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. What is Unique About Elucirem?

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XTalks

NOVEMBER 15, 2024

You know how to protect against COVID and flu so ask your pharmacist or doctor about scheduling an RSV vaccine, too.” The approval is pivotal as it opens up the vaccine to the under-60 adult population. Because moments like these matter,” the commercial ends off saying. including 67.4 percent efficacy against severe RSV-LRTD.

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pharmaphorum

APRIL 27, 2021

Cognoa has filed for FDA approval of a digital device that could be used to diagnose autism, which the company argues could redefine care standards. . Autism can be difficult to diagnose as there are no medical markers to show its presence – instead doctors look at the child’s developmental history and behaviour to make a diagnosis.

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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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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

OCTOBER 28, 2024

Insulet SmartAdjust Technology for Type 2 Diabetes: Simplified Insulin Dosing In August, the US Food and Drug Administration (FDA) approved Omnipod 5 for type 2 diabetes , marking it as the first automated insulin dosing device for this population. After one year, participants gained an average of 12.3 letter gain.

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World of DTC Marketing

JUNE 23, 2021

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39

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pharmaphorum

JUNE 14, 2022

Eli Lilly and Incyte’s Olumiant has secured the first FDA approval for a systemic drug to treat alopecia areata, an autoimmune condition causing patchy hair loss that affects more than 700,000 people in the US.

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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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XTalks

OCTOBER 7, 2022

Omlonti is the only product currently available with this unique pharmacological mechanism of action, so its approval in the US is an important milestone for progressing eye health as it is the first glaucoma offering in the country. XTALKS WEBINAR: Trials of Tomorrow: The Latest Technologies Advancing Dry Eye Disease Research.

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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

APRIL 21, 2023

With just under a week left before Theranos founder Elizabeth Holmes is set to begin her 11-year prison sentence, the former CEO has appealed her conviction, calling it ‘unjust,’ asking for a new trial or a reduced prison term. Holmes founded healthcare startup Theranos in 2003.

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XTalks

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

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Gene Therapy Gene Dermatology FDA Approval 97

Find Me Cure

SEPTEMBER 2, 2020

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. . Today let’s take a look at some of the barriers to trial participation and the issues that break the trust patients have in research. .

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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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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

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

FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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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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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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pharmaphorum

JUNE 13, 2022

The trial involved heavily pre-treated patients who had received a median of six prior therapies, including Seagen’s ADC Adcetris (brentuximab vedotin) and immunotherapy with PD-1 inhibitors such as Merck & Co’s Keytruda (pembrolizumab). “These results offer hope to patients and doctors who need a new option.”

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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

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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Drugs FDA Approval Doctors Doctor 98

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. Why This Guidance Now?

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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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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

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year. SVB has forecasted around $2.2

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The Pharma Data

MAY 17, 2023

ABBOTT RECEIVES FDA APPROVAL FOR ITS SPINAL CORD STIMULATION SYSTEMS TO TREAT CHRONIC BACK PAIN IN PEOPLE WHO HAVE LIMITED SURGICAL OPTIONS Abbott (NYSE: ABT) announced today that the U.S. years with pain, is the largest randomized controlled trial for SCS in people with chronic back pain when surgery is not an option.

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XTalks

SEPTEMBER 3, 2020

A leader in the medical device sphere, Medtronic plc announced the release of a US Food and Drug Administration (FDA) approved device called the MiniMed 770G hybrid closed loop system. This is an insulin pump system that offers the company’s most advanced SmartGuard technology.

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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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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. 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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Clinical Trial Podcast

FEBRUARY 23, 2021

Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. The reason why the project management role is so interesting is because it provides a holistic view of clinical trial management and clinical research. They are accountable of all aspects of a clinical trial.

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XTalks

MARCH 16, 2022

Although colonoscopy remains the gold standard test for colon cancer, doctors deem stool DNA tests as an acceptable alternative for people at average risk who may be hesitant to get the more invasive procedure. Exact Sciences is eyeing an FDA approval for a newer version of its test, Cologuard 2.0,

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DNA FDA Approval Doctors Doctor 98

pharmaphorum

OCTOBER 26, 2022

Food and Drug Administration approved Vtama (tapinarof) cream, an aryl hydrocarbon receptor agonist and the first FDA-approved steroid-free topical medication in its class. Two months later, Arcutis won approval for its Zoryve (roflumilast) cream. Both are once-a-day treatments. Side effects, front and centre.

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Hormones FDA Approval Doctors Doctor 98

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

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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