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Globe and Mail
an hour ago
- Globe and Mail
Trump administration cuts California sexual-health program grant over transgender policies
The Trump administration on Thursday terminated a grant for a program in California intended to prevent teenage pregnancy and childhood sexually transmitted infections, saying the state refused to remove 'radical gender ideology' from its curriculum. The Personal Responsibility Education Program educates young people on abstinence and contraception to prevent pregnancy and sexually transmitted infections, with particular focus on children who are homeless or living in foster care or in areas with high teen birth rates. The grant was worth US$12-million, said Andrew Gradison, an acting assistant secretary at the U.S. Department of Health and Human Services. 'If you continue to push radical ideology on our children, we will not pay for it anymore,' he told Fox & Friends, saying the program included 'radical gender ideology' without providing details. Canadians with an X gender marker will now have to select male or female on Nexus travel cards after Trump order Gradison said that his department is near completing a review of every state's curriculum, adding that by early next week, nearly 40 states will be notified that they need to change their curriculum or face the same consequences. It is the latest salvo in the Trump administration's fight against transgender rights as well as the state of California, led by Democratic Governor Gavin Newsom. Representatives for Newsom's office could not be immediately reached. Before the announcement, President Donald Trump said any California school district that does not adhere to his administration's transgender policies will not receive federal funding, but gave no other details. Representatives for the White House did not immediately respond to requests for detail following Trump's comment, posted to his social media platform. U.S. schools receive the vast majority of their funding through local and state sources, but do receive some money from the federal government. Trump's administration sued California in July over its policy allowing transgender athletes to compete in girls' school sports, alleging that it was a violation of federal anti-discrimination laws. In February, the Republican president signed a directive to strip federal funding from any school that allows transgender women or girls to compete in female sports.
Globe and Mail
2 hours ago
- Globe and Mail
Nutriband (NASDAQ: NTRB): When Regulatory Momentum Meets Leadership Continuity
FDA grants Type C Meeting for AVERSA(TM) Fentanyl to discuss Chemistry, Manufacturing, and Controls pathway from IND submission through NDA approval and commercialization CEO Gareth Sheridan temporarily steps aside to pursue Irish Presidential nomination while Chairman Serguei Melnik assumes interim CEO role during critical development phase Strategic partnership with Kindeva combines proven FDA-approved fentanyl patch technology with Nutriband's proprietary abuse-deterrent platform targeting $80-200 million peak U.S. market opportunity The pharmaceutical development landscape presents a fundamental shift as regulatory frameworks evolve beyond traditional efficacy-first approaches. The most significant patient impact now comes from innovations that enhance safety profiles of existing therapeutic options, particularly in pain management where the balance between therapeutic benefit and abuse potential creates urgent medical need alongside substantial regulatory complexity. The opioid crisis has reshaped how regulators approach pain management solutions. The most promising opportunities exist at the intersection of proven therapeutic benefit and enhanced safety mechanisms, requiring both technological innovation and regulatory expertise to navigate complex approval… Read More>> About BioMedWire BioMedWire ('BMW') is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, BMW brings its clients unparalleled recognition and brand awareness. BMW is where breaking news, insightful content and actionable information converge. To receive SMS alerts from BioMedWire, 'Biotech' to 888-902-4192 (U.S. Mobile Phones Only) For more information, please visit Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: BioMedWire San Francisco, CA 415.949.5050 Office Editor@ BioMedWire is powered by IBN
Globe and Mail
2 hours ago
- Globe and Mail
FDA Extends Review Period of REGN's Submission for Eylea HD
Regeneron Pharmaceuticals, Inc. ( REGN ) announced that the FDA has extended the target action dates for Eylea HD (aflibercept) injection 8 mg regulatory submissions. Eylea HD is the higher dose of Eylea. The regulatory body has now extended the target action dates to the fourth quarter of 2025 for two regulatory submissions for Eylea HD (aflibercept) Injection 8 mg. The submission includes a Chemistry, Manufacturing and Controls Prior-Approval Supplement for the Eylea HD prefilled syringe and a supplemental biologics license application seeking approval for both the treatment of macular edema following retinal vein occlusion (RVO) and the broadening of the dosing schedule to include every 4-week (monthly) dosing across approved indications. Despite the extension announcement, REGN shares were up 3.4%. This information was previously communicated by the company during its second-quarter earnings release. This is probably because Eylea HD remains available in the United States through vial administration. Regeneron's shares have lost 17% year to date against the industry 's gain of 3.8%. More on REGN's Eylea HD The FDA extended the review periods after determining that the information submitted following a recent inspection of a third-party manufacturer constituted a major amendment to each application. The anticipated delay resulted from observations during an FDA general site inspection of Catalent Indiana LLC, which Novo Nordisk A/S ( NVO ) acquired in December 2024. Novo Nordisk submitted a comprehensive response in early August 2025 to address the observations noted by the FDA. Eylea HD is approved with dosing intervals every 8 to 16 weeks for patients with wet age-related macular degeneration and diabetic macular edema, and every 8 to 12 weeks for patients with diabetic retinopathy, following three initial monthly doses. Eylea HD (known as Eylea 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG ( BAYRY ). While Regeneron holds exclusive rights to Eylea and Eylea HD in the United States, BAYRY holds the exclusive marketing rights outside the country. REGN and BAYRY equally share the profits from sales of Eylea and Eylea HD. REGN Banks on Eylea HD and Dupixent for Growth Regeneron's performance in the second quarter was encouraging. The company has finally managed to post revenue growth despite declining sales of lead drug Eylea. Eylea sales continue to decline due to competition from Vabysmo. To counter the decline in Eylea sales, Regeneron has developed a higher dose of the drug. Eylea HD sales in the United States surged 29% in the second quarter due to higher sales volumes driven by increased demand. REGN's top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi ( SNY ) records global net product sales of Dupixent. SNY and REGN are working to expand the drug's label further. The FDA had earlier approved Dupixent for chronic obstructive pulmonary disease (COPD). The approved indication is an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. Consistent label expansions of Dupixent continue to fuel its sales and help REGN earn higher profits. REGN is looking to strengthen its oncology portfolio to diversify its revenue stream. The recent progress with its oncology pipeline has been encouraging. The approval of Lynozyfic is a boost for its oncology portfolio. Zacks Rank Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. See our %%CTA_TEXT%% report – free today! 7 Best Stocks for the Next 30 Days Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report Novo Nordisk A/S (NVO): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report
