Pharmaceutical Technology

JULY 8, 2022

In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3% The trial demonstrated that after a median follow-up of 5.2 The post Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

FEBRUARY 13, 2023

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). The label expansion for Cibinqo was supported by the data obtained from the placebo-controlled, randomised Phase III JADE TEEN clinical trial.

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Bio Pharma Dive

AUGUST 2, 2021

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

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Pharmaceutical Technology

MAY 25, 2023

Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval. The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials. It will be offered to patients in prefilled syringe and autoinjector administration options.

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XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

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Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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Pharmaceutical Technology

MARCH 27, 2023

It is claimed to be the first and only therapy to receive approval in the US for the treatment of APDS, a rare and progressive primary immunodeficiency. After assessing the New Drug Application (NDA) under priority review, the FDA granted the approval based on the data obtained from a Phase II/III clinical trial.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 12, 2023

The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.​

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Earlier, the therapy had obtained FDA approval for usage in CF patients aged two years and above with two F508del mutation copies. The latest approval for use in children aged 12 to below 24 months is based on an open-label, multicentre Phase III clinical trial for 24 weeks.

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BioTech 365

SEPTEMBER 16, 2021

Neovasc Announces FDA Approval of COSIRA-II Clinical Trial Neovasc Announces FDA Approval of COSIRA-II Clinical Trial Company on Schedule to Commence Trial Late This Year VANCOUVER and MINNEAPOLIS, Sept. 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc.

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XTalks

JANUARY 2, 2024

For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. The clinical study also highlighted the favorable tolerability profile of Filsuvez. The most commonly reported adverse reactions in the clinical trial were pruritus (itching) and pain at the wound application site, occurring in 7.3

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Pharmaceutical Technology

JUNE 1, 2023

According to figures from GlobalData’s clinical trials database, research into mCRPC treatments has been on the rise over the past 10 years. Trials peaked at 115 in 2018 before declining to 91 last year. So far, 68 trials have been initiated in 2023.

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Pharmaceutical Technology

MARCH 6, 2023

The regulatory approval was supported by the data obtained from the randomised, open-label, two cohort, multicentre, global Phase III monarchE clinical trial, which was conducted in 5,637 HR+, HER2-, node-positive EBC adult patients who are at high risk of recurrence.

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Pharmaceutical Technology

MAY 22, 2023

It is claimed to be both the first re-dosable gene therapy and the first and only FDA-approved treatment for both recessive and dominant types of DEB, a rare and serious genetic disease affecting the skin and mucosal tissues. The regulatory approval was supported by data from the GEM-1/2 and GEM-3 clinical trials.

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BioTech 365

JULY 13, 2021

FDA Approves Accelerated Dosing in Non-Hodgkin’s Lymphoma/Leukemia Clinical Trial FDA Approves Accelerated Dosing in Non-Hodgkin’s Lymphoma/Leukemia Clinical Trial AVM Biotechnology eliminates dose cohorts in Non-Hodgkin’s Lymphoma/Leukemia clinical trial with FDA approval.

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XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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Drug Discovery World

MARCH 26, 2024

Clinical trial evidence for Pemgarda The EUA of Pemgarda is based on scientific evidence, such as data showing that immunobridging was established in the CANOPY clinical trial and that the calculated serum neutralising antibody titers against JN.1

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FDA Approval Antibody Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 6, 2023

GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.

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Drug Discovery World

AUGUST 11, 2023

The new complement C5 inhibitor is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase III clinical trials. The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.”

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Bio Pharma Dive

JUNE 8, 2021

Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it.

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STAT News

SEPTEMBER 9, 2022

… Running clinical trials remotely or virtually can provide substantial financial savings for pharmaceutical companies, STAT writes, citing a new pilot study. million, on average, for Phase 2 clinical trials. million when these methods were used during both trial stages. But be safe. And the return was $20.4

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Pharmaceutical Technology

MAY 1, 2023

The double-blind, multicentre, placebo-controlled, randomised RISE trial was designed to assess the efficacy of risperidone extended-release injectable suspension for subcutaneous use to treat schizophrenia patients aged 13 to 65 years.

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BioSpace

DECEMBER 14, 2023

Despite the lack of a randomized clinical trial to support eflornithine’s efficacy, the regulator approved US WorldMeds’ oral maintenance treatment for high-risk neuroblastoma in adults and children.

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FDA Approval Clinical Trials Clinical Trials Regulation 108

Drug Discovery World

FEBRUARY 19, 2024

“The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.” Amtagvi is the first FDA-approved tumour-derived T cell immunotherapy.

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BioPharma Reporter

MAY 5, 2022

Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the worldâs first Phase 3 study of oral insulin under FDA approved protocols.

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pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

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XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.

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XTalks

OCTOBER 4, 2022

XTALKS WEBINAR: Time for Change in NASH: How Non-Invasive Biomarkers are Driving a Paradigm Shift in Clinical Trials and Clinical Care. Outcomes of Clinical Trials of Terlipressin. The clinical trial results were published in the New England Journal of Medicine in March 2021. percent (vs. percent (vs.

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XTalks

DECEMBER 22, 2022

Neilan has contributed to the rare disease community through his comprehensive work in the rare disease space that has included research, academia, medical practice and clinical trial design and execution. Can you tell us a bit about the work you are doing at NORD and how it impacts clinical trials for rare diseases?

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XTalks

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio.

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XTalks

MAY 5, 2022

There are four FDA-approved ADHD-specific nonstimulant drugs, namely Eli Lilly’s Strattera (atomoxetine), Shionogi’s Kapvay (clonidine), Takeda’s Intuniv (guanfacine) and now Supernus’ Qelbree (viloxazine). In 2002, Strattera became the first FDA-approved nonstimulant drug to treat ADHD in adults.

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Outsourcing Pharma

JANUARY 25, 2022

The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

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Pharmaceutical Commerce

APRIL 15, 2024

Phase IIa clinical trial of SPG60 for Fragile X syndrome offers hope for disease with no current FDA-approved treatment options.

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XTalks

AUGUST 18, 2023

Izervay is the only approved treatment for geographic atrophy that has demonstrated a significant decrease in the rate of geographic atrophy progression at the 12-month primary endpoint, based on results from two rigorous Phase III clinical trials. The recommended dosage of Izervay is 2 mg (equivalent to 0.1

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FDA Approval Drugs Clinical Trials Clinical Trials 52

XTalks

OCTOBER 4, 2022

Register for this free webinar to learn new ways to operationalize hybrid oncology trials and how virtual sites help reduce patient burden. The featured speakers will discuss where the industry is headed with decentralized clinical trials and oncology. Clinical Trials and Commercialization. How Does Rolvedon Work?

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Pharmaceutical Technology

JUNE 15, 2023

This approval has been granted for ALE.C04 both as a monotherapy and in combination with pembrolizumab in a first-in-human clinical study in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The planned Phase I/II clinical trial in HNSCC will begin in the second half of 2023.

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FDA Approval Antibody Clinical Trials Clinical Trials 130

XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

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