The New England Journal of Medicine

EQS-News: PRECISIS GmbH: EASEE – ­­­World's first minimally invasive brain pacemaker for the treatment of epilepsy receives CE-certification and is available immediately

Retrieved on: 
Friday, September 23, 2022

Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.

Key Points: 
  • Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.
  • These drug-refractory patients wait an average of 22 years before they are offered further technical or surgical treatment options.
  • With this new, risk-minimized EASEE method, the treatment spectrum is expanded in the early phases of the disease."
  • EASEE is an acronym for Epicranial Application of Stimulation Electrodes for Epilepsy.

Veru to Participate in the Cantor Oncology, Hematology & HemeOnc Conference on September 28th, 2022

Retrieved on: 
Wednesday, September 21, 2022

Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.

Key Points: 
  • Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
  • The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
  • A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID at high risk for ARDS and death.
  • Verus late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.

Veru Announces FDA has Updated the Meeting Date for the Advisory Committee Meeting to Review Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

Retrieved on: 
Monday, September 19, 2022

The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.

Key Points: 
  • The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
  • A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID at high risk for ARDS and death.
  • In June, the Company submitted a request for emergency use authorization to FDA.
  • On July 27, 2022, The European Medicines Agencys Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries.

Press Release: CHMP recommends approval of Beyfortus® (nirsevimab) for prevention of RSV disease in infants

Retrieved on: 
Friday, September 16, 2022

This positive CHMP opinion underscores Beyfortus potential as a ground-breaking, first-in-class passive immunization that could transform the medical communitys approach to RSV prevention in infants.

Key Points: 
  • This positive CHMP opinion underscores Beyfortus potential as a ground-breaking, first-in-class passive immunization that could transform the medical communitys approach to RSV prevention in infants.
  • Beyfortus has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent LRTI caused by RSV.
  • Between November 2016 and December 2017, 1,453 infants were randomized (Beyfortus, n=969; placebo, n=484) at the RSV season start.
  • Infants were randomized (2:1) to receive a single 50mg (in infants weighing

Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (terlipressin) for injection for the Treatment of Hepatorenal Syndrome (HRS)

Retrieved on: 
Thursday, September 15, 2022

DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz® (terlipressin) for injection. Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 

Key Points: 
  • DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz (terlipressin) for injection.
  • The CONFIRM trial was completed prior to the updated diagnostic criteria and terminology published in the 2021 AASLD guidance on hepatorenal syndrome.
  • * Note, Terlivaz was not evaluated in comparison to other treatment options in a head-to-head clinical study.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.

SparingVision Raises €75 Million Series B to Continue Building World-Leading Portfolio of Genomic Medicines for Ocular Diseases

Retrieved on: 
Wednesday, September 14, 2022

SparingVision is a genomic medicines company with a mission to translate pioneering science into vision saving treatments.

Key Points: 
  • SparingVision is a genomic medicines company with a mission to translate pioneering science into vision saving treatments.
  • Leveraging its unparalleled understanding of retinal diseases, SparingVision has built the worlds most compelling portfolio of synergistic cutting-edge gene therapy and genome editing treatments for inherited retinal diseases (IRDs).
  • The Company also has a strategic collaboration with Intellia Therapeutics (NASDAQ: NTLA) to develop novel genome editing-based treatments for ocular diseases utilizing CRISPR-Cas9 technology.
  • Inherited retinal diseases are a group of progressive eye conditions that can cause severe vision loss and, in certain cases, lead to total blindness.

SparingVision Raises €75 Million Series B to Continue Building World-Leading Portfolio of Genomic Medicines for Ocular Diseases

Retrieved on: 
Wednesday, September 14, 2022

SparingVision is a genomic medicines company with a mission to translate pioneering science into vision saving treatments.

Key Points: 
  • SparingVision is a genomic medicines company with a mission to translate pioneering science into vision saving treatments.
  • Leveraging its unparalleled understanding of retinal diseases, SparingVision has built the worlds most compelling portfolio of synergistic cutting-edge gene therapy and genome editing treatments for inherited retinal diseases (IRDs).
  • The Company also has a strategic collaboration with Intellia Therapeutics (NASDAQ: NTLA) to develop novel genome editing-based treatments for ocular diseases utilizing CRISPR-Cas9 technology.
  • Inherited retinal diseases are a group of progressive eye conditions that can cause severe vision loss and, in certain cases, lead to total blindness.

Endpoint Health Appoints Ransi Somaratne, M.D. as Chief Medical Officer

Retrieved on: 
Tuesday, September 13, 2022

has joined the company as Chief Medical Officer.

Key Points: 
  • has joined the company as Chief Medical Officer.
  • It is an honor to welcome Ransi as our first chief medical officer, said Jason Springs, co-founder and CEO of Endpoint Health.
  • I am proud to join Endpoint Health and contribute to the next phase of its growth and accomplishment.
  • Prior to joining Endpoint Health, Dr. Somaratne was Chief Medical Officer at Spring Discovery, where he worked closely with engineers and scientists to translate small molecule candidates identified via machine-learning powered phenotypic discovery into clinical development programs."

United States Hospice (RHC, CHC) Market Trends/Analysis Report 2022: A $64.7 Billion Market by 2030 - Opportunities in the Adoption of New Technologies - ResearchAndMarkets.com

Retrieved on: 
Monday, September 12, 2022

The demand for palliative and hospice services is growing with the increasing geriatric population and the number of patients with life-threatening conditions.

Key Points: 
  • The demand for palliative and hospice services is growing with the increasing geriatric population and the number of patients with life-threatening conditions.
  • According to the NHPCO, 1.55 million Medicare enrollees got hospice care in 2018, increasing by 4% from 2017.
  • The COVID-19 pandemic adversely affected operational goals and long-term projections of hospice businesses in the United States.
  • In the hospice sector, the usage of telehealth is growing, which is projected to provide growth opportunities for the market in the coming years.

Tangent90 announces strategic collaboration with NEJM Group

Retrieved on: 
Thursday, September 8, 2022

LONDON, United Kingdom, Sep. 8, 2022 /PRNewswire-PRWeb/ -- Tangent90 Ltd, a leading provider of digital solutions to help pharmaceutical companies improve their engagement with healthcare professionals (HCPs), has entered into a strategic collaboration with NEJM Group publications (New England Journal of Medicine, NEJM Evidence, NEJM Catalyst, NEJM Journal Watch).

Key Points: 
  • LONDON, United Kingdom, Sep. 8, 2022 /PRNewswire-PRWeb/ -- Tangent90 Ltd , a leading provider of digital solutions to help pharmaceutical companies improve their engagement with healthcare professionals (HCPs), has entered into a strategic collaboration with NEJM Group publications (New England Journal of Medicine, NEJM Evidence, NEJM Catalyst, NEJM Journal Watch).
  • By working with Tangent90 to make these formats available to its clients via Trustrack, NEJM is expanding opportunities to engage physicians with its high-quality content.
  • Additionally, Tangent90 collaborated with NEJM to extend the Tangent90 Resource Centre platform to include NEJM Group content, tagged in a manner that will expose all appropriate content, beyond the traditional Original Research article.
  • "Our collaboration with NEJM Group will serve up more relevant scientific content in HCP communications, enabling pharma to better serve the HCP community, which ultimately results in better patient outcomes", he concluded.