Fierce Pharma’s Post

Thoughts on this? >> Controversies and pitfalls at ASCO24 >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #pharma #biotech #healthcare #competitivemarketing

Thoughts on this? >> Controversies and pitfalls at ASCO24 >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #competitivemarketing #pharmaceutical #biotech #healthcare

Catailyst Regulatory Event Snippets: Drug Approval in a Country Approval in China Shanghai Kechow Pharma, Inc. China National Medical Products Administration Approval of Tunlametinib (HL-085), the first approved targeted therapy NRAS Mutated Advanced Melanoma and Previously Treated with PD-1/PD-L1 #melanoma a potential best-in-class MEK inhibitor based on positive data from the pivotal Phase 2 study #Tunlametinib is a small molecule inhibitor of Mitogen-activated protein kinase kinase (MEK) 

Catailyst Clinical Event Snippet: First Patient Enrolled/Dosed, Phase 2B MindBio Therapeutics Major Depressive Disorder Phase 2B Take-Home Microdosing (MB22001) Clinical Trial Follows successful Phase 2A trial where 53% of depressed patients were in complete remission from their depression at week 8 marked by a mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale), a 60% mean drop in depressive symptoms. #cns #biotech #depression #biopharma https://lnkd.in/eMddutyN

@Catailyst, Inc. Trending Topics: Sangamo Therapeutics, Inc. Therapeutics Announces Alignment With FDA on Accelerated Approval Pathway for ST-920 in #Fabry Disease With BLA Submission Expected in 2025 https://lnkd.in/d-HxtncX FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway #Timeline Data supporting Accelerated Approval pathway available in first half of 2025 BLA submission expected in the second half of 2025. #Healthcare #FDA #Biotechnology #Fabry

Catailyst, Inc. Trending Topics UroGen Submits Completed UGN-102 NDA Seeking Approval as the First FDA-Approved Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer UroGen Pharma successfully completed the New Drug Application (NDA) submission for investigational drug UGN-102 (mitomycin) for intravesical solution. This marks a significant advancement in addressing the urgent need for innovative treatments for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UroGen is optimistic about potential FDA approval in early 2025, pending acceptance for filing and the granting of priority review. https://lnkd.in/eRbThV6F #Biotech #CancerResearch #FDAApproval

AlivaMab Biologics and Ablexis congratulate our partner, Anaveon, on the FDA’s approval of the IND for the ANV600-001(EXPAND) Phase I/II clinical study. “ANV600 uses a non-blocking anti-PD-1 antibody to target a powerful IL-2Rβ/γ selective IL-2 agonist to tumor-specific T cells, resulting in their proliferation and increase of tumor-killing potential. ANV600 is designed to administer in combination with approved PD-1 checkpoint inhibitors, thus enabling optimal dosing of IL-2 agonism and PD-1 blockade to maximize therapeutic benefit.”  https://t.ly/3yD_m ANV600 is just one member of the expanding pipeline of innovative biologics drug candidates discovered at AlivaMab Biologics and poised to change treatment paradigms for patients. Connect with us at info@alivamab.com to learn how we can enable success for your biologics drug discovery and engineering projects.

Qualifying for Discounted Yervoy Treatment: A Comprehensive Guide What is Yervoy? Yervoy, also known as ipilimumab, is... https://lnkd.in/eyMX8X_5

An Update from Catailyst's #Radiopharma Activity Tracker: Marketing Authorization Isotopia Molecular Imaging ltd #Isoprotrace®received marketing authorization in the Netherlands A single sterile vacuum - vial kit, intended for preparing multi-patient doses of Gallium (68Ga) Gozetotide (PSMA -11) within only 5 minutes, saving precious decay time in comparison to a standard synthesis.  https://lnkd.in/eWhuWnqd New Clinical Trials: Phase Ia/b Study Targeted Radionuclide Therapy in Metastatic Prostate Cancer  Castration-resistant Prostate Cancer https://lnkd.in/e758jW7N #ProstateCancer New Clinical Trials: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer  https://lnkd.in/eyQFSrHy New Clinical Trials: Actinium Pharmaceuticals, Inc. Iomab-ACT Targeted Radiotherapy as a conditioning therapy prior to CAR_T cell therapy; replace chemotherapy!! https://lnkd.in/e_tjpSwH Completion of Clinical Trial Nanobiotix, #NBTXR3: a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles  #Cancer, non-small cell lung cancer, #lungcancer #nsclc

Catailyst Transaction Snippet: BrickBio, Inc. #Antibodydrugconjugate #precisionbiologics #preclinical #ADCs #VC Samsung Invests in BrickBio to Develop Advanced Molecules and Therapies Using Protein Engineering Technology for Antibody-Drug Conjugates (ADC) & AAV gene therapy Samsung Bioepis #AAV #ADC https://lnkd.in/eB5qy3EN