Abhivandan Nagia’s Post

Hepatocellular Carcinoma Pipeline Analysis 2024 | Clinical Trials, FDA, EMA, and PMDA Approvals | Saronic Biotech, HiFiBiO Therapeutics, Sirnaomics, Exelixis, Tvardi Therapeutics, Portage Biotech #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech

Latest Healthcare News & Updates: Enhertu Receives US Approval as First HER2-focused Treatment for Metastatic Solid Tumors, Independent of Tumor Origin FDA Approves Basilea Pharmaceutica’s ZEVTERA Antibiotic for Three New Indications Genmab Expands Oncology Reach Through Acquisition of ProfoundBio European Medicines Agency Approves Rocket Pharmaceuticals’ RP-L102 Marketing Application for Fanconi Anemia Alexion Pharmaceuticals, Inc.’s AAN 2024 Data Highlights Ultomiris and Soliris' Promise for Rare Neurological Disorders Get more detailed analysis, at: https://lnkd.in/gESBK9NW #lifesciences #pharmaceuticals #marketresearch #marketanalysis #healthcare #markettrends #health #medical #news #healthcarenews #pharmanews #clinicaltrials #clinicalresearch

An important milestone for Aprea Therapeutics: Yesterday, we announced that the Safety Review Committee (SRC) overseeing our ongoing ABOYA-119 clinical trial has determined that dosing patients with ATRN-119 at 800 mg once daily (Cohort 6) can commence and that Cohort 6 is open for enrollment. This decision follows a review of the safety and pharmacokinetic data from patients treated at 550 mg once daily (Cohort 5). ATRN-119 is a differentiated, potent and highly selective first-in-class macrocyclic inhibitor of ATR, a clinically validated target. It is designed to be given to patients with mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need, and these patients have poor prognoses and currently have no approved effective therapies. Initial efficacy data from Part 1 of the study may be announced in the second half of this year. Read our press release about this significant development here: https://lnkd.in/eu-GNy8Z

Neuroendocrine Tumors Pipeline Therapeutics, Assessment, Companies, Products, Unmet Needs, Market Drivers and Barriers: DelveInsight’s, “Neuroendocrine tumors Pipeline Insight, 2024” report provides comprehensive insights about 100+ companies and 120+ pipeline drugs in Neuroendocrine tumors pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of … Continue reading → #PharmaceuticalsBiotech

𝑼𝒓𝒐𝑮𝒆𝒏 𝑷𝒉𝒂𝒓𝒎𝒂 𝑫𝒐𝒔𝒆𝒔 𝑭𝒊𝒓𝒔𝒕 𝑷𝒂𝒕𝒊𝒆𝒏𝒕 𝒊𝒏 𝑷𝒉𝒂𝒔𝒆 3 𝑻𝒓𝒊𝒂𝒍 𝒇𝒐𝒓 𝑼𝑮𝑵-103, 𝑨𝒅𝒗𝒂𝒏𝒄𝒊𝒏𝒈 𝑰𝒏𝒏𝒐𝒗𝒂𝒕𝒊𝒗𝒆 𝑩𝒍𝒂𝒅𝒅𝒆𝒓 𝑪𝒂𝒏𝒄𝒆𝒓 𝑻𝒓𝒆𝒂𝒕𝒎𝒆𝒏𝒕 UroGen Pharma (Nasdaq: URGN) has dosed the first patient in its Phase 3 trial for UGN-103 (mitomycin), a next-gen solution for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UGN-103 uses UroGen's innovative RTGel® platform to enhance drug delivery. This marks a key milestone following the NDA submission for UGN-102, with potential FDA approval expected in early 2025. UroGen Pharma is hiring for a Director, Commercial Data Strategy & Operations (Princeton, NJ Hybrid) https://lnkd.in/e9RJWx-a #Biotech #CancerResearch #BladderCancer #ClinicalTrials #Pharma #FDA

From the clinical data of Mersana Therapeutics' two anti-NaPi2b ADCs (XMT-1536, XMT-1592), we can learn that 'linker stability' can sometimes be more detrimental than beneficial, depending on the target. https://lnkd.in/gMbVi_H5

