Prednisone

Roivant Announces Positive NEPTUNE Study Results for Brepocitinib in NIU, as well as Board Authorization for up to $1.5 Billion Share Repurchase Program, Including Repurchase of Entire Sumitomo Pharma Stake for $648 Million

Retrieved on: 
Tuesday, April 2, 2024
Disease, Macular edema, NIU, Paratriathlon, Arm, Rule, Safety, Risk, Webcast, Inflammation, Patient, NEPTUNE, EDT, Master of Science, Haze, Prednisone, Visual acuity, Therapy, Sumitomo Pharma, Calendar, Share repurchase, JAK, Visual impairment, Physician, Hand, Pediatrics, Pharmaceutical industry

We are also pleased to announce our authorized share repurchase program, and our agreed repurchase of all shares owned by Sumitomo Pharma.

Key Points: 
  • We are also pleased to announce our authorized share repurchase program, and our agreed repurchase of all shares owned by Sumitomo Pharma.
  • The NEPTUNE study enrolled 26 subjects with active NIU who were randomized 2:1 to brepocitinib 45 mg once daily or brepocitinib 15 mg once daily.
  • All week 24 secondary efficacy endpoints, including haze grades, visual acuity, and macular thickness, were also positive and dose responsive.
  • The presentation and webcast details are also available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events.

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update

Retrieved on: 
Friday, March 29, 2024
Patient, PTCL, G&A, IND, Prednisone, Neoplasm, Therapy, SMDC, Medicinal chemistry, Lymphoma, Research, Frontiers Media, RNA polymerase II, Body modification, Primate, RNA, NIH, CPT, Potential, Safety, CDK9, ADC, MCL1, Solubility, Oncogene, RNA polymerase, Venetoclax, Journal, Manuscript, Cancer, Peripheral T-cell lymphoma, AACR, Antibody, MYC, Downregulation and upregulation, DLBCL, Annual general meeting, HER2, European Hematology Association, EHA, Spacecraft, PDX, Bangladesh Technical Education Board, Journal of Medicinal Chemistry, Blood, Pharmaceutical industry

PALO ALTO, Calif., March 29, 2024 (GLOBE NEWSWIRE) --  Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Vincerx presented preclinical data at the 2023 AACR Annual Meeting demonstrating significant activity in patient-derived xenograft (PDX) lymphoma mouse models.
  • Vincerx shared preclinical data at the 2023 ASH Annual Meeting showing superior activity and safety compared with commercially available B-cell targeted ADCs.
  • For the fourth quarter and full year 2023, Vincerx reported a net loss of $4.9 million, or $0.23 per share, and a net loss of $40.2 million, or $1.89 per share, respectively.
  • For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.8 million, or $0.65 per share, and a net loss of $63.0 million, or $3.00 per share, respectively.

IMFINZI® (durvalumab) significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial

Retrieved on: 
Friday, April 5, 2024
Research, FDA, Clinical Trials, Biometrics, Health, Pharmaceutical, General Health, Science, Oncology, Lung cancer, Chemoradiotherapy, CRT, Small-cell carcinoma, Radiation, AstraZeneca, Survival, NSCLC, Immunotherapy, Disease, Infection, Carcinoma, Incidence, Progression-free survival, Patient, Warning, Doctor of Philosophy, Prednisone, Adrenocorticotropic hormone, Creatinine, Prognosis, PFS, Recurrence, ACTH, Administration, Pneumonitis, SCLC, Vaccine

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Key Points: 
  • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (
  • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

GenFleet and BeiGene Enter into Trial Collaboration for a Potentially First-in-class Combination Therapy to Initiate Phase Ib/II Study of GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib) Treating Diffuse Large B Cell Lymphoma

Retrieved on: 
Thursday, March 28, 2024
B-cell lymphoma, Plasma, Shanghai Cancer Center, Rituximab, Apoptosis, Leukemia, International Journal of Hematology, Patient, Hospital, Doxorubicin, Vincristine, Fudan University, CC3, Standard of care, Acute myeloid leukemia, Epidemiology, Biomedical Chromatography, Prednisone, Peripheral T-cell lymphoma, PARP, National Cancer Center, Therapy, MYC, BTK, Safety, BeiGene, CDK9, Cyclophosphamide, DLBCL, Canadian International Council, MCL1, Follicular lymphoma, Pharmaceutical industry

The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.

