Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Prospecting 52

Legacy MEDSearch

SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., VisAble.IO “We are excited to receive 510(k) clearance for our VisAble.IO

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52

World of DTC Marketing

AUGUST 10, 2022

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. Time and time again, I’ve found, in research talking with patients, that they want a lot more information before they ask for a new drug. 2wo : Content shouldn’t be stagnant.

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Marketing Media Side effects Pharma 252

European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. There were 381 Parkinson’s patients enrolled in the trial. and Joan A.

Food and Drug Administration 94

Food and Drug Administration Medicine Physicians Food 94

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Recruitment 98

Pharmaceutical Technology

FEBRUARY 9, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat the retinopathy of prematurity (ROP) in preterm infants. For the first time, physicians will now have an FDA-approved medication in Eylea to treat this heartbreaking disease in these smallest of patients.”

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

pharmaphorum

SEPTEMBER 29, 2022

A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The post Digital tool cuts hospital readmissions in cirrhosis patients appeared first on.

Patients 52

Patients Management Consulting FDA 52

European Pharmaceutical Review

MARCH 8, 2023

Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and Drug Administration (FDA). I am a physician by training, and I worked in New York hospital emergency rooms for many years.

Leads 52

Leads Pharma Food and Drug Administration Medicine 52

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan. The first AdCom was critical of the study’s robustness.

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FDA Food and Drug Administration Physicians Side effects 98

Legacy MEDSearch

JANUARY 13, 2023

Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics.

FDA 98

FDA Safety Recruitment Patients 98

Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

Patients 98

Patients Recruitment Pharmacology Side effects 98

Legacy MEDSearch

JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Physicians 98

Legacy MEDSearch

MARCH 15, 2023

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring.

Food and Drug Administration 97

Food and Drug Administration FDA Recruitment Physicians 97

Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc.,

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

pharmaphorum

SEPTEMBER 15, 2022

Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt. That, in turn, allows toxins such as creatinine to build up in the body, causing damage to the liver and in 40% to 70% of cases leads to death within four weeks.

FDA 94

FDA Manufacturing Physicians Leads 94

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

Patients 86

Patients Pharma Consulting Transportation 86

Legacy MEDSearch

MAY 12, 2023

Novarad’s VisAR, a surgical navigation system that uses augmented reality, has received clearance from Indonesia’s FDA for intraoperative use in stereotactic spinal surgery. It also provides integrated 2D and 3D immersive navigation views and ongoing hologram-to-patient registration. Visit Novarad at novarad.net.

FDA 52

FDA Recruitment Medical Management 52

Legacy MEDSearch

APRIL 27, 2023

(Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced that it received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). For more information, visit Innoblative.com.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

FEBRUARY 24, 2023

SENSORA currently features AI that objectively identifies structural murmurs, a sign of valvular heart disease, and Care Pathway Analytics software that provides downstream visibility and metrics of the patient journey through the healthcare system. Left undetected and untreated, it can lead to heart failure, stroke, blood clots, and death.

Physicians 98

Physicians Recruitment Patients FDA 98

Legacy MEDSearch

JULY 27, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. TIGERTRIEVER 17 and 21, COMANECI , and COLUMBUS /DRIVEWIRE are CE marked and FDA cleared.

Medical 52

Medical FDA Recruitment Physicians 52

World of DTC Marketing

JANUARY 1, 2022

More and more patients demand a level of service they want with the increased costs of health insurance premiums. 1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections.

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Healthcare Healthcare Side effects Prescription 244

PM360

NOVEMBER 21, 2022

Patient Pages: PatientPoint Reveals Patients Are Anxious About Talking with Doctors. A notable 69% of Americans worry that they won’t be able to understand the terminology their doctors use and the same number of patients wish they knew how to describe their symptoms better before talking to an HCP. Patients have the answer.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52

Legacy MEDSearch

APRIL 19, 2023

Because NCCT imaging is readily available and is the initial imaging modality used for stroke and trauma patients, care teams can make time-sensitive workflow and transfer decisions faster. RapidAI – where AI meets patient care.

