Ligelizumab by Novartis for Food Allergy: Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 7, 2024
Ligelizumab is under clinical development by Novartis and currently in Phase III for Food Allergy.
Allergen for Grass Pollen Allergy by Roxall Medizin for Grass Pollen Allergy: Likelihood of Approval
Pharmaceutical Technology
DECEMBER 26, 2024
Allergen for Grass Pollen Allergy is under clinical development by Roxall Medizin and currently in Phase II for Grass Pollen Allergy.
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Moderna is corporate greed at its worst
World of DTC Marketing
NOVEMBER 19, 2021
government has provided Moderna with nearly $10 billion in taxpayer money for research and development and the purchase of 500 million doses of this mRNA COVID-19 vaccine. This includes almost the entire cost of clinical development. SUMMARY: The U.S. Additionally, Moderna used patents and non-exclusive rights that the U.S.
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Polyrizon IPO Strengthens Momentum in Non-Invasive Drug Delivery Solutions
XTalks
NOVEMBER 5, 2024
Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). The IPO, priced at $4.38 Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024.
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Providing the Blueprint for Gen AI Adoption in Clinical Trials
ACRP blog
OCTOBER 10, 2024
Within the clinical trials environment specifically, AI will reduce costs and speed up the trial process, facilitating the development of more drugs and increasing access to them. MGI puts the value of this contribution to clinical development at $15 billion to $25 b illion.
Complexity in Early Phase Clinical Trials with Dr. Oren Cohen?
Clinical Trial Podcast
SEPTEMBER 26, 2022
Cohen has more than 30 years of healthcare experience which includes his work on clinical development. such as Senior Vice President, Global Head of Early Clinical Development and Precision Medicine, Senior Vice President, Clinical Research Strategies, Vice President and Senior Director, Medical and Scientific Services, among others.
AZ expands phase 3 trials of COVID-19 vaccine frontrunner into US
pharmaphorum
SEPTEMBER 1, 2020
Results from the late-stage trials are anticipated later this year, depending on the rate of infection within clinical trial communities. The vaccine is still the frontrunner in a list of 30 COVID-19 vaccines in clinical development maintained by the World Health Organization.
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Blow for Novartis as ligelizumab can’t top Xolair in phase 3
pharmaphorum
DECEMBER 20, 2021
Biosimilars haven’t been approved yet but are in clinical development at the likes of Glenmark, BiosanaPharma and Celltrion. He said however that the company will “continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria and food allergy.”
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FDA approves Phase 1 trial for HIV gene therapy
The Pharma Data
AUGUST 24, 2020
The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases.
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Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications
The Pharma Data
APRIL 14, 2021
“Expanding treatment options for personalised care and self-management is always welcome news for the patient community,” said Kenneth Mendez, CEO and President, Asthma and Allergy Foundation of America. Genentech, a member of the Roche group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.
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Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials
XTalks
NOVEMBER 6, 2020
The Burnaby, BC-based company developed the oral DNA-based vaccine using its proprietary bacTRL Gene Therapy Platform, which uses genetically modified bifidobacteria as carriers of genetic vaccine elements on a DNA plasmid. Related: Red Meat Allergy Test Gets FDA Clearance. “We
Dr. Rod MacKenzie, 2020-2021 HBA Honorable Mentor
Pharma Marketing Network
APRIL 27, 2021
Rod MacKenzie, PhD, is Chief Development Officer and Executive Vice President for Pfizer. Rod joined Pfizer in Sandwich, UK as a Research Scientist and conducted medicinal chemistry research in the cardiovascular, GI, Sexual Health, Urology and Allergy & Respiratory diseases. Rod is the co-inventor of darifenacin (Enablex ).
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Webinar Recap: Unleashing the Power of PROs Throughout Oncology Drug Development
VirTrial
FEBRUARY 28, 2024
Everhart is board-certified in internal medicine and a fellow of the American College of Physicians with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical development.
