The Lancet

Psyence Biomed Partners with Fluence and iNGENū CRO to Train Research Therapists for Phase IIb Psilocybin Trial

Retrieved on: 
Monday, April 8, 2024
Diagnosis, The Lancet, Depression, NASW, Partnership, PAP, Psychotherapy, Palliative care, Patient, Research, Gold, American Psychological Association, Standard of care, Anxiety, Cancer, Doctor of Philosophy, Quality of life, Adjustment disorder, Social work, World Health Organization, Clinical trial, Safety, Adjustment, WHO, National Association, DSM-IV codes, APA, FDA, Physician, Health, PBM, Practitioner, Nursing

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that its Australian subsidiary, Psyence Australia Pty Ltd. (“Psyence Australia”), has entered into a partnership with Fluence , a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support an upcoming Phase llb clinical trial.

Key Points: 
  • NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that its Australian subsidiary, Psyence Australia Pty Ltd. (“Psyence Australia”), has entered into a partnership with Fluence , a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support an upcoming Phase llb clinical trial.
  • According to Lancet Oncology, Adjustment Disorder affects as many as 19% of patients following a life-limiting cancer diagnosis.
  • “The success of the clinical trial relies on rigorous, standardized therapist training designed to achieve the highest standard of patient care,” said Elizabeth Nielson, PhD, Fluence co-founder.
  • Psyence Biomed anticipates enrolling the first subject in the second quarter of 2024 and expects the primary endpoint results to be available in 2025.

Atara Biotherapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Operational Progress

Retrieved on: 
Thursday, March 28, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, The Lancet, Research, Graft-versus-host disease, LD, ASH, International Society, Partnership, Central nervous system, ATRA, Epstein–Barr virus, Patient, Follicular lymphoma, CNS, Biomarker, PTLD, Cancer, Lymphoproliferative disorders, SLE, EBV, NHL, Lymphoma, Mantle cell lymphoma, Investment, ATM, Safety, Pharmacokinetics, Depreciation, File, Workforce, Cell, FDA, BLA, Lupus nephritis, CD19, Food, Autoimmune disease, Pharmaceutical industry

“We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.

Key Points: 
  • “We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.
  • “This includes strong momentum for our lead CAR T program, ATA3219, which is positioned to deliver near-term clinical data for both non-Hodgkin’s lymphoma and lupus nephritis.
  • Subjects will receive lymphodepletion (LD) treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells.
  • Subjects will receive LD treatment followed by ATA3219 at a dose of 40, 80, 240, or 480 x 106 CAR+ T cells.

Italfarmaco Receives FDA Approval for Duvyzat™ (givinostat) in Duchenne Muscular Dystrophy

Retrieved on: 
Friday, March 22, 2024
Research, FDA, Genetics, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, HDAC, ITF, MAA, The Lancet, Caregiver, Disease, Magnetic resonance imaging, PPMD, Patient, Rehabilitation, Lancet Neurology, University, EMA, Doctor of Philosophy, MD, Duchenne muscular dystrophy, Pediatrics, Therapy, NSAA, DMD, Food, Pharmaceutical industry

“We are grateful for the support of those living with DMD and their dedicated caregivers, which played a central role in helping us reach this landmark FDA approval.

Key Points: 
  • “We are grateful for the support of those living with DMD and their dedicated caregivers, which played a central role in helping us reach this landmark FDA approval.
  • The FDA approval highlights the dedication of Italfarmaco’s research and clinical teams to achieve this milestone for the company.”
    The approval is based on the results of the pivotal multicentre, randomised, double-blind, placebo-controlled phase 3 EPIDYS trial ( NCT02851797 ).
  • Italfarmaco has significantly expanded its U.S. presence through the formation of a new fully owned subsidiary, ITF Therapeutics LLC.
  • Italfarmaco has a global presence and is also working with other regulatory agencies.

