Somatostatin

Chiesi Global Rare Diseases Showcases Ongoing Commitment to Multiple Rare Diseases Communities at ENDO 2024 Meeting Debut

Retrieved on: 
金曜日, 6月 14, 2024
ENDO, Incidence, Vomiting, Post hoc analysis, Patient, Insulin, OOC, Pregnancy, MACRO, Swelling, Weakness, Digoxin, Indigestion, Antacid, Arthralgia, Gallstone, Headache, Hypersensitivity, Lisinopril, LDS, Endocrine disease, Blood, Ciclosporin, Calcium channel, Bromocriptine, Arrhythmia, Anaphylaxis, Woman, Somatostatin, Bradycardia, AIS, Hyperhidrosis, Chronic pain, Octreotide, Clinical Global Impression, Chiesi Farmaceutici, Safety, Lipodystrophy, Common, Endocrine system, Gallbladder, Osteoarthritis, Nausea, Diarrhea, CYP3A4, Birth, Enzyme inhibitor, Sinusitis, FDA, CGI, Pharmaceutical industry

BOSTON, June 14, 2024 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced updates from their rare endocrine disease portfolio with two late-breaking poster presentations and one oral presentation during the Endocrine Society’s ENDO 2024 Meeting that was held June 1-4, 2024, in Boston, Massachusetts. Presentations included a post hoc analysis of three Phase 3 clinical trials (CH-ACM-01, OPTIMAL, MPOWERED) studying MYCAPSSA (octreotide) as well as real-world MYCAPSSA use data from the Chiesi Management of Acromegaly (MACRO) registry and presentation of the Lipodystrophy Severity Scoring tool designed to assess the disease burden of lipodystrophy.

Key Points: 
  • "We're thrilled to support this community of people living with burdensome rare endocrine diseases through the innovation of new resources and validated medicines to aid in disease management," said Giacomo Chiesi, Head of Chiesi Global Rare Diseases.
  • Median decrease of one symptom per patient and a mean decrease of 0.8 in Acromegaly Index of Severity (AIS) further underscored symptom improvement.
  • The mean time on OOC was 19.7 months, with the majority receiving treatment for at least 6 months.
  • Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

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

Retrieved on: 
火曜日, 4月 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: 
火曜日, 3月 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.

Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
水曜日, 2月 28, 2024
ENDO, SAN, Congenital adrenal hyperplasia, Holocene, Carcinoid syndrome, Research, Entrepreneurship, Investment, FDA, Food, Webcast, Growth, Graves' ophthalmopathy, Primary hyperparathyroidism, PTH1R, Somatostatin, Conference, Endocrinology, Safety, TSH, Patient, CAH, Trial of the century, NDA, PHPT, Pharmaceutical industry

SAN DIEGO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • ET Today
    SAN DIEGO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the fourth quarter and full year ended December 31, 2023.
  • We also expect full results from our Phase 2 study in carcinoid syndrome in the first half of this year.
  • In December 2023, Crinetics reported an initial analysis of data from a subset of 27 patients.
  • Earlier today, February 28, 2024, Crinetics announced a private placement equity financing for gross proceeds of approximately $350 million.

Lantheus Announces Acceptance of its First-to-File ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate)

Retrieved on: 
木曜日, 1月 11, 2024
Glomus tumor, Paragraph, Somatostatin, DOTA-TATE, Food, LNTH, FDA, Abbreviated New Drug Application, Certification

LUTATHERA® is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Key Points: 
  • LUTATHERA® is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
  • Based on the most recent update to the FDA’s online paragraph IV database listings,1 Lantheus believes it is the first applicant to have filed a substantially complete ANDA for Lutetium Lu 177 Dotatate containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act.
  • Should its ANDA be approved by the FDA, Lantheus believes it will be eligible for 180 days of generic marketing exclusivity in the U.S.
    Lantheus licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2003 from POINT Biopharma Global, Inc. in December of 2022.
  • To read the press release announcing that licensing transaction, please click here .

Crinetics Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
火曜日, 11月 7, 2023
Acromegaly, Data, Safety, Carcinoid syndrome, Trial of the century, Somatostatin, Carcinoid, Maintenance, SAN, Pharmaceutical industry

SAN DIEGO, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • SAN DIEGO, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the third quarter ended September 30, 2023.
  • We are enthusiastic about these upcoming key milestones for the paltusotine franchise.”
    Third Quarter 2023 and Operating Highlights:
    Phase 3 PATHFNDR-1 study met primary and all secondary endpoints.
  • In September 2023, Crinetics announced the pricing of an upsized underwritten public offering of 11,441,648 shares of its common stock at $30.59 per share.
  • Unrestricted cash, cash equivalents, and investments totaled $554.7 million as of September 30, 2023, compared to $334.4 million as of 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: 
火曜日, 10月 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.