Featured highlights from today's Efortless Update: [Clinical Trials] 08/15 「Niaid's PALM 007 trial of SIGA Technologies’ tecovirimat in monkeypox patients shows safety but does not meet primary endpoint for lesion resolution improvement」 same day : ( ↓ NASDAQ: SIGA | -38.18% ) 08/15 「DermBiont, Inc.'s phase 2a study shows clinical response in 7 subjects with basal cell carcinoma treated with SM-020 1% gel」 08/14 「Turnstone Biologics' phase 1 STARLING trial of TIDAL-01 in metastatic microsatellite stable colorectal cancer shows 25% overall response rate and 50% disease control rate」 same day : ( ↓ NASDAQ: TSBX | -48.85% ) [Deals] 08/15 「Abata Therapeutics receives equity investment from Bristol Myers Squibb to advance Treg cell therapy products for progressive multiple sclerosis and type 1 diabetes」 same day : ( ↑ NYSE: BMY | +1.24% ) 08/15 「Aarvik Therapeutics Inc and ArriVent Biopharma announce exclusive license agreement for novel ADC molecule 」 same day : ( ↓ NASDAQ: AVBP | -0.63% ) 08/15 「Pathos AI licenses PRT811 from Prelude Therapeutics, raises $40M to develop P-500 following promising phase 1 trial results in high-grade glioma and uveal melanoma」 same day : ( ↑ NASDAQ: PRLD | +8.62% ) 08/15 「Nanoform Finland Plc enters pre-clinical development agreement with Plasma-derived Therapies Business Unit of Takeda Pharmaceuticals to develop nano-formulations of biologics for rare conditions」 same day : ( ↑ NYSE: TAK | +0.91% ) [Regulatory] 08/14 「Gilead Sciences' Livdelzi receives FDA accelerated approval for primary biliary cholangitis in adults with inadequate response to or intolerance of UDCA based on phase 3 RESPONSE study data」 same day : ( ↑ NASDAQ: GILD | +0.22% ) 08/14 「FDA approves Niktimvo for treatment of chronic graft-versus-host disease in patients after failure of at least two prior therapies」 same day : ( ↑ NASDAQ: INCY | +1.05% ) View the full newsletter contents for free via the link in the comments.

Latest Healthcare News & Updates: Roche's Columvi Achieves Primary Endpoint of Prolonged Overall Survival in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Trial Latest Novartis Fabhalta Results Highlight a Substantial 38.3% Drop in Proteinuria Versus Placebo Among IgAN Patients, Indicating Significant Clinical Benefit Vertex Pharmaceuticals Announces Acquisition Deal with Alpine Immune Sciences FDA Grants Telix Pharmaceuticals Limited’ TLX101-CDx Fast Track Designation   FDA Grants Orphan Drug Designation (ODD) to NM5072 for Paroxysmal Nocturnal Hemoglobinuria (PNH) Get more detailed analysis, at: https://lnkd.in/geNX6Q9t #lifesciences #pharmaceuticals #marketresearch #marketanalysis #healthcare #markettrends #health #medical #news #healthcarenews #pharmanews #clinicaltrials #clinicalresearch

50% ORR: Impressive Clinical Trial Data for Irpagratinib Combined with Atezolizumab in Advanced Hepatocellular Carcinoma Stuns ESMO-GI Congress      28 June 2024, Abbisko Therapeutics（2256.HK） announced that it has presented new phase II clinical data of its highly selective FGFR4 inhibitor irpagratinib (ABSK011) in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma（HCC）at the 2024 ESMO-GI Congress. The presentation highlights that 220mg BID of irpagratinib in combination with atezolizumab demonstrated promising antitumor activity with an objective response rate (ORR) of 50% in FGF19+ HCC patients. ESMO-GI, a world-renowned gastrointestinal oncology conference, is being held in Munich, Germany, from June 26 to 29, 2024.   Abbisko presentations at ESMO-GI 2024: Title: A Phase 2 Study of Irpagratinib (ABSK-011) plus Atezolizumab in Patients with Advanced Hepatocellular Carcinoma (HCC) Poster display number：171P Poster display session: Hepatocellular and non-biliary liver cancer Poster display date and time: 27 June 2024, 15:35-16:30 PM (UTC+1)   At the 2024 ESMO-GI conference, Abbisko Therapeutics debuted new clinical trial results with the combination of irpagratinib and atezolizumab. In HCC patients with FGF19 overexpression, the objective response rate (ORR) was 50% (5/10)in the 220 mg BID cohort, demonstrating this novel combination therapy has notable benefits in enhancing the ORR. Notably, strong efficacy and good safety were also observed in patients who had previously received immune checkpoint inhibitor (ICI) therapy, providing further evidence that targeting FGF19-FGFR4 may provide a much-needed differentiated treatment option for HCC. Given the encouraging preliminary results from this study, Abbisko plans to explore dual/triple combinations with irpagratinib in earlier lines of therapy for HCC. Abbisko continues to look forward to combination approaches with irpagratinib to better address HCC and bring hope to patients, with aims to conduct further research and innovation in this area.   For more information, please visit www.abbisko.com.