Clinical trials

DARE-19 Phase III Collaboration between AstraZeneca, Saint Luke’s Mid America Heart Institute and George Clinical Shows Treatment’s Well-Established Safety Profile Was Consistent in Patients with COVID-19

Retrieved on: 
Thursday, July 29, 2021
Health sciences, Life sciences, Health, Clinical research, Pharmaceutical industry, Clinical trials, Adenoviridae, COVID-19 vaccines, Oxford–AstraZeneca COVID-19 vaccine, AstraZeneca, Contract research organization, COVID-19 drug development

The study was a collaboration of George Clinical, a global scientifically-backed clinical research organization and Saint Lukes Mid America Heart Institute and was funded by AstraZeneca.

Key Points: 
  • The study was a collaboration of George Clinical, a global scientifically-backed clinical research organization and Saint Lukes Mid America Heart Institute and was funded by AstraZeneca.
  • DARE-19 was the first large, randomized controlled study of hosptialized patients with COVID-19 to evaluate the safety and efficacy of SGLT2 inhibitors.
  • The trial was conducted in collaboration with Saint Lukes Mid America Heart Institute, the global sponsor, and George Clinical, a global contract research organization.
  • George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence.

NIH Advances ACTIV-5/BET-B Trial Evaluating Lenzilumab from a Phase 2 Exploratory Study to a Phase 2/3 Study for the Treatment of COVID-19

Retrieved on: 
Friday, July 30, 2021
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Clinical research, Monoclonal antibodies, Health, Medicine, Lenzilumab, Placebo, National Institutes of Health, Activ, Chevrolet Spin, ACTIV-5/BET-B, Lenzilumab, Humanigen, ACTIV-5/BET-B, LENZILUMAB, HUMANIGEN

We appreciate the close collaboration with NIH on this important study, said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen.

Key Points: 
  • We appreciate the close collaboration with NIH on this important study, said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen.
  • The ACTIV-5/BET-B study design has been adapted to align with the design of LIVE-AIR and may help support a future BLA for lenzilumab.
  • ACTIV-5/BET-B may provide prospective validation for lenzilumab in the treatment of COVID-19, said Cameron Durrant, MD, Chief Executive Officer, Humanigen.
  • The primary endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through 28 days following treatment.

Global Atrial Fibrillation Clinical Trials Review Report - H1, 2021 - ResearchAndMarkets.com

Retrieved on: 
Friday, July 30, 2021
Health, Clinical trials, Health sciences, Health, Clinical research, Clinical trial, Design of experiments, Food and Drug Administration, Pharmaceutical industry, Atrial fibrillation

The "Atrial Fibrillation - Global Clinical Trials Review, H1, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Atrial Fibrillation - Global Clinical Trials Review, H1, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This report provides an overview of Atrial Fibrillation Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Atrial Fibrillation.
  • Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe.

Global Coronavirus (COVID-19) Vaccine Market to 2026 By Infection Type, Vaccine Type, Product Type, Route of Administration, Patient Type, End User, Region - ResearchAndMarkets.com

Retrieved on: 
Friday, July 30, 2021
Health, Pharmaceutical, Coronaviridae, Medicine, Health sciences, Zoonoses, COVID-19 vaccines, Sarbecovirus, Bat virome, Clinical trials, COVID-19 vaccine, Severe acute respiratory syndrome, Coronavirus, COVID-19

The "Global Coronavirus Vaccine Market, By Infection Type (SARS-CoV-2, SARS-CoV, MERS-CoV), By Vaccine Type, By Product Type, By Route of Administration, By Patient Type, By End User, By Region, Competition Forecast & Opportunities, 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Coronavirus Vaccine Market, By Infection Type (SARS-CoV-2, SARS-CoV, MERS-CoV), By Vaccine Type, By Product Type, By Route of Administration, By Patient Type, By End User, By Region, Competition Forecast & Opportunities, 2026" report has been added to ResearchAndMarkets.com's offering.
  • The Global Coronavirus Vaccine Market is expected to grow at a robust rate during the forecast period.
  • The Global Coronavirus Vaccine Market is driven by the increasing prevalence of this disease across different parts of the globe.
  • The Global Coronavirus Vaccine Market is segmented based on infection type, vaccine type, product type, route of administration, patient type, end-user, company, and region.

Alzamend Neuro Announces Pre-IND Submission for AL002 as a Cell-Based Therapeutic Vaccine That Seeks to Restore the Ability of Patient’s Immunological System to Combat Alzheimer’s

Retrieved on: 
Friday, July 30, 2021
Health, FDA, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Vaccination, Vaccine, Virology, AL002, Alzamend Neuro, AL002, ALZAMEND NEURO

AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patients immunological system to combat Alzheimers.

