Rated R

MaaT Pharma Presents Positive 18-month Data for MaaT013 Showing a Clear Overall Survival Advantage in aGvHD from the Early Access Program at the 2024 EBMT Event

Retrieved on: 
Lunedì, Aprile 15, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, FDA, EAP, Cancer, MET, Hospital, Hematology, Food, Sorbonne University, Survival, Orphan, OS, DSMB, Disease, Rated R, Patient, ARES, D28, EMA, Symantec Endpoint Protection, Hematopoietic stem cell transplantation, EBMT, Toxicity, European Medicines Agency, Data monitoring committee, Pharmaceutical industry

Prof. Malard commented: “MaaT013 shows remarkable efficacy at 18 months, yielding more complete responses in aGvHD patients who have shown resistance to current treatments, as compared to other available therapies.

Key Points: 
  • Prof. Malard commented: “MaaT013 shows remarkable efficacy at 18 months, yielding more complete responses in aGvHD patients who have shown resistance to current treatments, as compared to other available therapies.
  • Notably, these results are achieved with just 3 doses in less than 2 weeks of treatment initiation.
  • The data presented highlights the strong safety profile of MaaT013 (full details here ) and translates into increased OS.
  • MaaT Pharma also presented its ongoing Phase 2b trial design for MaaT033 developed as an adjunctive therapy to enhance OS in allogeneic hematopoietic stem cell transplantation.

Biotech Innovations Paving the Way in Breast Cancer Fight

Retrieved on: 
Giovedì, Aprile 11, 2024
AstraZeneca, Breast cancer, Gilead Sciences, FDA, Radiation, University, PARP1, Cancer, Bone marrow, G1 Therapeutics, Paclitaxel, Protein, GILD, Safety, PARP, Pancreatic cancer, News, Progression-free survival, Survival, Estate (law), American Cancer Society, TSX, OS, Fast track (FDA), MBC, ONC, PETRA, Data monitoring committee, Rated R, Patient, Sacituzumab govitecan, Hologic, HOLX, Neoplasm, Death, DMC, AACR, Immune system, Type, TNBC, Trilaciclib, Pharmaceutical industry

VANCOUVER, BC, April 11, 2024 /PRNewswire/ -- USA News Group – The American Cancer Society is projecting 2024 to be the first year ever for the US to have more than 2 million new cases, which would represent a record high. Among 10 of the most common cancers, 6 have seen a rise in diagnoses, including the most common type of cancer in women—breast cancer. According to the World Health Organization breast cancer caused 670,000 deaths globally in 2022, and is predicting a 77% increase in new cancer cases by 2050. Based on the characteristics of each patient's tumor, how each patient is treated may be completely different from others. Broadening our ability to tackle breast cancer are several biotech developments including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Gilead Sciences, Inc. (NASDAQ:GILD), G1 Therapeutics, Inc. (NASDAQ:GTHX), AstraZeneca PLC (NASDAQ:AZN), and Hologic, Inc. (NASDAQ:HOLX).

Key Points: 
  • According to the World Health Organization breast cancer caused 670,000 deaths globally in 2022 , and is predicting a 77% increase in new cancer cases by 2050 .
  • Broadening our ability to tackle breast cancer are several biotech developments including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Gilead Sciences, Inc. (NASDAQ:GILD), G1 Therapeutics, Inc. (NASDAQ:GTHX), AstraZeneca PLC (NASDAQ:AZN), and Hologic, Inc. (NASDAQ:HOLX).
  • Coming off of a late-2022 FDA Fast Track Designation of Oncolytics Biotech Inc.'s (NASDAQ:ONCY) (TSX:ONC) flagship asset pelareorep for the treatment of pancreatic cancer, momentum is building towards another important FDA milestone, this time for breast cancer.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.

Biotech Innovations Paving the Way in Breast Cancer Fight

Retrieved on: 
Giovedì, Aprile 11, 2024
AstraZeneca, Breast cancer, Gilead Sciences, FDA, Radiation, University, PARP1, Cancer, Bone marrow, G1 Therapeutics, Paclitaxel, Protein, GILD, Safety, PARP, Pancreatic cancer, News, Progression-free survival, Survival, Estate (law), American Cancer Society, TSX, OS, Fast track (FDA), MBC, ONC, PETRA, Data monitoring committee, Rated R, Patient, Sacituzumab govitecan, Hologic, HOLX, Neoplasm, Death, DMC, AACR, Immune system, Type, TNBC, Trilaciclib, Pharmaceutical industry

VANCOUVER, BC, April 11, 2024 /PRNewswire/ -- USA News Group – The American Cancer Society is projecting 2024 to be the first year ever for the US to have more than 2 million new cases, which would represent a record high. Among 10 of the most common cancers, 6 have seen a rise in diagnoses, including the most common type of cancer in women—breast cancer. According to the World Health Organization breast cancer caused 670,000 deaths globally in 2022, and is predicting a 77% increase in new cancer cases by 2050. Based on the characteristics of each patient's tumor, how each patient is treated may be completely different from others. Broadening our ability to tackle breast cancer are several biotech developments including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Gilead Sciences, Inc. (NASDAQ:GILD), G1 Therapeutics, Inc. (NASDAQ:GTHX), AstraZeneca PLC (NASDAQ:AZN), and Hologic, Inc. (NASDAQ:HOLX).

