Phase

Global Microbiome Manufacturing Markets 2023-2024 & 2035: Industry Trends, Forecasts, Formulation, Primary Packaging Used, Scale of Operation, Company Size, Key Regions and Leading Developers - ResearchAndMarkets.com

Retrieved on: 
Friday, April 5, 2024
Vitamins, Supplements, Neurology, Fitness & Nutrition, Clinical Trials, Other Health, Biotechnology, Alternative Medicine, General Health, Pharmaceutical, Health, Clostridioides difficile infection, Type, Organization, Database, AOBiome, Microbiota, Patient, CNS, CGMP, Research, Fungus, FDF, Bacteria, Virus, Laboratory, Overalls, Infection, DSM-IV codes, API, Safety, Phase, Therapy, USD, LBP

Likewise, the ecological system of commensal, symbiotic, and pathogenic microorganisms that reside within a host system is called the microbiome.

Key Points: 
  • Likewise, the ecological system of commensal, symbiotic, and pathogenic microorganisms that reside within a host system is called the microbiome.
  • Further, this microbiome manufacturing market analysis highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry.
  • Around 43% of the global microbiome contract manufacturing capacity is installed in facilities owned by small contract manufacturing companies.
  • This market report includes an easily searchable excel database of all the microbiome contract manufacturing companies and their manufacturing facility, worldwide.

GenSight Biologics Reports Cash Position as of March 31, 2024, and Provides Business Update

Retrieved on: 
Thursday, April 4, 2024
Health, Neurology, Genetics, Pharmaceutical, Optical, Biotechnology, PIII, URD, Three-body problem, Patient, Good manufacturing practice, Health care, EAP, Acquisition, EMA, Risk, Chapter, GMP, MHRA, DS, ATU, AMF, Good, Phase, AAP, Ethics, FDA, Amendment, AAC, Medication, Pharmaceutical industry

GenSight Biologics ("GenSight Biologics" or the "Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of March 31, 2024 and provided a business update.

Key Points: 
  • GenSight Biologics ("GenSight Biologics" or the "Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of March 31, 2024 and provided a business update.
  • Once the AAC/AAP program resumes, the Company estimates that the cash runway would be extended to the end of Q1 2025.
  • GenSight successfully manufactured two Drug Substance (DS) batches of LUMEVOQ® meeting Good Manufacturing Practice (GMP) standards in September and November 2023.
  • As of March 31, 2024, GenSight Biologics’ number of outstanding shares was 78,370,724 ordinary shares.

Can-Fite: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients

Retrieved on: 
Wednesday, April 3, 2024
Research, FDA, Diabetes, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Human, Obesity, Cirrhosis, CANF, Inflammation, Patient, MASH, Fibrosis, Fatty liver disease, Phase, NASH, Liver disease, Food, Pharmaceutical industry

Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study.

Key Points: 
  • Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study.
  • The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH.
  • The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint.
  • "We are eager to look at the therapeutic effect of Namodenoson in patients with MASH," said Motti Farbstein, chief executive officer of Can-Fite.

InnoCare Releases 2023 Results and Business Highlights

Retrieved on: 
Thursday, March 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, QD, Tafasitamab, Patient, B-cell lymphoma, NDA, SLE, POC, IND, Clinical trial, Bone marrow, IKZF1, Phase, Therapy, IGA, MCD, Dexamethasone, MCL, Neuromyelitis optica spectrum disorder, IKZF3, AML, NMOSD, Outline of health sciences, DLT, Cancer, Autoimmune disease, Safety, TYK2, HSA, NRDL, BLA, Follicular lymphoma, Food, GC, Development, Multiple sclerosis, PD, CRBN, Public, Gordon Ramsay's Bank Balance, Multiple myeloma, ITP, BCL2, Leukemia, Cmax, Gadolinium, HKEX, SRI, AAD, Proteinuria, DLBCL, Glucocorticoid, IVIG, Loss, European Hematology Association, American Academy, EHA, Lenalidomide, NHL, Non-Hodgkin lymphoma, CCR8, US FDA, BTK, NRS, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
  • In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs.
  • In June 2023, the ITP Phase II result was orally presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023.

Beckley Psytech announces positive initial data from Phase IIa study of novel 5-MeO-DMT formulation BPL-003 for Treatment Resistant Depression

Retrieved on: 
Wednesday, March 27, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Other Health, Depression, Atypical depression, Data analysis, MDD, Patient, Beckley Foundation, DSM-IV codes, TRD, Treatment, Drug development, Safety, Phase, FDA, 5-MeO-DMT, Pharmaceutical industry

95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings .

Key Points: 
  • 95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings .
  • Acute effects were resolved and patients were deemed dischargeable within an average time of less than 2 hours.
  • Our single dose treatment model enables a short treatment duration which positions BPL-003 as a potentially exciting and scalable treatment opportunity.
  • The company’s lead compound, BPL-003, is a novel, synthetic 5-MeO-DMT benzoate salt candidate currently under investigation for the treatment of Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD).

