Pharmaceutical Technology

MAY 1, 2023

“The approval of Uzedy is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. The regulatory approval is based on the data obtained from the Risperidone Subcutaneous Extended-Release Study (RISE) and the SHINE Phase III trials.

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FDA Approval Clinical Trials Clinical Trials Trials 189

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

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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FDA Approval Genotype Clinical Trials Clinical Trials 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.

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FDA Approval Clinical Trials Clinical Trials Medicine 130

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.

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FDA Approval Dermatology Sales Clinical Trials 264

XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. The FDA approval sent Daiichi Sankyos shares soaring by 8.7%

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Antibody FDA Approval HR Trials 105

XTalks

FEBRUARY 4, 2025

Maze Therapeutics, a clinical-stage biopharmaceutical company, has raised $140 million in its upsized initial public offering (IPO), pricing shares at $16 each. The offering, which includes 8.75

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Clinical Trials Clinical Trials Trials Genetics 66

Delveinsight

AUGUST 13, 2021

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. What are Virtual Clinical Trials?

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Clinical Trials Clinical Trials Trials Drugs 98

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. Or simply plan the rest of your life.

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Clinical Trials Clinical Trials FDA Approval Trials 98

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

OCTOBER 1, 2022

The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients. An oral, fixed-dose medicine, Relyvrio is also approved with conditions in Canada such as Albrioza to treat ALS. For the first three weeks, the recommended dose is one packet a day.

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FDA Approval Pharmacy Doctors Doctor 244

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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FDA Approval Clinical Trials Clinical Trials Trials 97

XTalks

MARCH 10, 2025

The FDA has approved Genentechs TNKase (tenecteplase) for the treatment of acute ischemic stroke in adults, marking a milestone as the first new stroke medicine approved in nearly three decades. By dissolving these clots, TNKase helps restore blood flow to the brain, reducing the risk of permanent damage.

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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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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.

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FDA Approval Insulin Drugs Hormones 115

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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FDA Approval Protein RNA Clinical Trials 105

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.

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FDA Approval Medicine Vaccine Vaccination 98

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.

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FDA Approval Clinical Trials Clinical Trials Trials 98

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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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.

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FDA Approval Clinical Trials Clinical Trials Containment 130

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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FDA Approval Gene Therapy Gene Trials 111

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.

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FDA Approval Drugs Insulin Clinical Trials 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.

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FDA Approval Trials Clinical Trials Clinical Trials 101

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

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

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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XTalks

JANUARY 13, 2023

FDA approval represents achievement of a major milestone for Polarean’s technology. Register for this free webinar to hear use cases for imaging that include support for clinical trials, optimized dosing schedules and comparative effectiveness studies. Two More Devices Approved by the FDA Alongside Xenoview.

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FDA Approval Packaging Packaging 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

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.

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FDA Approval Sales Clinical Trials Clinical Trials 98

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.

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FDA Approval Clinical Trials Clinical Trials Drugs 105

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 BMS had targeted Camzyos in its acquisition of MyoKardia in 2020 for $13.1

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FDA Approval Drugs Clinical Trials Clinical Trials 98

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.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

APRIL 13, 2022

Pediatric rare disease clinical trials are vital to determining the safety and efficacy of medications for children living with a rare disease. Therefore, pediatric rare disease clinical trials are vital to determining the safety and efficacy of medications for children living with a rare disease.

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Clinical Trials Clinical Trials Clinical Research Trials 98

XTalks

FEBRUARY 12, 2025

Nerandomilast is Boehringers next candidate for PPF and IPF following their FDA-approved treatment, Ofev (nintedanib) one of only two approved therapies for IPF, alongside pirfenidone.

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Clinical Trials Clinical Trials Trials FDA Approval 66

Pharmaceutical Technology

JUNE 29, 2022

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications. An orphan drug designation does not automatically translate into approval.

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Drugs FDA Approval Development Marketing 246

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. Clinical Trials of Dupixent for EoE Treatment.

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FDA Approval Antibody Clinical Trials Clinical Trials 105

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

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FDA Approval Trials Antibody DNA 105