Survival rate

BridgeBio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Retrieved on: 
Monday, February 5, 2024
Mortality, CVH, ACM, TTR, MD, PALO, Patient, Safety, FDA, Food, Cancer, PDUFA, Doctor of Philosophy, Survival rate, NDA, Kaplan–Meier estimator, Pharmaceutical industry

PALO ALTO, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for acoramidis, an investigational drug for the treatment of ATTR-CM. The application was based on positive results from ATTRibute-CM, the Company’s Phase 3 study designed to evaluate the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of transthyretin (TTR). The FDA has set an action date of November 29, 2024 under the PDUFA. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • The FDA has set an action date of November 29, 2024 under the PDUFA.
  • The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application.
  • There is a need for more treatment options that can help fill the significant unmet need that exists for patients today.
  • The Company also received acceptance of its Marketing Authorization Application with the European Medicines Agency and is preparing for additional global regulatory submissions.

Tony Romo to be honored with 2024 Pat Summerall Award during Super Bowl LVIII week, Legends for Charity® dinner benefiting St. Jude Children’s Research Hospital®

Retrieved on: 
Tuesday, January 30, 2024
Marketing, Advertising, Communications, Other Philanthropy, Entertainment, Oncology, Parenting, Children, Hospitals, Celebrity, Health, Philanthropy, Physical Therapy, Men, General Health, Football, Fund Raising, Foundation, Family, Consumer, TV and Radio, People with Disabilities, Sports, Multimedia, NCI-designated Cancer Center, Charity, Travel, Dallas Cowboys, Hospital, National Cancer Institute, CBS Sports, Housing, Child, FOX, Athlete, Patient, Food, ALSAC, Love, CBS, Hope, Caesars Palace, Eye, Cancer, Survival rate, NFL, Human, Nursing

(Photo: Business Wire)

Key Points: 
  • (Photo: Business Wire)
    The coveted Pat Summerall Award will be presented to Romo in celebration of his successes in the NFL and throughout his broadcasting career with CBS Sports.
  • “I am incredibly honored to receive this award named for the legendary Pat Summerall,” said Romo.
  • Visit St. Jude Inspire to discover powerful St. Jude stories of hope, strength, love and kindness.
  • Support the St. Jude mission by donating at stjude.org , liking St. Jude on Facebook , following St. Jude on X , Instagram , LinkedIn and TikTok , and subscribing to its YouTube channel.

Domain Therapeutics Awarded Hospital-University Research in Health (RHU) SPRINT Consortium Grant to Progress Its Proprietary CCR8 Antibody Candidate to the Clinic

Retrieved on: 
Thursday, January 25, 2024
Technology, Biotechnology, Health, Biometrics, Other Health, Pharmaceutical, Artificial Intelligence, Oncology, Other Science, Research, Hospitals, Health Technology, Science, Clinical Trials, Patient, Therapy, G protein-coupled receptor, AP-HP, Multimedia, Fatigue, Intelligence, Medicen, Government, Cancer, Cutaneous T-cell lymphoma, Drug discovery, Quality of life, SPRINT, Survival rate, Regulatory T cell, National Cancer Institute, Disease, Study Group, Sarcoma, Hospital, GPCR, Pain, Gq alpha subunit, ANR, TME, RHU, Physician, Pharmaceutical industry

Domain Therapeutics (“Domain” or “the Company”), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), today announces it has been awarded a grant as part of the Hospital-University Research in Health (RHU) SPRINT consortium.

Key Points: 
  • Domain Therapeutics (“Domain” or “the Company”), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), today announces it has been awarded a grant as part of the Hospital-University Research in Health (RHU) SPRINT consortium.
  • View the full release here: https://www.businesswire.com/news/home/20240125583037/en/
    The SPRINT project aims to revolutionize the management of patients with CTCL and deliver a new cure paradigm as a standard-of-care.
  • The grant that we have been awarded by the RHU SPRINT consortium will support the progress of DT-7012, an anti-CCR8 monoclonal antibody which has incredible potential as a best-in-class therapeutic, into the clinic.
  • Domain was already awarded a first RHU grant, RHU CONDOR for Sarcoma, in the previous campaign, leveraging another proprietary asset.