Results from Italfarmaco Pivotal Phase 3 EPIDYS Study of Givinostat in Duchenne Muscular Dystrophy (DMD) Published in The Lancet Neurology

Retrieved on: 
Tuesday, March 19, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Hospitals, Genetics, Clinical Trials, VL, Civil service commission, Givinostat, Neurology, Catholic higher education, Diarrhea, MAA, The Lancet, Magnetic resonance imaging, Safety, Abdominal pain, NDA, Manuscript, Rehabilitation, Lancet Neurology, University, OLE, EMA, Degenerative disease, Doctor of Philosophy, MD, European Medicines Agency, Duchenne muscular dystrophy, European Commission, NSAA, FDA, DMD, Pediatrics, PDUFA, Pharmaceutical industry

Italfarmaco S.p.A. announced today that the full results from the Company’s pivotal phase 3 EPIDYS clinical trial with givinostat in ambulant boys 6 years of age and older with Duchenne muscular dystrophy (DMD) have been published in The Lancet Neurology.

Key Points: 
  • Italfarmaco S.p.A. announced today that the full results from the Company’s pivotal phase 3 EPIDYS clinical trial with givinostat in ambulant boys 6 years of age and older with Duchenne muscular dystrophy (DMD) have been published in The Lancet Neurology.
  • The full manuscript, titled, “Safety and efficacy of givinostat in boys with Duchenne muscular dystrophy (EPIDYS): a multicentre, randomized, double-blind, placebo-controlled, phase 3 trial,” is published on The Lancet Neurology website .
  • Participants attended study site visits every 12 weeks for 72 weeks and were evaluated for all endpoints within the study protocol.
  • Upon completion of the 18-month double-blind period, EPIDYS study participants were eligible to enroll in an open-label extension study (OLE study) to receive givinostat on an ongoing basis.

Asep Medical Confirms the Use of AI - Enables Improved Treatments for Common Biofilm Infections and Rapid Sepsis Diagnostics

Retrieved on: 
Thursday, March 14, 2024
Diagnosis, Stem cell, Dicarboxylic acid, Dental implant, Health, Dentistry, Gene, University, Chair, UBC, Erosion, Sepsis, Prevalence, Multiple organ dysfunction syndrome, Risk, COVID-19, Inflammation, Patient, Artificial intelligence, Bacteria, DSM-IV codes, AI, Death, Biofilm, Staphylococcus aureus, LASSO, Infection, Pathology, Therapy, ICU, FDA, The Lancet, Peptide

These markets include oral health (dental) care4, wounds5 and chronic rhinosinusitis6, all addressed by Asep peptides that show excellent activity in model infections.

Key Points: 
  • These markets include oral health (dental) care4, wounds5 and chronic rhinosinusitis6, all addressed by Asep peptides that show excellent activity in model infections.
  • AI was also used to simplify the extreme complexity7 of sepsis, which has limited treatments to date.
  • While others are trying to figure out how AI can be best used, we are already using it with amazing success in diagnostics and therapeutics.
  • Asep Inc. is dedicated to leveraging AI's power to improve human health," said Dr. Evan Haney, Chief Scientific Officer of Asep.

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

Retrieved on: 
Tuesday, February 27, 2024
Licensure, Investment, Growth, Exercise, Tolerability, Immunization, Host, Trial of the century, Ageing, PCV20, PCV, P-value, Safety, BLA, Success, Phase 10, Genetically modified bacteria, Net, G&A, CMC, SAN, Research and development, ID, OPA, Conference, The Lancet, Biologics license application, Breakthrough therapy, Advisory Committee, PCV15, POC, FDA, End, Food, Breakthrough, Element, Fireside chats, Administration, IPD

-- Significant Progress in Establishing Global Commercial Manufacturing Capacity for Vaxcyte's PCV Candidates, Including Expanded Collaboration with Lonza --

Key Points: 
  • ET / 1:30 p.m. PT --
    SAN CARLOS, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Additionally, as part of ongoing Chemistry, Manufacturing and Controls (CMC)-focused discussions, Vaxcyte received encouraging input from the FDA regarding the VAX-24 adult licensure requirements.
  • The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • Vaxcyte will host a conference call and webcast to discuss this announcement today, February 27, 2024, at 4:30 p.m.

Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2023 Financial Update and Pipeline Progress

Retrieved on: 
Thursday, March 7, 2024
COVID-19, Research, Infectious Diseases, FDA, Biotechnology, Health, Pharmaceutical, General Health, Science, Pfizer–BioNTech COVID-19 vaccine, Liver, European Commission, Ministry, Arcturus Therapeutics, Messenger, Ornithine transcarbamylase deficiency, Investment, Omicron, OTC, Lyme disease, CSL, MHLW, The Lancet, Vaccine, Gonorrhea, Observation, RNA, Civil service commission, Collaboration, Therapy, COVID, Ministry of Health, Patient, Valence (chemistry), Janssen, Immunity, Orphan, ARCT, Travel, Infection

“I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

Key Points: 
  • “I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
  • This marks the first marketing approval milestone for CSL and Arcturus since signing the Collaboration and License agreement in November 2022.
  • In November 2023, Arcturus received Orphan Drug Designation from the U.S. FDA for ARCT-032, for the treatment of Cystic Fibrosis.
  • We have achieved a total of approximately $396.0 million in upfront payments and milestones from CSL as of December 31, 2023.

Innoviva Reports Fourth Quarter and Full Year 2023 Financial Results; Highlights Recent Company Progress

Retrieved on: 
Thursday, February 29, 2024
Health, Sports, Infectious Diseases, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Therapy, New Drug Application, IST, Investment, FDA, Food, Growth, Exercise, The Lancet, Nursing care plan, CNS, Acinetobacter, Patient, Sulbactam, Infection, Gonorrhea, Pharmaceutical industry

Pavel Raifeld, Chief Executive Officer of Innoviva, said: “2023 was a successful and transformational year for Innoviva.

Key Points: 
  • Pavel Raifeld, Chief Executive Officer of Innoviva, said: “2023 was a successful and transformational year for Innoviva.
  • Share repurchase: During the fourth quarter 2023, Innoviva repurchased 1,121,835 shares of its outstanding common stock for $15.4 million.
  • Our portfolio of strategic assets under the Company’s various subsidiaries was valued at $561.0 million as of December 31, 2023.
  • In fourth quarter 2023, Innoviva invested an additional $5.0 million in one of our assets, Gate Neurosciences, to support its strategy of developing next generation targeted CNS therapies.

Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Results; Achieves 2023 Financial Guidance

Retrieved on: 
Thursday, February 15, 2024
Managed Care, Biotechnology, Pharmaceutical, Health, Acquisition, Liver, Autoimmune disease, Income tax, Hepatology, FDA, Food, Endometriosis, PBC, Interest expense, Constipation, Annual general meeting, Short bowel syndrome, Safety, Society, GAAP, The Lancet, UEG, Pharmacokinetics, Food and Drug Administration, Primary biliary cholangitis, Interest, Patient, Disease, STARS, Phase, Interstitial cystitis, Trial of the century, Ageing, United European Gastroenterology, CIC, Research, SBS, Depreciation, Video game

Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.

Key Points: 
  • Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.
  • Operating expenses in the fourth quarter of 2023 were $80.0 million, compared to $38.8 million in the fourth quarter of 2022.
  • Adjusted EBITDA was $39.9 million in the fourth quarter of 2023, compared to $68.7 million in the fourth quarter of 2022.
  • Ironwood generated $35.8 million in cash from operations in the fourth quarter of 2023, compared to $79.2 million in cash from operations in the fourth quarter of 2022.

Preterm Births Linked to 'Hormone Disruptor' Chemicals May Cost United States Billions

Retrieved on: 
Tuesday, February 6, 2024
ECHO, University, Columbia University, NYU, Cosmetics, Phthalate, Bangladesh Technical Education Board, Champaign–Urbana metropolitan area, Wayne State University, Lancet, NYU Langone Health, Food, National Institutes of Health, DEHP, MPH, Emory University, Woman, Johns Hopkins University, Population health, MPP, Blood, DIDP, Northeastern University, Infant, Risk, Doctor of Philosophy, Rutgers University, Cancer, Gestational age, Triangle Park (Quezon City), Racism, Mother, Research, Obesity, Preterm birth, RTI International, The Lancet, Pregnancy, Doctor of Science, Dartmouth College, Diabetes, Pennsylvania State University, Urine, Hormone, Achievement Medal, Pediatrics, Dietary supplement

Then, the team looked for associations between these metabolite levels and preterm births.

Key Points: 
  • Then, the team looked for associations between these metabolite levels and preterm births.
  • "Otherwise, investigators are likely going to find the same study results in another few years about the next group of chemicals used as replacements."
  • California, among a few states, has banned some use of phthalates in consumer products, as have European Union member states.
  • Trasande cautions that further research is needed to better understand the specific mechanisms behind the link between phthalate exposure and preterm birth.