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

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. XTALKS WEBINAR: Novel Protein-Like Synthetic Polymers with Superior Properties as Therapeutics, Diagnostics and Targeted Delivery Agents.

FDA Approval 105

FDA Approval Antibody Clinical Trials Clinical Trials 105

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.

Clinical Trials 119

Clinical Trials Clinical Trials FDA Approval Trials 119

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

XTalks

DECEMBER 27, 2022

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

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

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

XTalks

MARCH 10, 2023

But with Skyclarys (omaveloxolone), the first and only drug to treat Friedreich’s ataxia in patients aged 16 years and older, Reata Pharmaceuticals has developed a new treatment option to improve neurological function. This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher.

FDA Approval 52

FDA Approval Engineer Clinical Trials Clinical Trials 52

XTalks

SEPTEMBER 16, 2022

Last week, Bristol Myers Squibb (BMS) announced that their therapy Sotyktu (deucravacitinib) was approved by the US Food and Drug Administration (FDA) as a first-line treatment for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu (deucravacitinib) Clinical Results.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

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

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 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. The post 4th RAS-Targeted Drug Development Summit appeared first on. Access the official agenda for more information.

Development 52

Development Drugs FDA Approval Clinical Trials 52

Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals stated that the fast-track designation enables increased communication with the regulator across the development cycle of the gene therapy. Fast-track status also offers the potential for expedited approval of RP-A601 and permits a rolling review of the biologic licence application.

Gene Therapy 147

Gene Therapy Gene FDA Approval Trials 147

The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). It was developed with Genmab.

FDA Approval 52

FDA Approval Drug Delivery Doctors Doctor 52

Drug Discovery World

NOVEMBER 29, 2023

Researchers have created a mathematical model that can accurately depict Alzheimer’s disease progression in individual patients, paving the way for personalised treatment and faster development of therapies. These findings closely matched the results of the corresponding real-life clinical trials.

Development 52

Development Drugs Radiology Drug Trials 52

pharmaphorum

DECEMBER 1, 2021

The French group said that ORI-001, a vaccine based on recombinant proteins from the Cutibacterium acnes (formerly Propionibacterium acnes ) bacterium that is often found in acne lesions, could be the first ever vaccine for the condition. The post Sanofi snaps up acne vaccine developer Origimm Bio appeared first on.

Vaccination 105

Vaccination Vaccine Development Hormones 105

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. 1, 2, 3, 4.

FDA Approval 40

FDA Approval Clinical Trials Clinical Trials Trials 40

Drug Discovery World

NOVEMBER 14, 2023

The Antibody Society’s data confirmed that 3.63% of the approved mAbs were for the treatment of Covid-19, which is significant when considering that it has overtaken diseases such as Alzheimer’s, which has been studied for much longer. A prime example of repurposing for rare disease is Eculizumab, which targets the C5 protein.

Antibody 59

Antibody Development FDA Approval Trials 59

Drug Discovery World

OCTOBER 18, 2023

Sara Donnelly, Director of Research Planning and Business Development at PhoenixBio USA explores why the right pre-clinical model is essential for teams wanting to advance adeno-associated virus vector-based gene therapies.

Gene Therapy 64

Gene Therapy Gene Clinical Trials Clinical Trials 64

XTalks

MAY 10, 2022

Researchers at the University of Manchester have developed a new blood test that can help diagnose ovarian cancer faster and more accurately in women, particularly those under the age of 50, using a newer ovarian cancer biomarker. The test includes the use of the emerging ovarian cancer biomarker, human epididymis protein 4 (HE4).

Research 105

Research Development Clinical Trials Clinical Trials 105

XTalks

NOVEMBER 30, 2023

Global entities such as the WHO, the Global Fund and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have developed comprehensive strategies aligned with Sustainable Development Goal (SDG) target 3.3, This marked the first FDA-approved injectable, complete regimen for HIV-infected adults, administered once a month.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

XTalks

MAY 10, 2023

In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. Read more about the vaccine, including clinical trial results on its efficacy and safety.

Life Science 52

Life Science Vaccination Vaccine FDA Approval 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,

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

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. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” . CHENGDU, China , Feb. CHENGDU, China , Feb.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Pfizer

AUGUST 3, 2022

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Decision follows results of interim futility analysis which indicate Phase 3 REALM-DCM trial unlikely to meet primary endpoint.

Development 101

Development Vaccination Vaccine Production 101

XTalks

FEBRUARY 20, 2024

have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for sibeprenlimab, an investigational drug intended for treating immunoglobulin A (IgA) nephropathy, commonly known as Berger’s disease. Consequently, this damage causes blood and protein leakage into the urine.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

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. Genmab has achieved notable success with eight approved therapies and an impressive pipeline.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

XTalks

JULY 13, 2023

It measures the phosphorylated form of the tau 181 protein isoform, a biomarker for Alzheimer’s disease pathology. The protein is found at low levels in the blood, necessitating high analytical sensitivity to measure it reliably. It will be available as a lab-developed test through Quanterix’s CLIA-certified laboratory.

Protein 98

Protein FDA Approval Clinical Trials Clinical Trials 98

The Pharma Data

MAY 31, 2022

. “The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., ABOUT ZOKINVY (LONAFARNIB).

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

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.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

XTalks

APRIL 18, 2024

Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. This test, which is being co-developed with Eli Lilly, has the potential to facilitate earlier and more accurate detection of the disease.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 mL subcutaneous solution (2 mg/1.5 Jardiance brought in $2.06 billion in Q4 2022.

Sales 52

Sales Insulin FDA Approval Drugs 52

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. Farber extended congratulations to GSK on behalf of the alliance: “An effective treatment developed specifically for lupus nephritis has been desperately needed. MacroGenics Inc.

FDA Approval 52

FDA Approval Genome Genomics Production 52

XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. It is injected into a patient’s muscle tissue.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

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.

Gene Therapy 102

Gene Therapy Gene Trials Protein 102

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. What is SOD1 -ALS?

FDA Approval 89

FDA Approval Gene Genetics Protein 89