Clinical trial

Jazz Pharmaceuticals Announces U.S. FDA Approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Retrieved on: 
Thursday, July 1, 2021
Health sciences, Health, Life sciences, Drug discovery, Pharmaceuticals policy, Biotechnology law, Orphan drug, Jazz Pharmaceuticals, Clinical trial, Food and Drug Administration

We are pleased Rylaze was approved before the trial is complete and are diligently working to advance additional clinical trial data.

Key Points: 
  • We are pleased Rylaze was approved before the trial is complete and are diligently working to advance additional clinical trial data.
  • Rylazewas granted orphan drug designation for the treatment of ALL/LBL by FDA in June 2021.
  • "Before the approval of Rylaze, there was a significant need for an effective asparaginase medicine that would allow patients to start and complete their prescribed treatment program with confidence in supply."
  • 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2020 and future filings and reports by Jazz Pharmaceuticals.

Medsenic Partners With Phebra for the Clinical Development of the Oral Form of Arscimed® for the Treatment of Autoimmune Diseases

Retrieved on: 
Wednesday, June 30, 2021
Medical devices, Infectious diseases, Clinical trials, Stem cells, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Chemistry, Health sciences, Physical sciences, Hepatotoxins, Arsenic trioxide, Arsenic, Autoimmunity, Clinical trial, Pharmaceutical industry, the ATO, Medsenic -, Phebra, THE ATO, MEDSENIC -, PHEBRA

"We are impressed by the clinical results obtained by Medsenic with its product Arscimed in the treatment of cGvHD as an intravenous solution.

Key Points: 
  • "We are impressed by the clinical results obtained by Medsenic with its product Arscimed in the treatment of cGvHD as an intravenous solution.
  • Medsenic has demonstrated that its arsenic trioxide-based treatment has minimal toxicity and proven efficacy, leading to its wider application in other autoimmune diseases.
  • Medsenic is innovating and exploiting the new possibilities offered by the therapeutic use of arsenic trioxide in several autoimmune diseases and is currently in the process of clinical studies in Europe.
  • Phebra is an Australian based specialty pharmaceutical group which develops, manufactures and markets critical medicines in Australia and across the world.

Accelerating Clinical Trials with Streamlined Project Management Methodology, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, June 30, 2021
Health sciences, Health, Clinical research, Clinical trial, Design of experiments, Food and Drug Administration, Pharmaceutical industry, Project management, Medical research

TORONTO, June 30, 2021 /PRNewswire-PRWeb/ -- Clinical trial project management is becoming increasingly challenging with changing processes and regulatory hurdles, new technologies and overwhelming amounts of data to sift through.

Key Points: 
  • TORONTO, June 30, 2021 /PRNewswire-PRWeb/ -- Clinical trial project management is becoming increasingly challenging with changing processes and regulatory hurdles, new technologies and overwhelming amounts of data to sift through.
  • Register for this webinar to hear a discussion of the design of these platforms and the real-time metrics and project health scores they provide.
  • We will also dive into the change management required for implementation, the importance of organization-wide adoption and the benefits to studies including risk reduction.
  • For more information, or to register for this event, visit Accelerating Clinical Trials with Streamlined Project Management Methodology.

P.volve Unveils Clinical Advisory Board Amid Brand Growth Post-COVID

Retrieved on: 
Wednesday, June 30, 2021
Health sciences, Health, Clinical research, Pharmaceutical industry, Articles, Clinical pharmacology, Clinical trial, Design of experiments, Food and Drug Administration, Workplace wellness

The development of the Clinical Advisory Board marks the brand's investment in scientific and clinical research to develop and provide a new level of holistic health and wellness options to subscribers globally.

Key Points: 
  • The development of the Clinical Advisory Board marks the brand's investment in scientific and clinical research to develop and provide a new level of holistic health and wellness options to subscribers globally.
  • Alongside the top-tier Clinical Advisory Board with specific expertise in related fields, P.volve plans to launch a series of clinically-backed products and programs, with a focused attention on women's wellness and category expansions into nutrition.
  • In addition, the brand has initiated three clinical trial tracks with the University of Exeter in the UK, a top 10 globally ranked university in sports related subjects.
  • Please see here for hi-res imagery of P.volve's Clinical Advisory Board and for more information about the board, clinical trials and the Corporate Wellness Benefit Program, please visit www.pvolve.com and follow @pvolve on Instagram.

Vaccinex to Chair Panel Q&A Session and Present Poster at the XV European Meeting on Glial Cells in Health and Disease

Retrieved on: 
Wednesday, June 30, 2021
Medical specialties, Medicine, Branches of biology, Immunology, Glycoproteins, Antibody, Glia, SEMA4D, Clinical trial, Monoclonal antibody

Dr. Evans has organized and will co-chair with Dr Shawn Whitehead a live panel Q&A session.

Key Points: 
  • Dr. Evans has organized and will co-chair with Dr Shawn Whitehead a live panel Q&A session.
  • Panel participants and their respective presentations include:
    Elizabeth Evans, PhD: Targeting a signal of glial activation: clinical evaluation of Semaphorin 4D blocking antibody pepinemab
    Note: all presentations are live online and available to conference participants effective June 28.
  • The poster also describes the design of a Phase 1b/2a clinical trial of pepinemab in Alzheimers Disease, which was recently initiated.
  • The presentation and poster will be available on the Vaccinex website following the conclusion of the meeting.

