Pharmaceutical Technology

JUNE 21, 2023

It can be used as a monotherapy or along with cholesterol-lowering medicines. It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator.

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

MAY 1, 2023

“This milestone is a testament to advancing our robust biopharmaceutical pipeline of innovative medicines that aim to support more people living with mental health disorders and neurological diseases in the coming years.” Uzedy reduced the risk of schizophrenia relapse by up to 80% compared to placebo in a Phase III clinical trial.

FDA Approval 189

FDA Approval Clinical Trials Clinical Trials Trials 189

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 Regulation 74

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

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 101

FDA Approval Trials Clinical Trials Clinical Trials 101

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

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.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

XTalks

JUNE 3, 2024

In September 2023, Yesafili was granted marketing authorization by the European Medicines Agency (EMA), making it the first aflibercept biosimilar approved in the European Union (EU). It was also approved in the UK in November 2023. In the US, Biogen will market Yesafili.

FDA Approval 98

FDA Approval Sales Clinical Trials Clinical Trials 98

XTalks

JANUARY 2, 2024

For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. Safety and Efficacy of Filsuvez The FDA’s approval of Filsuvez is supported by compelling clinical evidence. The clinical study also highlighted the favorable tolerability profile of Filsuvez.

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111

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

Drug Discovery World

MARCH 26, 2024

“People who are immunocompromised continue to be disproportionally impacted by Covid-19 even after receiving multiple vaccine doses,” said Cameron Wolfe, Professor of Medicine, Transplant Infectious Disease at Duke University School of Medicine.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. It was previously approved in the US to treat PI in adults.

FDA Approval 130

FDA Approval Containment Clinical Trials Clinical Trials 130

pharmaphorum

FEBRUARY 1, 2022

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinical trial design that have historically led to trial failure?

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Clinical Trials Clinical Trials Trials Engineer 86

XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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Clinical Trials Clinical Trials Trials Clinical Research 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.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study.

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Clinical Trials Clinical Trials Trials Drugs 52

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

FDA Approval 130

FDA Approval Drugs Insulin Clinical Trials 130

Find Me Cure

APRIL 2, 2020

The last couple of weeks had us write many emails to patients applying for clinical trials informing them that the trial they are interested in has been suspended. We understand it’s even more disheartening for you to find out that the trial you were hoping would help you is not moving forward. Here’s how. .

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Clinical Trials Clinical Trials Trials Research 79

Drug Discovery World

JULY 25, 2023

The efficacy of quizartinib with chemotherapy was evaluated in the QuANTUM-First trial of 539 patients with newly diagnosed FLT3-ITD positive AML. FLT3-ITD status was determined prospectively with a clinical trial assay and verified retrospectively with the companion diagnostic LeukoStrat CDx FLT3 Mutation Assay.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

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

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Clinical Trials Clinical Trials FDA Approval Trials 234

Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children.

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Clinical Trials Clinical Trials Trials Research 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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Clinical Trials Clinical Trials FDA Approval Trials 52

Drug Discovery World

JUNE 6, 2023

The FDA’s decision is based on the data from the pivotal Phase III clinical trial RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease). The post FDA approves first vaccine for respiratory syncytial virus appeared first on Drug Discovery World (DDW).

FDA Approval 52

FDA Approval Vaccination Vaccine Clinical Trials 52

STAT News

OCTOBER 1, 2022

Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals, providing a desperately needed new treatment option for a devastating disease , STAT writes. The But be safe. Enjoy, and see you soon. … The U.S.

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Medicine FDA Approval Drugs Clinical Trials 98

Drug Discovery World

AUGUST 23, 2023

Pfizer’s Abrysvo (Respiratory Syncytial Virus Vaccine) was approved for use at 32-36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth to six months of age. In infants and children, the risk of RSV-associated LRTD is highest during the first year of life.

FDA Approval 52

FDA Approval Vaccination Vaccine Clinical Trials 52

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).

Clinical Trials 119

Clinical Trials Clinical Trials FDA Approval Trials 119

Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Jazz Pharmaceuticals announced the U.S.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

pharmaphorum

MAY 16, 2022

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks.

FDA Approval 101

FDA Approval Insulin Drugs Hormones 101

XTalks

MAY 4, 2022

Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The FDA approved 2.5 Live and On-Demand: Tuesday, May 24, 2022, at 1pm EDT (10am PDT).

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

pharmaphorum

SEPTEMBER 20, 2022

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc., Dr Kevin J.

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Trials Clinical Trials Clinical Trials FDA Approval 109

XTalks

AUGUST 2, 2023

Lawrence Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego, and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine. Dr. Eichenfield was also the principal investigator on clinical trials evaluating YCANTH.

Life Science 52

Life Science FDA Approval Dermatology Pharmacy 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

Scienmag

OCTOBER 21, 2020

While FDA-approved technique is used to treat other medical conditions, this study examines its effects on cognitive function Credit: Image courtesy of Ricardo Carrasco III of Keck Medicine of USC LOS ANGELES — An estimated 5.5 Keck […].

Medicine 52

Medicine Clinical Trials Clinical Trials FDA Approval 52

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.” It’s also been granted orphan designation by the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of TTP.

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

XTalks

MAY 25, 2022

On Thursday, the FDA granted De Novo authorization for NeuroMetrix to market the Quell® wearable neuromodulation device for treating fibromyalgia. This approval is significant because prior to Quell, there were no FDA-approved medical devices for fibromyalgia treatment.

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Drugs 105

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