DCGI

Pharmazz Inc. and Dr. Reddy's Laboratories have entered into a licensing agreement to market Centhaquine (Lyfaquin) as a resuscitative agent for hypovolemic shock in India

Retrieved on: 
Friday, March 22, 2024
Cardiac output, U.S. FDA, Internal bleeding, Partnership, System, Patient, Research, Trauma, Diarrhea, Hypovolemic shock, Mortality, Gastrointestinal bleeding, Manuscript, Laboratory, Blood volume, Standard of care, DRUGS, Clinical trial, Resuscitation, Safety, DCGI, Phase, Vomiting, Blood, FDA, Food, Shock (mechanics), Emerging market, Generic drug

Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).

Key Points: 
  • Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).
  • As per the agreement, Dr. Reddy's has received exclusive rights to market and distribute Centhaquine in India.
  • For patients with hypovolemic shock, I believe Dr. Reddy's is the best partner for Pharmazz to market Centhaquine, an innovative, first-in-class novel resuscitative agent, in India."
  • U.S. FDA clearance of our Phase III IND is an important milestone for Pharmazz and the potential future treatment of hypovolemic shock patients.

Foldax, Inc. Signs Manufacturing Agreement with Dolphin Life Science India LLP to Expedite Upcoming Commercial Availability

Retrieved on: 
Tuesday, February 27, 2024
Research, Medical Devices, Engineering, Chemicals, Plastics, Health Technology, Cardiology, Manufacturing, Biotechnology, Health, Science, Anticoagulant, Cardiovascular disease, CDSCO, Sale, RHD, Calcification, Mitral valve, Patient, Anatomy, LLP, Failure, DCGI, TRIA, Medical device

Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.

Key Points: 
  • Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.
  • The TRIA mitral valve is designed specifically to accommodate the anatomy and pressures of the mitral position.
  • Dolphin Life Science India LLP is an expert in manufacturing medical devices.
  • The company is registered with India’s regulatory bodies, the Drugs Controller General of India (DCGI), and the Central Drugs Standard Control Organization (CDSCO).

Aethlon Medical Announces Fiscal Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, February 14, 2024
Viral, Internet, Call, MAMC, Blood, Interest, Exosome, Marketing, Maulana Azad Medical College, Metastasis, Organ transplantation, Ethics, Interim, Intensive care medicine, COVID-19, Consolidated, DCGI, Virus, Patient, Clinical trial, Infection, Plasma, Insurance, Research, Travel, Cancer, Pharmaceutical industry

SAN DIEGO, Feb. 14, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal third quarter ended December 31, 2023 and provided an update on recent developments. 

Key Points: 
  • ET
    SAN DIEGO, Feb. 14, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal third quarter ended December 31, 2023 and provided an update on recent developments.
  • "While our research and development team has started to quantify our internal data, the results, to date, are inconclusive.
  • Financial Results for the Third Quarter Ended December 31, 2023
    As of December 31, 2023, Aethlon Medical had a cash balance of approximately $8.0 million.
  • ET to review its financial results for its fiscal third quarter ended December 31, 2023 and recent corporate developments.

CORBEVAX®, A COVID19 VACCINE DEVELOPED BY BIO E-INDIA BASED ON THE RBD PROTEIN ANTIGEN TECHNOLOGY FROM TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT, RECEIVES WORLD HEALTH ORGANIZATION EMERGENCY USE LISTING APPROVAL

Retrieved on: 
Monday, January 22, 2024
COVAXIN, World Health Organization, Texas Children's Hospital, UNICEF, COVID19, Tropical medicine, Dean (education), EUL, Medicine, DRS, CVD, BCM, National academy, Baylor College of Medicine, UN, RBD, Baylor University, GMP, Good, CDSCO, Dean, WHO, Safety, COVID-19, Hospital, Biomedical Research, Good manufacturing practice, Nobel Peace Prize, Alum, Vaccine, DCGI, SARS-CoV-2, National school, Biology

HOUSTON, Jan. 22, 2024 /PRNewswire/ -- Texas Children's Hospital announces today that Biological E's CORBEVAX®, a traditional, recombinant protein-based COVID-19 vaccine has received World Health Organization (WHO) approval under Emergency Use Listing (EUL). CORBEVAX® is developed and commercialized by Biological E Limited, an established global vaccine supplier based in Hyderabad, India, using Pichia pastoris yeast strain expressing Receptor Binding Domain (RBD) protein of SARS-CoV-2 engineered by Texas Children's Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine (BCM),

Key Points: 
  • "The recombinant yeast strains enable production of the RBD protein which can be further utilized by vaccine researchers globally to develop & manufacture effective and low-cost vaccines.
  • By providing access to the yeast strains via non-exclusive licensing, we continue our mission to support global vaccine accessibility and availability."
  • Biological E subsequently developed large scale manufacturing technology for production of the RBD protein complying with Good Manufacturing Practices (GMP) as well as testing & characterization suitable for use as vaccine antigen.
  • The RBD protein was then used as an antigen and formulated with optimized adjuvants (Alum and CpG1018) to develop a COVID-19 candidate vaccine.

