacturers are ensuring that ice cream remains a special part of our lives as consumer preferences change and the nation's regulatory priorities evolve," he said. Industry data shows Americans consume roughly 19 pounds (8.6 kg) of ice cream a year. The frozen treat contributes an estimated $12 billion to the economy and supports more than 27,000 dairy industry jobs. In April, Kennedy announced plans to revoke authorization for two synthetic dyes and to "work with industry" to eliminate six more -- an approach critics dismissed as too soft and overly reliant on voluntary action. By contrast, the Food and Drug Administration (FDA) in one of its final acts under President Joe Biden finalized a rule to actually ban Red Dye No. 3, one of the most widely used and controversial colorings. Yet there are signs that Kennedy's peer pressure strategy is yielding some results. Major food manufacturers including Nestle, Kraft Heinz, General Mills and PepsiCo have already signed on to ditch artificial dyes. Kennedy on Monday said between "35 and 40 percent" of the food industry has now pledged to make the shift, but it was notable the ice cream makers' pledge pushes past the health secretary's original target of end-2026, giving companies an extra year to adjust their supply chains. And key holdouts remain -- for example Mars, the maker of M&M's and Skittles, and its subsidiary Kellogg's, whose Froot Loops still use Red 40, Yellow 5, Blue 1, and Yellow 6 in the U.S., even though the same cereal is artificial dye-free in places like Canada. At the same time, Trump's FDA has fast-tracking natural-dye based alternatives, adding gardenia (genipin) blue to the list on Monday, the fourth such approval in two months. © 2025 AFP
Bloomberg
5 days ago
- Business
- Bloomberg
FDA's Push for 'Radical Transparency'
Wall Street Week FDA Commissioner Martin Makary says the agency will begin publishing drug rejection letters—long kept confidential—to help developers better understand what he calls the FDA's 'black box.' (Source: Bloomberg)
Business Wire
01-07-2025
- Business
- Business Wire
Cybin Reports Fiscal Year 2025 Financial Results and Recent Business Highlights
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today reported audited financial results for its fiscal year ended March 31, 2025, and recent business highlights. 'During the past 12 months, we have continued to focus on building out the strong foundation that underpins the clinical and regulatory milestones we anticipate in the coming year,' said Doug Drysdale, Chief Executive Officer of Cybin. 'Heartened by U.S. Food and Drug Administration Commissioner Dr. Martin Makary's recent comments in support of prioritizing this innovative scientific work, as well as the burgeoning government and media attention the field is receiving, we remain steadfastly committed to advancing our two lead programs, CYB003 and CYB004, toward potential approval and commercialization.' 'Developing novel therapies to address the unmet need in mental health care requires dedication, scientific rigor, and the integration of expertise across domains. To help us accelerate our clinical goals, we have entered into several strategic collaborations, including with Osmind and Thermo Fisher Scientific, and have formed strategic partnership agreements among our clinical trial sites. In this way, we leverage the competencies, resources, and infrastructures of these key stakeholders with a goal of expediting the development pathway. Cybin's lead clinical programs – CYB003, our Phase 3 pivotal program for the adjunctive treatment of major depressive disorder, and CYB004, our Phase 2 program in generalized anxiety disorder – continue to advance, and we look forward to sharing future updates.' Recent Business and Pipeline Highlights: Announced additional strategic clinical site partnerships ('SPAs') to support PARADIGM. The SPAs are designed to facilitate collaboration among sites, cultivate long-term partnerships, enhance efficiency in trial operations, and improve overall site performance. Engaged Thermo Fisher Scientific, a world-class manufacturing partner, to provide U.S.-based manufacturing for the CYB003 program. Thermo Fisher Scientific offers leading Contract Development and Manufacturing Organization services and has a successful track record across the manufacturing spectrum. Cybin broadened its existing strong relationship with Thermo Fisher Scientific to include the development of both the drug substance and drug product capsules for CYB003. Cybin has engaged Thermo Fisher Scientific as its manufacturing partner in the United States, including partnering with Thermo Fisher Scientific's pharma services sites in Florence, South Carolina, for Phase 3 clinical supply and future commercialization, and Cincinnati, Ohio, for Phase 3 capsule production. Partnered with Osmind, a leading service provider to psychiatry practices in the U.S., with the objective of accelerating commercial preparation for clinical-stage pipeline. Osmind advances psychiatry through technology and services to bring innovative mental health treatments to patients in need. Cybin expects to leverage Osmind's 800-clinic network, point-of-care software, and real-world data to support commercial preparation for its clinical-stage pipeline. Strengthened intellectual property portfolio with two additional U.S. patents in support of lead clinical programs CYB003 and CYB004. To-date, Cybin's growing intellectual property portfolio comprises more than 90 granted patents and over 230 pending applications. The recently issued patents are as follows: U.S. patent 12,291,499 includes pharmaceutical compositions and oral dosage forms within the CYB003 program with expected exclusivity until 2041. U.S. patent 12,318,477 is expected to provide exclusivity until 2040 and includes claims to novel formulations of DMT and deuterated isotopologues for intramuscular injection, including CYB004. Clinical Program Update CYB003: Summary of Phase 2 12-Month Efficacy Data in MDD Patients 100% of participants receiving two doses of 16 mg were responders. 