EFS

New CMJ-NBME Dissertation Fellow Selected to Promote Diversity and Equity in Measurement

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Mittwoch, Mai 8, 2024
Education, Stanford University, NBME, Learning, Bangladeshi Americans, Partnership, Doctor of Philosophy, Research, Parent, Ishita, EF, CMJ, EFS, Toy

PHILADELPHIA, May 08, 2024 (GLOBE NEWSWIRE) -- Ishita Ahmed was selected as the 2024 recipient of the CMJ-NBME Dissertation Fellowship , a program designed to promote diversity and anti-racist assessment and measurement practices.

Key Points: 
  • PHILADELPHIA, May 08, 2024 (GLOBE NEWSWIRE) -- Ishita Ahmed was selected as the 2024 recipient of the CMJ-NBME Dissertation Fellowship , a program designed to promote diversity and anti-racist assessment and measurement practices.
  • Ahmed was chosen because of her strong commitment toward creating a justice-focused assessment and measurement system.
  • “Her approach to assessment centers on examining executive functions and aims to make measurement more inclusive of lived experiences.
  • She sees a great opportunity during the fellowship to learn from a network of people who are passionate about creating justice-focused measurement.

Abstract for longer-term follow-up and additional data analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL selected for an oral presentation at ASCO

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Mittwoch, April 24, 2024
EFS, PIN, Conference call, Myelodysplastic syndrome, Conference, Webcast, ASCO, SCT, Society, Data analysis, Annual general meeting, Therapy, ALL, BST

LONDON, April 24, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the abstract for longer-term follow-up and additional data analysis from the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) was selected for an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, (May 31 – June 4, 2024, Chicago).

Key Points: 
  • LONDON, April 24, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the abstract for longer-term follow-up and additional data analysis from the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) was selected for an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, (May 31 – June 4, 2024, Chicago).
  • Title: Obecabtagene autoleucel (obe-cel, AUTO1) in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL): Overall survival (OS), event-free survival (EFS) and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and consolidative stem cell transplantation (SCT) in the open-label, single-arm FELIX Phase Ib/II study
    Session Title: Oral Abstract Session – Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
    A conference call and webcast to discuss the presented data will be held at 9:30 am EDT/2:30 pm BST on Saturday June 1, 2024.
  • Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.
  • A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.

Raydiant Oximetry Secures FDA Approval for Lumerah Investigational Device Exemption (IDE) Study

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Mittwoch, April 10, 2024
FDA, Nerve, Bangladesh Technical Education Board, Investment, Eastern Virginia Medical School, EFS, Pregnancy, NIH, DSM-IV codes, IDE, American Journal, NICHD, Trial of the century, Infant, Dean (education), Female, Obstetrics, Gynaecology, EVMS, CTG, Fetal distress, Pulse oximetry, Mother, Organization, SAN, Woman

“Each year 36,000 babies in the United States suffer neurological damage, which could be prevented through better monitoring tools, such as Lumerah,” says Raydiant Oximetry founder and CEO, Dr. Neil P. Ray.

Key Points: 
  • “Each year 36,000 babies in the United States suffer neurological damage, which could be prevented through better monitoring tools, such as Lumerah,” says Raydiant Oximetry founder and CEO, Dr. Neil P. Ray.
  • Lumerah has received FDA Breakthrough Device Designation for expedited market approval.
  • Completion of the EFS study will pave the path towards FDA IDE approval for a subsequent pivotal study.
  • Raydiant Oximetry is supported by leading organizations that include the March of Dimes and the National Institutes of Health (NIH).

Essential Pharma acquires Renaissance Pharma Ltd with its clinical stage immunotherapy for the treatment of high-risk neuroblastoma

Retrieved on: 
Dienstag, April 9, 2024
Survival, Immunotherapy, Neuroblastoma, Patient, Journal, EFS, Acquisition, Jazz Pharmaceuticals, Cancer, Radiation, Haematopoietic system, Pharmaceutical industry

This will be Essential’s first clinical development-stage asset and is targeted at addressing significant unmet needs in paediatric oncology patients.

Key Points: 
  • This will be Essential’s first clinical development-stage asset and is targeted at addressing significant unmet needs in paediatric oncology patients.
  • Simon Ball, CEO and co-founder of Renaissance Pharma, who has significant scientific and commercial expertise within the space, will continue to work with Essential Pharma on Hu14.18’s development, as will many of the Renaissance Pharma team.
  • Approximately half of all neuroblastoma patients have high risk (HRNB) disease which has an overall survival of ~50% over five years23.
  • Essential Pharma will be responsible for clinical development and defining the optimal route for regulatory approval and eventual commercial launch of Hu14.18.

Envoy Medical Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Dienstag, April 2, 2024
House, Growth, Congress, Patient, COCH, EFS, Classification, Hope, Esteem, Business analyst, Insurance, Kool-Aid, Clinical trial, Patent, Medicare, Marketing, CMS, Hearing, Representative

WHITE BEAR LAKE, Minn., April 02, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing devices, today announced its corporate and financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Completed Business Combination transaction at the end of September and began trading on Nasdaq under its own ticker, COCH, the first week of October 2023.
  • Early Feasibility Study (EFS) continues to meet milestones with all three implanted patients surpassing twelve-month post-activation visits remaining implanted.
  • Sales and marketing expenses increased $0.8 million for the year ended December 31, 2023 compared to the same period in 2022.
  • The increase is primarily due to a $2.8 million rise in professional and legal fees in 2023 related to the finalization of the Business Combination in the third quarter of 2023.

