Medical Affairs Bureau

Polaris Group Initiates Rolling Submission of Biologic License Application (BLA) for ADI-PEG 20 with U.S. FDA to Treat Malignant Pleural Mesothelioma

Retrieved on: 
Friday, November 17, 2023
SAN, Chemistry, Food, BLA, Pemetrexed, Patient, FDA, Medical Affairs Bureau, MPM, Mesothelioma, Biologics license application, Pharmaceutical industry

The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline.

Key Points: 
  • The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline.
  • Dr. John Bomalaski, Executive Vice President of Medical Affairs at Polaris Group, commented, "Our clinical trials have demonstrated promising results, with ADI-PEG 20 showing statistically significant potential to address the medical needs of patients with malignant pleural mesothelioma.
  • Howard Chen, CEO and Chairman of Polaris Group, added, "We are fully committed to addressing the urgent medical needs of patients facing malignant pleural mesothelioma.
  • Today’s submission brings us one step closer to expanding treatment options for patients impacted by MPM in the U.S.

Ardelyx Announces Departure of Board Member

Retrieved on: 
Monday, November 13, 2023
Chronic kidney disease, Associate, Senior, Patient, Dialysis, Medical Affairs Bureau, FDA, Pleasure, MD

Dr. Block currently serves as the Associate Chief Medical Director and Senior Vice President of Clinical Research and Medical Affairs at U.S. Renal Care.

Key Points: 
  • Dr. Block currently serves as the Associate Chief Medical Director and Senior Vice President of Clinical Research and Medical Affairs at U.S. Renal Care.
  • “On behalf of our board and Ardelyx’s leadership team, we thank Geoff for his unwavering commitment and the instrumental role he played in helping guide and evolve Ardelyx from a developmental, clinical-stage biopharmaceutical company to an established commercial entity,” said David Mott, Chair of the Ardelyx Board of Directors.
  • “Ardelyx is well-positioned for the future, following the U.S. FDA approval of the first-in-class phosphate absorption inhibitor XPHOZAH® (tenapanor) which is a new option for the many patients with chronic kidney disease on dialysis, a community I have dedicated my career to serving.
  • The time is right for me step down from the board of directors as Ardelyx embarks on its next phase.”

Aspira Women’s Health Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Transfer, Assistant, Woman, Methodist Hospital, Research, Senior, Gynecologic Oncology (journal), Travel, University, Conference call, Risk, Gynaecology, Protein, MicroRNA, Dana–Farber Cancer Institute, Algorithm, Medical Affairs Bureau, Marketing, Metadata, AUP, COVID-19, Conference, Ovarian cancer, Harvard Medical School, University of Oxford, Brigham, CAB, Reproductive biology, Medical school, Aspira, Government, AACR, Hospital, Video game, Arms industry, Rare-earth element, Pharmaceutical industry, Birth control, Cryptocurrency, Obstetrics

AUSTIN, Texas, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today reported its financial results for the three- and nine-month period ended September 30, 2023.

Key Points: 
  • “We are pleased to report another quarter of year-over-year growth, with revenues this quarter of $2.2 million.
  • The Company expects general and administrative expenses to remain flat for the fourth quarter of 2023.
  • Our cash balance this quarter benefited from the registered direct offering where we raised $4.7 million in gross proceeds.
  • The Company reiterates its operating cash utilization target for the second half of 2023 to between $6.0 million and $8.0 million.

Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy

Retrieved on: 
Wednesday, December 13, 2023
Research, Neurology, Diabetes, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Medicine, Safety, Pain, Aes, Vertex, Pain management, Patient, TID, Week, Diabetic neuropathy, Medical Affairs Bureau, Autonomic, VRTX, DPN, Șaeș, Neuropathic pain, Vertex Pharmaceuticals, Pharmaceutical industry, Birth control

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from its Phase 2 dose-ranging study of the selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy (DPN).

