XTalks

DECEMBER 29, 2023

. “The FDA’s Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy,” said David M.

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Clinical Trials Clinical Trials FDA Approval Trials 119

XTalks

JUNE 2, 2021

The sotorasib approval is therefore a major breakthrough in the world of cancer and targeted therapies. The oral treatment was approved for adults with locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

XTalks

MAY 26, 2022

The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. These proteins cause the type 2 inflammation characteristic of EoE and related allergic diseases like asthma and atopic dermatitis (both treated with Dupixent).

FDA Approval 105

FDA Approval Antibody Clinical Trials Clinical Trials 105

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Regulatory Approvals for CTC-Based Assays in Oncology.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Drug Discovery World

JANUARY 23, 2023

“Put simply, radioresistant GBM cells prefer to stock up on fatty acids instead of utilising them as an energy source in order to reduce mitochondrial reactive oxygen species that may cause damage to their DNA, RNA, and proteins, and, in turn, cell death,” explains Prof Youn.

FDA Approval 52

FDA Approval Drugs In-Vivo In-Vitro 52

XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

Pharmaceutical Technology

DECEMBER 23, 2022

This approval is backed by findings from the multicentre, double-blinded, placebo-controlled, international Phase II/III CAPELLA clinical trial of lenacapavir plus an optimised background regimen. Subcutaneous lenacapavir’s antiviral activity administered every six months was analysed in the trial.

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Drugs FDA Approval Clinical Trials Clinical Trials 147

Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. The prospective, double-blind, placebo-controlled Phase III clinical trial enrolled 95 patients at 36 sites globally, including 17 sites in the U.S., Credit: Octapharma. PARAMUS, N.J. – The U.S. residents. . 1, 2, 3, 4.

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FDA Approval Clinical Trials Clinical Trials Trials 40

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

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Vaccination Vaccine Protein Antibody 52

Pharmaceutical Technology

AUGUST 23, 2022

It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,

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Vaccination Vaccine Gene Therapy Protein 130

The Pharma Data

MAY 31, 2022

.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

Drug Discovery World

OCTOBER 18, 2023

We’re beginning to see their potential come to fruition, with the FDA having approved three treatments as of January 2023 — for retinal dystrophy 1 spinal muscular atrophy, 2 and haemophilia B.

Gene Therapy 64

Gene Therapy Gene Clinical Trials Clinical Trials 64

XTalks

MAY 9, 2024

As we explore Genmab’s strategic vision, technological advancements and the next frontier in antibody research, we gain insights into the future of medicine — a future where Genmab’s cutting-edge therapies are poised to transform patient care and meet the complex challenges of the next generation of healthcare.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

pharmaphorum

SEPTEMBER 16, 2022

A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”. Kim recognised then, he said, that better tools for medicine needed to be developed, and that they still do.

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Development Research Drugs Clinical Trials 135

The Pharma Data

DECEMBER 17, 2020

Lupus causes the production of proteins called autoantibodies in the immune system, which attack tissues and organs, including the kidneys. There will be a brand-new treatment for actinic keratosis on the market next year, with Tuesday’s FDA approval of Athenix’s Klisyri® (tirbanibulin). Athenex, Inc.

FDA Approval 52

FDA Approval Genome Genomics Production 52

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif., ABOUT ZOKINVY (LONAFARNIB).

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

pharmaphorum

MAY 13, 2021

The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinical trial and part of 55 globally, across 15 countries. The trial is expected to enrol 99 ambulatory male patients, aged four to seven.

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Gene Therapy Gene Trials Protein 102

Drug Discovery World

MAY 21, 2024

Modern experimental procedures, such as immunisation, B-cell screening, and synthetic library generation, have been pivotal in developing approximately 80 FDA-approved antibody therapeutics. Existing antibody discovery methods have mostly failed for certain target groups, such as G protein-coupled receptors (GPCRs) and ion channels.

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Antibody Development FDA Approval Contract Manufacturing 59

Drug Discovery World

NOVEMBER 14, 2023

Takeda’s Adzynma has become the first recombinant protein product approved in the US for prophylactic or on-demand enzyme replacement therapy (ERT) for congenital thrombotic thrombocytopenic purpura (cTTP).