Affimed Reports 2023 Financial Results and Operational Progress

Retrieved on: 
Donnerstag, März 28, 2024
Research, EGFR, GVHD, NSCLC, Genentech, ASH, AML, PD, Disease, International, International Financial Reporting Standards, Patient, Webcast, EFS, EDT, CRS, Cancer, Record, Insurance, Trial of the century, Bank statement, Investment, Safety, Workforce, Roivant Sciences, PFS, IASB, Hodgkin lymphoma, Book, NK, HL, Cytokine release syndrome

MANNHEIM, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.

Key Points: 
  • MANNHEIM, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.
  • Based on the promising results, Affimed expanded enrollment in this cohort to 40 patients.
  • Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB.
  • Affimed will host a conference call and webcast on March 28, 2024, at 8:30 a.m. EDT / 13:30 CET to discuss full year 2023 financial results and corporate developments.

Allogene Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update

Retrieved on: 
Donnerstag, März 14, 2024
Research, Kite Pharma, PIN, CLL, Disease, AID, Patient, EFS, Observation, Pivotal, Cancer, Renal cell carcinoma, Bank statement, News, RCC, Therapy, CRISPR, Projection, MRD, GAAP, Autoimmune disease, Cyclophosphamide, CD19, Pharmaceutical industry

These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.

Key Points: 
  • These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.
  • Research and development expenses were $54.7 million for the fourth quarter of 2023, which includes $7.0 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $17.2 million for the fourth quarter of 2023, which includes $8.2 million of non-cash stock-based compensation expense.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable Non-Small Cell Lung Cancer (NSCLC) at High Risk of Recurrence in Adults

Retrieved on: 
Donnerstag, März 28, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Civil service commission, OS, Lung cancer, Survival, Disease, Risk, Patient, Committee, Neoplasm, EFS, Merck & Co., Cancer, Death, MRK, European Commission, Recurrence, PD-L1, Marketing, Pharmaceutical industry

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.
  • For patients who received the KEYTRUDA-based regimen, median OS was not reached (95% CI, NR-NR) versus 52.4 months (95% CI, 45.7-NR) for patients who received the chemotherapy-placebo regimen.
  • The KEYTRUDA-based regimen also improved event-free survival (EFS), reducing the risk of disease recurrence, progression or death by 41% (HR=0.59 [95% CI, 0.48-0.72]) compared to the chemotherapy-placebo regimen.
  • KEYTRUDA is now approved for six indications in NSCLC, and for 27 indications overall in the EU.

InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Mittwoch, März 6, 2024
CMS, Pi, Growth, Radiology, IDE, State university system, CAD, Buffalo, PMA, MDR, TEL, Medical device regulation, Health, Stroke, CAS, TCAR, EPS, EFS, Thomas Jefferson University, European, Carotid artery stenosis, Myocardial infarction, CE marking, Vascular disease, Thrombectomy, Clinical trial, Medicaid, NPS, CEA, Good Samaritan Hospital, Stenosis, Risk, Blood vessel, Medicare, Death, Stent, Patient, Medicine, NSPR, Pharmaceutical industry

TEL AVIV, Israel and MIAMI, March 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • Fourth Quarter 2023 and Recent Developments:
    Generated record CGuard revenue in the fourth quarter 2023 of $1.76 million, a 71.6% increase over the fourth quarter of 2022.
  • Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of 74.5%.
  • Financial Results for the Fourth Quarter Ended December 31, 2023
    For the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022.
  • Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter of 2022.

Third Pole Therapeutics Announces Successful Completion of Feasibility Study with eNOfit™ Portable Inhaled Nitric Oxide Delivery System

Retrieved on: 
Dienstag, Februar 27, 2024
Oxygen, Pulmonary hypertension, Blood pressure, Blood, FDA, Quality of life, Gestational sac, Nitric oxide, Travel, Carbon, Lung, Medicine, Rest, Fatigue, Third Pole, Death, ILD, Patient, Artery, Heart, UCLA, Tissue, EFS, COPD

This study evaluated eNOfit™, a miniaturized, portable inhaled nitric oxide (iNO) generator and delivery system for the ambulatory treatment of patients suffering from pulmonary hypertension (PH) associated with Interstitial Lung Disease (ILD).

Key Points: 
  • This study evaluated eNOfit™, a miniaturized, portable inhaled nitric oxide (iNO) generator and delivery system for the ambulatory treatment of patients suffering from pulmonary hypertension (PH) associated with Interstitial Lung Disease (ILD).
  • “The successful completion of our EFS which validated the safe and practical use of our eNOfit™ system, enables us to confidently move into larger randomized placebo-controlled safety and efficacy studies.
  • Importantly, this value creating milestone will trigger the final funding of Third Pole’s Series B investment round.” said Bill Athenson, CEO of Third Pole.
  • Inhaled nitric oxide relaxes smooth muscle within the pulmonary vasculature, increasing the diameter of pulmonary arteries and decreasing their resistance to blood flow.