Drugs Controller General of India

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

Retrieved on: 
Lundi, avril 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.

Plasmid DNA Contract Manufacturing Global Market Report 2023: Sector to Reach $1.1 Billion by 2030 at a CAGR of 19.3% - ResearchAndMarkets.com

Retrieved on: 
Mardi, mars 7, 2023
Biotechnology, Genetics, Health, Vaccine, Incidence, Prevalence, Research, Viral, Growth, Chapter Three, Drugs Controller General of India, DNA, Malignancy, Entrepreneurship, Spinal muscular atrophy, Cancer, Immunotherapy, COVID-19, Safety, Conditional sentence

Hence, the growing adoption of gene therapy in the treatment of cancer is propelling the growth of the plasmid DNA contract manufacturing market.

Key Points: 
  • Hence, the growing adoption of gene therapy in the treatment of cancer is propelling the growth of the plasmid DNA contract manufacturing market.
  • However, the COVID-19 resulted into positive impact on the plasmid DNA contract manufacturing market.
  • The market would certainly benefit from the efforts of biotechnology companies that produce COVID-19 vaccines made from plasmid DNA.
  • Plasmid DNA Contract Manufacturing Market Variables, Trends & Scope

Review Highlights Growing Evidence That PharmaJet’s Precision Delivery Devices Improve Nucleic Acid Vaccine Performance

Retrieved on: 
Jeudi, février 23, 2023
Biotechnology, Pharmaceutical, Health, Medical Devices, Stratis, Tissue, Safety, HIV, Orthohantavirus, University of Cape Town, Vaccine (journal), DNA, University, Antigen, Bureau of Oceans and International Environmental and Scientific Affairs, Molecular medicine, Injection, Infection, Cell, Use, MDPI, Trial of the century, Subcutaneous tissue, TROPI, Therapy, Probability, Human, Drugs Controller General of India, Multimedia, Messenger, Vaccine, COVID-19, RNA

(Graphic: Business Wire)

Key Points: 
  • (Graphic: Business Wire)
    The COVID-19 pandemic increased visibility of nucleic acid vaccines, such as messenger RNA (mRNA), that provide scalability and can be quickly adapted as new variants appear.
  • Historical limitations can be addressed with new administration technologies such as modern needle-free precision delivery systems.
  • “We currently have eighty-three studies ongoing with novel pharmaceuticals focusing on nucleic acid technology in addition to other new vaccine technology platforms.
  • We believe that our precision delivery devices have the potential to increase the performance and therefore probability of regulatory success of many of these candidate vaccines.”
    Refer to Instructions for Use to ensure safe injections and to review risks.

Millions Suffer From Untreatable Rare Diseases While Medical Costs Skyrocket

Retrieved on: 
Lundi, décembre 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.

Global Hair Care Products Market to 2028 - by Type, Distribution Type, and Region - ResearchAndMarkets.com

Retrieved on: 
Mercredi, juin 15, 2022
Cosmetics, Retail, Other Retail, CAGR, Industry, Hyaluronic acid, Safety, US, Technology, Government, Cosmetics, Drugs Controller General of India, Efficiency, Hair, Depression, Man, TRESemmé, Region, Marketing, CDSCO, Human, Drug, Serum, Woman, Federal Food, Drug, and Cosmetic Act, Hair loss, Beauty salon

The "Hair Care Products Market, by Type, by Distribution Type, and by Region - Size, Share, Outlook, and Opportunity Analysis, 2022 - 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Hair Care Products Market, by Type, by Distribution Type, and by Region - Size, Share, Outlook, and Opportunity Analysis, 2022 - 2028" report has been added to ResearchAndMarkets.com's offering.
  • Demand for hair care products is increasing due to growing hair and scalp problems, around 50% of all women start losing their hair by the time they reach 50 years of age.
  • The hair care products market has been growing exponentially in India at an accelerating rate, especially in the urban areas.
  • Hair care products manufacturing companies are focusing on the launch of new and advanced products to enhance their market position.

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

Retrieved on: 
Mardi, mai 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.

