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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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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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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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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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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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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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

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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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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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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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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Pharma Marketing Network

MARCH 3, 2025

Imagine launching a campaign that reaches the right doctor at the right time or helps a patient understand treatment options without feeling overwhelmed. Short-Form Video Ads Quick, informative clips highlighting new drug mechanisms, clinical trial data, or FDA approvals.

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Pharma Marketing Network

MARCH 3, 2025

Imagine launching a campaign that reaches the right doctor at the right time or helps a patient understand treatment options without feeling overwhelmed. Short-Form Video Ads Quick, informative clips highlighting new drug mechanisms, clinical trial data, or FDA approvals.

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Compliance Branding Doctors Doctor 52

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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pharmaphorum

SEPTEMBER 15, 2022

Pfizer’s close-fought contest with GSK to bring a next-generation meningitis vaccine to market has entered the final rounds, with the former ahead on points following the readout of a pivotal phase 3 clinical trial.

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The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Do not start any new medicines until you have told your doctor that you have received BOTOX ® Cosmetic in the past.

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The Pharma Data

MAY 4, 2021

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ).

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Delveinsight

OCTOBER 1, 2021

Myasthenia Gravis Approved Therapies. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis. Some of the approved drugs are: Prograf (Tacrolimus). This medication is administered by injection under the skin or slowly into a vein as directed by the doctor.

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The Pharma Data

SEPTEMBER 10, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% Tell your doctor if you have any breathing-related problems.

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The Pharma Data

MARCH 30, 2021

Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.

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The Pharma Data

SEPTEMBER 8, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% Tell your doctor if you have any breathing-related problems.

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The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. The submission of an application for the pediatric indication of thromboprophylaxis after Fontan procedure is planned in the EU as well. EINSTEIN-Jr. About the EINSTEIN-Jr.

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The Pharma Data

APRIL 6, 2022

“We are encouraged by the results from the VIRGO trial, which suggest that administering VUITY twice daily may provide an additional dosing option for people with presbyopia to improve their near vision without compromising their distance vision,” said Christopher Lievens, O.D., About VUITY.

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XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. The safety of the vaccines is continuously monitored.”.

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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. For the first three weeks, the recommended dose is one packet a day. Following this time period, the dosage is raised to one packet twice daily.

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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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