Key Points: 
  • The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.
  • This study will be the first combination trial conducted by a Chinese biotech to combine CDK9 inhibitor and BTK inhibitor targeting DLBCL.
  • The trials of GFH009 treating peripheral T-cell lymphoma and acute myeloid leukemia have entered into phase II stage in China and the U.S. respectively.
  • Epidemiology of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the United States and Western Europe: population-level projections for 2020–2025, Leukemia & Lymphoma, 2021
    3.

Withdrawn application: Adcetris, 23/02/2024

Retrieved on: 
Wednesday, April 3, 2024
PTCL-NOS, Lymphoma, B-cell lymphoma, CHOP, Patient, PTCL, Doxorubicin, Vincristine, CHP, Cancer, Vinblastine, European Medicines Agency, CTCL, Prednisone, Lymphocyte, Agency, Clinical trial, Skin, Dacarbazine, CD30, Cyclophosphamide, Medicine

Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.

Key Points: 
  • Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.
  • The cytotoxic molecule then enters the cancer cells and prevents them from dividing, causing the cancer cells to die.
  • The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company.
  • If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

Catalyst Pharmaceuticals Announces Publication of Santhera Pharmaceutical’s VISION-DMD Vamorolone (AGAMREE®) Study Results in the Peer-Reviewed Journal Neurology

Retrieved on: 
Wednesday, February 21, 2024
Vamorolone, Catalyst Pharmaceuticals, NSAA, Safety, Prednisone, DMD, Growth, Duchenne muscular dystrophy, Neurology, Biomarker, BMI, Patient, LSM, JAMA Neurology, Pharmaceutical industry

Catalyst holds the exclusive rights to commercialize AGAMREE® (vamorolone) in North America.

Key Points: 
  • Catalyst holds the exclusive rights to commercialize AGAMREE® (vamorolone) in North America.
  • Based on the published study, Santhera has reported that the results of the VISION-DMD study support the long-term efficacy and safety profile of vamorolone and conclude that vamorolone was generally well tolerated, consistent with the 24-week study findings, as published previously in JAMA Neurology [2].
  • This study [VISION-DMD] was conducted to determine the efficacy and safety of vamorolone over 48 weeks and to study crossover participants (prednisone to vamorolone; placebo to vamorolone).
  • Improvements of motor outcomes seen with 6 mg/kg/d of vamorolone at 24 weeks of treatment were maintained to 48 weeks of treatment.

Santhera Announces Publication of Efficacy, Safety and Tolerability Data with Vamorolone (AGAMREE®) in Patients with Duchenne Muscular Dystrophy in Neurology

Retrieved on: 
Wednesday, February 14, 2024
Vamorolone, NSAA, Safety, Prednisone, DMD, Growth, Duchenne muscular dystrophy, Neurology, European, Biomarker, BMI, Patient, Disease, LSM, JAMA Neurology, Pharmaceutical industry

“Vamorolone is a dissociative corticosteroid that selectively binds to the glucocorticoid receptor and has shown similar efficacy and reduced safety concerns in comparison with prednisone in Duchenne muscular dystrophy (DMD) [3].