TEXAS SCIENTISTS URGE WHITE HOUSE TO COMMIT TO GLOBAL FUNDING OF NON-PATENTED COVID-19 VACCINE

Retrieved on: 
Mardi, avril 26, 2022
Public health, News, Tropical medicine, Urgent care center, DCGI, COVID-19, Pediatrics, Twitter, Research, Neglected tropical diseases, Center, Baylor, Texas Medical Center, Education, National school, Partnership HealthPlan of California, Congress, Hospital, Baylor University, Baylor College of Medicine, PDP, Vaccination, Jan, Vaccine, Health, Kings County Hospital Center, Fermentation, Philosophy, HMO, SEC, Policy, Foreign Affairs Committee, Coronavirus, Safety, Committee, COVID-19 vaccine, Multimedia, Foreign Affairs, Drugs Controller General of India, View, Pharmaceutical industry, Woman, Texas Children's Hospital

HOUSTON, April 26, 2022 /PRNewswire/ -- Texas Children's Hospital announces nearly 30 million doses of CORBEVAX, a traditional, recombinant protein-based COVID-19 vaccine technology created and engineered by Texas Children's Center for Vaccine Development specifically to combat the worldwide problem of vaccine access and availability, have been administered in children across India with second doses currently underway. Originally granted Emergency Use Authorization for distribution in India where more than 500,000 doses are distributed each day, the vaccine has been approved in Botswana, where more than 100 million doses have been procured, which could lead towards its administration in the African continent.

Key Points: 
  • This requires Congressional funding to support worldwide distribution of CORBEVAX, the only safe, effective, low-cost, easily scalable vaccine currently available in the world.
  • Its low cost, ease of production and distribution, safety, and acceptance make it well suited for addressing global vaccine inequity.
  • "Texas Children's is prepared, ready, and willing to walk together with national and global leaders to vaccinate millions throughout our global community."
  • Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world.

Global Antibiotic Resistance Market to Hit US$16.5 Billion By 2030

Retrieved on: 
Jeudi, avril 21, 2022
CSE, AMR, Project, Opioid, U.S. Securities and Exchange Commission, COVID-19, Security (finance), NASDAQ, Research, Article, Diagnosis, Infection, Hospital, CAGR, Patient, CpG, ICU, Securities Exchange Act of 1934, Review, Technology, UBC, Drug, Forward-looking statement, 1018, ANY, Securities Act of 1933, Annual report, DCGI, CSA, Private Securities Litigation Reform Act, Biological E. Limited, RNA, Conference, Mortality, Solution, Sepsis, Disease, Septic shock, News, ASEP, COO, Growth, MPAR, Commercial, Industry, Prevalence, Cancer, Immunity, FNM, Drugs Controller General of India, Death, Form 10-K, Vaccine, Biology, CAR, NOT, Organ dysfunction, Length of stay, Physician, MSC, Pharmaceutical industry, Financial adviser, ImmunityBio, Nafamostat, Amyris, Author

NEW YORK, April 21, 2022 /PRNewswire/ -- Resistance to antibiotics is a growing concern. About 750,000 people die each year worldwide from drug–resistance infections. If solutions aren't found and put in place, 10 million people could die from antibiotic resistance-related diseases by 2050. According to SPER Market Research, the global antimicrobial resistance (AMR) market was valued at US$10.2 billion in 2021 and estimated at US$16.4 billion by 2030 with a CAGR of 5.74%. The main cause of death from COVID-19 is sepsis, a serious medical condition caused by the body's reaction to an infection. ASEP Medical Holdings Inc. (CSE:ASEP) (OTCQB:SEPSF) proposes to address this problem with a new diagnostic capable of detecting the dysfunctional immune response underlying the most severe form of sepsis. Other companies like ImmunityBio, Inc. (NASDAQ:IBRX), Dynavax Technologies Corporation (NASDAQ:DVAX), Allogene Therapeutics (NASDAQ:ALLO) and Ensysce Biosciences (NASDAQ:ENSC) are looking to combat COVID-19 and cancer.

Key Points: 
  • If solutions aren't found and put in place, 10 million people could die from antibiotic resistance-related diseases by 2050.
  • According to SPER Market Research, the global antimicrobial resistance (AMR) market was valued at US$10.2 billion in 2021 and estimated at US$16.4 billion by 2030 with a CAGR of 5.74%.
  • The company, which entered the public markets in December 2021, just commenced trading on the OTCQB Venture market under the symbol SEPSF.
  • Sepsis, which occurred in 48.9 million people worldwide and caused 11 million deaths globally in 2017, has become increasingly concerning during the global pandemic.

