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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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

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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Drug Discovery World

OCTOBER 18, 2023

We’re beginning to see their potential come to fruition, with the FDA having approved three treatments as of January 2023 — for retinal dystrophy 1 spinal muscular atrophy, 2 and haemophilia B.

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World of DTC Marketing

JUNE 2, 2021

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.”

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World of DTC Marketing

JUNE 17, 2021

SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product. ” Thank you, FDA.

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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

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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pharmaphorum

DECEMBER 22, 2022

Decentralised oncology trials, for example, have shown actual predictive outcome value. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept.

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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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Botox FDA Approval Doctors Doctor 52

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. KENILWORTH, N.J.–(BUSINESS Verquvo (vericiguat) 2.5

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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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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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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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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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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

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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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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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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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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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 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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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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pharmaphorum

NOVEMBER 11, 2022

Last year, Biogen won controversial FDA approval of Aduhelm, billed as the first drug to treat Alzheimer’s underlying cause. However, Viehbacher comes on board following a surprising clinical trial success for lecanemab , another Alzheimer’s drug Biogen is developing, in partnership with Eisai.

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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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XTalks

JANUARY 12, 2023

The approval is based on Phase II data that demonstrated a reduction in amyloid-beta plaques (the defining characteristic of Alzheimer’s disease) in patients with early Alzheimer’s disease treated with Leqembi. Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors.

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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. Right now, no medication is approved specifically for pulmonary hypertension caused by ILD, said Dr. Steven Nathan, senior researcher on the new trial.

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XTalks

NOVEMBER 9, 2022

Novo’s obesity version of semaglutide (at a higher dose) is marketed as Wegovy and was approved in 2021. Lilly is also working towards an obesity treatment form of tirzepatide, with trials currently underway to evaluate its weight loss effects. The obesity drug market is currently valued at $2.82 Mounjaro Versus Ozempic.

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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

JUNE 8, 2021

In addition, recent data from a Phase I trial has shown ‘remarkable’ long-term results of the gene therapy in children with the disease. 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? With a price tag of over $2.5

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Pharmaceutical Technology

FEBRUARY 3, 2023

It was initially FDA-approved in December 2021 and is claimed to be the only biologic approved to treat severe asthma with no phenotype or biomarker limitation. In the PATH-HOME trial, 92% of healthcare providers, patients and caregivers successfully administered Tezspire in the clinic and at home throughout the study.

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Intouch Solutions

AUGUST 5, 2021

For trans individuals, years may pass between doctor visits because of the emotional and financial tolls that can accompany them. Aside from being casually misgendered by office staff, she was eventually placed with a doctor that had working knowledge of trans needs, but even then, experienced hurdles.

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XTalks

NOVEMBER 11, 2020

Evaluation of bamlanivimab in a Phase II trial has shown that the antibody can reduce COVID-19-related hospitalization or visits to the emergency room within 28 days after treatment, when compared to placebo (from ten percent to three percent), among patients at high risk for disease progression. Phase II BLAZE-1 Trial.

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The Pharma Data

APRIL 6, 2022

Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. . Robinson, M.D., ” About Presbyopia.

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The Pharma Data

SEPTEMBER 10, 2021

Levodopa/Carbidopa Intestinal Gel (LCIG) Reduces Fluctuations and Shortens Time to On Without Troublesome Dyskinesia in Advanced Parkinson’s Disease: Post-Hoc Analyses of 54-week LCIG-Monotherapy Trial. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6%

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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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