Lutetium (177Lu) oxodotreotide

FDA Roundup: April 26, 2024

Retrieved on: 
Vendredi, avril 26, 2024
FDA, Lutetium (177Lu) oxodotreotide, Sale, Answer, Public, Report, Cosmetics, Syringe, Dietary supplement, News, Safety, DCM, Food, Research, Human services, GFI, Animal, Dilated cardiomyopathy, Cardinal Health, Commitment, Diabetes, Furosemide, Glomus tumor, Vaccine, Development, VFD, Osteoporosis, Novartis, BRAF, Inflammatory bowel disease, Tablet, Patient, Rheumatoid arthritis, Psoriasis, Heated tobacco product, Macular degeneration, Multimedia, Dog, Cancer, LGG, Food and Drug Administration, BRAF V600, Heart, Pharmaceutical industry

On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.

Key Points: 
  • On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.
  • The FDA expects this firm to fully address the violations described in the warning letter.
  • This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs.
  • This represents the first FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions.

Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors

Retrieved on: 
Mardi, avril 23, 2024
FDA, Lutetium (177Lu) oxodotreotide, Brain, Cancer, Prostate, RLT, Hospital, Food, CHOP, Breast, B cell, Somatostatin, Disease, Incidence, Patient, Lung, National Cancer Institute, Diagnosis, Children's Hospital of Philadelphia, NETS, Ageing, Pharmaceutical industry

This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs.

Key Points: 
  • This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs.
  • "Lutathera is now the very first therapy approved specifically for children with GEP-NETs, offering new hope to young patients living with this rare cancer," said Tina Deignan, Therapeutic Area Head, Oncology US.
  • NETs are a type of cancer that originates in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies1.
  • In addition, the estimated radiation absorbed dose in pediatric patients was within established organ thresholds for external beam radiation and comparable to that in adults for the approved dose.

New Data Show ClearNote Health’s Epigenomic Platform Provides a Novel Tissue-Free, Liquid Biopsy-Based Approach to Identify Potential Predictive Biomarker Candidates to Radioligand Therapy Response in Patients With Pancreatic Neuroendocrine Tumors

Retrieved on: 
Mardi, mars 26, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Plasma, Novartis, Nucleic acid thermodynamics, Patient, Biomarker, DNA, Cancer, Virtuoso, Oslo University Hospital, Rikshospitalet, Lutetium (177Lu) oxodotreotide, Medicine, Biobank, Somatostatin, FDA, Medical imaging

Differences in plasma-derived cell free DNA (cfDNA) 5hmC profiles after administration of Lutathera revealed biological responses consistent with radioligand therapy mechanism of action hypothesis.

Key Points: 
  • Differences in plasma-derived cell free DNA (cfDNA) 5hmC profiles after administration of Lutathera revealed biological responses consistent with radioligand therapy mechanism of action hypothesis.
  • “Our research collaboration with Novartis has demonstrated the power of ClearNote Health’s cutting-edge epigenomic technology in the interrogation of predictive biomarkers of radioligand therapy response from a single blood draw,” said Dave Mullarkey, CEO of ClearNote Health.
  • The comparison of plasma-derived cfDNA 5hmC profiles revealed differences that distinguish patients responding to therapy from those not responding before and on treatment.
  • This collaboration underscores ClearNote Health's commitment to empowering biopharmaceutical innovation in developing better drugs through cutting-edge molecular diagnostic technologies.

Biotech's Role in Addressing the Pancreatic Cancer Emergency

Retrieved on: 
Jeudi, mars 14, 2024
Ovarian cancer, Immunotherapy, Patient, History, Lutetium (177Lu) oxodotreotide, IND, Cancer, NVS, NUVB, NCI, Novartis, Science, Colorectal cancer, Risk, American Cancer Society, FOLFIRINOX, PDAC, Pancreatic Cancer Action Network, Safety, Immune system, Interim, University, Translational research, Survival rate, Disease, Clinical professor, Associate, Tumor microenvironment, Death, TSX, Pancreatic cancer, Sunnybrook Health Sciences Centre, ACRS, FDA, DCP, Diagnosis, Entrepreneurship, Environment, Physician, Triple-negative breast cancer, Mortality, News, PROC, DDC, Hereditary nonpolyposis colorectal cancer, Optimism, ONC, Pharmaceutical industry

VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). 