Longeveron Announces Two Abstracts Accepted for Presentation at the Gerontological Society of America 2021 Annual Scientific Meeting

Retrieved on: 
Wednesday, June 30, 2021
Health sciences, Health, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Pharmaceutical industry

The full abstracts, including the dates and times of presentations, will be provided closer to the meeting once the GSA has provided these details to Longeveron.

Key Points: 
  • The full abstracts, including the dates and times of presentations, will be provided closer to the meeting once the GSA has provided these details to Longeveron.
  • The titles of the presentations are as follows:
    Title: A Phase 2b Clinical Trial Assessing Lomecel-B Infusion in Individuals with Aging Frailty: Study Design and Rationale.
  • Title: A Phase 1 Trial Assessing Lomecel-B Infusion in Individuals with Alzheimers Disease: Study Design and Rationale
    Additional meeting information can be found on the GSA Annual Scientific Meeting website at www.gsa2021.org .
  • Once published, the presented posters will also be available under Events & Presentations in the Investors section of the Companys website at investors.longeveron.com .

Axcella Announces Initiation of EMMPOWER℠ Phase 2 Clinical Trial of AXA1665

Retrieved on: 
Wednesday, June 30, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Health, Chemical compounds, Alcohol and health, Cirrhosis, Pharmaceutical industry, Ohe, EMM, Ammonia, Clinical trial

In prior clinical studies, AXA1665 has demonstrated the potential to have a multifactorial benefit to patients inclusive of improvements in amino acid balancing, ammonia metabolism, muscle function and neurocognition.

Key Points: 
  • In prior clinical studies, AXA1665 has demonstrated the potential to have a multifactorial benefit to patients inclusive of improvements in amino acid balancing, ammonia metabolism, muscle function and neurocognition.
  • I look forward to investigating AXA1665s ability to replicate these findings and reduce OHE events in EMMPOWER.
  • Axcella has branded the Phase 2 trial EMMPOWER based on the potential for AXA1665, an EMM composition, to help patients, physicians and other caregivers overcome significant challenges associated with cirrhosis and OHE.
  • The initiation of EMMPOWER is an important milestone, ushering in an exciting new era of clinical development for Axcella as we seek to tackle a variety of complex diseases utilizing proprietary, multi-targeted EMM compositions, said Bill Hinshaw, President and Chief Executive Officer of Axcella.

Madrigal Pharmaceuticals Completes Enrollment of the 52 Week Liver Biopsy Patient Population in the Phase 3 MAESTRO-NASH Study of Resmetirom

Retrieved on: 
Wednesday, June 30, 2021
Health sciences, Clinical research, Design of experiments, Health, Medical research, Hepatitis, Non-alcoholic fatty liver disease, Placebo-controlled study, Clinical trial, TIMI

Madrigal will continue to enroll additional patients beyond those required for accelerated approval to provide for the clinical outcomes portion of the MAESTRO-NASH Phase 3 clinical trial of resmetirom.

Key Points: 
  • Madrigal will continue to enroll additional patients beyond those required for accelerated approval to provide for the clinical outcomes portion of the MAESTRO-NASH Phase 3 clinical trial of resmetirom.
  • We expect that the timing of the MAESTRO-NASH study will enable us to report topline 52-week data by the third quarter of 2022.
  • Madrigal is currently conducting two Phase 3 Clinical trials, MAESTRO-NASH and MAESTRO-NAFLD-1, to demonstrate the safety and efficacy of resmetirom for the treatment of NASH.
  • MAESTRO-NASH is a Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom in patients with liver biopsy confirmed NASH and was initiated in March 2019.

Saniona Initiates Phase 1 Clinical Trial of SAN711

Retrieved on: 
Wednesday, June 30, 2021
Health sciences, Clinical research, Health, Food and Drug Administration, Design of experiments, Clinical trial, Drug discovery, Pharmaceutical industry, Medical research

Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that it has dosed the first patient in a Phase 1 clinical trial of SAN711, a novel molecule derived from Sanionas proprietary ion channel drug discovery engine.

Key Points: 
  • Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that it has dosed the first patient in a Phase 1 clinical trial of SAN711, a novel molecule derived from Sanionas proprietary ion channel drug discovery engine.
  • The Phase 1 clinical trial will be conducted in approximately 80 healthy volunteers.
  • Lead candidate SAN711 is in a Phase 1 clinical trial and may be applicable in the treatment of rare neuropathic disorders, with SAN903 for rare inflammatory and fibrotic disorders advancing through preclinical development.
  • Saniona is currently evaluating SAN711 in a Phase 1 clinical trial.

Aditum Bio Announces Formation of Ancora Bio, to Focus on Treatment-Resistant Depression

Retrieved on: 
Wednesday, June 30, 2021
Pharmaceutical industry, Health sciences, Life sciences, Health, Drug discovery, Clinical research, Food and Drug Administration, Design of experiments, Clinical trial, Drug development, Medication

Ancora Bio is the fifth company launched by Aditum Bio, whose mission is to give large patient populations access to medicines which otherwise may not be developed.

Key Points: 
  • Ancora Bio is the fifth company launched by Aditum Bio, whose mission is to give large patient populations access to medicines which otherwise may not be developed.
  • To speed these drugs to market, Aditum Bio fosters an incubator model, focusing on the translational phase of drug development.
  • Aditum Bio has partnered with TrialSpark, a technology driven research company that can complete clinical trials faster and at a lower cost than traditional trials.
  • Aditum Bio focuses on basic mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiology's, and spins-out individual companies dedicated to bringing each candidate through Phase II clinical trials.