71% of participants receiving two doses of 16 mg were in remission. Mean change from baseline in MADRS was approximately -23 points after two 16 mg doses. CYB004: Phase 2 proof-of-concept study in generalized anxiety disorder ('GAD') is underway The Phase 2 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with GAD, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed. The Phase 2 study is being conducted at sites in the U.S. and is expected to complete around mid-2025. 1 Q4 and Fiscal-Year 2025 Financial Highlights Cash totaled C$135 million as of March 31, 2025. Net loss was C$31 million for the quarter ended March 31, 2025, compared to a net loss of C$21 million in the same period last year. Net loss was C$113 million for the year ended March 31, 2025, compared to a net loss of C$78 million in the same period last year. Cash-based operating expenses consisting of research, general, and administrative costs totaled C$31 million for the quarter ended March 31, 2025, compared to C$24 million, in the same period last year. Cash-based operating expenses consisting of research, general, and administrative costs totaled C$100 million for the year ended March 31, 2025, compared to C$65 million, in the same period last year. Cash flows used in operating activities were C$21 million for the quarter ended March 31, 2025, compared to C$21 million in the same period last year. Cash flows used in operating activities were C$101 million for the year ended March 31, 2025, compared to C$69 million in the same period last year. About Cybin Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions. With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. Notes: There is no assurance that timelines will be met. Anticipated timelines regarding the initiation, advancement and results of clinical trials are based on reasonable assumptions informed by current knowledge and information available to the Company. See 'Cautionary Notes and Forward-Looking Statements'. Cautionary Notes and Forward-Looking Statements Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, 'forward-looking statements') and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as 'may', 'should', 'could', 'potential', 'possible', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe' or 'continue', or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company's plans to complete its Phase 2 study for CYB004 around mid-year 2025; the ability of the Company to enroll participants and add additional clinical sites for the PARADIGM program; the Company's expectation to enroll 220 participants at approximately 45 clinical sites across the United States for the APPROACH study; initiation of EMBRACE study around mid-year 2025; the anticipated approval and commercialization of CYB003 and CYB004; the ability to accelerate commercial preparation of clinical-stage programs through the Company's partnership with Osmind; and the Company's plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the year ended March 31, 2025 and the Company's annual information form for the year ended March 31, 2025, which are available under the Company's profile on SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations.
Yahoo
28-05-2025
- Business
- Yahoo
3 Surprising Stocks That Have More Than Doubled in 2025
Hims & Hers Health, FuboTV, and Groupon have all more than doubled in 2025. These companies took very different paths to their stellar year-to-date results. Hims & Hers Health has had to make some major changes to its business in recent months, but it's still positioned for healthy growth. 10 stocks we like better than Hims & Hers Health › This year has had its ups and downs on Wall Street, but some investments are rolling. There are 14 stocks with market caps north of $1 billion that have more than doubled so far in 2025 -- and some of the names will surprise you. Hims & Hers Health (NYSE: HIMS), FuboTV (NYSE: FUBO), and Groupon (NASDAQ: GRPN) -- yes, that Groupon -- are among those 14 stocks that have more than doubled their shareholder money this year. All three have taken entirely different routes to thumping the market this year. After it posted a whopping 183% gain last year, it wouldn't have been shocking to see Hims & Hers Health stock take a breather in 2025. The online healthcare platform that got its start by making it easier for people to secure prescriptions for erectile dysfunction drugs and hair growth treatments blew up last year due to the popularity of its compounded GLP-1 injectables for weight loss. Because Novo Nordisk (NYSE: NVO) was unable to produce Wegovy fast enough to meet surging demand, the Food and Drug Administration put the drug on its official shortage list. That opened up a legal loophole for businesses that operate as compounding pharmacies to produce and sell their own versions of the patented treatment. Hims & Hers cashed in with its own GLP-1 drug, featuring the same active ingredient found in Wegovy and Ozempic -- semaglutide. More importantly, it offered that treatment at more aggressive discounts than Novo Nordisk was putting on the name-brand versions. Hims & Hers Health was doing fine even before it hopped on the GLP-1 bandwagon in spring 2024. Its revenue has risen by at least 65% in each of the last six years. However, the popular new product helped it accelerate its top-line growth in 2024, and it continued to speed up in the first quarter of this year, when revenue more than doubled. This year began with early gains. Late in 2025, incoming President Donald Trump said he would tap Martin Makary to head the FDA. Makary