Pharmaceutical Technology

APRIL 6, 2023

The Miami, US-based company will carry out a Phase IIb trial that will investigate hippocampal volume changes and assess multiple AD and cognition scales over 12 months in patients with mild Alzheimer’s disease. The difficulty in finding a treatment for Alzheimer’s disease has plagued the drug industry for decades.

FDA Approval 264

FDA Approval Licensing Licensing Antibody 264

XTalks

JANUARY 22, 2025

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. The findings reveal a remarkable 98.3%

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Immune Response Vaccination Vaccine Trials 59

XTalks

NOVEMBER 21, 2024

The test, the first of its kind approved for over-the-counter (OTC) use in the US, detects antibodies for Treponema pallidum , the bacterium responsible for syphilis. Using a single drop of blood, it delivers highly accurate results, with clinical trials showing a 99.5 percent accuracy rate for negative cases and 93.4

Bacterium 104

Bacterium Antibody Manufacturing Pharmacy 104

XTalks

NOVEMBER 12, 2024

Thus, to address drug-resistant infections, pharma and biotech companies are developing novel treatments such as bacteriophage therapies, immunomodulators and monoclonal antibodies. Monoclonal Antibody Therapies Monoclonal antibodies are gaining traction as targeted treatments for bacterial and viral infections.

Bacteria 110

Bacteria Life Science Vaccination Vaccine 110

pharmaphorum

AUGUST 25, 2020

The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections. The phase 1 trial – funded by the US government – will take place in the UK and will test the safety of AZD7442 and its pharmacokinetic profile.

Antibody 84

Antibody Trials Trial Funding Licensing 84

Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. Still, the country’s clinical trials sector remains insular. Tracking the news. Alzheimer’s disease drugs were constantly in the news, and not always for the right reasons.

Clinical Trials 306

Clinical Trials Clinical Trials Trials Vaccination 306

STAT News

JANUARY 10, 2023

SAN FRANCISCO — For months, drugmakers have been pleading with regulators to lower the bar for authorizing antibody drugs for Covid. The virus, they noted, had evolved fast enough to render every previous antibody obsolete.

Antibody 98

Antibody Clinical Trials Clinical Trials Regulation 98

Pharmaceutical Technology

NOVEMBER 22, 2022

The iPSC-based allogeneic cell therapy platform of Umoja leverages its synthetic receptor enabled differentiation (ShRED) manufacturing process to guide iCIL differentiation and development with robust anti-tumour activity. In the initial stage, the partnership will focus on acute myeloid leukaemia (AML) to boost accessibility to patients.

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Development In-Vivo Engineer Clinical Trials 276

Fierce Pharma

JANUARY 9, 2024

But the Japanese company will have to clear up manufacturing issues first. The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility.

Manufacturing 88

Manufacturing Antibody Licensing Licensing 88

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

Pharmaceutical Technology

AUGUST 15, 2022

The latest MHRA decision is based on findings from the Phase II/III clinical trial, where the mRNA-1273.214 vaccine met all primary endpoints. In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1) 1) versus the 50µg mRNA-1273 booster dose.

Vaccination 214

Vaccination Vaccine Immune Response Clinical Trials 214

pharmaphorum

APRIL 9, 2021

The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.

Antibody 98

Antibody Insulin Trials Production 98

Pharmaceutical Technology

MARCH 31, 2023

A study involving 765 adults indicate that Bimervax, in addition to reducing antibodies against original SARS-CoV-2 strain, led to higher levels of antibodies against Beta and Omicron variants. Moreover, these events also have ramifications for planned clinical trials.

Vaccination 277

Vaccination Vaccine Immune Response Antibody 277

Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. These two molecules are presently being analysed by the research and development (R&D) team of Sanofi, with one currently being evaluated in clinical trials.

Development 264

Development Engineer Clinical Trials Clinical Trials 264

XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

XTalks

MARCH 15, 2021

Eli Lilly (NASDAQ: LLY ) shared the latest results from a late-stage study which show its combination antibody COVID-19 treatment can reduce hospitalizations and deaths by an impressive 87 percent, compared with placebo. The study is part of Lilly’s ongoing Phase III BLAZE-1 trial evaluating the antibody duo.

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Antibody Trials Protein Regulation 92

pharmaphorum

SEPTEMBER 4, 2020

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. They said the trials would involve 440 adults at 11 sites across the US. If data from the phase 1/2 trial are positive, the companies aim to move into a phase 3 trial by the end of the year.

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Clinical Trials Clinical Trials Vaccination Vaccine 106

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

pharmaphorum

JUNE 28, 2021

AstraZeneca and Sanofi now have the data they need in hand to press ahead with regulatory filings next year for nirsevimab, an antibody designed to prevent respiratory syncytial virus (RSV) – the leading cause of hospitalisations in infants. . The post AZ, Sanofi prep filings for one-shot RSV antibody after trial win appeared first on.

Antibody 66

Antibody Trials Sales Development 66

XTalks

JANUARY 20, 2025

Pfizer announced promising results from its Phase III trial investigating the efficacy of sasanlimab, an anti-PD-1 monoclonal antibody, in combination with standard of care Bacillus Calmette-Guerin (BCG) immunotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are BCG-nave.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

XTalks

MARCH 17, 2025

This system captures and enriches circulating tumor cells (CTCs) and related biomarkers from patient blood samples using a physical, antigen-independent method offering an alternative to conventional antibody-based techniques. recovery rate, surpassing their performance targets.

Production 71

Production Manufacturing DNA Genetics 71

Pharmaceutical Technology

APRIL 14, 2023

The new, highly potent neutralising immunoglobulin antibody has been developed for preventing or reducing severe outcomes of Type A and Type B influenza infection in patients at high risk for severe complications, including immunocompromised individuals.

Antibody 130

Antibody Trials Clinical Trials Clinical Trials 130

Pharmaceutical Technology

MAY 26, 2023

GlobalData separates immuno-oncology treatments into six broad classes, which include bispecific antibodies, cancer vaccines, and cell therapies. There are about 149 cell therapies in Phase I trials now , with additional 146 in Phase II studies, noted Chalk. Click here to watch this webinar and access the presentation.

Marketing 264

Marketing Vaccine Vaccination Development 264

Pharmaceutical Technology

DECEMBER 16, 2022

Spearheaded by collaborations between non-profit groups and pharma players, new treatments are edging closer to late-stage trials in malaria and neglected tropical diseases such as sleeping sickness. However, Mosquirix’s efficacy is limited, while results from a Phase III licensure trial of R21 are expected this year.

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Development Drugs Vaccine Vaccination 264

XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

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Antibody Immune Response Trials Clinical Trials 75

Pharmaceutical Technology

APRIL 13, 2023

The therapy will be assessed in a Phase I trial. It will conduct the Phase I trial, while AstraZeneca will handle the subsequent clinical development of FPI-2068. FPI-2068 is a bispecific targeted alpha therapy (TAT) being jointly developed by Fusion and AstraZeneca under a multi-asset collaboration agreement.

Clinical Development 147

Clinical Development Antibody Development Trials 147

Pharmaceutical Technology

JANUARY 19, 2023

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. It has been developed using the company’s recombinant nanoparticle technology.

Vaccination 147

Vaccination Vaccine Immune Response Protein 147

pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. times more neutralising antibodies than in younger patients aged 18-55 recovering from SARS-CoV-2 infection. There could be up to 1.3

Vaccination 122

Vaccination Vaccine Antibody Regulation 122

Pharmaceutical Technology

JUNE 5, 2023

The funding will be used to fuel the company’s pipeline of targeted radionuclide therapies alongside manufacturing capacities. ITM-11 is being studied in the Phase III COMPETE (NCT03049189) and COMPOSE (NCT04919226) trials, which investigate the drug’s use in patients with different grades of GEP-NETs.

Trials 147

Trials Containment Antibody Manufacturing 147

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . The post Altimmune ditches nasal COVID vaccine on weak trial data appeared first on.

Vaccination 98

Vaccination Vaccine Trials Immune Response 98

pharmaphorum

MAY 11, 2022

A pooled analysis of data for AstraZeneca and Sanofi’s respiratory syncytial virus (RSV) antibody nirsevimab has concluded that the drug is almost 80% effective at preventing lower respiratory tract infections caused by the pathogen. versus placebo. versus placebo.

Antibody 64

Antibody Vaccination Vaccine Trials 64

pharmaphorum

NOVEMBER 6, 2022

The antibody-based drug has been cleared by the European Commission with a broad label, covering both full-term and pre-term babies and those with a range of health conditions that could make the vulnerable to RSV, said the two pharma groups in a statement. It is sold by Sobi in the US.

Antibody 64

Antibody Vaccination Vaccine Sales 64

Pharmaceutical Technology

SEPTEMBER 2, 2022

lenalidomide) + a steroid ± an anti-CD38 antibody. Last month, the European Medicines Agency's (EMA) approval of Johnson & Johnson’s (J&J) anti-CD3/BCMA bispecific antibody Tecvayli (teclistamab) marked the fourth anti-BCMA biologic to enter the R/R MM market. Should CAR-T cells, or antibodies be used first?

Antibody 147

Antibody Sales FDA Approval Production 147

Pharmaceutical Technology

JANUARY 30, 2023

This is mixed news for contract manufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manufacture of the most innovative products. Lilly has disclosed only in-house manufacturing locations for the drug.

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Drugs Manufacturing Contract Manufacturing FDA Approval 130

pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. Roche meanwhile is continuing to trial its drug in combination with remdesivir.

Drugs 97

Drugs Antibody Contract Manufacturing Immune Response 97

pharmaphorum

JULY 22, 2021

Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19. It was identified as a potential treatment through the screening of antibody candidates from recovered patients and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. Overcoming obstacles.

Antibody 105

Antibody Clinical Trials Clinical Trials Trials 105