Axios International’s Post

[🔔 📣 REGISTER TODAY FOR CDDF LIVE WEBINAR: EU Clinical Trial Regulations, 12 November 2024, 17:00 CET]   The Cancer Drug Development Forum (CDDF) is delighted to inform stakeholders that its live webinar on “EU Clinical Trial Regulations (#CTR)” will take place on 12 November 2024 at 17:00 CET. 🔍 [WEBINAR OUTLINE] The EU CTR was introduced in January 2022 and aims to harmonize the processes for assessment and supervision of #clinicaltrials throughout the EU. Following a one year transition period, all studies are submitted under these new guidelines. In this webinar, Tarec Christoffer El-Galaly (Aahrus University) and Stéphanie Kromar (EORTC - European Organisation for Research and Treatment of Cancer), who have been closely involved during the implementation, will discuss some of the challenges and benefits of the new process. 🎙 [SPEAKER PRESENTATIONS] ⭕ Tarec Christoffer El-Galaly, a consultant haematologist and chair of one the Danish National Ethics Committee, will discuss how they have worked to implement the new system. He will explore some of the challenges, benefits and also opportunities for the use of novel trial designs under the new legislation in order to enable acceleration of drug development to patient benefit. ⭕Stéphanie Kromar, head of Regulatory Affairs at the EORTC, will reflect on the implementation process from an #academic sponsors perspective and the practicalities of changes to the regulatory set up of studies across Europe. Join the CDDF webinar and stay informed of the European oncology clinical trials landscape. ➡ Webinar outline: https://lnkd.in/ezJ6mN-N ➡ Registration: https://lnkd.in/e7DbTuVk #oncology #cancer #cancerresearch #EU #CTR

Faron Pharma shares rise 6% on latest positive data on blood cancer drug @Faronpharm #AIM #FARN. Shares in Faron Pharmaceuticals Limited (AIM:FARN) climbed 6% after the company reported "remarkable" trial data for its lead drug, bexmarilimab, being tested for myelodysplastic syndrome (MDS), a rare and aggressive blood cancer. In the ongoing Phase II BEXMAB study, 80% of patients responded positively to a combination of bexmarilimab and azacitidine, a significant improvement over the typical 0-20% response rate seen with existing treatments. Patients in the trial showed an estimated median overall survival of 13.4 months, more than double the 5-6 months... http://ow.ly/IsFu105Q0J9

AstraZeneca positive data from Imfinzi’s Phase III ADRIATIC trial follows the raft of positive readouts and approvals across a range of cancer types, notes Shore Capital. Already these have stimulated a strong uptick in sales momentum for its burgeoning IO (immunotherapy) franchise during 2023 ($4.24bn, +55% CER). “With c.85% of the FY27F consensus forecasts for Imfinzi already attributable to its use for lung cancer, we don’t anticipate any significant upgrades based on these data alone. “We view the opportunities outside of lung cancer as a more important source of near- to medium-term upgrades. “Looking longer term, we highlight the trials looking at novel combinations designed to improve efficacy or address low PD-1 expressing cancers that could support upgrades for the broader IO franchise.” ShoreCap adds that a clearer picture of how AZN will support its ambition of industry-leading revenue growth... More at #Proactive #ProactiveInvestors http://ow.ly/BR3k105oxxm

Today is the last day to save on Regular Registration Rates for #SITC 2024! SITC 2024 will feature Beyond Checkpoint Inhibitors: New Immuno-oncology Modalities and Approaches. This program is one of the Pre-Conference Programs that will be held on Wednesday, Nov. 6, 2024 in Houston, TX. The program will address clinical and scientific considerations combining these modalities with other #cancer therapies. Attendees will be better equipped to develop and utilize cancer immunotherapy-based treatment strategies that are cost-efficient, safer, and more effective for patients. Register NOW to Save up to $200: go.sitcancer.org/4dkakMV Program Organizers: Nick Botwood, MD - Bristol Myers Squibb, Ivan Diaz-Padilla, MD,PhD - GSK, Charles Drake, MD, PhD - The Janssen Pharmaceutical Companies of Johnson & Johnson, Jane ann Healy/ meehan, MD, PhD - MSD Merck Sharp & Dohme A.G., Priti Hegde, PhD - Kite Pharma, Stephen Lim, MD - Novartis, Giovanni Melillo, MD - AstraZeneca. #ai #immunooncology #cancertherapies #cure #immunotherapy

