Core Insights - OS Therapies received a positive regulatory update from the European Medicines Agency (EMA) following a meeting with the Dutch Medicines Evaluation Board (MEB) on October 6, 2025, regarding its OST-HER2 Phase 2b clinical trial for osteosarcoma [2][3] Regulatory Developments - The meeting aligned on key areas such as safety, non-clinical data, and chemistry, manufacturing, and controls (CMC) data, supporting the ongoing clinical trial [3][8] - The overall survival results from the trial, showing statistically significant final two-year data, may serve as a primary endpoint for conditional marketing authorization (CMA) [3][8] - A formal EMA Scientific Advice is anticipated in December 2025, establishing a potential pathway for a confirmatory randomized clinical development program [4][10] Clinical Trial Insights - The safety profile from the Fully Resected Osteosarcoma clinical study was confirmed as positive, with data from over 500 patients treated across four other therapeutic indications potentially supporting a CMA [8] - The rapporteur indicated that overall survival (OS) could provide a stronger measure of clinical benefit compared to 12-month Event-Free Survival (EFS) [8] - Efficacy data from other settings, such as recurrent, unresectable pulmonary metastatic osteosarcoma, could be incorporated into a post-market confirmatory clinical development program [8] Market Access and Future Plans - OS Therapies has commenced the Marketing Authorisation Application (MAA) submissions process with the UK MHRA, which has granted an expedited Market Access Scientific Advice Meeting [6] - The company plans to pursue a conditional marketing authorization while advancing a global randomized clinical study to evaluate OST-HER2 in various osteosarcoma clinical settings [10] - OST-HER2 has received multiple designations from the U.S. FDA and EMA, including Rare Pediatric Disease Designation and Fast-Track status [11]

Bari Weiss’s journey from a New York Times resignation to a top TV news gig https://t.co/N3aG3Dponz ...

Core Insights - OS Therapies is actively participating in multiple conferences and events in October 2025, showcasing its commitment to advancing cancer treatment and engaging with industry stakeholders [1][2][3][4][5]. Company Overview - OS Therapies Inc. is a clinical-stage biotechnology company focused on developing treatments for Osteosarcoma and other solid tumors, with its lead asset being OST-HER2, an immunotherapy targeting the HER2 protein [5][6]. - OST-HER2 has received several designations from the U.S. FDA, including Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations, indicating its potential significance in treating rare diseases [5]. - The company reported positive results from its Phase 2b clinical trial of OST-HER2, demonstrating statistically significant benefits in the 12-month event-free survival primary endpoint for patients with recurrent, fully resected, lung metastatic osteosarcoma [5]. Upcoming Events - OS Therapies will participate in the Cell and Gene Meeting on the Mesa from October 6-8, 2025, in Phoenix, AZ, focusing on partnering and one-on-one meetings [2]. - The company will also attend the Roth Annual Healthcare Opportunities Conference on October 9, 2025, in New York City, where it will engage in meetings with potential investors [2]. - A workshop on advancing osteosarcoma drug development will take place on October 10, 2025, in Washington, DC, where OS Therapies management will be available for discussions [2]. - The BIOFuture 2025 event is scheduled for October 13-15, 2025, in New York City, featuring a spotlight panel and one-on-one meetings [3]. - The company will be present at the 52nd Daytime Emmy Awards on October 17, 2025, where its documentary "Shelter Me: Cancer Pioneers" has received two nominations [3]. - The Maxim Growth Summit will occur on October 22, 2025, in New York City, where corporate presentations and meetings will be held [4]. - OS Therapies will also participate in BIO - Europe from November 3-5, 2025, in Vienna, Austria, focusing on partnering and meetings [5]. Product Development - OST-HER2 has shown preclinical efficacy in various models of breast cancer and has been conditionally approved by the U.S. Department of Agriculture for treating canines with osteosarcoma [5]. - The company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6].

Bari Weiss’s journey from a New York Times resignation to a top TV news gig https://t.co/XuUHqywLUG ...

Core Insights - The former opinion editor and co-founder of the Free Press has been appointed as the editor in chief of CBS News [1] Company Overview - The new editor in chief brings a background in opinion journalism and media innovation to CBS News [1]

Remember when I said that the ACA premium tax credit extensions that Democrats are asking for is popular. Well, when I say popular, I mean really popular. I mean like puppies and apple pie popular.According to new polling from the KFF, a whopping 78% of people say that Congress should extend those tax credits. That of course includes 92% of Democrats. No surprise, but also 82% of independents and even 59% of Republicans.Let's dig even deeper into that last number because this is very interesting. A full 57% ...

Well, the New York Times is lost. The New York Times is still the greatest newspaper in America by far and one of the greatest newspapers in the world. But tonight, the New York Times is lost. The New York Times has no idea how to cover the madness of Donald Trump. And so the New York Times ignores it.Just as the madness of King George III had to be ignored by the London Times in 1789, the Washington press corps is lost along with the New York Times. There is no one working at the New York Times tonight who ...

Group 1 - The Trump administration is characterized as highly active, generating significant news coverage [1] - Gary Alexander has extensive experience in technology companies and startups, contributing to industry insights [1] - His articles are featured on platforms like Seeking Alpha and popular trading apps such as Robinhood [1]

But we begin this hour with President Trump's retribution tour entering uncharted waters with a stunning indictment of former FBI Director James Comey. Comey was charged Thursday with two felony counts making a false statement and obstruction of a congressional proceeding just five days after Trump publicly pressured his attorney general on social media to prosecute Comey as well as several other of Trump's perceived enemies including Senator Adam Schiff and New York Attorney General Leticia James. And now ...

Core Insights - Laura Numeroff, a New York Times bestselling author, has released a new picture book titled "Max and Mama," illustrated by Masha Sudovykh, which emphasizes the bond between mother and son [1][2] - The book features engaging illustrations of corgis and aims to promote early childhood literacy through playful writing and relatable daily activities [1][2] - "Max and Mama" encourages children to embrace challenges and celebrate family connections [1] Publishing Industry - Laura Numeroff is renowned for her series based on "If You Give a Mouse a Cookie," which has sold over 72 million copies and has been adapted into an animated TV series [2] - The success of Numeroff's previous works includes significant recognition, such as being featured by celebrities and First Ladies during notable events [2] - The new release is positioned as a heartwarming addition to children's literature, appealing to both young readers and their families [2][4] Market Position - Michael Sampson Books is the publisher of "Max and Mama," indicating a focus on children's literature and family-oriented themes [1][4] - The book is part of a broader trend in the publishing industry that emphasizes social and emotional learning through engaging storytelling [7] - The release aligns with current market interests in books that foster family bonds and support early literacy [1][2]