Key Points: 
  • “Vamorolone is a dissociative corticosteroid that selectively binds to the glucocorticoid receptor and has shown similar efficacy and reduced safety concerns in comparison with prednisone in Duchenne muscular dystrophy (DMD) [3].
  • This study [VISION-DMD] was conducted to determine the efficacy and safety of vamorolone over 48 weeks and to study crossover participants (prednisone to vamorolone; placebo to vamorolone).
  • There was an increase in BMI after 24 weeks of treatment that then stabilized for both vamorolone groups.
  • Improvements of motor outcomes seen with 6 mg/kg/d of vamorolone at 24 weeks of treatment were maintained to 48 weeks of treatment.

Adverum Biotechnologies Announces Positive Preliminary Efficacy and Safety Data from LUNA Phase 2 Trial of Ixo-vec in Patients with Wet AMD

Retrieved on: 
Thursday, February 8, 2024
Chorioretinitis, Injection, Principal, Inflammation, Life, Adverum Biotechnologies, VEGF, AMD, Partner (business rank), Vasculitis, Patient, Safety, Paratriathlon, Prednisone, University of Nevada, Reno, Intraocular pressure, Data, Webcast, University, Retinitis, M.A, Clinical research, CST, Vascular occlusion, Pharmaceutical industry

These data are being presented by Dr. Arshad Khanani today at the 47th Annual Meeting of the Macula Society.

Key Points: 
  • These data are being presented by Dr. Arshad Khanani today at the 47th Annual Meeting of the Macula Society.
  • “Wet AMD is a leading cause of blindness in people over the age of 65, requiring life-long anti-VEGF injections.
  • Our goal with Ixo-vec is to provide patients virtually injection-free management of their wet AMD lasting years and potentially for life,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies.
  • The LUNA trial builds on our experience with the OPTIC study, where landmark 2-year data was recently published in The Lancet’s eclinicalmedicine.

Santhera Launches AGAMREE® (Vamorolone) in Germany as First Market for the Treatment of Duchenne Muscular Dystrophy

Retrieved on: 
Monday, January 15, 2024
Medication package insert, Patient, European Medicines Agency, Prednisone, Steroid, EMA, Mutation, Disease, Vamorolone, Marketing, DMD, Duchenne muscular dystrophy, Growth, Pharmaceutical industry

“We are very happy that AGAMREE is now commercially available in Germany, the first country worldwide, for the treatment of DMD,” said Dario Eklund, CEO of Santhera.

Key Points: 
  • “We are very happy that AGAMREE is now commercially available in Germany, the first country worldwide, for the treatment of DMD,” said Dario Eklund, CEO of Santhera.
  • “This significant milestone represents Santhera’s commitment to fill the unmet need in DMD and provide a safe and effective treatment for DMD patients.
  • Now the time has come—with the new drug AGAMREE, patients suffering from Duchenne muscular dystrophy have access to a better tolerated alternative to steroids.
  • For more information about AGAMREE in the European Union, please see the Summary of Product Characteristics (SmPC) [1].

Santhera Receives Approval for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy in the United Kingdom

Retrieved on: 
Friday, January 12, 2024
Ageing, Patient, MHRA, Medication, MD, European Medicines Agency, Health care, Prednisone, Civil service commission, Dual-energy X-ray absorptiometry, European Commission, Steroid, Medicine, DXA, Spine, EMA, Mutation, Food, Safety, Vamorolone, FDA, Biomarker, DMD, Duchenne muscular dystrophy, Organic, Lead, Growth, Pharmaceutical industry

We are working towards making AGAMREE available to patients in the UK in the second half-year 2024, after NICE completes its pricing review.

Key Points: 
  • We are working towards making AGAMREE available to patients in the UK in the second half-year 2024, after NICE completes its pricing review.
  • Duchenne UK and our partner charities, Joining Jack and the Duchenne Research Fund, funded the early-stage clinical research to test vamorolone in patients, when no-one else would.
  • Santhera will continue to collect data to further characterize the long-term effectiveness and the broader safety differentiation of vamorolone.
  • This makes AGAMREE the first and only medicinal product fully approved in the EU and UK for DMD, and the first treatment approved for the treatment of DMD all three geographies.