XTalks

OCTOBER 4, 2022

Guerbet, a pharmaceutical company based in France that specializes in medical imaging, obtained US Food and Drug Administration (FDA) approval for Elucirem (gadopiclenol), a new macrocyclic GBCA. XTALKS WEBINAR: Response Prediction in Oncology Clinical Trials. Clinical Trials of Elucirem.

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pharmaphorum

FEBRUARY 21, 2022

One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. Clinical trial diversity improved during COVID-19 (but not enough) .

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XTalks

JUNE 17, 2024

Numerous doctors offer minimally invasive treatments aimed at reducing the visibility of frown lines. RELATED: Innovations and Clinical Trial Diversity in Medical Aesthetics: Insights from Dr. Stephanie Manson Brown, VP & Head of Clinical Development at Allergan Aesthetics – Xtalks Life Science Podcast Ep.

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Pharmaceutical Technology

AUGUST 12, 2022

Dr Merit Cudkowicz, a co-principal investigator in Amylyx’s clinical trials, says patients and investigators are pushing for an approval given the unmet need for therapies. “By Another objective deals with improving trial infrastructure and encouraging enrolment on decentralised clinical trials (DCT).

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Find Me Cure

SEPTEMBER 2, 2020

As part of our patient advocacy efforts, at FindMeCure we are dedicated to creating a bridge between patients and the world of clinical research. This includes spreading clinical trial awareness, connecting patients to the trials they are interested in but also speaking up about the issues in the clinical research industry. .

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

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pharmaphorum

OCTOBER 21, 2021

Many are still predicting multibillion-dollar sales for the drug, albeit with a longer runway, despite reservations about its clinical efficacy among doctors and payers. Analysts meanwhile have suggested that Aduhelm may start to pick up momentum if that review is positive.

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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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pharmaphorum

AUGUST 13, 2020

Viltepso can be used to treat around 8% of DMD patients and previously approved DMD drugs has not been shown to change the course of the disease. It’s bad form to compare performance of drugs in separate clinical trials, but results suggest that Viltepso helps patients produce more dystrophin than Sarepta’s rival Vyondys 53 (golodirsen).

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XTalks

JUNE 26, 2024

percent reporting unmet healthcare needs and barriers such as inadequate information, poor access to treatment and unsatisfactory patient-doctor relationships. The stigma surrounding hyperhidrosis often prevents patients from seeking treatment, with 64.8 Botulinum toxin A (BTX) and microwave thermolysis (MWT) are two significant modalities.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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XTalks

OCTOBER 7, 2022

Register for this free webinar to learn how dry eye disease ophthalmic trials are embracing new technologies to accelerate programs and gain better insights into product efficacy. Omlonti Reduces Intraocular Pressure and is Well-Tolerated in Clinical Trials. in the press release.

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Pharmaceutical Technology

JULY 28, 2022

Roche’s Susvimo (ranibizumab sustained release formulation) follows a similar theme; patients who are implanted with Susvimo are expected to visit their doctor only twice a year to have the implant refilled so that the medicine can be delivered to their eyes continuously. The therapy received FDA approval in October last year.

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pharmaphorum

DECEMBER 22, 2022

For instance, at a recent presentation to the Society of Quality Assurance 2022 Annual Meeting , the FDA Office of Regulatory Affairs Bioresearch Monitoring Division Director Anne Johnson emphasised that DCTs are largely reliant on electronic data integrity and therefore subject to firmly established 21 CFR Part 11 compliance. NPJ Digit Med.

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pharmaphorum

SEPTEMBER 12, 2022

Across LabCorp , we innovate through science and technology, with access to approximately 2,500 [doctors] and PhDs and over 700 patients. This reach allows us to support 82% of the novel drugs and therapeutic products approved by the US FDA, including 63% of those specific to oncology,” Reddy states.

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The Pharma Data

JULY 29, 2021

BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX ® compared to 2 of the 542 treated with placebo.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial. Related Articles: Verquvo (vericiguat) FDA Approval History.

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The Pharma Data

DECEMBER 12, 2020

In some disappointing vaccine news, Sanofi and GlaxoSmithKline said Friday that their experimental coronavirus vaccine did not work well in older adults, delaying the start of their late-stage clinical trial that had been set to begin in the United States in December, the Times reported.

