Marder

JFrog Appoints Gal Marder to Executive Vice President of Strategy

Retrieved on: 
Tuesday, November 7, 2023
Supply Chain Management, Retail, Data Management, Technology, Software, EVP, Engineering, Marder, Face, Gal, Multimedia, Blog, Management, DevOps, Open source, Strategy

(“JFrog”) (Nasdaq: FROG), the Liquid Software company and creators of the JFrog Software Supply Chain Platform , today announced Gal Marder will join its leadership team as Executive Vice President of Strategy.

Key Points: 
  • (“JFrog”) (Nasdaq: FROG), the Liquid Software company and creators of the JFrog Software Supply Chain Platform , today announced Gal Marder will join its leadership team as Executive Vice President of Strategy.
  • View the full release here: https://www.businesswire.com/news/home/20231107799465/en/
    JFrog's veteran technology and business leader, Gal Marder, has been appointed as new EVP of Strategy for the company.
  • Trainologic was then acquired by JFrog in 2018 and Marder took the role of Vice President of Solution Engineering and Training to advise and instruct JFrog’s 7K+ customers.
  • In the last five years, I’ve spent most of my time working with JFrog customers, witnessing the challenges they face around securing and managing the software supply chain,” said Gal Marder, EVP of Strategy, JFrog.

KarXT, invented at PureTech, submitted for FDA Approval in Schizophrenia

Retrieved on: 
Thursday, September 28, 2023
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, Mental Health, Psychiatry, PANSS, LSE, Somnolence, New Drug Application, Food and Drug Administration, NDA, PureTech Health, Weight gain, Extrapyramidal symptoms, Patient, Nature, Treatment, KRTX, Marder, Therapy, Pharmacology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PRTC, Food, Safety, Pharmaceutical industry, KarXT, Schizophrenia

“We are thrilled to note this additional exciting milestone from the KarXT program, following the achievement of three successful, registration enabling studies in schizophrenia.

Key Points: 
  • “We are thrilled to note this additional exciting milestone from the KarXT program, following the achievement of three successful, registration enabling studies in schizophrenia.
  • The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia.
  • The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia.
  • Discontinuation rates due to treatment emergent adverse events were low and similar between KarXT and placebo across all trials.

Karuna Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KarXT for the Treatment of Schizophrenia

Retrieved on: 
Thursday, September 28, 2023
FDA, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Psychiatry, PANSS, Somnolence, NDA, Weight gain, Extrapyramidal symptoms, Patient, Nature, KRTX, Marder, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, KarXT, Schizophrenia

It is also a defining moment for Karuna Therapeutics.

Key Points: 
  • It is also a defining moment for Karuna Therapeutics.
  • The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia.
  • Discontinuation rates due to treatment emergent adverse events were low and similar between KarXT and placebo across all trials.
  • Notably, KarXT was not associated with common side effects of currently available antipsychotics, including changes in metabolic function, weight gain, somnolence, and extrapyramidal symptoms.

Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

Retrieved on: 
Monday, October 17, 2022
Avolition, Emotion, U.S. Securities and Exchange Commission, Anhedonia, Risk, Thought, Prevalence, New Drug Application, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Roluperidone, Perception, Research, Security (finance), Neuroscience, Giuseppe Galderisi, Asociality, Nasdaq, NERV, Harvey, Private Securities Litigation Reform Act, Food, Goal, World, Behavior, Marder, World Health Organization, CNS, GLOBE, Forward-looking statement, Alogia, FDA, Central nervous system, Language, Pharmaceutical industry, Residential care, Schizophrenia

The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.

Key Points: 
  • The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.
  • The company intends to request a Type A meeting and looks forward to continued discussions with the FDA.
  • Schizophrenia is a chronic, severe, and debilitating type of mental illness characterized by distortions in thinking, perception, emotions, language, sense of self and behavior.
  • Negative symptoms can cause individuals with schizophrenia to withdraw from society, become disinterested or unable to complete tasks or feel pleasure.

