The New England Journal of Medicine

Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma

Retrieved on: 
Wednesday, January 26, 2022

Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options.

Key Points: 
  • Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options.
  • When my husband, Gregg, was diagnosed with metastatic uveal melanoma, it was devastating to learn that there were no treatment options shown to extend life.
  • KIMMTRAK was granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma by the FDA in February 2021.
  • Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

Allergy Therapeutics announces FDA clearance of IND application for novel peanut allergy vaccine candidate VLP Peanut

Retrieved on: 
Wednesday, January 26, 2022

The potential of an effective short-course peanut allergy vaccine represents a significant opportunity in the $8 billion worldwide food allergy market1.

Key Points: 
  • The potential of an effective short-course peanut allergy vaccine represents a significant opportunity in the $8 billion worldwide food allergy market1.
  • Peanut allergy is one of the most common types of food allergy and its symptoms can range from mild to severe and life-threatening.
  • Manuel Llobet, CEO of Allergy Therapeutics,stated: We have achieved a key milestone with the FDAs clearance of our IND application and look forward to advancing our innovative peanut allergy vaccine candidate into the clinic.
  • VLP Peanut is being developed as a novel VLP-based therapy for the treatment of peanut allergy.

Chiesi USA Announces New Publication of Post Hoc Analysis on Timing of Ischemic Events in Cardiac Patients and Role of KENGREAL® (cangrelor) in Reducing Risk

Retrieved on: 
Tuesday, January 25, 2022

The analysis is published in Circulation: Cardiovascular Interventions, a journal of the American Heart Association, and can be accessed here .

Key Points: 
  • The analysis is published in Circulation: Cardiovascular Interventions, a journal of the American Heart Association, and can be accessed here .
  • There was no rebound increase in cardiovascular events during the time period in which patients were transitioned from KENGREAL to an oral P2Y12 inhibitor.
  • The most common early event was SCAI-MI (44%), followed by ARC-ST (7%), IDR (7%) and death (5%).
  • This analysis also characterizes a post hoc secondary composite endpoint described earlier that was not part of the original trial design.

Eisai: Results From Pivotal Phase 3 Study 309/KEYNOTE-775 Trial of LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) in Advanced Endometrial Carcinoma

Retrieved on: 
Thursday, January 20, 2022

(1) Results showed that the LENVIMA plus KEYTRUDA combination demonstrated statistically significant improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy.

Key Points: 
  • (1) Results showed that the LENVIMA plus KEYTRUDA combination demonstrated statistically significant improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy.
  • Objective response rate (ORR) data and additional detailed efficacy and safety data, including subgroup analyses, are also featured in the publication.
  • "KEYNOTE-775/Study 309 is an important Phase 3 study that supported recent approvals of KEYTRUDA plus LENVIMA for certain types of advanced endometrial carcinoma in the U.S. and other countries around the world, where it became the first immunotherapy and tyrosine kinase inhibitor combination approved for these patients."
  • LENVIMA plus KEYTRUDA is also approved in the European Union and Japan for certain patients with advanced or recurrent endometrial carcinoma regardless of mismatch repair status.

New England Journal of Medicine Publishes Data from ECOSPOR lll Phase 3 Study Evaluating Investigational Microbiome Therapeutic SER-109 in Recurrent C. Difficile Infection

Retrieved on: 
Wednesday, January 19, 2022

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the publication in the New England Journal of Medicine (NEJM) of data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapeutic for the treatment of recurrent C. difficile infection (rCDI).

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the publication in the New England Journal of Medicine (NEJM) of data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapeutic for the treatment of recurrent C. difficile infection (rCDI).
  • The SER-109 ECOSPOR III Phase 3 study ( ClinicalTrials.gov identifier: NCT03183128) was a multicenter, randomized, placebo-controlled study.
  • In May 2021, Seres presented 24-week clinical data from the study that demonstrated significantly reduced recurrence rates compared to placebo.
  • The SER-109 program is being advanced to reduce the recurrence of C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Stanford Health Care Selects HeartVista’s MRI Automation Platform to Deliver Rapid, AI-Powered Cardiac Scans

Retrieved on: 
Wednesday, January 19, 2022

The initial three-year agreement will enable Stanford Health Care to grow their cardiac MRI practice with on-site customer support and training provided by HeartVista.

Key Points: 
  • The initial three-year agreement will enable Stanford Health Care to grow their cardiac MRI practice with on-site customer support and training provided by HeartVista.
  • The AI-enabled MRI technology will be used by the health systems radiology and cardiology departments.
  • We believe that by providing cardiovascular centers of excellence like Stanford Health Care with our One-Click cardiac package, we can provide physicians with improved cardiac MRI studies, while also reducing the burden to the system and technologists.
  • The agreement between Stanford Health Care and HeartVista went into effect on January 1, 2022, and following staff training and scheduling, patient scans are to commence later this month.