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from its Phase 2 dose-ranging study of the selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy (DPN).
  • The study also included an active reference arm of pregabalin to support the evaluation of the VX-548 treatment effect.
  • VX-548 was generally well tolerated at all doses tested in the study.
  • Most adverse events (AEs) were mild to moderate and there were no serious adverse events (SAEs) related to VX-548.

Positive Results from Pivotal Trials of CASGEVY™ (exagamglogene autotemcel) Highlighted in Oral Presentations at the American Society of Hematology (ASH) Annual Meeting and Exposition

Retrieved on: 
Tuesday, December 12, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Genetics, Clinical Trials, Medicaid, Food, BLA, Sickle cell disease, ASH, Vertex, Patient, Prevalence, Cohort study, Medical Affairs Bureau, TDT, Volatile organic compound, SCD, PDUFA, Pharmaceutical industry

Data from 96 patients (44 sickle cell disease [SCD], 52 transfusion-dependent beta thalassemia [TDT]) treated with CASGEVY in pivotal studies, with the longest follow-up of more than four years, continue to reinforce the consistent and durable response to treatment.

Key Points: 
  • Data from 96 patients (44 sickle cell disease [SCD], 52 transfusion-dependent beta thalassemia [TDT]) treated with CASGEVY in pivotal studies, with the longest follow-up of more than four years, continue to reinforce the consistent and durable response to treatment.
  • In addition, new data illustrating improvements in patient-reported outcomes after treatment with CASGEVY were featured in poster presentations at ASH.
  • The use of CASGEVY for the treatment of TDT in the U.S. remains investigational.
  • In addition to the two oral presentations, there are additional poster presentations by Vertex at ASH.

ImmunoGen Presents Findings from Newly Diagnosed Acute Myeloid Leukemia Cohorts in Phase 1b/2 Study of Pivekimab Sunirine in Combination with Azacitidine and Venetoclax at ASH

Retrieved on: 
Sunday, December 10, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Molecular Pharmacology, Fever, Associate, Azacitidine, Hypotension, Safety, CCR, Spacecraft, Pneumonia, ASH, University, Cytopenia, Disease, Cellular, Constipation, Fatigue, Mortality, Penile ultrasonography, Patient, IMGN, DNA, MRD, Medical Affairs Bureau, Pharmacokinetics, Peripheral edema, Flow cytometry, Capillary leak syndrome, MD, Diarrhea, Cancer, Nausea, Survival, Drug resistance, Transplant, AML, Apoptosis, MD Anderson Cancer Center, Society, ImmunoGen, Hypokalemia, Hypophosphatemia, Venetoclax, Rare-earth element, Pharmaceutical industry, Birth control, Vaccine, Medicinal plants, Research

These findings will be presented in a poster session at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, California.

Key Points: 
  • These findings will be presented in a poster session at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, California.
  • “The MRD negativity rates, which are indicative of a deep remission, are particularly promising in the treated patient population.
  • Response rates and MRD negativity were numerically comparable between cohorts 1 and 2, despite differences in the venetoclax schedule.
  • We look forward to continuing to expand our cohort of newly diagnosed unfit patients to inform the development path for pivekimab in AML.”
    ImmunoGen is also presenting two preclinical posters at ASH.

FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer

Retrieved on: 
Tuesday, December 5, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, National Medical Products Administration, Priority review, Annual general meeting, Food, European Medicines Agency, Spacecraft, Progression-free survival, US Foods, ADC, Patient, IMGN, ASCO, New Drug Application, Medical Affairs Bureau, ImmunoGen, MD, Cancer, Mirvetuximab soravtansine, Society, PDUFA, Pharmaceutical industry, Research

The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024.

Key Points: 
  • The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024.
  • We look forward to collaborating closely with the FDA throughout the review process."
  • The confirmatory Phase 3 MIRASOL trial of ELAHERE in platinum-resistant ovarian cancer forms the basis of the sBLA.
  • ELAHERE was granted accelerated approval by the FDA in November 2022 based on data from the pivotal SORAYA trial.

