SEQUOIA

Theravance Biopharma to Present New Ampreloxetine Data at the 34th International Symposium on The Autonomic Nervous System

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목요일, 11월 16, 2023
SEQUOIA, American Autonomic Society, Autonomic nervous system, OHQ, Orthostatic hypotension, AAS, Patient, University School, Research, Week, Noh, Neurology, Dysautonomia, Pharmaceutical industry, Medical imaging

DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that a new, anchor-based analysis of ampreloxetine data in neurogenic orthostatic hypotension (nOH) will be presented at the 34th International Symposium on The Autonomic Nervous System, a meeting of the American Autonomic Society (AAS), taking place November 15-18, 2023, in Rio Grande, Puerto Rico.

Key Points: 
  • DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that a new, anchor-based analysis of ampreloxetine data in neurogenic orthostatic hypotension (nOH) will be presented at the 34th International Symposium on The Autonomic Nervous System, a meeting of the American Autonomic Society (AAS), taking place November 15-18, 2023, in Rio Grande, Puerto Rico.
  • Anchor-based analyses help establish thresholds used to interpret the clinical meaningfulness of changes in patient-reported outcomes measures such as the Orthostatic Hypotension Questionnaire (OHQ).
  • This anchor-based analysis model will aid in the interpretation of clinically meaningful changes to the OHSA composite score observed in CYPRESS.
  • Further, establishment of an anchor-based, clinically meaningful change in the OHSA composite primary endpoint will be important for clinicians, regulators, and payors.

BRUKINSA® Receives Positive Recommendation from NICE in U.K. for Adult Patients with Chronic Lymphocytic Leukemia

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금요일, 10월 20, 2023
Biotechnology, Pharmaceutical, Health, Oncology, National Institute for Health and Care Excellence, SSE, United Kingdom, BGNE, BR, Leeds Teaching Hospitals NHS Trust, TP53, NICE, FCR, NHS, Disease, Leukemia, Healthcare Improvement Scotland, FDG, BTK, Patient, SEQUOIA, Pharmaceutical industry, CLL, EU, BeiGene

“This follows the previous approval of BRUKINSA by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia.

Key Points: 
  • “This follows the previous approval of BRUKINSA by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia.
  • “This decision represents a significant milestone for patients in England and Wales with CLL, the most common form of leukemia in adults,” said Nick York, Patient Advocacy Healthcare Liaison Officer, U.K. Leukemia Care.
  • “Despite continued treatment advances, many patients with CLL will relapse and need additional treatment options.
  • Furthermore, a proportion of patients have a disease which is refractory to initial treatment.”
    BRUKINSA is the third BTKi for CLL to be recommended by NICE for routine commissioning.

Arrowhead Presents Updated Data from Phase 2 SEQUOIA Study of Investigational RNAi Therapy Fazirsiran in Patients with Alpha-1 Antitrypsin Deficiency Liver Disease

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토요일, 6월 24, 2023
Research, General Health, Pharmaceutical, Oncology, Infectious Diseases, Genetics, Clinical Trials, Science, Cardiology, Biotechnology, FDA, Health, SEQUOIA, Arrowhead, EASL, Liver disease, Serum, The New England Journal of Medicine, TAK, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Trial of the century, Congress, Arrowhead Pharmaceuticals, Patient, European Association for the Study of the Liver, F4, Pharmaceutical industry, Takeda, Liver

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented updated results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD).

Key Points: 
  • Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented updated results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD).
  • The SEQUOIA Phase 2 data are consistent with the promising results from an open-label Phase 2 trial of fazirsiran (AROAAT2002) that were published in The New England Journal of Medicine .
  • Takeda (TSE:4502/NYSE:TAK) and Arrowhead are further investigating fazirsiran in the ongoing pivotal Phase 3 REDWOOD clinical study which is actively recruiting a total of 160 patients.
  • Fazirsiran treatment demonstrated a substantial effect on several key markers of liver disease,” said Javier San Martin, M.D., chief medical officer at Arrowhead.

BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma

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목요일, 6월 15, 2023
Biotechnology, Health, Science, Research, Oncology, Neutropenia, SEQUOIA, Rituximab, Obinutuzumab, Lymphocytosis, BGNE, Progression-free survival, Lymphoid leukemia, Atrial fibrillation, ICML, Lymphoma, Lenalidomide, Multimedia, Petechia, BTK, PFS, EMA, MRD, Acalabrutinib, SSE, International Conference on Population and Development, Patient, CEST, Lower respiratory tract infection, Bone marrow, Fever, Recurrence, Abstract, Thrombocytopenia, Conference, Pharmaceutical industry, Hematology, BeiGene

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA® (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place from June 13-17 in Lugano, Switzerland.