Key Points: 
  • AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patients immunological system to combat Alzheimers.
  • Based on AL002s recent positive good laboratory practices toxicology results, we are proposing to conduct a first-in-human Phase 1 study.
  • We believe AL002 could potentially reverse the effects of Alzheimers, said Stephan Jackman , the Chief Executive Officer of Alzamend.
  • AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that reduces beta-amyloid plaque and seeks to restore the ability of the patients immunological system to combat Alzheimers.

Adaptive Phage Therapeutics Appoints Robert J. Hopkins, MD, MPH & TM, FACP, FIDSA, to Chief Medical Officer

Retrieved on: 
Friday, July 30, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Infectious diseases, Clinical trials, Biomedical Advanced Research and Development Authority, Bacteriophage, Articles, Life sciences, Organisms, Bacteriophages, Robert T. Schooley, Center for Innovative Phage Applications and Therapeutics, Pharmaceutical industry

Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that it has promoted Robert Hopkins, M.D., to Chief Medical Officer.

Key Points: 
  • Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that it has promoted Robert Hopkins, M.D., to Chief Medical Officer.
  • Dr. Robert Hopkins joined Adaptive Phage Therapeutics in 2019, after serving as Senior Medical Advisor in the Division of Clinical Services (DCS) for the Biomedical Advanced Research and Development Authority (BARDA) in Washington, D.C.
  • Combating infectious diseases presents a critical need that affects a large portion of the population, said Dr. Robert Hopkins.
  • Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat multi-drug resistant infections.

Imago BioSciences Receives Orphan Designation From European Medicines Agency for Bomedemstat for the Treatment of Essential Thrombocythemia

Retrieved on: 
Friday, July 30, 2021
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical trials, Life sciences, Health sciences, Health, Biotechnology law, Drug discovery, Orphan drug, Pharmaceuticals policy, Myeloproliferative neoplasm, European Medicines Agency, Zotiraciclib

Imago BioSciences, Inc. (Imago) (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), today announced that the European Medicines Agency (EMA) has granted orphan designation for bomedemstat, a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of essential thrombocythemia (ET).

Key Points: 
  • Imago BioSciences, Inc. (Imago) (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), today announced that the European Medicines Agency (EMA) has granted orphan designation for bomedemstat, a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of essential thrombocythemia (ET).
  • The Phase 2 clinical trial of bomedemstat for the treatment of ET continues to actively enroll globally ( NCT04254978 ).
  • Gaining this designation is an important regulatory milestone that gives us added momentum in advancing the development of bomedemstat.
  • Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of ET and MF, European Medicines Agency (EMA) Orphan Designation for the treatment of ET and MF, and PRIority MEdicines (PRIME) Designation by the EMA for the treatment of MF.

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy

Retrieved on: 
Friday, July 30, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Drugs, Clinical medicine, Cancer treatments, Antineoplastic drugs, Orphan drugs, Breakthrough therapy, Bristol-Myers Squibb, Nivolumab, Bristol Myers Squibb, Cabozantinib, Chemoradiotherapy, Renal cell carcinoma

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).
  • Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
  • By harnessing the bodys own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
  • OPDIVO (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Cyclo Therapeutics Announces New Positive Safety and Efficacy Data from Ongoing Phase 1 Open-Label Extension Study of Trappsol® Cyclo™ for the Treatment of Niemann-Pick Disease Type C1

Retrieved on: 
Friday, July 30, 2021
Research, Clinical trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, NPC1, Niemann-Pick Disease Type C1 (NPC), Cyclo Therapeutics, NIEMANN-PICK DISEASE TYPE C1 (NPC), CYCLO THERAPEUTICS

We are incredibly pleased with the continued trends of safety and efficacy being demonstrated by Trappsol Cyclo in the treatment of NPC.

Key Points: 
  • We are incredibly pleased with the continued trends of safety and efficacy being demonstrated by Trappsol Cyclo in the treatment of NPC.
  • The first patient was dosed in the Open-Label extension study in May 2019 and the last patient enrolled was in February 2020.
  • The Company previously reported data on the Phase 1 extension study in January 2021 based on the initial efficacy results at a data cut-off of September 2020.
  • Trappsol Cyclo is currently being evaluated in the pivotal Phase 3 study, TransportNPC, for the treatment of NPC1.

ImmunoGen Reports Recent Progress and Second Quarter 2021 Financial Results

Retrieved on: 
Friday, July 30, 2021
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical trials, Clinical medicine, Medicine, Antineoplastic drugs, Immunology, ImmunoGen, Antibody-drug conjugate, Health care

ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2021.

Key Points: 
  • ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2021.
  • Operating expenses for the second quarter of 2021 were $44.3 million, compared with $33.4 million for the same quarter in 2020.
  • The increase was largely driven by research and development expenses, which were $34.6 million for the second quarter of 2021, compared with $22.9 million for the second quarter of 2020.
  • General and administrative expenses for the second quarter of 2021 were $9.7 million, compared to $9.8 million for the second quarter of 2020.