CR

Rigel Announces Poster Presentations at the 65th American Society of Hematology Annual Meeting and Exposition

Retrieved on: 
Thursday, November 2, 2023
CR, IVO, VEN, Haematopoiesis, Constipation, Platelet, Acute myeloid leukemia, CRC, Prior, Thrombocytopenia, Vomiting, MDS, Diarrhea, Treatment, Rigel, Fostamatinib, Bone marrow, Hematopoietic stem cell transplantation, CRH, CRi, Inflammation, Azacitidine, Nausea, Society, Progress, ASH, Poster, Myelodysplastic syndrome, Cell death, Relapse, ITP, SAN, ORR, University, Safety, Venetoclax, IRAK, Cellular, MD Anderson Cancer Center, Cytopenia, Transplant, Neutropenia, AML, HSCT, Fatigue, Pharmaceutical industry, Dentistry, Dietary supplement, Bookkeeping, Vaccine, Patient, Cancer

SOUTH SAN FRANCISCO, Calif., Nov. 2, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the upcoming presentation of four posters highlighting data from their commercial and clinical-stage hematology-oncology portfolio at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, California and virtually.

Key Points: 
  • "We are also excited by the compelling data in patients with mIDH1 MDS and look forward to evaluating this potential opportunity further.
  • On top of the olutasidenib data, we are delighted to share other updates and data across our development portfolio, demonstrating our presence in the hematology-oncology space."
  • These results support the use of fostamatinib as a second-line treatment in patients with primary ITP.
  • To learn more about Rigel Pharmaceuticals and their clinical and commercial hematology/oncology portfolio visit Booth #2805 during ASH 2023.

Syndax Announces Updated Data Supporting Impressive Clinical Profile of Revumenib in Genetically-Defined Acute Leukemias to Be Presented at the 65th ASH Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
CR, CRP, Acute myeloid leukemia, Food, Trae Waynes, Thrombocytopenia, Decitabine, Febrile neutropenia, Safety, CRH, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Phenotype, Maintenance, Poster, Society, IDMC, ASH, DLT, Abstract, MRD, QT interval, ORR, SNDX, SAVE, NDA, Acute leukemia, Cellular, Transplant, ALL, AML, Neutropenia, Phase 1, HSCT, Pharmaceutical industry, Dentistry, Patient

WALTHAM, Mass., Nov. 2, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that updated data from multiple trials across its clinical program for revumenib, the Company's highly selective, oral menin inhibitor, will be featured in three poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023, in San Diego, California. Copies of the abstracts are now available online via the ASH website at www.hematology.org.

Key Points: 
  • The Company previously announced positive topline data from the protocol-defined pooled analysis of the pivotal Phase 2 portion of the AUGMENT-101 trial.
  • Based on the Independent Data Monitoring Committee (IDMC) recommendation, the Company stopped the trial to further accrual in the KMT2Ar cohorts.
  • Full data from the pivotal portion of the study will be reported at the meeting.
  • Title: Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemias: Efficacy and Safety Results from the Augment-101 Phase 1/2 Study
    Session Name: 616.

Bolt Biotherapeutics Presents Updated Clinical Data from Phase 1 Dose-Escalation Trial of BDC-1001 as Monotherapy and in Combination with Nivolumab in HER2-Expressing Tumors at ESMO 2023 Congress

Retrieved on: 
Monday, October 23, 2023
CR, Memorial Sloan Kettering Cancer Center, PRS, Trastuzumab, Plasma, Cholangiocarcinoma, Aes, ESMO, ISAC, MPH, Nivolumab, Publication, HER2, Congress, LVEF, Salivary gland tumour, European Society for Medical Oncology, MSK, Phenotype, Pharmacodynamics, Bolt, Oncology, SDS, Cancer, Therapy, Patient, Breast, Toxicity, ASCO, TLR, Pharmaceutical industry, Vaccine

BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist.

Key Points: 
  • BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist.
  • The Phase 1 dose-escalation trial enrolled 131 patients with 16 different HER2-expressing solid tumor types across 18 dose levels in two arms, monotherapy and in combination with nivolumab.
  • The response rate at the RP2D was 29% in evaluable patients with HER2-positive tumors, both in monotherapy (2/7, 29%) and in combination with nivolumab (2/7, 29%).
  • Additionally, a copy of the presentation is available on the Publications page of the Bolt Therapeutics website.

