The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

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Pharmaceutical Technology

JULY 7, 2022

Often referred to as a type of gene-modified cell therapy, CAR-T cell therapies involve genetically modifying a patient’s own T cells to produce a protein that enables them to identify and kill cancer cells. Using a similar treatment to target solid tumours could be the industry’s next major milestone. Securing the supply chain.

Gene Therapy 245

Gene Therapy Gene Medicine Genetics 245

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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The Pharma Data

JANUARY 31, 2021

The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. . CHENGDU, China , Feb. S-Trimer is intended to be adjuvanted.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Pharmaceutical Technology

FEBRUARY 24, 2023

ACE-1334 is under clinical development by Merck and currently in Phase I for Lung Disease. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is developed based on protein engineering platform.

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Production Vaccination Vaccine Engineer 100

Pharmaceutical Technology

JUNE 10, 2023

RT-002 is under clinical development by Revance Therapeutics and currently in Phase II for Upper Limb Muscle Spasticity. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

JUNE 10, 2023

RT-002 is under clinical development by Revance Therapeutics and currently in Phase II for Upper Limb Muscle Spasticity. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Development Drugs Clinical Trials Clinical Trials 130

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Neuroendocrine Tumors. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is a new chemical entity.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Head And Neck Cancer Squamous Cell Carcinoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is a new chemical entity.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

Roots Analysis

FEBRUARY 27, 2024

On November 1, 2019, Avacta Group and ADC Therapeutics have announced a collaboration agreement for the development of novel drug candidates. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization.

Antibody 52

Antibody Licensing Licensing Contract Manufacturing 52

pharmaphorum

NOVEMBER 12, 2020

The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 There is an option for a further 100 million doses. billion doses in 2021.

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pharmaphorum

DECEMBER 2, 2021

In September, it reported a fourth patient death in a clinical trial of its AT132 (resamirigene bilparvovec) gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), possibly linked to liver side effects. Those safety issues have hit Astellas’ aspirations in gene therapy directly.

Gene Therapy 97

Gene Therapy Gene Manufacturing Clinical Trials 97

pharmaphorum

AUGUST 16, 2022

GSK was an early mover, joining forces with CureVac on a candidate which failed to pass muster in clinical trials, forcing them to come up with a second, but it has said that building a position in mRNA is a strategic imperative. Meanwhile, Sanofi ended up buying its mRNA partner Translate Bio for $3.2

RNA 98

RNA Vaccination Vaccine Clinical Trials 98

pharmaphorum

JULY 21, 2022

A COVID-19 vaccine developed using the technology cleared a phase 1 proof-of-concept study in Australia, but Vicebio is focusing first on RSV, with clinical trials of VXB-211 scheduled to in the second half of next year. ” He said. ” The post Ex-GSK vaccine chief to lead new UK biotech Vicebio appeared first on. .

Vaccination 104

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The Pharma Data

APRIL 15, 2022

A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. “Our minibinders sit on top of the spike protein like a tripod and block all three.

Antibody 52

Antibody Protein Engineer Manufacturing 52

pharmaphorum

DECEMBER 7, 2020

China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile.

Vaccination 58

Vaccination Vaccine Production Clinical Development 58

pharmaphorum

FEBRUARY 19, 2021

billion cumulative doses of its NVX-CoV2373 recombinant protein-based vaccine candidate, which is yet to be approved by regulators. The vaccine doses will be manufactured and distributed globally by Novavax and Serum Institute of India (SII), the latter under an existing agreement between Gavi and SII.

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Vaccination Vaccine Manufacturing RNA 75

The Pharma Data

SEPTEMBER 2, 2020

Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

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Vaccination Vaccine Trials Immune Response 52

Drug Discovery World

JANUARY 15, 2024

OHB-607 is a recombinant version of insulin-like growth factor-1 (IGF-1), a key driver of foetal growth and development, and its binding protein, IGFBP-3. Chiesi and Oak Hill Bio intend to continue a Phase IIb clinical trial in 2024 in the United States, Europe, and Japan.

Drugs 59

Drugs Licensing Licensing Protein 59

XTalks

JANUARY 23, 2024

Hawkins: I started my professional journey at Johnson & Johnson, gaining extensive experience in both the preclinical and clinical development of pharmaceuticals, as well as regulatory insights. Together, we developed the world’s first growth hormone receptor antagonist, Somavert (pegvisomant), targeting acromegaly.

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Development Hormones Drugs Trials 72

pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

Bacteria 52

Bacteria Vaccination Vaccine Immune Response 52

The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. For more information about the COVE study, click here. mRNA-1273 currently is not approved for use by any regulatory body.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. Prior to Taiho, he held the positions of senior vice president of Clinical Oncology and CMO at Geron Corporation. and CMO for Taiho Oncology, Inc.

Gene Therapy 52

Gene Therapy Engineer Gene Research Analyst 52

The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

Drug Discovery World

NOVEMBER 9, 2023

T-cell activation not only causes the death of cancer cells through the release of special T-cell proteins which punch holes in their surface, but it also triggers the proliferation of killer T-cells at the tumour site (thereby increasing the ‘hotness’ of the tumour). RA: What kind of cancers could benefit from this treatment approach?

Antibody 64

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The Pharma Data

OCTOBER 28, 2020

We appreciate the confidence of the MHLW in Moderna and mRNA-1273, which we hope will help address the pandemic, especially given the encouraging data we have recently published together with the NIH related to the clinical trial in the elderly and older adult population,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We

Vaccination 40

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pharmaphorum

JANUARY 25, 2021

The World Health Organization’s regularly updated vaccine tracking webpage says there are 64 vaccines in clinical development, with several approved or close to the market. government to advance the manufacturing and initial distribution of MK-7110. The company was more upbeat about the prospects for its two therapies, however.

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Vaccination Vaccine Immune Response Clinical Trials 52

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. that are fast progressing clinical trials. SAN FRANCISCO and SUZHOU, China , Nov.

Clinical Trials 52

Clinical Trials Clinical Trials Manufacturing Production 52

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) COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

Pfizer

AUGUST 3, 2022

Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. mitogen activated protein kinase pathway, which demonstrated improvement in functional capacity (6-minute walk test; 6MWT) in a 48-week, open-label, Phase 2 study among patients with symptomatic LMNA-related DCM.

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Development Vaccination Vaccine Production 101

The Pharma Data

DECEMBER 10, 2020

“We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

Containment 52

Containment Clinical Development Development Protein 52

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. This means COVID-19 can quickly produce viral proteins once inside the host cell, which may make its replication cycle faster than influenza.

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Vaccination Vaccine RNA Manufacturing 105

The Pharma Data

MAY 31, 2022

More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

FDA Approval 52

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Pfizer

DECEMBER 8, 2022

Pfizer and BioNTech previously announced the start of a Phase 1 trial to examine the safety, tolerability, and immunogenicity of their combined influenza and COVID-19 candidate vaccine among healthy adults. . SARS-CoV-2 led to a global pandemic with more than 6.5 million deaths ii and a high socio-economic burden worldwide. INDICATION.

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Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

NOVEMBER 10, 2020

The NCT03763149 study is a phase 1a clinical study evaluating the tolerability, safety, and PK/PD properties of IBI188 (letaplimab) as monotherapy for advanced malignancies that failed in standard treatments. . About NCT03763149 Trial. . SAN FRANCISCO , U.S. and SUZHOU, China , Nov.

Antibody 52

Antibody Clinical Trials Clinical Trials Manufacturing 52

Pfizer

SEPTEMBER 28, 2022

1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . 5-adapted bivalent vaccine.

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101