Professor Daniel Brodie, the President of the International Extracorporeal Organization (ELSO) and Director of Critical Care from New-York Columbia - Presbyterian Hospital, Has Joined Inspira Technologies' Advisory Board

Retrieved on: 
Wednesday, January 19, 2022

Ltd.(Nasdaq: IINN) (Nasdaq: IINNW)(the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced today that Professor Daniel Brodie, an expert in critical care medicine and extracorporeal life support methods, has joined Inspira Technologies' Scientific Advisory Board.

Key Points: 
  • Ltd.(Nasdaq: IINN) (Nasdaq: IINNW)(the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced today that Professor Daniel Brodie, an expert in critical care medicine and extracorporeal life support methods, has joined Inspira Technologies' Scientific Advisory Board.
  • Prof. Brodie's appointment to the Scientific Advisory Board follows the appointments of Prof. Eddy Fan and Dr. Stephan Ledot, world-renowned key opinion leaders in intensive care medicine and extracorporeal life support.
  • Prof. Brodie is the Section Chief for Critical Care within the Division of Pulmonary, Allergy and Critical Care Medicine, the Director of the Adult ECMO Program and the Director of the Center for Acute Respiratory Failure at the Columbia University/New York-Presbyterian Hospital.
  • Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, stated: "It is a great honor to have Professor Brodie on Inspira Technologies' Scientific Advisory Board.

Adagene Announces First Patients with Advanced Non-Small Cell Lung Cancer Dosed in Phase 1b/2 Clinical Trial of ADG106 in Combination with Nivolumab in Singapore

Retrieved on: 
Thursday, January 13, 2022

The phase 1b/2 open label trial is designed to evaluate safety, tolerability, and anti-tumor activity of the combination in up to 53 patients with advanced NSCLC who have progressed after prior treatment.

Key Points: 
  • The phase 1b/2 open label trial is designed to evaluate safety, tolerability, and anti-tumor activity of the combination in up to 53 patients with advanced NSCLC who have progressed after prior treatment.
  • The trial will also include exploratory biomarker analyses of a novel predictive biomarker and immune cell profiling in response to the treatment.
  • The trial also applies a convenient flat dosing regimen presenting long-term development opportunities for ADG106.
  • A trial in combination with toripalimab is underway in China, and one in combination with pembrolizumab is planned.

Sana Joins Forces With Proactive MD to Open Sana MD, a First-of-its-Kind Advanced Primary Care Health Center for Small and Midsize Businesses

Retrieved on: 
Wednesday, January 12, 2022

Sana , a value-based health care company that provides Fortune 500-level health care to small businesses at affordable prices, and Proactive MD , a leader in advanced primary care, today announced that their first joint primary care health center, Sana MD, will open on Jan. 24.

Key Points: 
  • Sana , a value-based health care company that provides Fortune 500-level health care to small businesses at affordable prices, and Proactive MD , a leader in advanced primary care, today announced that their first joint primary care health center, Sana MD, will open on Jan. 24.
  • View the full release here: https://www.businesswire.com/news/home/20220112005110/en/
    Sana Joins Forces With Proactive MD to Open Sana MD, a First-of-its-Kind Advanced Primary Care Health Center for Small and Midsize Businesses (Photo: Business Wire)
    The health center is located at 1715 W. 35th St. in Austin, Texas.
  • Sana MD meets the needs of small and medium-sized businesses, providing better and more affordable care options for employees.
  • Adding Sana MD to our Sana Care ecosystem of providers will enable us to empower members to take control of their health with unrivaled primary care at no cost, said Sana CEO and co-founder Will Young.

Ronaldo B. Supena is recognized by Continental Who's Who

Retrieved on: 
Tuesday, January 11, 2022

Many of his patients come to his office with HIV infections, sexually transmitted infections, COVID-19, or other infectious diseases.

Key Points: 
  • Many of his patients come to his office with HIV infections, sexually transmitted infections, COVID-19, or other infectious diseases.
  • He currently has admitting privileges at Detroit Medical Center, Harper Hospital, Detroit VA Healthcare System, and Detroit Receiving Hospital.
  • Dr. Supena received his Medical Degree in 1965 from the University of Santo Tomas Faculty of Medicine and Surgery in Manila, the Philippines.
  • For his five decades of exceptional work, he has been recognized with profile features on IssueWire and SpinDigit.