FDA Approval 52

FDA Approval Gene Clinical Trials Clinical Trials 52

Drug Discovery World

MARCH 12, 2024

Two trends are emerging: firstly, a rise in the use of novel mAbs as companies step beyond pre-approved monoclonal antibodies for conjugation. Secondary, there is a growing interest in replacing the cytotoxic head with non-toxic alternatives, like protein degraders.

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Antibody FDA Approval Drugs Development 81

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

FDA Approval 52

FDA Approval Production Research Doctors 52

XTalks

SEPTEMBER 17, 2021

The ALS Association is pushing for rapid FDA approval of Amylyx Pharmaceuticals Inc.’s The complex is designed to target the toxic unfolded proteins in the endoplasmic reticulum, as well as mitochondrial dysfunction, which is being increasingly recognized as a pathogenic mechanism underlying the disease.

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Trials Drugs FDA Approval Clinical Trials 98

The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 26, 2020

As the second wave of the pandemic continues to grip much of the world, the study is part of efforts to identify existing FDA-approved drugs that can be repurposed to treat or prevent COVID-19 as it is the most efficient and inexpensive approach. The study was published in the journal PLOS Biology. The list also included melatonin.

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Research Hormones Protein Regulation 98

XTalks

JUNE 8, 2021

SMA is caused by mutations in the survival motor neuron 1 ( SMN1) gene, which along with the SMN2 gene, encode the SMN protein. It is administered as a one-time IV administration and expression of the SMN protein from the gene improves muscle movement and function, and ultimately survival. Zolgensma Gene Therapy: START Trial.

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Gene Therapy Gene Protein Trials 110

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

XTalks

MAY 2, 2023

In December 2021, AstraZeneca and Amgen’s Tezspire (tezepelumab) was approved by the FDA for patients 12 years of age and older with severe asthma that is not controlled by their current asthma medicine. Regeneron and Sanofi’s Dupixent (dupilumab) received FDA approval in 2018 for the treatment of moderate-to-severe asthma.

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Protein FDA Approval Clinical Trials Clinical Trials 109

The Pharma Data

SEPTEMBER 28, 2021

“These new data for Evrysdi may help extend the potential benefits of this medicine to the youngest SMA patients. Also, the info from SRP-9001 have helped to optimise the planning of the upcoming phase III clinical trial trial for DMD,” said Levi Garraway, M.D., Roche’s Chief medic and Head of worldwide development.

Gene Therapy 52

Gene Therapy Protein Gene Clinical Trials 52

STAT News

MARCH 6, 2023

It works with commercial partners and researchers at the Washington University School of Medicine in St. Louis to create a promising but yet-to-be-approved treatment known as a personalized neoantigen synthetic long peptide vaccine. Therapeutic vaccines represent the next frontier in cancer medicine.

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Vaccination Vaccine Drugs Clinical Trials 98

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 52

Antibody Medicine Production Trials 52

Delveinsight

AUGUST 13, 2020

Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. The call follows an evaluation of Gilead’s remdesivir clinical trials, which found the studies that flunked to offer an equal representation of Black, Latinx, and Native Americans.

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Trials Research Drugs Protein 52

XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

FDA Approval 81

FDA Approval Clinical Trials Clinical Trials Trials 81

XTalks

MARCH 28, 2024

Early clinical trials have shown promising results and this therapy could become a valuable addition towards CRC treatment in the future. There are early-stage clinical trials that are investigating the efficacy and safety of CAR T-cell therapy for treating CRC, with a focus on targeting cancer-specific antigens.

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Gene Editing Life Science Clinical Trials Clinical Trials 59

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. Almirall S.A.’s

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Trials Clinical Trials Clinical Trials Medicine 40

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

FDA Approval 101

FDA Approval Drugs Sales Development 101

The Pharma Data

JANUARY 6, 2021

The vaccine was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. The approval in India is an important milestone as it will enable to supply India but also a large number of countries around the world.

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Vaccination Vaccine Clinical Trials Clinical Trials 52