Drug Discovery World

JUNE 6, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo in individuals 60 years and older. The post FDA approves first vaccine for respiratory syncytial virus appeared first on Drug Discovery World (DDW).

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FDA Approval Vaccination Vaccine Clinical Trials 52

XTalks

DECEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. The landmark approvals were awarded to bluebird bio’s Lyfgenia (lovo-cel) and Vertex Pharmaceuticals and CRISPR Therapeutics’ jointly developed Casgevy (exa-cel).

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Gene Therapy FDA Approval Gene In-Vivo 98

XTalks

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

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FDA Approval Gene Therapy Gene Clinical Trials 59

Pharmaceutical Technology

NOVEMBER 14, 2022

Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial. binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4. The ADC comprises an FR?-binding

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FDA Approval Antibody Clinical Trials Clinical Trials 246

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.

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FDA Approval Manufacturing Trials Clinical Trials 52

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.

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FDA Approval Antibody Clinical Trials Clinical Trials 105

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.

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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).

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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.

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FDA Approval Engineer Clinical Trials Clinical Trials 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.

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FDA Approval Manufacturing In-Vivo Trials 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

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.

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FDA Approval Drugs In-Vivo In-Vitro 52

pharmaphorum

MARCH 29, 2021

The modified cells recognise and bind to B-cell maturation antigen (BCMA), a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of cells expressing it. The delay was caused by coronavirus restrictions delaying the site inspections necessary for approval.

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FDA Approval Genetics Protein Antibody 85

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.

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Gene Therapy FDA Approval Gene 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.

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FDA Approval Clinical Trials Clinical Trials Trials 52

XTalks

JANUARY 28, 2022

Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore. Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Related: Cancer Blood Test Developed by University of Oxford Researchers Can Detect Metastasis.

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FDA Approval Development Licensing Licensing 98

Roots Analysis

JANUARY 19, 2024

Introduction In a strategic move to accelerate the development and launch of genetic medicines, BridgeBio Pharma has successfully secured up to USD 1.25 In a deal worth USD 500 million in cash, BridgeBio Pharma has committed to providing the investors with a 5% royalty on worldwide net sales of its drug, acoramidis, pending FDA approval.

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pharmaphorum

MAY 13, 2021

The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. 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.

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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.

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Gene Therapy Gene FDA Approval Trials 147

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. months (the median duration of response was not evaluable).

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Clinical Trials Clinical Trials FDA Approval Trials 119

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.

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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. each year.

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FDA Approval Drug Delivery Doctors Doctor 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.

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Development Drugs FDA Approval Clinical Trials 52

Drug Discovery World

NOVEMBER 14, 2023

Additionally, interim results from an ongoing Phase I/II trial for Aulos Bioscience’s monoclonal antibody AU-007 were positive, showing that AU-007 is well tolerated in patients with unresectable locally advanced or metastatic cancer and there are early signs of anti-tumour activity.

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Antibody Development FDA Approval Trials 57

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.

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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.

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Development Vaccination Vaccine Production 101

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.

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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

Pharmaceutical Technology

FEBRUARY 21, 2023

C5 is a protein that is involved in the activation of the complement system. The antibody is developed using the company’s VelocImmune technology. In the trial, the clinical symptoms were assessed, including the number of bowel movements per day, abdominal pain, and investigator-assessed facial and peripheral edema.

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Antibody FDA Approval Licensing Licensing 130

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., Patients were allowed to switch treatment if they deteriorated during the trial.

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FDA Approval Clinical Trials Clinical Trials Trials 40

XTalks

JULY 10, 2023

Euronext Brussels (UCB), a biopharma company headquartered in Brussels, Belgium, recently announced that the US Food and Drug Administration (FDA) has granted approval for its drug, Rystiggo (rozanolixizumab), for the treatment of generalized myasthenia gravis (gMG). How Does Rystiggo (Rozanolixizumab) Work?

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FDA Approval Antibody Protein Engineer 98

XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells.

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Gene Therapy Gene Protein FDA Approval 98

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).

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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.

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Life Science Vaccination Vaccine FDA Approval 52

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.

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Clinical Trials Clinical Trials FDA Approval Trials 59

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

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. The Utility of cfDNA for Cancer Management and Predicting Outcomes.

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Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

FEBRUARY 11, 2021

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial. . The vaccine stimulated antibodies against the protein in all 32 patients with early-stage AD in the study at levels that AC Immune thinks should have a therapeutic effect.

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