Global Antibiotic Resistance Market to Hit US$16.5 Billion By 2030

Retrieved on: 
Jeudi, avril 21, 2022
CSE, AMR, Project, Opioid, U.S. Securities and Exchange Commission, COVID-19, Security (finance), NASDAQ, Research, Article, Diagnosis, Infection, Hospital, CAGR, Patient, CpG, ICU, Securities Exchange Act of 1934, Review, Technology, UBC, Drug, Forward-looking statement, 1018, ANY, Securities Act of 1933, Annual report, DCGI, CSA, Private Securities Litigation Reform Act, Biological E. Limited, RNA, Conference, Mortality, Solution, Sepsis, Disease, Septic shock, News, ASEP, COO, Growth, MPAR, Commercial, Industry, Prevalence, Cancer, Immunity, FNM, Drugs Controller General of India, Death, Form 10-K, Vaccine, Biology, CAR, NOT, Organ dysfunction, Length of stay, Physician, MSC, Pharmaceutical industry, Financial adviser, ImmunityBio, Nafamostat, Amyris, Author

NEW YORK, April 21, 2022 /PRNewswire/ -- Resistance to antibiotics is a growing concern. About 750,000 people die each year worldwide from drug–resistance infections. If solutions aren't found and put in place, 10 million people could die from antibiotic resistance-related diseases by 2050. According to SPER Market Research, the global antimicrobial resistance (AMR) market was valued at US$10.2 billion in 2021 and estimated at US$16.4 billion by 2030 with a CAGR of 5.74%. The main cause of death from COVID-19 is sepsis, a serious medical condition caused by the body's reaction to an infection. ASEP Medical Holdings Inc. (CSE:ASEP) (OTCQB:SEPSF) proposes to address this problem with a new diagnostic capable of detecting the dysfunctional immune response underlying the most severe form of sepsis. Other companies like ImmunityBio, Inc. (NASDAQ:IBRX), Dynavax Technologies Corporation (NASDAQ:DVAX), Allogene Therapeutics (NASDAQ:ALLO) and Ensysce Biosciences (NASDAQ:ENSC) are looking to combat COVID-19 and cancer.

Key Points: 
  • If solutions aren't found and put in place, 10 million people could die from antibiotic resistance-related diseases by 2050.
  • According to SPER Market Research, the global antimicrobial resistance (AMR) market was valued at US$10.2 billion in 2021 and estimated at US$16.4 billion by 2030 with a CAGR of 5.74%.
  • The company, which entered the public markets in December 2021, just commenced trading on the OTCQB Venture market under the symbol SEPSF.
  • Sepsis, which occurred in 48.9 million people worldwide and caused 11 million deaths globally in 2017, has become increasingly concerning during the global pandemic.

Ranibizumab Biosimilars Market Research 2022: Comprehensive Insights About 17+ Companies and 17+ Marketed and Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Lundi, février 14, 2022
Pharmaceutical, Health, Optical, Vascular endothelial growth factor A, VEGF-A, EMA, Macular edema, VEGFR2, DME, Choroidal neovascularization, Risk, Diabetic retinopathy, European Medicines Agency, CNV, Central retinal vein occlusion, Endothelium, DR, Leakage, III, Clinical trial, Drugs Controller General of India, MAA, Therapy, Technology, Neovascularization, RVO, Stada Arzneimittel, Atomic mass, Biosimilar, AMD, Acquisition, NDA, Eye, VEGF, VEGFR1, Macular degeneration, Immunoglobulin G, Discovery, News, Intas Biopharmaceuticals, II, Vascular occlusion, Generic drug, Pharmaceutical industry, Vaccine, Ranibizumab, Choroid, Ranibizumab

The publisher's, "Ranibizumab Biosimilars - Pipeline Insight, 2022," report provides comprehensive insights about 17+ companies and 17+ marketed and pipeline drugs in Ranibizumab Biosimilars pipeline landscape.

Key Points: 
  • The publisher's, "Ranibizumab Biosimilars - Pipeline Insight, 2022," report provides comprehensive insights about 17+ companies and 17+ marketed and pipeline drugs in Ranibizumab Biosimilars pipeline landscape.
  • A detailed picture of the Ranibizumab Biosimilars pipeline landscape is provided which includes the disease overview and Ranibizumab Biosimilars treatment guidelines.
  • The assessment part of the report embraces, in depth Ranibizumab Biosimilars commercial assessment and clinical assessment of the pipeline products under development.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Ranibizumab Biosimilars R&D.