Key Points: 
  • According to the World Health Organization breast cancer caused 670,000 deaths globally in 2022 , and is predicting a 77% increase in new cancer cases by 2050 .
  • Broadening our ability to tackle breast cancer are several biotech developments including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Gilead Sciences, Inc. (NASDAQ:GILD), G1 Therapeutics, Inc. (NASDAQ:GTHX), AstraZeneca PLC (NASDAQ:AZN), and Hologic, Inc. (NASDAQ:HOLX).
  • Coming off of a late-2022 FDA Fast Track Designation of Oncolytics Biotech Inc.'s (NASDAQ:ONCY) (TSX:ONC) flagship asset pelareorep for the treatment of pancreatic cancer, momentum is building towards another important FDA milestone, this time for breast cancer.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.

eFFECTOR Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Lunedì, Marzo 25, 2024
Rated R, Fulvestrant, KICKSTART, Patient, Sale, G&A, Investment, Therapy, Anemia, Vomiting, Artificial intelligence, Effector, Research, Science, AML, Expense, Pembrolizumab, Breast cancer, Safety, Fatigue, PD-L1, Database, NSCLC, Associate, Cancer, University, PFS, Hematology, FDA, OS, Azacitidine, ZF, Administration, Assistant, MNK, Progression-free survival, COVID-19, Fast Track, Messenger, Cell, Nausea, Research and development, DARPA, Interval (mathematics), Pharmaceutical industry

SOLANA BEACH, Calif. and REDWOOD CITY, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • The primary analysis will reflect 37 PFS events, which provides approximately 80% power to detect a PFS hazard ratio of 0.65 at a p≤0.2.
  • Revenue: Revenue was zero for the quarter ended December 31, 2023, compared to approximately $0.7 million for the same quarter of 2022.
  • Research and Development (R&D) Expenses: R&D expenses were $6.1 million for the quarter ended December 31, 2023, compared to $6.6 million for the same quarter of 2022.
  • The earn-out period expired in August 2023 resulting in a reduction of the corresponding earn-out liability to zero as of December 31, 2023.

MaaT Pharma Announces Long Term Follow-Up Data for MaaT013 in Early Access Program to be Presented at the Upcoming EBMT Conference

Retrieved on: 
Martedì, Marzo 12, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Rated R, Toxicity, Survival, ASH, Hematology, Risk, Patient, Hospital, ARES, EAP, Policy, Cancer, Quality of life, MET, DSMB, D28, Pharmaceutical industry

Details from the presentation will be disclosed in a press release on April 17th, 2024, in compliance with the conference embargo policy.

Key Points: 
  • Details from the presentation will be disclosed in a press release on April 17th, 2024, in compliance with the conference embargo policy.
  • Aligned with its mission to enhance the survival of cancer patients, MaaT Pharma has been actively involved in the EAP in Europe since 2019.
  • The Company has consistently presented real-world data from its EAP at major hematology conferences over the past four years.
  • To date, over 220 patients have been treated with MaaT013 in Europe in clinical trials and the EAP.

Cellworks Personalized Therapy Biosimulation Study Produces Superior OS and DFS Predictions for Gastroesophageal Cancer Patients

Retrieved on: 
Lunedì, Marzo 11, 2024
Technology, Biotechnology, Health, Other Health, Pharmaceutical, Oncology, Research, Software, General Health, Genetics, Health Technology, Science, Data Management, Clinical Trials, Biopsy, OS, HER2, Cancer, Radiation, Kingdom of Poland, Anthracycline, Survival, Disease, Neoadjuvant therapy, CBM, International Cancer Genome Consortium, TNM, University, Patient, Rated R, NGS, Biomarker, MSI, Artificial intelligence, Standard of care, DFS, TRI, MD, Medicine, TRG, Platinum, Publication, Biosimulation, OGA, Whole genome sequencing, PD-L1, Taxane, Medical imaging

The study also showed a significant association between a patient’s TRI score and disease-free survival (DFS) and tumor regression grade (TRG).

Key Points: 
  • The study also showed a significant association between a patient’s TRI score and disease-free survival (DFS) and tumor regression grade (TRG).
  • Despite progress in gastroesophageal cancer therapy, only a small proportion of patients attain long-term survival.
  • This study concluded that TRI scores for gastroesophageal adenocarcinoma patients predict OS and DFS beyond clinical factors.
  • These results highlight the clinical value of employing Cellworks biosimulation for personalized therapy selection and warrant additional clinical evaluation.