Ariceum Therapeutics' targeted radiopharmaceutical 177Lu-satoreotide exhibits promising clinical response and good tolerability profile in patients with advanced neuroendocrine tumours

Retrieved on: 
木曜日, 9月 28, 2023
Neutropenia, NETS, Carcinoma, Radiation, Clinical trial, GEP, Somatostatin, Molecular imaging, DCR, Call of the Wild (D-A-D album), Nuclear medicine, Doctor of Philosophy, SCLC, Lymphocytopenia, Patient, Paraganglioma, Cancer, Pheochromocytoma, SSTR2, Diagnosis, Phase, Therapy, Thrombocytopenia, European Journal, Safety, European Journal of Nuclear Medicine and Molecular Imaging, Medical imaging, Pharmaceutical industry, Ipsen

This international study was conducted in 7 countries - Australia, Austria, Canada, Denmark, France, Switzerland, and the UK - and enrolled 40 patients with advanced, SSTR2-positive NETs.

Key Points: 
  • This international study was conducted in 7 countries - Australia, Austria, Canada, Denmark, France, Switzerland, and the UK - and enrolled 40 patients with advanced, SSTR2-positive NETs.
  • The primary tumours of the patients included progressive, grade 1 and 2 (≈60%) gastroenteropancreatic (GEP), and (a)typical lung NETs, paraganglioma, and pheochromocytoma.
  • Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "These exciting new data demonstrate the great potential of our targeted radiopharmaceutical, satoreotide, for treating patients with advanced neuroendocrine tumours.
  • A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours.

Ariceum Therapeutics' targeted radiopharmaceutical 177Lu-satoreotide exhibits promising clinical response and good tolerability profile in patients with advanced neuroendocrine tumours

Retrieved on: 
木曜日, 9月 28, 2023
Neutropenia, NETS, Carcinoma, Radiation, Clinical trial, GEP, Somatostatin, Molecular imaging, DCR, Call of the Wild (D-A-D album), Nuclear medicine, Doctor of Philosophy, SCLC, Lymphocytopenia, Patient, Paraganglioma, Cancer, Pheochromocytoma, SSTR2, Diagnosis, Phase, Therapy, Thrombocytopenia, European Journal, Safety, European Journal of Nuclear Medicine and Molecular Imaging, Medical imaging, Pharmaceutical industry, Ipsen

This international study was conducted in 7 countries - Australia, Austria, Canada, Denmark, France, Switzerland, and the UK - and enrolled 40 patients with advanced, SSTR2-positive NETs.

Key Points: 
  • This international study was conducted in 7 countries - Australia, Austria, Canada, Denmark, France, Switzerland, and the UK - and enrolled 40 patients with advanced, SSTR2-positive NETs.
  • The primary tumours of the patients included progressive, grade 1 and 2 (≈60%) gastroenteropancreatic (GEP), and (a)typical lung NETs, paraganglioma, and pheochromocytoma.
  • Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "These exciting new data demonstrate the great potential of our targeted radiopharmaceutical, satoreotide, for treating patients with advanced neuroendocrine tumours.
  • A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours.

RayzeBio to Present at Upcoming Medical Conferences

Retrieved on: 
月曜日, 5月 22, 2023
Oncology, Health, Radiology, Research, Science, Pharmaceutical, Biotechnology, Somatostatin, GEP-NET, ASCO, Society of Nuclear Medicine and Molecular Imaging, Hepatocellular carcinoma, IL, SSA, Society, Carcinoma, American Society of Clinical Oncology, Pharmaceutical industry

RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs.

Key Points: 
  • RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs.
  • 2023 American Society for Clinical Oncology (ASCO) annual meeting: June 2 - 6 in Chicago, IL
    Title: ACTION-1 phase 1b/3 trial of RYZ101 in somatostatin receptor subtype 2–expressing (SSTR2+) gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Initial safety analysis.
  • Australian and New Zealand Society of Nuclear Medicine (ANZSNM): May 26 - 28 in Adelaide, Australia
    Title: Anti-tumor activity of RYZ101 in somatostatin receptor-expressing preclinical models of small-cell lung cancer.
  • Title: Novel peptide binder to Glypican-3 for targeted radiopharmaceutical therapy of hepatocellular carcinoma.