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Webinar Recap: Unleashing the Power of PROs Throughout Oncology Drug Development
VirTrial
FEBRUARY 28, 2024
Everhart is board-certified in internal medicine and a fellow of the American College of Physicians with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical development.
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Webinar Recap: Unleashing the Power of PROs Throughout Oncology Drug Development
VirTrial
FEBRUARY 28, 2024
Everhart is board-certified in internal medicine and a fellow of the American College of Physicians with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical development.
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Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…
The Pharma Data
AUGUST 7, 2020
Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development. These manufactured antibodies have been developed and manufactured by Eli Lilly and Company ’s Lilly Research Laboratories in a partnership with AbCellera.
Webinar Recap: Unleashing the Power of PROs Throughout Oncology Drug Development
VirTrial
FEBRUARY 28, 2024
Everhart is board-certified in internal medicine and a fellow of the American College of Physicians with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical development.
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Fixed-dose combination of albuterol and budesonide (PT027) demonstrated significant benefits.
The Pharma Data
SEPTEMBER 9, 2021
It is an inhaled, fixed-dose combination of albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and is being developed in a pMDI using AstraZeneca’s Aerosphere delivery technology. 2 Inflammation is a distinctive feature of asthma 3 and plays a key role in asthma symptoms, 4 exacerbations 5 and deaths.
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FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis
The Pharma Data
APRIL 4, 2022
The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.
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What Challenges Is the Vaccine Industry Facing When Dealing with the Flu and COVID-19?
XTalks
OCTOBER 26, 2023
She has 23 years of experience working with clients to move vaccine candidates through the clinical development pipeline, including regulatory submission. Several companies including Pfizer-BioNTech and Moderna are now developing mRNA-based influenza vaccines.
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Bayer: Strong growth, guidance upgrade
The Pharma Data
AUGUST 5, 2021
The platform already has potentially ground-breaking medical innovations in clinical development, such as a therapy for the treatment of Parkinson’s. and from a strong allergy season in North America, which resulted in a 15.8 in sales in the Allergy & Cold category. Group sales in the second quarter increased by 12.9
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Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19
Pfizer
NOVEMBER 2, 2022
The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) have a fever. have a bleeding disorder or are on a blood thinner.
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Donidalorsen Shows Sustained HAE Attack Reduction According to New Trial Data
XTalks
FEBRUARY 24, 2025
Carlsbad, California-based Ionis Pharmaceuticals announced it will be sharing promising new trial data for its RNA-targeted prophylactic treatment donidalorsen for hereditary angioedema (HAE) at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, California.
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59 Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza
Pfizer
DECEMBER 8, 2022
Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), 5), COMIRNATY® (COVID-19 Vaccine, mRNA), and Pfizer-BioNTech COVID-19 Vaccine. have a fever. have a bleeding disorder or are on a blood thinner.
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TAS-117 by Taiho Pharmaceutical for Chondrosarcoma: Likelihood of Approval
Pharmaceutical Technology
JUNE 10, 2023
TAS-117 is under clinical development by Taiho Pharmaceutical and currently in Phase II for Chondrosarcoma. It was under development for the treatment of gastric cancer and multiple myeloma. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the TAS-117 LoA Report.
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TAS-117 by Taiho Pharmaceutical for Chondrosarcoma: Likelihood of Approval
Pharmaceutical Technology
JUNE 10, 2023
TAS-117 is under clinical development by Taiho Pharmaceutical and currently in Phase II for Chondrosarcoma. It was under development for the treatment of gastric cancer and multiple myeloma. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the TAS-117 LoA Report.
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Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design
Pfizer
JULY 26, 2022
Tell your vaccination provider about all of the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 6 months through 11 years of age should not be used interchangeably with COMIRNATY® (COVID-19 Vaccine, mRNA). has a fever.
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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age
Pfizer
SEPTEMBER 28, 2022
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), 5), COMIRNATY® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine. 5) may not protect all vaccine recipients. . • You should not receive Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 5) could cause a severe allergic reaction.
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Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age
Pfizer
JULY 8, 2022
Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. IMPORTANT SAFETY INFORMATION . have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart). have a fever. have a bleeding disorder or are on a blood thinner.