Exelixis and Arcus Biosciences Announce Clinical Trial Collaboration to Evaluate Zanzalintinib in Combination with AB521 in Patients with Advanced Renal Cell Carcinoma

Retrieved on: 
Monday, December 4, 2023
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Exelixis, NYSE, Patient, TKI, Kidney cancer, Medical Affairs Bureau, ClinicalTrials.gov, Pharmaceutical industry

Exelixis, Inc. (Nasdaq:EXEL) and Arcus Biosciences (NYSE:RCUS) today announced that the companies have entered into a clinical trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating zanzalintinib, Exelixis’ next-generation tyrosine kinase inhibitor (TKI), in combination with AB521, an inhibitor of the transcription factor HIF-2⍺, in patients with advanced solid tumors, including clear cell renal cell carcinoma (ccRCC).

Key Points: 
  • Exelixis, Inc. (Nasdaq:EXEL) and Arcus Biosciences (NYSE:RCUS) today announced that the companies have entered into a clinical trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating zanzalintinib, Exelixis’ next-generation tyrosine kinase inhibitor (TKI), in combination with AB521, an inhibitor of the transcription factor HIF-2⍺, in patients with advanced solid tumors, including clear cell renal cell carcinoma (ccRCC).
  • Exelixis is sponsoring STELLAR-009, and Arcus is co-funding the study and providing AB521 for use in the trial.
  • Patient enrollment for STELLAR-009 is expected to begin before the end of 2023.
  • More information about this trial will be available soon on ClinicalTrials.gov.

Exelixis and Arcus Biosciences Announce Clinical Trial Collaboration to Evaluate Zanzalintinib in Combination with AB521 in Patients with Advanced Renal Cell Carcinoma

Retrieved on: 
Monday, December 4, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Exelixis, NYSE, Patient, Multimedia, TKI, Kidney cancer, Medical Affairs Bureau, ClinicalTrials.gov, Pharmaceutical industry

Exelixis, Inc. (Nasdaq: EXEL) and Arcus Biosciences (NYSE: RCUS) today announced that the companies have entered into a clinical trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating zanzalintinib, Exelixis’ next-generation tyrosine kinase inhibitor (TKI), in combination with AB521, an inhibitor of the transcription factor HIF-2⍺, in patients with advanced solid tumors, including clear cell renal cell carcinoma (ccRCC).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) and Arcus Biosciences (NYSE: RCUS) today announced that the companies have entered into a clinical trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating zanzalintinib, Exelixis’ next-generation tyrosine kinase inhibitor (TKI), in combination with AB521, an inhibitor of the transcription factor HIF-2⍺, in patients with advanced solid tumors, including clear cell renal cell carcinoma (ccRCC).
  • Exelixis is sponsoring STELLAR-009, and Arcus is co-funding the study and providing AB521 for use in the trial.
  • Patient enrollment for STELLAR-009 is expected to begin before the end of 2023.
  • More information about this trial will be available soon on ClinicalTrials.gov.

Exelixis Announces Initiation of the STELLAR-305 Phase 2/3 Pivotal Trial Evaluating Zanzalintinib in Combination with Pembrolizumab in Patients with Previously Untreated Recurrent or Metastatic Head and Neck Cancer

Retrieved on: 
Monday, December 4, 2023
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, SCCHN, Neck, Progression-free survival, Head, RECIST, Exelixis, Neoplasm, Patient, PFS, Medical Affairs Bureau, Pembrolizumab, BIRC, ClinicalTrials.gov, Immunotherapy, Pharmaceutical industry

Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
  • Patients must not have received prior systemic therapy for recurrent or metastatic disease.
  • Patients will be randomized 1:1 to receive zanzalintinib in combination with pembrolizumab or placebo in combination with pembrolizumab.
  • Secondary endpoints include PFS per RECIST 1.1 by investigator and objective response rate and duration of response per RECIST 1.1 by BIRC and by investigator.