FDA 52

FDA Recruitment Medical Patients 52

Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

Legacy MEDSearch

JUNE 12, 2023

Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (AST) solutions announced today the submission of its eQUANT TM system for FDA 510(k) clearance. “The global emergence of superbugs and rise in antimicrobial resistance is a leading public health concern. . and other countries.

FDA 52

FDA Medical Recruitment Physicians 52

Legacy MEDSearch

JUNE 28, 2023

1 Early treatment of PWS during childhood leads to the best clinical response. 2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 1 Early treatment of PWS during childhood leads to the best clinical response. Geronemus, M.D.,

Medical 52

Medical FDA Recruitment Side effects 52

Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration (FDA) for UroActive. .

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

Legacy MEDSearch

AUGUST 21, 2023

It is the next generation of highly crosslinked polyethylene with vitamin E antioxidant that is intended to further our primary goal of providing immense benefits to our patients.” This new generation polyethylene is the latest, first-of-a-kind innovation by Orhun Muratoglu, Ph.D., Headquartered in Gainesville, Fla., Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

PM360

APRIL 7, 2023

Patient Pages: How Healthcare Costs Affect Insured Patients Today A new study shows an insured American with an employer-sponsored health insurance plan can expect to spend more than $320,000 (including insurance premiums and out-of-pocket costs) during his/her adult lifetime.

Healthcare 52

Healthcare Healthcare Insurance Physicians 52

Pharmaceutical Technology

JUNE 30, 2022

A key challenge in the development of treatments for such indications is the fact that these indications are neglected and often affect populations in lower-income countries, says Dr David Mabey an infectious disease physician at the London School of Hygiene & Tropical Medicine. For example, Merck & Co.

Leads 64

Leads Pharma Medicine FDA 64

PM360

SEPTEMBER 21, 2023

The recent wave of Alzheimer’s Disease (AD) drug approvals and promising pivotal trial data from various drug manufacturers has been celebrated by physicians, patients, caregivers, and advocacy groups across the U.S. 2 Yet the largest payer in the U.S. has seemingly taken a different point of view.

Manufacturing 99

Manufacturing FDA Recruitment Prospecting 99

Legacy MEDSearch

APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery. Pacifico, Founding President and Chief Executive Officer of Abyrx.

FDA 52

FDA Food and Drug Administration Recruitment Manufacturing 52

pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.

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FDA Patients Electronics Medical 90

Medgadget

DECEMBER 1, 2022

Bigfoot Biomedical , a medtech company based in California, has developed the Bigfoot Unity System, a diabetes management technology for patients on multiple daily injection therapy. The system uses continuous glucose monitoring data and doctor recommendations to provide insulin dose recommendations, helping patients to avoid uncertainty.

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Management Patients Doctors Healthcare 99

pharmaphorum

DECEMBER 12, 2022

The San Antonio Breast Cancer Symposium (SABCS) has highlighted some of the most promising clinical research being undertaken by drugmakers in the category, with AstraZeneca leading the charge with a trio of major trial readouts. The FDA is already reviewing a marketing application based on the data, with a verdict due in February.

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Pharma Physicians Patients Leads 98

PM360

DECEMBER 14, 2023

A standard dose of the medicine causes acute kidney damage in 20% of patients and 50% of those who receive higher dosages used to treat life-threatening infections on a broad spectrum. for adult patients with progressing desmoid tumors who require systemic treatment. The tablets are created by SpringWorks Therapeutics Inc.

Healthcare 52

Healthcare Healthcare FDA Education 52

Legacy MEDSearch

FEBRUARY 28, 2023

RADIANCE II is a randomized, sham-controlled US FDA IDE pivotal trial of the Paradise uRDN System in the treatment of patients with uncontrolled hypertension. Patients were to remain off antihypertensive medications throughout the two months of follow-up unless specified BP criteria were exceeded. mmHg (p<0.0001).

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Networking Medical Physicians Safety 98