🗞️ Last week’s Pharma industry news in Germany and Switzerland 🗞️ atai Life Sciences reports 2023 as a pivotal year with significant financial and clinical milestones in psychedelic-based therapies, ensuring operations into 2026. Medigene AG's 2023 showcased strategic advances in TCR-T therapy for solid tumors, despite financial recalibrations, setting a clear path forward with operational funding until April 2025. Affimed highlights 2023 as a year of substantial clinical progress in cancer immunotherapy, with a financial foundation extending into the second half of 2025. Roche secures FDA approval for the first molecular malaria test for U.S. blood donors, promising enhanced blood supply safety by Q2 2024. #pharmaceuticalindustry #pharma #Monday_Pharma_News

Faron Pharma CEO talks about MHRA fast-track and phase III plans - ICYMI @Faronpharm #AIM #FARN. Faron Pharmaceuticals Limited (AIM:FARN) CEO, Dr Juho Jalkanen, talked with Proactive about the significant fast-track designation awarded to their cancer immunotherapy, bexmarilimab, by the UK's MHRA. The drug is being used to treat people with relapsed refractory Myelodysplastic Syndrome (r/r MDS). Looking ahead, Jalkanen shared that a confirmatory phase III study is being planned for high-risk MDS patients globally, in collaboration with major regulatory authorities. For more insightful interviews, visit Proactive's YouTube channel. Don’t forget to like this... http://ow.ly/Th22105QYBu

Faron Pharmaceuticals unveils 'remarkable' overall response rate to its cancer treatment @Faronpharm #AIM #FARN. Faron Pharmaceuticals Limited (AIM:FARN) CEO Dr Juho Jalkanen described the latest data read-out from its lead asset as' remarkable'. Specifically, he was referring to the overall response rate (ORR) to bexmarilimab, which increased as the number of patients added to the latest clinical trial expanded. The drug is being developed to treat myelodysplastic syndrome (MDS), a blood-borne cancer, and in this instance was administered to people with the advanced form of the disease. On the potential efficacy of the treatment, Jalkanen observed: "It is... http://ow.ly/xeac105Q0xn

September is Prostate Cancer Awareness Month. The month focuses on raising awareness about the impact of prostate cancer, encourage PSA screenings, and support patients and families affected by the disease. Check out this video to hear from Viktoria Friedrich , Country President and GM, Pharmaceutical Division in Canada, and Shurjeel Choudhri , SVP and Head, Medical & Scientific Affairs, about what that means for the team at #BayerCanada.

This is loaded with information! For any #regulatory and #biotech friends in the #oncology space, I encourage you to click through and sign up for this newsletter. #EMA #drugdevelopment

  I am excited to share my upcoming talk at the 19th BioPharma Drug Discovery #Nexus Conference, set to take place in Basel, Switzerland on April 25th.   Join me as we delve into the unique potential of G Protein-Coupled Receptors (#GPCRs) in reshaping the landscape of #cancertreatment through #precisionmedicine.   Despite GPCRs have delivered 30% of currently marketed drugs, their role in cancer treatment remains underexplored. With approximately 56% of GPCRs remaining non-targeted, the potential for GPCRs in immuno-oncology is immense.   At #DomainTherapeutics, one mission drives us all: to #beatresistance and #defeatcancer. Our precision research sheds light to the pivotal role of GPCRs in shaping the #tumormicroenvironment and modulating the #immuneresponse against cancer. Through the meticulous identification and validation of GPCRs implicated in immunosuppression, we're spearheading innovative therapies. Our pipeline boasts a wealth of #clinical and #preclinical fully owned best-in-class and first-in-class therapeutics.   #Joinme as we explore how our precision research is propelling GPCR science forward and bringing in a new era of groundbreaking cancer treatments.   #Immunooncology #PrecisionMedicine #drugdevelopment