Cannabis Community College Public Invite: Free Virtual Tour of a Commercial Cultivation Facility by Evan Marder

Retrieved on: 
Monday, September 12, 2022
Faculty, Sale, Knowledge, Cannabis, Industry, Curriculum, Student, Professor, CCC, Marder, Plant, Drug, Medicine

LAS VEGAS, Sept. 12, 2022 /PRNewswire/ -- Cannabis Community College , a leading online cannabis education platform, announces the addition of Evan Marder as Professor of Cultivation for the Cultivation Essentials course.

Key Points: 
  • LAS VEGAS, Sept. 12, 2022 /PRNewswire/ -- Cannabis Community College , a leading online cannabis education platform, announces the addition of Evan Marder as Professor of Cultivation for the Cultivation Essentials course.
  • Register for a free virtual tour of a commercial cannabis cultivation facility by grower & Fleur President, Evan Marder
    "We are beyond thrilled to welcome Evan to our team of expert instructors," said Christi McAdams, CCC Chairman.
  • "We strive to bring the best the industry has to offer to our students.
  • As President and grower in Nevada's largest licensed organic cultivation facility,
    "I'm honored to join the esteemed faculty of Cannabis Community College," Marder said.

Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

Retrieved on: 
Monday, August 22, 2022
CGI, Safety, Research, Social skills, Perception, Pâ, Maintenance, NSFS, U.S. Securities and Exchange Commission, PSM, NERV, GLOBE, Population, OL, Risk, Patient, Marder, Caregiver, Personal, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ITT, Giuseppe Galderisi, Food, Alogia, Thought, PANSS, Nasdaq, FDA, World, PSP, Security (finance), Asociality, Mitt, NDA, Division, Study, New Drug Application, Disability, Behavior, Roluperidone, Anhedonia, Double Blind, Emotion, Neuroscience, Language, Private Securities Litigation Reform Act, Review, Type, Avolition, Central nervous system, Goal, Positive, Harvey, CNS, Forward-looking statement, World Health Organization, Pharmaceutical industry, Medical device, Dietary supplement, Residential care, Schizophrenia

The roluperidone clinical development program aims to provide effective treatment for negative symptoms of schizophrenia, a significant unmet medical need in a large patient population.

Key Points: 
  • The roluperidone clinical development program aims to provide effective treatment for negative symptoms of schizophrenia, a significant unmet medical need in a large patient population.
  • The NDA submission is supported by results from two late-stage, well-controlled studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia (Studies MIN-101C03 and MIN-101C07).
  • Both studies were planned to constitute the bulk of evidence of roluperidones effectiveness for the indication of treating negative symptoms of schizophrenia.
  • Results of Study MIN-101C03 supported the primary hypothesis that after 12 weeks of treatment, roluperidone is superior to placebo in reducing negative symptoms of schizophrenia.

Zai Lab Partner Karuna Therapeutics Announces Positive Results from Phase 3 EMERGENT-2 Trial of KarXT in Schizophrenia

Retrieved on: 
Monday, August 8, 2022
FDA, NDA, KRTX, GLOBE, Schizophrenia, PANSS, SAN, HKEX, Marder, Safety, NASDAQ, Positive, Pharmaceutical industry

SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the company’s partner, Karuna Therapeutics, Inc. (NASDAQ: KRTX), reported positive topline results from its Phase 3 EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium), in adults with schizophrenia. The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful 9.6-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-21.2 KarXT vs. -11.6 placebo, p

Key Points: 
  • Results at Week 5 include:
    2.9-point reduction in the PANSS positive subscale with KarXT compared to placebo(-6.8 KarXT vs. -3.9 placebo, p
  • 1.8-point reduction in the PANSS negative subscale with KarXT compared to placebo(-3.4 KarXT vs. -1.6 placebo, p=0.0055).
  • 2.2-point reduction in the PANSS negative Marder factor subscale with KarXT compared to placebo (-4.2 KarXT vs. -2.0 placebo, p=0.0022).
  • Mean blood pressure measures were similar between KarXT and placebo throughout the trial, and no syncopal events were observed.