US monetary policy is more powerful in low economic growth regimes

Retrieved on: 
Martedì, Aprile 2, 2024
Tao, Research Papers in Economics, Excess, American Economic Journal, Doan, Policy, RT, Interpolation, Economic growth, Absorption, Business, E32, Low, Browning, European Economic Review, UST, NBER, Forecasting, Macroeconomics, European Economic Association, Journal of Monetary Economics, Journal of Applied Econometrics, TVAR, Oxford University Press, Time series, Economic Inquiry, Paper, Linearity, Joshua Angrist, Nobuhiro, Environment, Political economy, Journal of Financial Economics, Rated R, R2, Website, Emi, Energy economics, Probability, Medical classification, Eurozone, Sigismund, Quarterly Journal of Economics, Zero lower bound, History, Nature, Chapter, ZT, Journal of Political Economy, Bocconi University, OLS, Statistics, University of California, Irvine, PDF, Classification, ECB, XS, ITP, Impact, Estimation, DGP, Mark Thoma, Social science, Elsevier, JEL, Cambridge University Press, Real, M1, Research, Textbook, Private sector, FED, Credit, UTT, Literature, Federal Reserve, Knotek, Evelyn Regner, Table, European Central Bank, Chow, FRED, Monetary economics, Wald, Ben Bernanke, Premium, P500, BIS, EWMA, International Economic Review, Federal funds rate, Money, Treasury, C32, The Economic Journal, Federal Reserve Economic Data, Employment, Risk, FFR, Suggestion, FOMC, Monte Carlo method, Sigmoid, VAR, Database, Projection, Ascari, The Journal of Finance, Yield curve, United States Treasury security, Economy, Fed, Figure, NFCI, Financial economics, EXP, Freedom, Central bank, PCE, Monetary policy, American Economic Review, Exercise, Interest, Samuel, URR, Rigidity, Business cycle, XT, Landing slot, Chap, Daron Acemoglu, Markov, Blue chip, Kuttner, Response, Quarterly Journal, YT, Channel, GDP, Standard, Effect, Federal, Cost, Christian Social Union (UK), Journal of Econometrics, Comm, Mark Gertler, Use, Economic statistics, IW, Bank for International Settlements, Finance Secretary (India), UC, Bank, Reproduction, Section, News, Housing, Data, Food industry
Key Points: 

    AB Science announces that Health Canada has issued a Notice of Non-Compliance-Withdrawal (NON/w) for masitinib in ALS

    Retrieved on: 
    Lunedì, Febbraio 26, 2024
    Bias, PFS, EMA, Function, ALS, Health Canada, ANCOVA, Progression-free survival, JTR, OS, Observation, Tracheotomy, Patient, Clinical trial, CIR, Drug, Science, CAFS, Rated R, Pharmaceutical industry

    Health Canada stated that a Request for Reconsideration can be filed within 30 days of receiving the NON/w.

    Key Points: 
    • Health Canada stated that a Request for Reconsideration can be filed within 30 days of receiving the NON/w.
    • The reconsideration process will re-examine, with new assessors, the decision based on information that was included in the original submission.
    • AB Science provided a methodologically justified new claim “patients with ALS prior to any loss of function”, where CAFS and Overall Survival (OS) are significantly improved.
    • Based on the supporting arguments and counterarguments outlined above, AB Science intends to submit a Request for Reconsideration.

    Gamida Cell Data Presented at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

    Retrieved on: 
    Venerdì, Febbraio 23, 2024
    Tandem, Therapy, Infection, MD, TCT, FDA, Bone marrow, Cell, Health, Hematology, Society, Duke Cancer Institute, Science, White, Non-Hodgkin lymphoma, Patient, Fungal infection, NK, NAM, Rated R, Transplant, Rituximab, Cytokine release syndrome, EAP, Lymphoma, Pharmaceutical industry

    BOSTON, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today presented data highlighting its expanded access program (EAP) for FDA-approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and Phase 1 data for its allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas.

    Key Points: 
    • The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas.
    • “The data presented at Tandem provide further evidence of the potential of Gamida Cell’s nicotinamide (NAM) technology to develop potentially curative therapies by expanding and enhancing cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell.
    • It allowed for institutional variability in conditioning regimens and supportive care, more closely reflecting the real-world environment.
    • Patients were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant.

    G1 Therapeutics to Continue Pivotal Phase 3 Trial of Trilaciclib in Metastatic Triple Negative Breast Cancer Following Interim Analysis by Independent Data Monitoring Committee

    Retrieved on: 
    Lunedì, Febbraio 12, 2024
    G1 Therapeutics, Carboplatin, Breast cancer, Bone marrow, Data monitoring committee, DMC, OS, Safety, Therapy, TNBC, Patient, Survival, ITT, Rated R, Pharmaceutical industry

    The DMC did not express any concerns regarding safety or recommend any other changes to the study.

    Key Points: 
    • The DMC did not express any concerns regarding safety or recommend any other changes to the study.
    • G1 remains blinded to all data as the early stopping criteria were not met during the interim analysis.
    • PRESERVE 2 is a global, multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in patients with locally advanced unresectable or metastatic TNBC.
    • Patients meeting eligibility requirements were randomized 1:1 to receive either trilaciclib or placebo administered prior to first-line gemcitabine and carboplatin (GCb).