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. Food and Drug Administration in 2017.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

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

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 94

Clinical Trials Clinical Trials Trials Drugs 94

XTalks

OCTOBER 23, 2024

The primary endpoint of the trial was a reduction in 24-hour urine protein-to-creatinine ratio (uPCR) compared to placebo after nine months of treatment, which indicates improved kidney function. All participants were receiving standard care, including ACE inhibitors or angiotensin II receptor blockers (ARBs).

Trials 101

Trials Clinical Trials Clinical Trials Antibody 101

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

XTalks

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. New treatment options are critically needed for FL.

Drugs 52

Drugs FDA Approval Antibody Medicine 52

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. 07.27.2022.

Development 101

Development Vaccination Vaccine Production 101

Delveinsight

AUGUST 13, 2020

Even so, the decision marked the end of the interest of Roche in developing the asset. million to fund late-phase clinical development of its antifungal agent olorofim and gear up commercialization. Protein implication in Alzheimer’s could enhance cancer immunotherapy. F2G raises USD 60.8 F2G has raised USD 60.8

Trials 52

Trials Research Drugs Protein 52

pharmaphorum

SEPTEMBER 12, 2022

Reddy says one of LabCorp’s groundbreaking tests, OmniSeq INSIGHT, is an “all-in-one test that includes comprehensive genomics and immune profiling from a single tissue sample to identify all FDA-approved therapeutics, confirm immunotherapy eligibility for a patient, and identify appropriate nearby clinical trials.”.

Genome 105

Genome Genomics Clinical Trials Clinical Trials 105

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

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

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

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. Source link.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

APRIL 12, 2021

synuclein is a hallmark of Parkinson’s, and it’s been postulated that dysfunction of GCase in neurons could contribute to build-up of the protein and the resulting inflammation and neurodegeneration characteristic of the disorder. According to Neuropore’s pipeline page, both UCB0599 and NPT520-34 remain in Phase I clinical development.

Gene Therapy 96

Gene Therapy Gene Trials Development 96

pharmaphorum

JANUARY 16, 2023

Even as innovative pharmacotherapies are approved, there’s still intense discussion as the basic research level on the role of beta amyloid plaques in Alzheimer’s. This is linked to wider questions about the role damaged proteins and their build up plays in ageing across different tissues and organs.

Gene Therapy 98

Gene Therapy In-Vitro Gene Medicine 98

The Pharma Data

DECEMBER 8, 2020

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. Through its Shielded Living Therapeutics platform, the company is developing functional cures for chronic diseases.

RNA 52

RNA Antibody Life Science Protein 52

The Pharma Data

DECEMBER 18, 2020

The NDA remains under regulatory review, with the FDA having set a new action date of 20 March 2021. Anemia Anemia can be a serious medical condition in which patients have insufficient red blood cells (RBCs) and low levels of haemoglobin, a protein in RBCs that carries oxygen to cells throughout the body. .

Medicine 52

Medicine FDA Approval Development Production 52

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. There is a real need to advance new treatment options for triple-negative breast cancer, an aggressive form of the disease,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in July 2020.

Licensing 52

Licensing Licensing Drugs Gene 52

The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

Clinical Trials 52

Clinical Trials Clinical Trials Trials Protein 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

XTalks

MAY 9, 2024

We also invented four proprietary antibody technologies, including our DuoBody® bispecific technology which is the backbone of four FDA-approved bispecifics and over ten in development.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

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

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

XTalks

SEPTEMBER 19, 2024

The mechanism of action of our BTK CDAC allows for complete degradation of the BTK protein and has distinct advantages over current BTK inhibitors. Zanubrutinib has five US Food and Drug Administration (FDA)-approved indications and the broadest label in its class.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

JANUARY 5, 2021

Developed by Ellume Therapeutics , the test is a rapid, lateral flow antigen test, which involves passing a liquid sample along a surface with detection antibodies. The test identifies SARS-CoV-2 protein fragments from nasal swab samples. The burden of clinical trials is on all patient groups and patient segments.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

Pfizer

DECEMBER 8, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron sublineages BA.4/BA.5, SARS-CoV-2 led to a global pandemic with more than 6.5 million deaths ii and a high socio-economic burden worldwide.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

JUNE 7, 2022

. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” Almirall also plans to submit these results this year to the European Medicines Agency (EMA) for authorization.

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

The Pharma Data

NOVEMBER 30, 2020

It showcases our ability to advance strategically important candidates against specific disease targets through early development to become attractive partnering opportunities in parallel with the multi-target deals we have established. GPCR – G protein-coupled receptors. About Sosei Heptares.

Licensing 40

Licensing Licensing Production Development 40

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

OCTOBER 30, 2020

To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.

Production 52

Production Antibody Manufacturing Trials 52

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

DECEMBER 15, 2020

Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. The protein may be involved in such conditions, and a CRP test may be used to find or monitor conditions that cause inflammation. These include inflammatory bowel disease, lupus or rheumatoid arthritis.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

JANUARY 15, 2021

3 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancer. mg/kg) is also approved in the U.S. About the Enhertu Clinical Development Program. 2,5 In the U.S., Enhertu (6.4 Cancer Stat Facts: Stomach Cancer.

Medicine 52

Medicine Trials Antibody HR 52

The Pharma Data

DECEMBER 5, 2020

BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. and the world, respectively, in 2020.

Antibody 40

Antibody Production Trials Medicine 40

The Pharma Data

OCTOBER 25, 2020

FDA approval. 1 SCD is a lifelong inherited rare blood disorder that impacts hemoglobin, a protein carried by red blood cells that delivers oxygen to tissues and organs throughout the body. 1 It also affects people of Hispanic, South Asian, Southern European and Middle Eastern ancestry.

Medicine 40

Medicine Development Containment FDA Approval 40

The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. The development and manufacturing of the antibody cocktail has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S.

Antibody 52

Antibody Trials Production Clinical Trials 52

XTalks

JANUARY 6, 2025

Just before the end of 2024, Novo Nordisk nabbed US Food and Drug Administration (FDA) approval for its awaited hemophilia drug Alhemo (concizumab-mtci). This, in turn, leads to improved thrombin generation a crucial protein involved in blood clotting.

FDA Approval 105

FDA Approval Antibody Drugs Clinical Trials 105