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XTalks

JUNE 19, 2023

Clinical trial results revealed that a single dose of Nurtec ODT alleviated pain in two hours for about 21 percent of patients, and 35 percent of patients experienced relief from their most troublesome symptom (light sensitivity, sound sensitivity or nausea) at two hours. .” Talk to a doctor about Nurtec ODT.”

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Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. However, subsequent RSV drugs, like Medimmune’s motavizumab, failed in clinical trials. In a Phase III trial, GSK’s vaccine demonstrated a 94.1%

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XTalks

AUGUST 21, 2023

The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Ipsen that can be used for subsequent drug applications that would not qualify for a priority review. The FDA approval of Sohonos is a breakthrough for the US FOP community,” said Howard Mayer, head of R&D at Ipsen, in the company’s news release.

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The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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STAT News

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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The Pharma Data

NOVEMBER 18, 2020

The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. The California company said that clinical trials showed 100% of patients were able to perform the Lucira test in about two minutes.

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Triage Cancer

AUGUST 18, 2020

One study conducted over a 10-year period (January 2005 to December 2014) by Dr. Steven Joffe from the University of Pennsylvania’s Perelman School of Medicine found that the FDA approved 99% of all expanded access requests for almost 9,000 investigational drugs. For more information, read: FDA’s Guide to Expanded Access.

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XTalks

MAY 1, 2023

RELATED: Sacral Nerve Stimulation Study with Neuspera’s Nuvella System Moves into Second Phase FDA-Approved Axonics Therapies Axonics has recently launched two SNM implantable neurostimulators (INS). The Axonics R20 has received FDA approval in January of this year. How Effective is Axonics?

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Pharmaceutical Technology

OCTOBER 5, 2022

It is also important to ask whether doctors are being paid fair market value and if they are providing the services for which they’re being compensated, he adds. In 2005, Biogen withdrew Tysabri from the market following a clinical trial that resulted in two participants contracting progressive multifocal leukoencephalopathy (PML).

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XTalks

AUGUST 8, 2024

In a press release announcing Tecelra’s approval, Adrian Rawcliffe, CEO of Adaptimmune said, “This is a watershed moment for cell therapy and for people with synovial sarcoma,” emphasizing the company’s commitment to expanding its clinical pipeline with future treatments like lete-cel , an engineered TCR T-cell therapy.

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XTalks

NOVEMBER 9, 2022

Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Mounjaro and Ozempic are both FDA approved for glycemic control in adults with type 2 diabetes, in combination with diet and exercise.

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XTalks

MAY 17, 2024

The therapy is the first and only US Food and Drug Administration (FDA)-approved treatment that reduces the loss of kidney function in adults with the disease. He also traced his personal journey from the clinic to leading a rare disease biotech and winning FDA approval for a rare disease drug. Can they do it?

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XTalks

JUNE 8, 2021

It was first approved in the US in 2019 to treat children below the age of two with SMA. Related: Is $2 Million Too Much For FDA-Approved SMA Gene Therapy? Zolgensma Gene Therapy: START Trial. With a price tag of over $2.5 million, Zolgensma is currently the world’s most expensive drug.

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Delveinsight

AUGUST 3, 2021

Nevro Received FDA Approval of its 10 kHz High-Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy. received approval for its Senza System, Nevro’s unique 10 kHz stimulation, to treat chronic pain associated with Painful Diabetic Neuropathy (PDN).

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XTalks

SEPTEMBER 12, 2024

Xtandi for Non-Metastatic Prostate Cancer In late 2023, Pfizer and Astellas’ Xtandi (enzalutamide) received the US Food and Drug Administration (FDA) approval for use in non-metastatic castration-sensitive prostate cancer (nmCSPC) patients. Prostate Cancer Awareness Month is a time to act.

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XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. There has been significant growth in the number of registered clinical trials globally, with a focus on interventional studies.

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The Pharma Data

JANUARY 15, 2021

15, 2021 — An inhaled medication might make every day physical activity a bit easier for patients with serious scarring of the lungs, a new clinical trial finds. Food and Drug Administration to approve Tyvaso for ILD patients. FRIDAY, Jan. The study, published online Jan. © 2021 HealthDay. All rights reserved.

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