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

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 Drugs Clinical Trials Clinical Trials 246

Bio Pharma Dive

JANUARY 6, 2023

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

FDA Approval 344

FDA Approval Drugs Clinical Trials Clinical Trials 344

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 Clinical Trials Clinical Trials Drugs 147

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

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2023

The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.

FDA Approval 189

FDA Approval Drugs Clinical Trials Clinical Trials 189

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 Clinical Trials Clinical Trials Antibody 130

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.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Drugs 52

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 Clinical Trials 130

Pharmaceutical Technology

FEBRUARY 17, 2023

In 2021, the FDA granted Amgen’s (NASDAQ:AMGN) non-small cell lung cancer (NSCLC) drug Lumakras (sotorasib) an expedited approval, making it the first FDA-approved KRAS inhibitor. In standard and expedited programs, the FDA expects sponsors to adhere to the optimised dose model when appropriate.

Clinical Trials 289

Clinical Trials Clinical Trials Drugs Trials 289

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

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 Clinical Trials Trials 147

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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FDA Approval Gene Therapy Genetic Disease Gene 130

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

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

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 Clinical Trials Clinical Trials Hormones 130

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. Another noteworthy contender is Novan Inc.’s

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Dermatology 98

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

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.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

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 185

FDA Approval Drugs Medicine Clinical Trials 185

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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FDA Approval Clinical Trials Clinical Trials Clinical Research 52

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 Clinical Trials Clinical Trials Hormones 244

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.

FDA Approval 343

FDA Approval Drugs Clinical Trials Clinical Trials 343

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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Gene Therapy Clinical Trials Clinical Trials Gene 98

XTalks

NOVEMBER 10, 2023

Today, we are proud to further support the rare disease community by delivering Adzynma as the first FDA-approved therapeutic option for people with cTTP.” No adverse events were reported during the clinical trials following the administration of Adzynma. Adzynma’s approval is the second for Takeda this week.

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

XTalks

MARCH 9, 2023

Results for this endpoint are expected in the final quarter of 2023 and are expected to support the traditional approval of Filspari. The ongoing PROTECT Phase III trial is the largest interventional study to date on IgA nephropathy. The results demonstrated that after 36 weeks of treatment, patients receiving sparsentan showed a 49.8

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

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

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

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

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.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

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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Botox FDA Approval Clinical Trials Clinical Trials 98

XTalks

JUNE 26, 2023

Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, president and CEO of Surmodics, in the company’s press release. “It SurVeil has an edge over IN.PACT as it is coated with a lower dose of the drug.

FDA Approval 96

FDA Approval Drugs In-Vitro Clinical Trials 96

FDA Law Blog

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

Clinical Trials 64

Clinical Trials Clinical Trials Trials Drugs 64

Drug Discovery World

AUGUST 4, 2023

GSK’s Jemperli (dostarlimab) has been approved in the US plus chemotherapy as the first new frontline treatment option in decades for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Drugs 52

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.

FDA Approval 40

FDA Approval Clinical Trials Clinical Trials Trials 40

XTalks

APRIL 7, 2022

Abbott Laboratories announced on Monday that the US Food and Drug Administration (FDA) approved its Aveir™ single-chamber (VR) leadless pacemaker system. The Illinois-based company received the FDA nod for its new pacemaker to treat patients with bradycardia (slow heart rhythms).

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Cardiology 105

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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Clinical Trials Clinical Trials Trials Drugs 100

XTalks

JULY 25, 2023

Efficacy of Cyfendus The FDA approval of the Cyfendus anthrax vaccine is grounded in a series of studies supported by the US government and carried out by Emergent. The non-inferiority of Cyfendus to BioThrax was statistically determined in the clinical study results. Additionally, at Day 64, 86.6 percent in the BioThrax group.

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98