FAIR Congratulates Speaker Johnson: Real Border Enforcement Measures Must Be Top Priority as the House Moves Forward

Retrieved on: 
Wednesday, October 25, 2023
CR, Policy, Federation for American Immigration Reform, Continuing resolution, Government, Federation, Congress, House, FAIR, Multimedia, Representative, FBI, Nationality and Borders Act 2022

WASHINGTON, Oct. 25, 2023 /PRNewswire/ -- "The Federation for American Immigration Reform congratulates Mike Johnson on being elected Speaker of the House of Representatives. With a little more than three weeks remaining before the Continuing Resolution (CR) expires to keep the government funded, there is urgent work that must be done in the House of Representatives.

Key Points: 
  • "Since the CR was approved last month, the dangers of our uncontrolled borders have become even more acute.
  • Not only is there a humanitarian crisis, but we have significant public safety and national security threats against Americans.
  • Iran and its proxies have issued overt terror threats against the United States and other Western democracies.
  • "Unfortunately, the response from the Biden administration has not been commensurate with the gravity of the threats we are facing.

Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer

Retrieved on: 
Wednesday, October 25, 2023
CR, Response evaluation criteria in solid tumors, Bevacizumab, Survival, Patient, PD-L1, Carboplatin, New Drug Application, Cervical cancer, Incidence, ESMO, Progression-free survival, Trae tha Truth, Center for Drug Evaluation and Research, DOR, DCR, Squamous-cell carcinoma, Cisplatin, The New England Journal of Medicine, Neoplasm, Treatment, European Society for Medical Oncology, PFS, PD-1, American Society of Clinical Oncology, HIV disease progression rates, CC, Chinese, CPS, Paclitaxel, Immunotherapy, CDE, Diagnosis, Oncology, ORR, Anemia, RECIST, NDA, Safety, Ira Pastan, OS, Toxicity, Cohort, Performance, CI, Pharmaceutical industry, Medical imaging

This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).

Key Points: 
  • This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).
  • Moreover, the treatment exhibited a manageable safety profile without any new safety signals observed, making it a potential new first-line treatment option for r/mCC patients.
  • Currently, the preferred standard first-line treatment for r/mCC patients is cisplatin or carboplatin and paclitaxel plus bevacizumab, and efficacy and safety of the treatment also need to be considered.
  • For r/mCC patients with positive PD-L1 expression, the PD-1 inhibitor pembrolizumab, administered with chemotherapy and with or without bevacizumab, is recommended as the standard first-line treatment.

Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer

Retrieved on: 
Wednesday, October 25, 2023
CR, Response evaluation criteria in solid tumors, Bevacizumab, Survival, Patient, PD-L1, Carboplatin, New Drug Application, Cervical cancer, Incidence, ESMO, Progression-free survival, Trae tha Truth, Center for Drug Evaluation and Research, DOR, DCR, Squamous-cell carcinoma, Cisplatin, The New England Journal of Medicine, Neoplasm, Treatment, European Society for Medical Oncology, PFS, PD-1, American Society of Clinical Oncology, HIV disease progression rates, CC, Chinese, Multimedia, CPS, Paclitaxel, Immunotherapy, CDE, Diagnosis, Oncology, ORR, Anemia, RECIST, NDA, Safety, Ira Pastan, OS, Toxicity, Cohort, Performance, CI, Pharmaceutical industry, Medical imaging

This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).

Key Points: 
  • This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).
  • Moreover, the treatment exhibited a manageable safety profile without any new safety signals observed, making it a potential new first-line treatment option for r/mCC patients.
  • Currently, the preferred standard first-line treatment for r/mCC patients is cisplatin or carboplatin and paclitaxel plus bevacizumab, and efficacy and safety of the treatment also need to be considered.
  • For r/mCC patients with positive PD-L1 expression, the PD-1 inhibitor pembrolizumab, administered with chemotherapy and with or without bevacizumab, is recommended as the standard first-line treatment.

Servier Announces FDA Approval of TIBSOVO® (ivosidenib tablets) for the Treatment of IDH1-Mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)

Retrieved on: 
Tuesday, October 24, 2023
CR, Survival, Abbott, FDA, Food, MDS, Hope, IDH, News, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Syndrome, Priority review, Caregiver, Disease, Risk, Commercial, Breakthrough therapy, ORR, IDH1, Safety, Overalls, Patient, Diagnosis, Prognosis, Mutation, Pharmaceutical industry, Laboratoires Servier

BOSTON, Oct. 24, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced the U.S. Food and Drug Administration (FDA) has approved TIBSOVO® (ivosidenib tablets) for the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). This is the fifth indication for TIBSOVO across IDH1-mutated cancers, and the first and only approved targeted therapy for people diagnosed with R/R MDS within this molecularly defined subset.

