Pharmaceutical Technology

NOVEMBER 18, 2022

Tzield was evaluated in the placebo-controlled, double-blind, randomised, event-driven TN-10 clinical trial, for delaying T1D (Stage 3, or clinical T1D) in Stage 2 T1D patients. Provention Bio stated that Tzield delayed the median onset of Stage 3 T1D by 25 months, or nearly two years, compared to a placebo in a clinical trial.

FDA Approval 246

FDA Approval Clinical Trials Clinical Trials Antibody 246

Pharmaceutical Technology

JANUARY 9, 2023

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Pharmaceutical Technology

MARCH 1, 2023

“With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”

FDA Approval 245

FDA Approval Clinical Trials Clinical Trials Trials 245

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

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.

FDA Approval 298

FDA Approval Clinical Trials Clinical Trials Trials 298

Pharmaceutical Technology

SEPTEMBER 19, 2022

bluebird bio was granted a rare paediatric priority review voucher following approval. The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. 1) in Skysona-treated and untreated subjects. “For thalassemia.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

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.

FDA Approval 246

FDA Approval HR Drugs Hormones 246

World of DTC Marketing

AUGUST 27, 2021

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. According to antidote.com. No, not at all.

Clinical Trials 187

Clinical Trials Clinical Trials Trials Drugs 187

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.

FDA Approval 246

FDA Approval Cardiology Clinical Trials Clinical Trials 246

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.​

FDA Approval 245

FDA Approval Drugs Medicine Clinical Trials 245

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.

FDA Approval 244

FDA Approval Hormones Trials Clinical Trials 244

Pharmaceutical Technology

AUGUST 29, 2022

The US Food and Drug Administration (FDA) has granted approval for Incyte ’s Pemazyre (pemigatinib) to treat adults with relapsed or refractory (r/r) myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

FDA Approval 147

FDA Approval Clinical Trials Trials Clinical Trials 147

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.

FDA Approval 147

FDA Approval Trials Clinical Trials Clinical Trials 147

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.

FDA Approval 189

FDA Approval Clinical Trials Clinical Trials Trials 189

XTalks

JANUARY 2, 2025

Anteris approach has shown promising results in clinical trials, demonstrating better hemodynamics and exercise capacity compared to traditional three-piece valves. With US Food and Drug Administration (FDA) approval for an early feasibility study (EFS), Anteris has treated 15 patients across multiple heart valve centers in the US.

FDA Approval 110

FDA Approval Marketing Clinical Trials Clinical Trials 110

Pharmaceutical Technology

FEBRUARY 1, 2023

The FDA IND clearance allows the company to expand its ongoing first-in-human Phase I/II clinical trial of EP0042. This will enable the addition of US trial sites, as well as the recruitment of eligible patients in the country to the trial.

FDA Approval 130

FDA Approval In-Vivo In-Vitro Trials 130

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.

Insulin 127

Insulin Clinical Trials Clinical Trials FDA Approval 127

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

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.

FDA Approval 130

FDA Approval Genotype Clinical Trials Clinical Trials 130

Pharmaceutical Technology

MAY 22, 2023

The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignancies.”

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Antibody 130

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.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Medicine 130

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 14, 2023

The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday.

FDA Approval 246

FDA Approval Pharmacy Marketing Drugs 246

Pharmaceutical Technology

AUGUST 25, 2022

The latest approval is mainly based on positive findings from the single-arm, open-label, multicentre Phase I/II iMAGINE clinical trial of Imbruvica to treat moderate or severe cGVHD in paediatric and young adults aged one year to under 22 years.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Protein 130

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.

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

Gene Therapy 105

Gene Therapy Protein Genetic Disease Gene 105

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

Clinical Trials 234

Clinical Trials Clinical Trials FDA Approval Trials 234

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.

FDA Approval 130

FDA Approval HR Hormones Clinical Trials 130

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

Clinical Trials 98

Clinical Trials Clinical Trials FDA Approval Trials 98

XTalks

FEBRUARY 4, 2025

Related: FDA Approves New Use for Ozempic to Reduce the Risks of Kidney Disease Maze stands out in the biotech space with its Compass platform, which analyzes genetic data to identify disease-linked variants. The offering, which includes 8.75

Clinical Trials 66

Clinical Trials Clinical Trials Trials Genetics 66

STAT News

JULY 18, 2022

Patients with vitiligo will now have access to the first ever at-home therapy for skin repigmentation approved by the Food and Drug Administration.

FDA Approval 145

FDA Approval Clinical Trials Clinical Trials Trials 145

XTalks

FEBRUARY 19, 2025

Looking ahead, Deciphera is exploring additional clinical trials and potential collaborations in the TGCT space. Ryota Udagawa, Decipheras president and CEO, emphasized that the drugs tolerability marks a significant advancement for patients at risk from surgical interventions.

FDA Approval 59

FDA Approval Drugs Trials Clinical Trials 59

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.

FDA Approval 130

FDA Approval Gene Therapy Genetic Disease Gene 130

pharmaphorum

OCTOBER 25, 2021

Hard on the heels of some impressive clinical trial results, Luminopia has won FDA approval for its digital therapeutic (DTx) for amblyopia or lazy eye in children that is based on watching TV shows. The post Luminopia scores FDA approval for TV-based amblyopia therapy appeared first on.

FDA Approval 111

FDA Approval Clinical Trials Clinical Trials Development 111

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.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Regulation 100

ACRP blog

SEPTEMBER 4, 2024

Clinical trials provide the scientific foundation for justifying the safety and efficacy of drugs, biologics, and devices—but are laborious, expensive, and risky. Only 10% of drugs entering clinical trials receive U.S. clinical trial workforce reported burnout since the 2020 COVID-19 pandemic.{4}

Clinical Trials 105

Clinical Trials Clinical Trials Trials Drugs 105

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

FDA Approval 264

FDA Approval Dermatology Sales Clinical Trials 264

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.

Botox 98

Botox FDA Approval Cosmetics Clinical Trials 98