Aethlon Medical Announces Fiscal Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 14, 2023
Interest, Research, GNA, Ethics, Interim, Clinical trial, Consolidated, Patient, Depreciation, FDA, Exosome, Infection, Call, Blood, IDE, Cancer, Internet, Metastasis, Government, DCGI, COVID, Pharmaceutical industry, Management, Cryptocurrency, Conference

SAN DIEGO, Nov. 14, 2023 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, today reported financial results for its fiscal second quarter ended September 30, 2023 and provided an update on recent developments. 

Key Points: 
  • ET
    SAN DIEGO, Nov. 14, 2023 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, today reported financial results for its fiscal second quarter ended September 30, 2023 and provided an update on recent developments.
  • Financial Results for the Second Quarter Ended June 30, 2023
    As of September 30, 2023, Aethlon Medical had a cash balance of approximately $10.2 million.
  • ET to review its financial results for its second quarter ended September 30, 2023 and recent corporate developments.
  • The replay can be accessed via Aethlon Medical's website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658.

Aethlon Medical Announces Appointment of James B. Frakes, M.B.A. as Interim Chief Executive Officer and Guy Cipriani, M.B.A. as Chief Operating Officer

Retrieved on: 
Monday, November 13, 2023
Safety, SAN, Senior, Ethics, Interim, Patient, Strategic planning, Infection, Cancer, DCGI, Management

Mr. Frakes also was appointed as a member of the Board of Directors and will remain as Chief Financial Officer of the Company.

Key Points: 
  • Mr. Frakes also was appointed as a member of the Board of Directors and will remain as Chief Financial Officer of the Company.
  • Additionally, Guy Cipriani, formerly Chief Business Officer, has been appointed as the Company's Chief Operating Officer and has resigned from the Board of Directors.
  • Additionally, Guy's extensive track record in the industry and execution at Aethlon Medical makes him ideally positioned to be our Chief Operating Officer.
  • Prior to joining Aethlon Medical, Mr. Frakes served as the Chief Financial officer of four public companies over a sixteen year period.

PharmaJet Partner Gennova Biopharmaceuticals Seeks Emergency Use Authorization in India for the First Needle-Free mRNA Vaccine Omicron Booster

Retrieved on: 
Monday, April 3, 2023
Medical Devices, Medical Supplies, Infectious Diseases, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, General Health, EUA, Vaccine, Injection, DNA, Partnership, Omicron, Use, COVID-19, Drugs Controller General of India, Temperature, Messenger, Ministry, PDS, Developing country, DCGI, Phase, COVAXIN, Safety

The submission corresponds with an increase in COVID-19 cases in India1 and is the first booster in India targeted specifically for the Omicron variant.

Key Points: 
  • The submission corresponds with an increase in COVID-19 cases in India1 and is the first booster in India targeted specifically for the Omicron variant.
  • The vaccine, GEMCOVAC-OM, will be delivered exclusively with the PharmaJet Tropis Precision Delivery System (PDS).
  • After launching this Omicron booster, we are eager to grow the partnership with PharmaJet to leverage all the benefits of needle-free delivery and our lyophilized mRNA platform,” said Sanjay Singh, CEO of Gennova Biopharmaceuticals.
  • “The Tropis System is already commercially available in India, and we are well-prepared to rapidly support demand for the GEMCOVAC-OM Omicron booster.

Celebrating Rare Disease Day and 40 Years of the Orphan Drug Act Advocating for Rare Disease Patients and Their Families

Retrieved on: 
Wednesday, February 8, 2023
Caregiver, Human, Infection, Therapy, Investment, Medicine, Neurology, Patient, JD, Second Continental Congress, Research, U.S. Department of Defense Strategy for Operating in Cyberspace, Congress, Person, Clinical, Policy, Rare, Office of National Drug Control Policy, Office of Inspector General, U.S. Department of Health and Human Services, Orphan Drug Act of 1983, Disease, FDA, DSM-IV codes, Education, Orphan drug, MPH, DHHS, DCGI, Quality of life, MS, Registry, Pharmaceutical industry

