pharmaphorum

MARCH 12, 2021

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. A joint development team is working on a -20C storage temperature for late-stage clinical development and at launch.

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Clinical Trials Clinical Trials Trials Vaccination 52

Pharmaceutical Technology

APRIL 25, 2023

German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. 3BP receives an initial payment of $40m, and $425m as development, regulatory and commercial milestone payments.

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Licensing Licensing Clinical Development Clinical Trials 130

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

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Gene Clinical Trials Clinical Trials Gene Therapy 162

Pharmaceutical Technology

FEBRUARY 22, 2023

Taldefgrobep is a complete human anti-myostatin recombinant protein that is developed for lowering free myostatin. Biohaven Clinical Development vice-president Lindsey Lee Lair said: “We are very pleased the FDA granted Fast Track designation for taldefgrobep alfa for the treatment of SMA.

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Clinical Trials Clinical Trials Genetics Protein 246

Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Cervical Cancer. 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 developed based on DARPin technology.

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Protein Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Colorectal Cancer. 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 developed based on DARPin technology.

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The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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Clinical Development Vaccination Vaccine Development 52

Pharmaceutical Technology

FEBRUARY 20, 2023

Different approaches that are studied include antisense oligonucleotides (ASOs), and gene therapies, which are in early clinical trials. Other lines of research look at the genetic overlap between FTD and amyotrophic lateral sclerosis (ALS), which could be used in the development of treatments for both conditions.

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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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Clinical Trials Clinical Trials Vaccination Vaccine 52

Drug Discovery World

MARCH 26, 2024

CAMP4 Therapeutics has dosed the first participant in its Phase I clinical study of CMP-CPS-001, a potential first-in-class therapeutic for the treatment of urea cycle disorders (UCDs). UCDs are a group of rare, severe, inherited metabolic diseases impacting protein metabolism.

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Trials Gene Expression Protein Gene 52

Pharmaceutical Technology

FEBRUARY 20, 2023

ABN-401 is under clinical development by Abion and currently in Phase II for Solid Tumor. 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

FEBRUARY 19, 2023

STRO-002 is under clinical development by Sutro Biopharma and currently in Phase I for Refractory Acute Myeloid Leukemia. 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 6, 2023

According to Globaldata, it is involved in 1 clinical trial, which is ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. MRNA-0184 Overview mRNA-0184 is under development for the treatment decompensated heart failure.

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RNA Protein Antibody Vaccination 100

Pharmaceutical Technology

FEBRUARY 9, 2023

Buntanetap tartrate is under clinical development by Annovis Bio and currently in Phase III for Parkinson’s Disease. 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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Clinical Trials Clinical Trials Drugs Development 100

Pharmaceutical Technology

FEBRUARY 9, 2023

Buntanetap tartrate is under clinical development by Annovis Bio and currently in Phase III for Alzheimer’s Disease. 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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Clinical Trials Clinical Trials Drugs Development 100

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.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

Pharmaceutical Technology

MARCH 2, 2023

Povetacicept is under clinical development by Alpine Immune Sciences and currently in Phase I for Systemic Lupus Erythematosus. 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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Protein Engineer Clinical Trials Clinical Trials 100

Pharmaceutical Technology

MAY 31, 2023

ATRN-119 is under clinical development by Aprea Therapeutics and currently in Phase II for Solid Tumor. 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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Production Clinical Trials Clinical Trials Development 100

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

JULY 22, 2021

(NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. The companies will equally share worldwide development costs, commercialization expenses, and profits. Chief Executive Officer at Arvinas.

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Protein Development HR Hormones 52

The Pharma Data

SEPTEMBER 22, 2020

Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This guidance provides clarity on the path to registration for AVXS-101 IT.

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Clinical Development Gene Therapy Development Gene 52

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

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The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

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Clinical Trials Clinical Trials Trials Bacteria 40

The Pharma Data

DECEMBER 22, 2020

AVA6000 has been shown in animal models to significantly increase the amount of active drug in a tumour compared with the heart and should thereby improve tolerability and achieve better clinical outcomes for patients. Dosing of first patients will commence when we have responded to that feedback and received approval to proceed.

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Clinical Trials Clinical Trials Trials Development 52

Pharmaceutical Technology

MAY 31, 2023

Sym-021 is under clinical development by Les Laboratoires Servier and currently in Phase I for Solid Tumor. 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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Generic Drugs Hormones Manufacturing Development 100

Drug Discovery World

DECEMBER 26, 2023

Scientists from the Chemistry and Biochemistry Departments at the University of Liverpool and Nanjing Medical School in China discovered a possible way to block proteins that cause metastasis. Data analytics company Phesi released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Development Clinical Trials Clinical Trials Drugs 64

XTalks

JULY 17, 2023

protein on the surface of gastric epithelial cells, which display abnormal expression levels of this protein compared to normal cells. Phase III Clinical Trials Underpinning the Applications The applications are grounded on two Phase III clinical trials, SPOTLIGHT and GLOW. How Does Zolbetuximab Work?

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Clinical Trials Clinical Trials Trials Antibody 95

pharmaphorum

APRIL 28, 2022

The Oxford-based company said the financing, led by venture capital arms of Google and Sanofi as well as Northpond Ventures, will be used to bring its portfolio of drug candidates for immunological and rare disease into clinical trials. Robinson is OMass’ founder and scientific advisor.

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Protein Drugs Development Clinical Trials 90

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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Development Drugs Clinical Trials Clinical Trials 130

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

JUNE 5, 2023

BI-765063 is under clinical development by Boehringer Ingelheim International and currently in Phase I for Hypopharyngeal Cancer. 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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XTalks

SEPTEMBER 21, 2023

“HIV continues to be a major global public health challenge with no approved vaccines despite decades of research efforts,” said Carey Hwang, Vir’s Senior Vice President, Clinical Research, Head of Chronic Infection, in the company’s press release. mRNA, 2) BG505 MD39.3 gp151 mRNA and 3) BG505 MD39.3 gp151 CD4KO mRNA.

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Vaccination Vaccine Trials Clinical Trials 59

XTalks

APRIL 11, 2024

RELATED ON-DEMAND XTALKS WEBINAR: Leveraging Digital Biomarkers to Generate Real-World Physiological and Behavioral Data in CNS Clinical Studies Register for this free webinar to learn about an AI-based, multi-domain digital biomarker platform designed to provide objective, diverse and home-based patient data collection in CNS clinical trials.

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Clinical Trials Clinical Trials Development Clinical Development 110

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. ” The Phase III clinical development program consists of three studies, the BRIDGE study, the BALANCE study and the BRIGHT study. CARMIEL, Israel and BOSTON , Dec. Galactosidase-A enzyme.

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Clinical Trials Clinical Trials Trials Protein 52

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.

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Gene Editing DNA Cosmetics Life Science 100