Key Points: 
  • BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA® (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place from June 13-17 in Lugano, Switzerland.
  • View the full release here: https://www.businesswire.com/news/home/20230615000227/en/
    BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma - Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene (Photo: Business Wire)
    “The data presented at ICML provide further evidence supporting our confidence in BRUKINSA.
  • The complete response rate for BRUKINSA in combination with obinutuzumab was 39.3% compared to 19.4% for obinutuzumab alone.
  • The most common grade ≥3 adverse events were neutropenia (23.1%), thrombocytopenia (7.7%), lung infection (5.8%) (Abstract #153)

BeiGene Highlights Promising Data from Blood Cancer Portfolio and Pipeline at the European Hematology Association Hybrid Congress

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금요일, 6월 9, 2023
Oncology, Health, General Health, Clinical Trials, Research, Science, Biotechnology, CLL, SEQUOIA, European Medicines Agency, Abstract, Lymphocytosis, Obinutuzumab, BGNE, Doctor of Philosophy, Chronic lymphocytic leukemia, SLL, Progression-free survival, Lymphoid leukemia, Neoplasm, Bone marrow, BTK, PFS, Acalabrutinib, SSE, Patient, CDAC, Blood, EHA, Prevalence, IGHV, Society, Safety, Pharmaceutical industry, BeiGene

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the presentation of new data from its broad blood cancer portfolio of approved therapies and promising early-stage pipeline products at the 2023 European Hematology Association (EHA) Hybrid Congress.

Key Points: 
  • BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the presentation of new data from its broad blood cancer portfolio of approved therapies and promising early-stage pipeline products at the 2023 European Hematology Association (EHA) Hybrid Congress.
  • BeiGene has ten accepted abstracts at EHA, which is taking place from June 8-11 in Frankfurt, Germany.
  • “We are excited to share the latest research from our robust hematology portfolio and pipeline, including new results that further deepen our understanding of BRUKINSA across a number of hematologic malignancies,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene.
  • The European Medicines Agency recently validated BeiGene’s Type II variation application for BRUKINSA for the treatment of adult patients with R/R FL.

BRUKINSA® Approved in Canada for the Treatment of Chronic Lymphocytic Leukemia

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화요일, 5월 30, 2023
Biotechnology, Health, Genetics, Clinical Trials, Oncology, CLL, SEQUOIA, BGNE, Princess Margaret Cancer Centre, The New England Journal of Medicine, Chronic lymphocytic leukemia, Hematology, Bone marrow, Master, Toxicity, BTK, SSE, The Lancet, MD, Patient, Chairperson, FRCPC, Zanubrutinib, Leukemia, Health Canada, Society, Safety, Conditional sentence, Pharmaceutical industry, BeiGene

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, announced today that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi), has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, announced today that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi), has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
  • “BRUKINSA now has four approved indications in Canada, demonstrating our commitment to bring this innovative BTKi treatment option to more patients across the world,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.
  • The approval of zanubrutinib represents a significant advance for patients who can benefit from an additional treatment option,” says Raymond Vles, Board Chair, CLL Canada.
  • “More importantly, becoming informed and connecting with the CLL patient community will enable people with CLL to discuss with their doctor the treatment and dosing options that will work best for them and their lifestyle.”

Real-world study data reveals better outcomes for cancer patients who receive comprehensive genomic testing

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화요일, 5월 30, 2023
SEQUOIA, DNA, CGP, Genomics, American Society of Clinical Oncology, Marie Cassidy, NGS, Survival, Cancer, Research, Biomarker, Plasma, Patient, Standard of care, SAN, Illumina, Inc., Annual general meeting, Diagnosis, Health, Society, Allegheny Health Network, Medical imaging, Pharmaceutical industry, Illumina

SAN DIEGO, May 30, 2023 /PRNewswire/ -- Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced some of the latest data on the impact of comprehensive genomic profiling (CGP) for oncology patients, which will be presented at the American Society of Clinical Oncology's Annual Meeting June 2–6 in Chicago. In addition to the real-world study data, Illumina, along with study collaborators, will also present on findings that expose gaps in current standard-of-care and unmet needs for cancer patients.