Tvardi Therapeutics Announces Presentation of REVERT LIVER CANCER Phase 2 Clinical Trial Using TTI-101, A Novel STAT3 Inhibitor, at 2024 ASCO Gastrointestinal Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, STAT3, HCC, Patient, Therapy, Overalls, Standard of care, Poster, Prognosis, Liver cancer, Hepatocellular carcinoma, Survival rate, Disease, Safety, Doctor of Philosophy, Pharmaceutical industry

Tvardi Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced it will present a trials in progress poster at the upcoming 2024 ASCO Gastrointestinal Cancers Symposium on Friday, January 19, 2024, in San Francisco, CA.

Key Points: 
  • Tvardi Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced it will present a trials in progress poster at the upcoming 2024 ASCO Gastrointestinal Cancers Symposium on Friday, January 19, 2024, in San Francisco, CA.
  • The poster will highlight the design of the ongoing REVERT LIVER CANCER study, a Phase 1b/2 trial evaluating safety and clinical activity of TTI-101, a novel STAT3 inhibitor, as monotherapy and in combination with standard of care in patients with locally advanced or metastatic, and unresectable hepatocellular carcinoma (HCC).
  • TTI-101 is an orally delivered, small molecule, direct inhibitor of STAT3.
  • For more information about the REVERT LIVER CANCER trial, please visit ClinicalTrials.gov (NCT05440708) .

Deciphera Pharmaceuticals Presents Long-Term Follow-Up Results from INTRIGUE Phase 3 Clinical Study in Second-Line GIST Patients at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Patient, Progression-free survival, KIT, Neoplasm, OS, Hypertension, ASCO, Fatigue, Society, Cancer, Myalgia, Survival rate, Public health, INSIGHT, AP, PFS, Safety, Diarrhea, GIST, Sunitinib, Nature Medicine, Preventive healthcare, Pharmaceutical industry

There were fewer patients with Grade 3/4 drug-related treatment emergent adverse events (TEAE) with QINLOCK (26.5%) compared with sunitinib (55.2%).

Key Points: 
  • There were fewer patients with Grade 3/4 drug-related treatment emergent adverse events (TEAE) with QINLOCK (26.5%) compared with sunitinib (55.2%).
  • Dose interruptions and reductions as well as treatment discontinuations due to TEAEs were lower with QINLOCK versus sunitinib.
  • Patients with mutations in KIT exon 11 and 17/18 had improved progression-free survival, objective response rate, and overall survival with QINLOCK versus sunitinib.
  • Based on the results of this prespecified exploratory objective in INTRIGUE, the Company is enrolling the INSIGHT pivotal Phase 3 clinical study of QINLOCK in second-line GIST patients with mutations in KIT exon 11 and 17/18 only.

BridgeBio Pharma Announces Publication of Positive Results from Phase 3 ATTRibute-CM Study of Acoramidis for Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in the New England Journal of Medicine

Retrieved on: 
Wednesday, January 10, 2024
ACT, Mortality, Social Security, Serum, American Heart Association, Patient, ACM, Research, Hospital, PALO, TTR, Cancer, Survival rate, Food, NDA, Safety, ATTR, FDA, Cardiology, NEJM, Marketing, New Drug Application, CVH, KCCQ, Amyloidosis, University college, Dietary supplement

ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, small molecule stabilizer of transthyretin (TTR).

Key Points: 
  • ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, small molecule stabilizer of transthyretin (TTR).
  • Findings presented in the NEJM support acoramidis as an effective and safe treatment option for patients with ATTR-CM and reinforce the hypothesis that greater stabilization of TTR may be associated with improved clinical outcomes.
  • BridgeBio has also presented additional detailed results from ATTRibute-CM at the European Society of Cardiology Congress 2023 in August and at the American Heart Association Scientific Sessions 2023 in November .
  • The Company submitted a New Drug Application to the U.S. FDA in 2023 and intends to submit additional marketing authorization applications to regulatory bodies in 2024.