Key Points: 
  • There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13% .
  • "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients."
  • It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC).
  • Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors.

Biotech's Role in Addressing the Pancreatic Cancer Emergency

Retrieved on: 
Jeudi, mars 14, 2024
Ovarian cancer, Immunotherapy, Patient, History, Lutetium (177Lu) oxodotreotide, IND, Cancer, NVS, NUVB, NCI, Novartis, Science, Colorectal cancer, Risk, American Cancer Society, FOLFIRINOX, PDAC, Pancreatic Cancer Action Network, Safety, Immune system, Interim, University, Translational research, Survival rate, Disease, Clinical professor, Associate, Tumor microenvironment, Death, TSX, Pancreatic cancer, Sunnybrook Health Sciences Centre, ACRS, FDA, DCP, Diagnosis, Entrepreneurship, Environment, Physician, Triple-negative breast cancer, Mortality, News, PROC, DDC, Hereditary nonpolyposis colorectal cancer, Optimism, ONC, Pharmaceutical industry

VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). 

Key Points: 
  • There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13% .
  • "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients."
  • It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC).
  • Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors.

Perspective Commences Recruitment for Second Dose Escalation Cohorts in Clinical Studies of Two Lead Programs: [(212)Pb]VMT-α-NET and [(212)Pb]VMT01

Retrieved on: 
Mercredi, janvier 17, 2024
Cohort, SSTR2, Neoplasm, Lutetium (177Lu) oxodotreotide, Patient, Therapy, Safety, CATX, TAT, Pharmaceutical industry

In addition, the first patient in cohort 2 of the [212Pb]VMT01 study was already dosed.

Key Points: 
  • In addition, the first patient in cohort 2 of the [212Pb]VMT01 study was already dosed.
  • [212Pb]VMT01 is a TAT in development for second-line or later treatment of patients with progressive MC1R-positive metastatic melanoma.
  • “Preliminary safety data from these Phase 1 studies of [212Pb]VMT-α-NET and [212Pb]VMT01 demonstrate good tolerability and support further dose escalation.
  • The [212Pb]VMT-α-NET data are consistent with the data collected at similar doses from the clinician-initiated ongoing study in India.

Novartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis

Retrieved on: 
Vendredi, janvier 5, 2024
Marketing, Regulation, Food, INN, Pandemic, Sale, Government, Physician, Research, FDA, Breast, Lung, USAN, Lutetium, Prostate cancer, DOTA-TATE, Clinical trial, Lutetium (177Lu) oxodotreotide, Ligand, RLT, Isotope, Pancreatic cancer, Prostate, Cancer, Growth, Cell, Patient, Diagnosis, Safety, Pharmaceutical industry

The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world.

Key Points: 
  • The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world.
  • The Indianapolis site represents the next phase of RLT manufacturing growth as this new addition brings substantial supply increases for the foreseeable future.
  • “The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” said Steffen Lang, President, Operations, Novartis.
  • Novartis is committed to expanding the radioligand therapy platform to shape the future of RLT as a treatment class.

Perspective Therapeutics Reports Third Quarter Fiscal 2023 Results and Recent Business Highlights

Retrieved on: 
Mardi, novembre 14, 2023
Lung, Lutetium (177Lu) oxodotreotide, Seed, EANM, Patient, Clinical study report, Research, Radiation therapy, Marketing, Stony Brook University, UPMC Hillman Cancer Center, Medullary thyroid cancer, Growth, Congress, University, Fortis Healthcare, Pelvic exenteration, Radiation, PRRT, Toxicity, IND, GEP-NET, MTC, Melanoma, Perspective, CATX, Communication, NET, Society, ASTRO, Therapy, NETS, Wilfrid Sellars, Brain, Biology, Nuclear Medicine and Biology, Glomus tumor, NYSE, PET/CT, SPECT/CT, Clinical trial, MC1R, Prostate cancer, NIH, Survival, UPMC, GEP, Rare-earth element, Medical imaging, Pharmaceutical industry, Medical device, Cryptocurrency, Nuclear medicine, Brachytherapy

Two additional patients were enrolled in the third quarter for a total of 9 GEP-NET patients and 2 medullary thyroid cancer (MTC) patients.