Electronic Trial Master File Systems Market Analysis Report 2024: Rising Adoption of eTMF Solutions Spurs Growth Amid Surge in Clinical Trials - Global Forecast to 2030 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 26, 2024
Health, Clinical Trials, Cloud, ChromeOS, Growth, ClinicalTrials.gov, Partnership, COVID-19, Lotus, Research, Artificial intelligence, Clinical trial, Data collection, Investment, Drug development, Safety, Veeva Systems, Phase, Machine learning, USD, Medical device

The global electronic trial master file systems market size is estimated to reach USD 1.9 billion by 2030, registering a CAGR of 14.7% from 2024 to 2030

Key Points: 
  • The global electronic trial master file systems market size is estimated to reach USD 1.9 billion by 2030, registering a CAGR of 14.7% from 2024 to 2030
    The market growth is attributed to a stringent regulatory structure for clinical trials and a heightened need for safety monitoring.
  • Moreover, growing adoption of electronic trial master file (eTMF) solutions owing to the increasing number of clinical trials also contributes to the market growth.
  • The growing adoption of electronic trial master file solutions in research contributes to the segment growth
    North America dominated the market with the largest revenue share of 49.5 % in 2023.
  • The market growth is attributed to an increasing target population, a rise in lifestyle-associated diseases, and the launch of new products by key market players

Promising Intracranial Anti-Tumor Activity and Safety Data for Ivonescimab in NSCLC Patients with Brain Metastases Featured at ELCC 2024

Retrieved on: 
Friday, March 22, 2024
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, SMMT, Intraparenchymal hemorrhage, Sun, EGFR, Central European Time, Metastasis, ELCC, Progression-free survival, Anaplastic lymphoma kinase, Constipation, Brain, Drug, HKEX, Safety, Anemia, Phase, Summit, TKI, Time in Europe, PFS, ALK, Pharmaceutical industry

The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline.

Key Points: 
  • The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline.
  • This analysis consisted of the 35 patients with advanced or metastatic NSCLC who had asymptomatic brain metastases at baseline; 28 patients were treated with ivonescimab plus chemotherapy in AK112-201, and seven patients were treated with monotherapy ivonescimab in AK112-202.
  • Patients across both cohorts experienced an intracranial response rate of 34%, and eight patients (23%) experienced a complete response by RANO criteria.
  • The most frequent TEAEs were anemia and decreased neutrophil counts in squamous patients and anemia and constipation in non-squamous patients.

Positive topline results from Phase III long-term study OASIS 3 support submissions for marketing authorization for Bayer’s elinzanetant

Retrieved on: 
Tuesday, March 19, 2024
Health, Fitness & Nutrition, Clinical Trials, Research, Pharmaceutical, Science, International Menopause Society, VMS, Menopause, OASIS, Executive Committee, Imperial College London, Woman, Hot, Safety, Elinzanetant, Phase, Marketing, Pharmaceutical industry

Bayer today announced positive topline results of the Phase III study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.

Key Points: 
  • Bayer today announced positive topline results of the Phase III study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.
  • The long-term safety profile observed over 52 weeks in the OASIS 3 study is overall consistent with previously conducted studies and published data1,2 on elinzanetant.
  • “OASIS 3 was designed to address the important question of the long-term profile of elinzanetant.
  • “These results, coupled with the recent announcement of topline data for OASIS 1 and OASIS 2, strengthen our confidence in the proposed efficacy and safety of elinzanetant as a potential novel non-hormonal solution for women experiencing menopause-related symptoms.”
    OASIS 3 (NCT05030584) is the third Phase III study in the OASIS clinical development program with positive topline results.

Oragenics Appoints James Kelly MD, Chief Medical Officer, to Lead Phase II Clinical Trials for Treating Concussion

Retrieved on: 
Monday, March 18, 2024
Pharmaceutical, Health, Neurology, Clinical Trials, Depression, Metabolism, Brain, NCE, Acute stress disorder, Concussion, Veterans' affairs, Executive, Common, Inflammation, Patient, United States Congress, TBI, Foundation (nonprofit), Anxiety, CTE, University, Military personnel, Oxidative stress, Human, GMP, Nasal cavity, Traumatic brain injury, DSM-IV codes, Phase, Traffic, Swelling, FDA, Animal, Pentagon, Chronic traumatic encephalopathy, Phase II, Marcus Foundation, Medical device

Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion.

Key Points: 
  • Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion.
  • Dr. Kelly was also National Director of the Avalon Action Alliance TBI Programs for which the MIBH serves as the clinical coordinating center.
  • “I am excited to join Oragenics as its Chief Medical Officer at such an important and pivotal time in the drug development process.
  • Dr. Kelly has interacted with the FDA and clinical trials for brain injury throughout his esteemed career.

Intracranial Anti-Tumor Activity and Safety of Ivonescimab in NSCLC Patients with Brain Metastases to be Featured at ELCC 2024

Retrieved on: 
Thursday, March 14, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, SMMT, Sun, EGFR, Central European Time, ELCC, NSCLC, Anaplastic lymphoma kinase, Drug, HKEX, Safety, Phase, Summit, TKI, Time in Europe, ALK, Pharmaceutical industry

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic.
  • Two posters featuring updated ivonescimab data will be displayed on Friday, March 22 from 12:00 to 12:45pm Central European Time.
  • The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline.
  • These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC.