Rated R

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

Retrieved on: 
Monday, March 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: 
Tuesday, March 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: 
Monday, March 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: 
Tuesday, April 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: 
    Monday, February 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: 
    Friday, February 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: 
    Monday, February 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).

    Korea University Researchers Unveil Benefits of Perioperative Radiotherapy for Treating Liver Cancer with High Recurrence Risk

    Retrieved on: 
    Wednesday, February 7, 2024
    OS, Radiation therapy, Rated R, Hepatocellular carcinoma, Survival, Meta-analysis, Patient, HCC, Recurrence, Canadian International Council, Radiation, Disease, Risk, DFS, Neoplasm, Cancer, Liver cancer, Liver, Survival rate, Korea University, Pharmaceutical industry

    SEOUL, South Korea, Feb. 7, 2024 /PRNewswire/ -- More than two-thirds of patients with hepatocellular carcinoma (HCC), who receive surgical interventions, experience recurrence owing to lack of an established perioperative treatment. Now, researchers from Korea University have performed a meta-analysis to examine the oncological benefits of administering radiotherapy before or after surgery. The findings suggest that perioperative radiotherapy decreases the chances of recurrence in patients, improving their survival rate.

    Key Points: 
    • Researchers have found that radiotherapy during liver cancer surgery reduces chances of recurrence and boosts survival for high-risk patients.
    • Now, researchers from Korea University have performed a meta-analysis to examine the oncological benefits of administering radiotherapy before or after surgery.
    • The findings suggest that perioperative radiotherapy decreases the chances of recurrence in patients, improving their survival rate.
    • This emphasizes the need for an adjuvant treatment like radiotherapy along with surgery for treating HCC patients with a high risk of recurrence.

    ImmunityBio Quality-of-Life Study in BCG-Unresponsive Bladder Cancer Trial Indicates Improved Physical Function in the 71% Complete Responders Suggesting a Favorable Risk-Benefit Ratio for N-803 Plus BCG

    Retrieved on: 
    Monday, February 5, 2024
    Oncology, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, Gemcitabine, Quality of life, Rated R, Docetaxel, NAI, NMIBC, Patient, Safety, CIS, UCLA, DSS, Pros, PRO, Incidence, Progression-free survival, Cancer, Diagnosis, FDA, SOC, Medicine, Cystectomy, Global health, Experiment (probability theory), DFS, Pembrolizumab, Carcinoma in situ, PDUFA, Associate, Bladder cancer, BCG, BLA, Bacillus

    Overall, participants who achieved a complete response with the novel combination therapy reported better physical function by month six of the study than those who did not achieve a complete response.

    Key Points: 
    • Overall, participants who achieved a complete response with the novel combination therapy reported better physical function by month six of the study than those who did not achieve a complete response.
    • “Many current therapies for bladder cancer slow disease progression but can cause debilitating side effects,” said Principal Investigator Karim Chamie, M.D., Associate Professor of Urology at UCLA.
    • Bladder cancer is the 10th most-commonly diagnosed cancer, with approximately 80% of newly diagnosed cases being NMIBC.
    • Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.

    Gamida Cell to Present at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

    Retrieved on: 
    Wednesday, January 17, 2024
    NK, Patient, Infection, Transplant, Hematology, Safety, Rituximab, Society, Bone marrow, Cytokine release syndrome, Lymphoma, TCT, EAP, FDA, Therapy, Rated R, Cell

    The hybrid meetings will take place virtually and in person at the Henry B. González Convention Center in San Antonio, Texas, February 21-24.

    Key Points: 
    • The hybrid meetings will take place virtually and in person at the Henry B. González Convention Center in San Antonio, Texas, February 21-24.
    • Eligible patients ≥12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards.
    • Omidubicel was approved under the brand name Omisirge® (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant.
    • There were no reported cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease.