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.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

FDA Approval 52

FDA Approval Production RNA Medicine 52

XTalks

JUNE 9, 2022

It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. Evkeeza works by binding to and blocking the function of ANGPTL3, which is a protein that plays a role in lipid metabolism.

Trials 52

Trials Antibody Genetics Gene 52

pharmaphorum

MAY 30, 2022

Despite this, the first-ever FDA-approved KRAS G12C inhibitor has demonstrated that RAS is in fact druggable and that drugging this protein unlocks a world of successful therapeutic interventions. For decades, RAS has existed as an elusive therapeutic target, and drugging this high-value oncogene was deemed impossible.

Development 52

Development Drugs FDA Approval Clinical Trials 52

Delveinsight

AUGUST 13, 2020

Researchers call out Gilead over the diversity of remdesivir trials. Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. Roche was preparing to commence another combination trial in lymphoma patients when it withdrew the study before enrolling in the first subject in 2018.

Trials 52

Trials Research Drugs Protein 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

MARCH 10, 2021

With so many novel drug candidates for Alzheimer’s disease failing in clinical development, researchers in the US have started using artificial intelligence (AI) to screen already-approved therapies for activity against the neurodegenerative disorder. .

Clinical Trials 88

Clinical Trials Clinical Trials Trials FDA Approval 88

pharmaphorum

JANUARY 5, 2022

Having already brought their mRNA-based CVID-19 vaccine Comirnaty to market at breakneck speed, Pfizer and BioNTech are hoping to fast-track a vaccine for shingles based on the same technology platform through clinical development, with trials due to start later this year.

Vaccination 95

Vaccination Vaccine Sales Clinical Development 95

Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

Antibody 98

Antibody Marketing Drugs Licensing 98

Drug Discovery World

AUGUST 21, 2023

Diana Spencer investigates therapies in clinical development for triple-negative breast cancer and asks what future treatments might look like. The addition of pembrolizumab was supported by further trial results in 2022. months for those who received chemotherapy alone. and 79.6%, respectively.

Protein 52

Protein Trials Clinical Trials Clinical Trials 52

The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Source link: [link].

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC®) targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma cells.

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 52

XTalks

MAY 9, 2024

XTALKS CLINICAL EDGE: Issue 2 — Genmab’s Interview Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. Celebrating 25 years of innovation is a significant milestone.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

Drug Discovery World

DECEMBER 13, 2023

Anti-idiotype antibodies are critical for the development and validation of antibody-based biologics, CAR therapies including CAR T cells, and VHH. Fortis can also generate antibodies against small molecule drugs, and cell surface, secreted and intracellular targets including proteins that have undergone post-translational modifications.

Life Science 59

Life Science Antibody Manufacturing In-Vivo 59

Pfizer

AUGUST 3, 2022

Decision follows results of interim futility analysis which indicate Phase 3 REALM-DCM trial unlikely to meet primary endpoint. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. Wednesday, August 03, 2022 - 05:00pm. NEW YORK, AUGUST 3, 2022 – Pfizer Inc.

Development 101

Development Vaccination Vaccine Production 101

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. and globally.”.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Protein 52

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

Drug Discovery World

MARCH 7, 2023

Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialisation, and at Georgetown Law School as an adjunct professor. She founded Neuroute in 2019, with the aim of empowering patients from diverse backgrounds to participate in drug trials.

Life Science 98

Life Science DNA Clinical Development Development 98

XTalks

APRIL 12, 2021

Like other neurodegenerative disorders, such as Alzheimer’s disease and dementias, Parkinson’s disease research has been immensely challenging for biotechs, with a high rate of late-stage attrition in trials leading to a lack of disease-modifying therapies being approved. Cellular accumulation of ?-synuclein Axovant Gene Therapies.

Gene Therapy 96

Gene Therapy Gene Trials Development 96

The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is also approved in Australia and Canada. IDHIFA is also approved in Australia and Canada.

Trials 52

Trials FDA Approval Development Clinical Trials 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,

Antibody 52

Antibody Trials Production Clinical Trials 52

Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

Medicine 59

Medicine DNA Genome Genomics 59

Drug Discovery World

OCTOBER 4, 2022

New York-based Oligomerix is an emerging clinical-stage biotechnology company focused on developing disease-modifying therapeutics for neurodegenerative diseases characterised by aberrant tau protein ranging from rare tauopathies such as progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD) to Alzheimer’s disease (AD).

Development 52

Development In-Vivo Compound Screening Clinical Development 52

The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. Spinal Muscular Atrophy (SMA). Multiple Sclerosis (MS). Neuromyelitis Optica Spectrum Disorder (NMOSD). Roche will present five sets of data on adults living with NMOSD.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. Pending discussions with the FDA, the oral vaccine will enter Phase I trials as a prime and boost, and will be explored to provide a boost to subcutaneous vaccinations.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. Roche’s Chief Medical Officer and Head of Global Product Development. Evrysdi is designed to treat SMA by increasing and sustaining the production of the survival of motor neuron (SMN) protein. months of age.

Protein 52

Protein In-Vitro Medicine FDA Approval 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

Immune Response 52

Immune Response Vaccination Vaccine FDA Approval 52

The Pharma Data

MARCH 16, 2021

Evrysdi is the first and only at home SMA treatment approved by the FDA, and has proven efficacy across adults, children and infants 2 months and older. More than 2,500 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings. and 0%, respectively) and influenza (0.8%

Protein 52

Protein Medicine Trials Clinical Trials 52

XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

XTalks

MAY 31, 2023

The success of Acelyrin can be attributed to its industry-leading immunology portfolio and a robust pipeline of clinical and preclinical programs. One of its notable candidates is izokibep, a small protein inhibitor of interleukin-17A (IL-17A). This therapy holds promise in the field of cancer treatment.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Production 97

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

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. Patent Trial and Appeal Board (PTAB) had instituted inter partes review (IPR) against U.S. The data was based on the Phase III KEYNOTE-355 trial. The drug was approved for that indication on November 13. On October 14, Liquidia announced the U.S.

Licensing 52

Licensing Licensing Drugs Gene 52

The Pharma Data

DECEMBER 8, 2020

Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Nuance Pharma .

RNA 52

RNA Antibody Life Science Protein 52