Key Points: 
  • "Servier is proud to lead the way in mutant IDH inhibition through continued innovations that support patients living with difficult and hard-to-treat cancers," said Arjun Prasad, Head of Commercial, Servier Pharmaceuticals.
  • "As the first and only targeted therapy available for patients with IDH1-mutated relapsed or refractory myelodysplastic syndromes, today's FDA approval for TIBSOVO reinforces our commitment to deliver significant advances in areas of high unmet need and bring the right treatment, to the right patient, at the right time."
  • "This new indication in IDH1-mutated relapsed or refractory myelodysplastic syndromes reinforces the importance of mutational testing to inform treatment decisions and potentially improve patient outcomes."
  • "Before today, there were no approved targeted therapies available to relapsed or refractory MDS patients harboring the IDH1-mutation.

Crane Company Reports Third Quarter 2023 Results and Raises Full Year EPS Guidance

Retrieved on: 
Monday, October 23, 2023
Other Manufacturing, Engineering, Other Energy, Chemicals, Plastics, Oil, Gas, Aerospace, Manufacturing, Energy, Nuclear, CR, Sale, Electronics, Optimism, NYSE, Crane Holdings, Gesellschaft mit beschränkter Haftung, GAAP, Acquisition, Growth, China Academy of Aerospace Electronics Technology, EPS, Crane, Credit Accumulation and Transfer Scheme, Asbestos, Credit, Retail

Crane Company ("Crane," NYSE: CR) today announced its financial results for the third quarter of 2023 and updated its full-year outlook.

Key Points: 
  • Crane Company ("Crane," NYSE: CR) today announced its financial results for the third quarter of 2023 and updated its full-year outlook.
  • Max Mitchell, Crane's President and Chief Executive Officer, stated: “Crane delivered yet another strong quarter, consistently demonstrating our differentiated execution and accelerating results from growth initiatives.
  • Core year-over-year sales growth of 9% drove a 42% increase in adjusted operating profit from continuing operations, with strong operational performance across all businesses."
  • Third quarter 2023 GAAP earnings from continuing operations per diluted share (EPS) was $0.96, and adjusted EPS was $1.03.

ImmunityBio Announces Biological License Application Resubmission for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma-In-Situ

Retrieved on: 
Monday, October 23, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, CR, Survival, CIS, FDA, Patient, Bladder cancer, Food, E pluribus unum, Treatment, Vol, Safety, The New England Journal of Medicine, Pivotal trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Maintenance, Literature, Immune system, NK, Massachusetts Medical Society, NEJM, Probability, Case series, PMID, Cystectomy, BCG, NMIBC, BLA, Exception, Vaccine, ImmunityBio COVID-19 vaccine, Tolerability

The BLA is supported by the results of ImmunityBio’s studies in bladder cancer including the pivotal QUILT-3.032 study (NCT03022825), published in NEJM Evidence1 in November 2022.

Key Points: 
  • The BLA is supported by the results of ImmunityBio’s studies in bladder cancer including the pivotal QUILT-3.032 study (NCT03022825), published in NEJM Evidence1 in November 2022.
  • Of the nine subjects, two were deceased from causes other than bladder cancer and one was lost to follow-up.
  • Final clinical Results of Pivotal Trial of IL-15rαfc Superagonist N-803 with BCG in BCG-Unresponsive CIS and Papillary Non-Muscle Invasive Bladder Cancer (NMIBC).
  • Phase II/III Clinical Results of IL-15rαfc Superagonist N-803 with BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma in Situ (CIS) Patients.

ENHERTU® Approved in the EU as the First HER2 Directed Therapy for Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer

Retrieved on: 
Monday, October 23, 2023
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, CR, Female, Neoplasm, ERBB2, Lymphocytopenia, NSCLC, AstraZeneca, Journal of Thoracic Oncology, DOR, Thrombocytopenia, Vomiting, Hypokalemia, HER2, Diarrhea, Lung cancer, News, Nausea, Pneumonia, Transaminase, Lung, ADC, Disease, Daiichi Sankyo, TSE, Immunotherapy, ORR, Anemia, Leukopenia, Safety, European, Patient, Diagnosis, Neutropenia, Mutation, Fatigue, Pharmaceutical industry, Medical imaging, MD, EU

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).

Key Points: 
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • In DESTINY-Lung02, ENHERTU (5.4 mg/kg) demonstrated a confirmed objective response rate (ORR) of 49.0% (95% confidence interval [CI]: 39.0-59.1) in patients with previously treated advanced or metastatic HER2 mutant NSCLC as assessed by blinded independent central review (BICR).
  • Grade 5 adverse reactions occurred in 1.4% of patients, including interstitial lung disease (1.0%).
  • Following approval in the EU, an amount of $75 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment in HER2 mutant non-small cell lung cancer.