Key Points: 
  • Two additional patients were enrolled in the third quarter for a total of 9 GEP-NET patients and 2 medullary thyroid cancer (MTC) patients.
  • Third quarter 2023 revenue was the highest since the second quarter of 2022, with a return to growth over the third quarter of 2022.
  • Total operating expenses for the quarter ended September 30, 2023 were $11.3 million, compared to $4.6 million for the same period in 2022, an increase of 144%.
  • Cash and cash equivalents as of September 30, 2023 was $18.0 million as compared to $43.9 million on December 31, 2022.

Global Peptide Drug Conjugates Market Expected to Reach $4.21 Billion by 2030, Driven by Rising Cancer Cases - ResearchAndMarkets.com

Retrieved on: 
Mardi, octobre 24, 2023
Health, Pharmaceutical, WHO, FDA, Clinical trial, Multiple myeloma, Lung cancer, Mortality, Carcinoma, Christian democracy, Death, Wuxi, Lutetium (177Lu) oxodotreotide, Growth, Novartis, World Health Organization, PDC, Partnership, Brain, USD, Cancer, ANG1005, Somatostatin, Melphalan, Compound annual growth rate, Fine chemical, Pharmaceutical industry

The global peptide drug conjugates market is poised for significant growth, with an expected value of USD 4.21 billion by 2030, registering a remarkable Compound Annual Growth Rate (CAGR) of 28.58% during the forecast period.

Key Points: 
  • The global peptide drug conjugates market is poised for significant growth, with an expected value of USD 4.21 billion by 2030, registering a remarkable Compound Annual Growth Rate (CAGR) of 28.58% during the forecast period.
  • Rising Cancer Cases: The market's growth is driven by the global surge in cancer cases and related mortality.
  • The increasing demand for novel treatments like peptide drug conjugates (PDCs) to target uncontrolled cell growth is expected to fuel market growth.
  • For instance, in December 2021, Coherent Biopharma and WuXi STA announced a strategic partnership agreement to develop their current and future therapeutic drugs, including peptide drug conjugates.

Next Generation Drug Conjugates Market to Soar with Over 20% CAGR: Revolutionizing Rare Disease Treatment and Oncology Therapies - ResearchAndMarkets.com

Retrieved on: 
Mardi, octobre 17, 2023
Pharmaceutical, Health, Oncology, Ligand, Cancer, Lipid, Antibody, USFDA, U.S.–Afghanistan Strategic Partnership Agreement, Lutetium (177Lu) oxodotreotide, LICA, Oligonucleotide, Traction, Success, Radionuclide, USD, Therapy, Janssen, Generic drug, Novartis, SMDC, FDA, AstraZeneca, Peptide, Growth, Brown sugar, Rare disease, Region, Rare, Clinical trial, PRRT, Spacecraft, N-Acetylgalactosamine, Alnylam Pharmaceuticals, Patient, Fine chemical, Pharmaceutical industry, Vaccine, Lutetium (177Lu) vipivotide tetraxetan

This growing burden of rare diseases has driven the search for alternative therapies, and next generation drug conjugates have emerged as a viable option.

Key Points: 
  • This growing burden of rare diseases has driven the search for alternative therapies, and next generation drug conjugates have emerged as a viable option.
  • Advantages Over Antibody Drug Conjugates (ADCs): Next generation drug conjugates share similarities with antibody drug conjugates (ADCs) but offer advantages in terms of clinical efficacy and stability.
  • Types of Next Generation Drug Conjugates: Various types of next generation drug conjugates have emerged, including peptide drug conjugates, peptide receptor radionuclide therapy (peptide radionuclide conjugates), GalNac conjugates, peptide oligonucleotide conjugates, si-RNA conjugates, small molecule-drug conjugates (SMDC), ligand-conjugated antisense medicine (LICA), and peptide-conjugated phosphorodiamidate morpholino oligomers (PPMO).
  • Peptide Drug Conjugates: Peptide drug conjugates have emerged as a promising alternative to antibody drug conjugates (ADCs).