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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate
Pfizer
JULY 19, 2022
Tell your vaccination provider about all of the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies. IMPORTANT SAFETY INFORMATION. has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart). has a fever. has received another COVID-19 vaccine.
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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends
XTalks
AUGUST 2, 2023
With Blackstone Life Sciences, up to €300 million (around $315 million USD) will be invested to accelerate pivotal studies and clinical development programs for formulating the subcutaneous delivery of the anti-CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma.
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Tiziana announces appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer
The Pharma Data
JANUARY 12, 2021
Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g.
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HIV Vaccine Trial of Vir Biotech’s New Candidate VIR-1388 Begins
XTalks
SEPTEMBER 21, 2023
This groundbreaking endeavor has received support from the National Institute of Allergy and Infectious Diseases (NIAID). Since 2004, the NIAID has been championing the discovery and development of the cytomegalovirus (CMV) vector used to deliver the HIV vaccine material to the immune system without causing disease.
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Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
The Pharma Data
NOVEMBER 30, 2020
and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. “I
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52 Euro-Australian collaboration offers scalable solutions for biotech: announced at Bio-Europe 2020
The Pharma Data
OCTOBER 29, 2020
Clinical Development Strategy – we provide expert guidance on study design, favorable venues, local and global landscape to improve study outcomes. About Avance Clinical www.avancecro.com. Media Contacts: Avance Clinical Chris Thompson: media@avancecro.com. Source link.
Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®
Pfizer
JULY 8, 2022
IMPORTANT SAFETY INFORMATION Tell your vaccination provider about all the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies. has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart). has a fever. has received another COVID-19 vaccine.
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Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union
Pfizer
OCTOBER 19, 2022
Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), 5), COMIRNATY® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine. have a fever. have a bleeding disorder or are on a blood thinner.
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Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union
Pfizer
SEPTEMBER 16, 2022
Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), 5), COMIRNATY® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine. have a fever. have a bleeding disorder or are on a blood thinner.
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2020 Year in Review: COVID-19, CRISPR and Immunotherapies Define the Year for the Life Sciences
XTalks
DECEMBER 24, 2020
Omer maintains that the solution to this challenge is something that’s already in practice by developers of the mRNA vaccines. What you do is you insist that a proper clinical development program is followed and that has been followed with trial data of tens of thousands of people,” says Dr. Omer. Vaccine Considerations.
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Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine
pharmaphorum
AUGUST 12, 2020
billion, including $955 million previously awarded to Moderna to fund clinical development and manufacturing of mRNA-1273. The shot is in a phase 3 trial called COVE which started last month with the help of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
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Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine
pharmaphorum
AUGUST 12, 2020
billion, including $955 million previously awarded to Moderna to fund clinical development and manufacturing of mRNA-1273. The shot is in a phase 3 trial called COVE which started last month with the help of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
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Aurobindo Pharma and COVAXX Sign an Exclusive Agreement to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF
The Pharma Data
DECEMBER 23, 2020
. Under the signed agreement, Aurobindo Pharma has obtained the exclusive rights to develop, manufacture and sell COVAXX’s UB-612 vaccine in India and to UNICEF, as well as non-exclusive rights in other select emerging and developing markets. The Company is marketing these products globally, in over 150 countries.
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COVAXX and Aurobindo Pharma Announce COVID-19 Vaccine Partnership
The Pharma Data
DECEMBER 23, 2020
Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612. Under the signed license agreement, Aurobindo Pharma has obtained the exclusive rights to commercialize in India and to UNICEF and non-exclusive rights in other select emerging and developing markets.
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COVID-19 Pandemic Coverage
XTalks
SEPTEMBER 14, 2020
These companies include Moderna, a US biotech company which has formed a partnership with the National Institute of Allergy and Infectious Diseases (NIAID), Oxford University who has partnered with AstraZeneca, and Johnson & Johnson, Merck and Pfizer. Addressing the Rapidly Evolving Vaccine Development Landscape.
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