Medacta’s QUADRA-H hip stem achieves 13A* exemplary quality rating from the British Orthopaedic Data Evaluation Panel (ODEP)

Retrieved on: 
Monday, January 8, 2024
Niobium, AMIS, Survival, Survival rate, Surgeon, Registry, SAN, Education, Estate (law), Patient, Sports medicine, Medical device

QUADRA-H is part of the QUADRA System , a comprehensive system of rectangular straight stems to be used in both primary and revision surgeries.

Key Points: 
  • QUADRA-H is part of the QUADRA System , a comprehensive system of rectangular straight stems to be used in both primary and revision surgeries.
  • Available in an extensive range of sizes for multiple stem versions, QUADRA system allows for a high personalized approach.
  • The X-acta is a cemented double-tapered femoral stem intended to be implanted with a uniform cement mantle about 2 mm thick around the stem.
  • Institute is at the forefront of education on hip procedures and products with personalized, high-level educational pathways.

Human medicines European public assessment report (EPAR): Tecovirimat SIGA, tecovirimat monohydrate, Date of authorisation: 06/01/2022, Revision: 3, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, Family, Agency, Human body, INN, Survival, Infection, Survival rate, Virus, ATC, Capsule, International, Mortality, Headache, Nausea, Language, Mouth, Human, Vaccination, Medicine, Poxviridae, Animal, European Medicines Agency, Viral, Orthopoxvirus, Select, Patient, Diagnosis, Safety, Anatomy, IIA, Vaccine

Human medicines European public assessment report (EPAR): Tecovirimat SIGA, tecovirimat monohydrate, Date of authorisation: 06/01/2022, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Tecovirimat SIGA, tecovirimat monohydrate, Date of authorisation: 06/01/2022, Revision: 3, Status: Authorised

New Novotech Report on Metastatic Breast Cancer Identifies 1,000 Clinical Trials Globally Since 2018

Retrieved on: 
Saturday, December 30, 2023
Clinical trial, Immunotherapy, Metastatic breast cancer, Breast cancer, Survival rate, Physician, Mortality, ROW, Optimism, Patient, Medicine, Birth control

The Metastatic Breast Cancer - Global Clinical Trial Landscape 2023 report found that there were over 1,000 clinical trials worldwide since 2018.

Key Points: 
  • The Metastatic Breast Cancer - Global Clinical Trial Landscape 2023 report found that there were over 1,000 clinical trials worldwide since 2018.
  • In addition, the report noted that “Out of 2.3 million global breast cancer cases, 0.67 million were identified as metastatic breast cancer, with Asia accounting for 45%, Western regions 35%, and the remaining regions 20%”.
  • Metastatic Breast Cancer, also known as Stage IV breast cancer, occurs when cancer cells from the breast spread to other parts of the body.
  • Despite advancements in screening and treatment, 20%-30% of those initially diagnosed with breast cancer progress to metastatic breast cancer, posing challenges with a 30% 5-year survival rate.

Purple Biotech Completes Patient Enrollment in Phase 2 Pancreatic Cancer Trial

Retrieved on: 
Thursday, December 14, 2023
Drug resistance, Neoplasm, Tumor microenvironment, Survival, Survival rate, Nivolumab, CM24, Cancer, Pancreatic cancer, BMS, PDAC, CEACAM1, Patient, Bristol Myers Squibb, Escape Room, Pharmaceutical industry

REHOVOT, Israel, Dec. 14, 2023 (GLOBE NEWSWIRE) --  Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced it has completed patient enrollment in a Phase 2 study of CM24, a multi-functional immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC).

Key Points: 
  • “Having completed patient enrollment, we now look forward to reporting overall survival results in 2024.
  • Survival rates in pancreatic cancer are unfortunately very low and with CM24’s novel CEACAM1 target, we believe we may have a positive impact on extending survival,” stated Purple Biotech CEO, Gil Efron.
  • An estimated 60,000 people are diagnosed with pancreatic cancer in the U.S. alone with a 5-year survival rate of only 12%.
  • In patients treated with chemotherapy as a 2nd line treatment, the 5-year survival drops to 3%.