HERNDON, Va., Feb. 8, 2023 /PRNewswire-PRWeb/ -- Global life expectancy has more than doubled over the last two centuries, from less than 30 years to more than 72 years.(1) Despite the advances during the 'golden age of medicine' throughout the first half of the 20th century, for persons living with rare diseases, 26% still die before the age of five, and depending on the severity of the disease, 37% have a reduced life expectancy.(2) Pharmaceutical companies were historically loathe to research and develop life-saving drugs and treatments for rare diseases because it wasn't profitable marketing drugs to such a small segment of the population. Rare disease patients became known as 'orphans,' having been abandoned by prescription drug manufacturers.(3) In 1983, the U.S. Congress passed the Orphan Drug Act to incentivize drug manufacturers to pursue the development of drug treatments for rare diseases. Dr. Harsha Rajasimha is the Founder and Executive Chairman of the Indo-US Organization for Rare Diseases (IndoUSrare), a not-for-profit organization that seeks to bridge the gap between the western and eastern hemispheres when it comes to orphan diseases. He notes, "It has been 40 years since this watershed moment in the research and development of treatments for rare diseases. While we celebrate our significant progress, we must continue to look toward the still foggy road ahead."

Key Points: 
  • Rare disease patients became known as 'orphans,' having been abandoned by prescription drug manufacturers.
  • (3) In 1983, the U.S. Congress passed the Orphan Drug Act to incentivize drug manufacturers to pursue the development of drug treatments for rare diseases.
  • The FDA's Orphan Drug Act describes a rare disease as a medical condition that affects less than 200,000 people in the United States.
  • Rare Disease Day features special talks by key opinion leaders, panel discussions, and lived experience accounts from patients living with rare diseases worldwide.

Millions Suffer From Untreatable Rare Diseases While Medical Costs Skyrocket

Retrieved on: 
Monday, December 12, 2022
Travel, Degenerative disease, Pevsner, Retirement, Confusion, Person, State Institute for Drug Control, Drugs Controller General of India, Rare disease, Interest group, Diagnosis, George Frideric Handel, Drug discovery, National Policy, Volume, Idea, Hanson, Patient, HEALTH, Garrison, Research, Dave's Picks Volume 18, Disease, Child, Drug development, Mental health, Health care, Orphanet Journal of Rare Diseases, World Economic Forum, Caregiver, Clinical trial, Page, DCGI, McMurry, Value-based health care, Pharmaceutical industry, Health insurance, Medical device, Pariser, Health, Cederroth

HERNDON, Va., Dec. 12, 2022 /PRNewswire-PRWeb/ -- The economic burden of rare diseases has been vastly underestimated. A retrospective study of medical and insurance records indicates medical costs for people with a rare disease are three to five times greater than for other medical conditions.(1) Additional studies identified inpatient care, longer lengths of stay, higher charges per admission, and high readmission charges as contributing to the disproportionate direct costs of $768 billion for rare disease patients compared to $880 billion for all other conditions combined.(2) IndoUSrare is a U.S.-based humanitarian nonprofit 501(c)(3) tax-exempt public charity organization dedicated to addressing the unmet needs of patients living with rare diseases around the world.

Key Points: 
  • Impacting about 30 million people in the United States alone, the direct and indirect medical costs of rare diseases approach $1 trillion annually.
  • Meanwhile, individuals living with rare diseases are often misdiagnosed, which prolongs their suffering as they are burdened personally and financially.
  • A retrospective study of medical and insurance records indicates medical costs for people with a rare disease are three to five times greater than for other medical conditions.
  • Still, the National Policy for Rare Diseases (NPRD) has identified three groups of rare diseases based on their treatability, treatment availability, and status.

First Patients Outside of U.S. Treated with TRIA Biopolymer Surgical Aortic Heart Valve in India Clinical Trial

Retrieved on: 
Tuesday, May 3, 2022
Medical Devices, Health, Hospitals, Surgery, Clinical Trials, Cardiology, Bleeding, New York Heart Association Functional Classification, Failure, Anticoagulant, Death, Hemodynamics, Patient, Calcification, Aortic valve, Clinical trial, EOA, TRIA, Workforce, NYHA, Quality of life, Sale, JACC: Cardiovascular Interventions, DCGI, Drugs Controller General of India, Medical imaging, Medical device, California Institute of Technology

Foldax , Inc. today announced that the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIA biopolymer surgical aortic heart valve.

Key Points: 
  • Foldax , Inc. today announced that the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIA biopolymer surgical aortic heart valve.
  • We are honored to be the first center outside of the U.S. to implant the TRIA heart valve.
  • We look forward to completing enrollment in the study in the next few months and seeing how this novel biopolymer heart valve can improve the lives of our patients.
  • The trial is studying the ability of the TRIA biopolymer aortic valve to surgically treat patients with aortic valve disease and is designed to support commercial approval in India.