served on the board of a company that also was into GLP-1 compounding, so the market took the view that Hims & Hers' upticks would continue even after Novo Nordisk finished ramping up Wegovy production to a level that could meet patient demand. Matters didn't exactly play out that way. Hims & Hers stock scored an all-time high on Feb. 19, but within weeks, the share price was cut by more than half. Novo Nordisk's production of semaglutide reached the volume necessary to close the FDA loophole, and it seemed as if the semaglutide compounding ride was ending for Hims & Hers and its peers. Then, two things happened that brought investors back. Novo Nordisk cut deals with a small number of telehealth companies, including Hims & Hers, giving them the right to sell discounted monthly subscriptions of Wegovy. Hims & Hers also reported a blowout first quarter earlier this month, and management forecast that the balance of its business outside of compounding would still grow at a healthy 30% clip this year. One of the first stocks to double in 2025 was FuboTV. The company behind the namesake sports-centric live TV streaming service more than tripled in the first week of trading after it struck a transformative deal with Disney (NYSE: DIS). Fubo had just 1.7 million paid subscribers heading into this year, less than 10% of the roughly 20 million households paying for live TV streaming services that digitally recreate versions of the familiar cable or satellite TV bundle. The stock entered this year trading 98% below the peak it touched in late 2020, when management had dreams of turning the company into a streaming platform with an online sportsbook component. Fubo had to fold that hand, but it still had an ace up its sleeve. Disney and two other media giants had been hoping to launch Venu Sports, a monthly subscription service that would bundle content from all of their sports properties -- anchored by Disney's majority-owned ESPN -- into a digital subscription costing $43 a month. But Fubo sued, and last summer, it won an injunction blocking Venu's launch. In a move to clear that obstacle, Disney offered to acquire a 70% stake in FuboTV. The House of Mouse will contribute its larger Hulu + Live TV service -- with 4.6 million subscribers -- to Fubo. Fubo will also receive $220 million from the Venu partners in exchange for dropping its lawsuit. The deal with Disney isn't expected to close until the the first half of next year, but if it falls apart, Fubo would collect another $130 million. It also has access to a $145 million term loan from Disney. Then something amusing happened. Within days of the deal that would give Disney a majority stake in Fubo but keep the smaller company's management in control, the three Venu partners decided not to go through with their digital bundle. Fubo has had its share of growing pains, but it's in an interesting win-win situation here. However, the shares have been meandering along at levels well below those they reached during that initial spike in January. Finally, we have a more conventional doubling chart. Groupon's rise this year can be traced to two specific events: the fourth-quarter earnings report it delivered in early March, and the first-quarter report it released earlier this month. After eight consecutive years of declining revenues, the online discounter of local experiences is starting to turn the corner. Revenue did decline 5% in Q4 2024, but gross billings for its flagship North American business climbed 8%. Its latest report showed even more improvement. Groupon posted a strong and unexpected profit. Analysts now predict it will make a return to revenue growth this year, and that its improvements will accelerate in 2026. Its business model could also prove to be attractive to lead-seeking businesses if the U.S. economy loses steam -- so don't discount this discounter. Before you buy stock in Hims & Hers Health, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Hims & Hers Health wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $639,271!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $804,688!* Now, it's worth noting Stock Advisor's total average return is 957% — a market-crushing outperformance compared to 167% 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 May 19, 2025 Rick Munarriz has positions in Walt Disney. The Motley Fool has positions in and recommends Walt Disney and fuboTV. The Motley Fool has a disclosure policy. 3 Surprising Stocks That Have More Than Doubled in 2025 was originally published by The Motley Fool
Forbes
27-05-2025
- General
- Forbes
Kennedy Says Routine Covid Vaccines No Longer Recommended For Children And Pregnant Women
The Centers for Disease Control and Prevention no longer recommends routine Covid-19 vaccines for pregnant women and healthy children, Health and Human Services Secretary Robert F. Kennedy Jr. announced Tuesday, as Kennedy—a noted vaccine skeptic—and other health officials pushed new federal guidelines in recent weeks. Health and Human Services Secretary Robert F. Kennedy Jr. announced the change, saying it was based ... More on 'common sense' and 'good science.' Kennedy, who appeared with National Institutes of Health director Jay Bhattacharya and Food and Drug Administration Martin Makary, said in a video posted to X the Covid vaccine was removed from the CDC's immunization schedule for pregnant women and healthy children. The CDC, whose website has not been updated with the change, previously recommended Covid vaccines for anyone six months and older, pregnant women and women trying to get pregnant. Kennedy claimed the Biden administration recommended children receive an additional Covid vaccine 'despite the lack of any clinical data to support the repeat booster strategy' among healthy youth. This is a developing story and will be updated.