Key Points: 
  • In addition to the real-world study data, Illumina, along with study collaborators, will also present on findings that expose gaps in current standard-of-care and unmet needs for cancer patients.
  • This study showcases the significant impact of implementing CGP testing systematically at the point of diagnosis, underscoring its potential to significantly improve survival rates in advanced stage cancer patients."
  • Illumina will also present two posters illustrating both the gaps in current testing practices and a study indicating that a large percentage of cancer patients who are eligible for biomarker testing are not receiving any genomic testing whatsoever.
  • It found that across tumor types, between 50% and 80% of advanced cancer patients (those eligible for biomarker testing and with clinical practice guidelines recommending testing) do not receive any kind of genomic testing.

Interim Management Statement Q1 2023 of Molecular Partners: Well Capitalized to Pursue Highly Differentiated DARPin Portfolio Strategy

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목요일, 5월 11, 2023
SEQUOIA, DARPin, Antigen, Society, AACR, Nephrotoxicity, ASH, Therapy, DME, CD70, CD3, TAA, Neoplasm, TAT, Diabetic retinopathy, NAMD, American Society of Clinical Oncology, LR, SITC, American Association for Cancer Research, Immunotherapy, RDT, Toxicity, Research, FAP, Cell, Stem cell, ASCO, Service provider, Society for Immunotherapy of Cancer, Radiation, DLL3, International Symposium on Symbolic and Algebraic Computation, Novartis, Patient, CD123, Molecular Partners, CD33, CD40, Kidney, Depreciation, Ranibizumab, R, Letter, CHF, Tumor microenvironment, Targeted alpha-particle therapy, Pharmaceutical industry, Vaccine, CONCORD, AML

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR: Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, today announced its interim management statement for the quarter ending March 31, 2023.

Key Points: 
  • 53 LR:
    Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, today announced its interim management statement for the quarter ending March 31, 2023.
  • “This quarter we made advances across our portfolio, including two clinical-stage oncology programs, MP0317 for solid tumors and MP0533 for AML.
  • We anticipate analyzing these data and working with potential partners to determine the best combinations and indications for the program.
  • The Company continues to evaluate potential business opportunities for abicipar outside of internal development at Molecular Partners.

BeiGene Receives New Approvals for BRUKINSA® (zanubrutinib) in China

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토요일, 5월 6, 2023
Biotechnology, Pharmaceutical, Health, CLL, Lymphoma, Lymphocytosis, BGNE, Doctor of Philosophy, Chronic lymphocytic leukemia, SLL, Central Waqf Council, Lymphoid leukemia, Hematology, Global health, Multimedia, BTK, WM, Harbin Institute of Technology, SSE, Patient, Mantle cell lymphoma, National Medical Products Administration, MCL, Chinese, Safety, NMPA, Pharmaceutical industry, SEQUOIA, BeiGene, ASPEN

View the full release here: https://www.businesswire.com/news/home/20230506005006/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230506005006/en/
    BeiGene BeiGene Receives New Approvals for BRUKINSA® (zanubrutinib) in China (Photo: Business Wire)
    “These approvals further support BRUKINSA as the BTKi of choice in China for the treatment of B-cell malignancies such as CLL and WM,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene.
  • NMPA converted these conditional approvals to regular approvals for R/R CLL/SLL and R/R WM in April 2023.
  • With these important approvals, BRUKINSA now becomes the only approved new-generation BTK inhibitor in China for the first-line treatment of adult CLL/SLL and WM patients, bringing healthcare providers in China with a new standard of care for their patients."
  • The new approvals of BRUKINSA for CLL/SLL are supported by data from SEQUOIA (NCT03336333), in patients with previously untreated CLL/SLL.

Arrowhead Pharmaceuticals Reports Fiscal 2023 Second Quarter Results

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화요일, 5월 2, 2023
Health, Genetics, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Molecule, SEQUOIA, Arrowhead, Volunteering, GSK, Idiopathic pulmonary fibrosis, Asthma, Central nervous system, NASH, Takeda, Triglyceride, Clinical trial, Folate targeting, Brain, Research, Part, CNS, Trial of the century, PIN, Outline, Patient, PNPLA3, Fatty liver disease, Webcast, RNA interference, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Janssen Pharmaceuticals, Food, Pharmaceutical industry, Vaccine, C3

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal second quarter ended March 31, 2023.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal second quarter ended March 31, 2023.
  • The company is hosting a conference call today, May 2, 2023, at 4:30 p.m.
  • Reported interim results from an ongoing Phase 1/2 clinical study of ARO-RAGE, an investigational RNAi therapeutic for treatment for inflammatory pulmonary diseases, such as asthma.
  • Key results from Part 1 of the study in normal healthy volunteers included the following:
    These results include 4 of 5 escalating dose levels.