Bridgehampton Estate on 5 Landscaped Acres Asking $11.75M

Retrieved on: 
Thursday, August 4, 2022
Steps, GLOBE, Country, Tree, Biltmore Estate, Garden, Cooking, Marder, Interior design, Hotel, Self storage

The front walkway, which was redesigned by John Verderber Jr., leads to a columned front porch with natural stone flooring and a sitting area.

Key Points: 
  • The front walkway, which was redesigned by John Verderber Jr., leads to a columned front porch with natural stone flooring and a sitting area.
  • The front door opens to a foyer with natural stone and a grand staircase.
  • A hallway leads to a spacious, light-filled living room featuring a fireplace and an adjoining wet bar.
  • This estate, located within close proximity to Bridgehampton center and the ocean beaches, offers a private retreat with not only an elevated design but an outdoor oasis that would take many years to create.

Minerva Neurosciences Provides Update from Type C Meeting with FDA and Next Steps in Preparation for Submission of a New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

Retrieved on: 
Thursday, April 7, 2022
Private Securities Litigation Reform Act, Risk, Avolition, Behavioural sciences, Research, Language, Neuroscience, Acquisition, Goal, Nasdaq, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Alogia, GLOBE, NDA, Annual report, University, Security (finance), Recurrence, Behavior, Population, Marketing, Central nervous system, Perception, New Drug Application, SAP, U.S. Securities and Exchange Commission, Minerva, Collection, Giuseppe Galderisi, World Health Organization, NASDAQ, Roluperidone, Neurotransmission, Investor, Forward-looking statement, ID, Emotion, CNS, World, Psychiatry, Harvey, Review, Anhedonia, Type, FDA, Patient, Asociality, Food, Thought, NERV, Safety, Division, Marder, Pharmaceutical industry, Residential care, Schizophrenia

Presently, there is no approved treatment for negative symptoms in the United States.

Key Points: 
  • Presently, there is no approved treatment for negative symptoms in the United States.
  • I believe roluperidonehas the potential totransform the lives of people who are unable to participate in and enjoy everyday activitiesdue totheir negative symptoms.
  • The Division acknowledged at the time that the studies appear to show promising signals and encouraged Minerva to continue the drug development program for this indication.
  • Negative symptoms can cause individuals with schizophrenia to withdraw from society, become disinterested or unable to complete tasks or feel pleasure.

Minerva Neurosciences Announces Publication of Roluperidone Phase 3 Study Results in Schizophrenia Bulletin

Retrieved on: 
Monday, February 28, 2022
GLOBE, Marder, Asociality, Central nervous system, Risk, ITT, Type, PANSS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Perception, Neuroscience, Emotion, Avolition, NSFS, Security (finance), Anhedonia, COVID-19, Language, Company, Thought, Clinical trial, World, CNS, NERV, U.S. Securities and Exchange Commission, Alogia, Food, Safety, FDA, Roluperidone, Nasdaq, Forward-looking statement, World Health Organization, Patient, NDA, Goal, Giuseppe Galderisi, Behavior, Pâ, Harvey, PSP, SEC, Pharmaceutical industry, Residential care, Schizophrenia, Schizophrenia Bulletin

The study authors conclude that this study confirms the potential of roluperidone to treat the negative symptoms in individuals with schizophrenia as well as improve everyday functioning.

Key Points: 
  • The study authors conclude that this study confirms the potential of roluperidone to treat the negative symptoms in individuals with schizophrenia as well as improve everyday functioning.
  • The Company previously disclosed results of the Phase 3 trial of roluperidone in May 2020 and open-label results in May 2021.
  • The Phase 3 study included 513 patients with schizophrenia with moderate to severe negative symptoms.
  • Study patients were administered either 32 mg/day of roluperidone, 64 mg/day of roluperidone, or placebo for 12 weeks.