Pharmaceutical Technology

APRIL 12, 2023

Pharming Group has conducted the first commercial shipments of oral selective PI3Kδ inhibitor Joenja (leniolisib) to patients diagnosed with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in the US. Under its terms, Pharming has paid a $10m milestone payment to Novartis for the first commercial sale of Joenja.

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Food and Drug Administration Patients FDA Food 59

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan.

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Sales FDA Marketing Competition 52

Legacy MEDSearch

NOVEMBER 28, 2022

Director of Global Sales and Marketing of NeuroLogica. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite. The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently.

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FDA Food and Drug Administration Electronics Recruitment 92

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options. The company intends to launch the biosimilar in the US in July 2023.

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Food and Drug Administration FDA Food Safety 52

pharmaphorum

AUGUST 16, 2022

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. The post FDA grants swift review to Lynparza in first-line prostate cancer appeared first on.

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Legacy MEDSearch

DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today. market today.

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FDA Food and Drug Administration Recruitment Medical 95

Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. In 2022, US sales of Ozempic contributed to 65% of global sales; this is expected to continue, with the US market forecast to continue capturing the majority of sales, generating $71bn between 2023–2029.

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Sales Marketing Medical Patients 52

Legacy MEDSearch

NOVEMBER 1, 2022

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. The new 7.5mm device is designed to simplify surgery and to provide strong, stable, curved fixation in smaller patients. CurvaFix, Inc., every year.

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Food and Drug Administration FDA Recruitment Food 98

pharmaphorum

OCTOBER 27, 2022

Santhera should hear from the FDA whether the speedy review has been granted within the next 60 days, and if so the review time will be cut from 10 to six months. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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FDA Side effects Biopharma Marketing 91

World of DTC Marketing

JULY 21, 2021

DTC ads do NOT lead to unnecessary Rxs. The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. Some DTC budgets are only released when certain sales targets are hit.

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Marketing Prescription Side effects Doctors 285

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. .

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Food and Drug Administration FDA Side effects Recruitment 98

Legacy MEDSearch

APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR metal resection guides sit noticeably better on the bone and offer greater saw control compared to the historically polymer patient-specific instruments.

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FDA Patients Food and Drug Administration Recruitment 52

Pharmaceutical Technology

JUNE 7, 2023

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. of patients’ body weight (52lb or 24kg) and greater than 50% of patients taking Mounjaro achieving at least 20% body weight reductions.

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Leads Marketing FDA Sales 98

Legacy MEDSearch

JANUARY 31, 2023

The newly approved Axonics R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour. This compares to the third-generation’s recharge interval of once a month for one hour.

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FDA Food and Drug Administration Recruitment Medical 98

Legacy MEDSearch

JULY 18, 2023

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). 1 The ReddyPort elbow also enables patients and clinicians to use the ReddyPort microphone.

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FDA Food and Drug Administration Recruitment Patients 52

Legacy MEDSearch

AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. The FDA clearance of BAROguard is a major step in providing transplant teams with leading technology to enhance organ transplantation outcomes.”

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FDA Food and Drug Administration Transportation Recruitment 52

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.

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FDA Safety Recruitment Patients 98

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 solution is not yet approved for sale or distribution in the USA and is limited by USA law to investigational use. VisAble.IO

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FDA Food and Drug Administration Physicians Recruitment 52

Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.

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FDA Food and Drug Administration Recruitment Medical 52

pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. Here is a patient (*written consent obtained) I saw just 2 weeks ago with severe disease. — Brian S.

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FDA Patients Leads Safety 67

Legacy MEDSearch

SEPTEMBER 7, 2023

FDA clearance for distribution in the United States. FDA approval, coupled with strategic partnerships like the one with AstraZeneca, positions alveofit® for broader international expansion, particularly in the U.S. FDA-cleared, portable digital spirometer, alveoair® is part of alveofit’s ecosystem. and emerging economies.

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FDA Recruitment Distribution Healthcare 52

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. This system fills that void for both surgeons and patients.” For these patients, total knee replacement is a reluctant option, as it is an end-stage treatment for end-stage disease.

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Marketing FDA Food and Drug Administration Specialization 96

Legacy MEDSearch

MARCH 16, 2023

The DeltaScan Brain State Monitor provides a quick and objective measurement of acute brain failure even before symptoms appear, enabling clinicians to provide immediate treatment and help patients regain cognitive well-being. This delay often leads to cognitive impairment, worse health outcomes, and increased costs,” said Dr. .

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FDA Food and Drug Administration Patients Recruitment 52

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.

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Patients Recruitment Pharmacology Side effects 98

Legacy MEDSearch

JULY 31, 2023

Axial3D, a leader in medical segmentation and 3D solutions, today announced that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications.

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pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. billion or more.

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Sales Biopharma Medicine Patients 108

Legacy MEDSearch

AUGUST 15, 2022

This first-generation anatomical segment analysis tool emerged over 10 years ago from research aimed at detecting subtle volumetric and shape abnormalities in patients with mild traumatic brain injury. More importantly, it provides point-based correspondence longitudinally and across patients. About ClearPoint Neuro.

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FDA Recruitment Safety Patients 98

pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. Mirati also says its drug penetrates the central nervous system more readily, making it a better option for patients whose disease has metastasised to the brain.

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FDA Side effects Competition Patients 52

Evolve Your Success

JANUARY 31, 2023

In this episode, Samuel Adeyinka interviews John Crowder who covers how to sell effectively in medical sales. Tune in now and get medical sales-ready! — Watch the episode here Listen to the podcast here Selling Effectively In Medical Sales With John Crowder We have with us another special guest. I’m wonderful.

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Medical sales Sales Medical Training 64

Legacy MEDSearch

JULY 12, 2023

AccurKardia , a medical technology company delivering clinical-grade ECG interpretation software, announced today that its flagship product, the AccurECG Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance. It is indicated for adults aged 22 and older. It is indicated for adults aged 22 and older.

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FDA Recruitment Medical Healthcare Provider 52

MaBiCo

NOVEMBER 15, 2023

The Future of the Medical Sales Profession: Challenges and Approaches in a Fast-Changing Healthcare Market. Medical sales representatives are professionals who promote medical and health related products or services to healthcare providers, such as hospitals, clinics, pharmacies, and doctors.

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Medical sales Medical sales reps Sales Medical 52

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.,

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Food and Drug Administration FDA Recruitment Food 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. IntelliSep will be available in the United States in the coming weeks.

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Food and Drug Administration FDA Recruitment Physicians 98

pharmaphorum

JUNE 23, 2022

Novartis’ two-drug regimen of Tafinlar and Mekinist has been approved by the FDA as the first therapy for solid tumours that have a BRAF V600E mutation – regardless of where they occur in the body. The post Novartis bags FDA okay for BRAF-positive tumour combination appeared first on. Tabrecta approved in Europe.

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Legacy MEDSearch

SEPTEMBER 8, 2023

a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the United States. Aquedeon Medical, Inc.,

Medical 52

Medical FDA Recruitment Specialization 52

World of DTC Marketing

APRIL 6, 2022

For that matter, click-through rates don’t correlate with any meaningful brand metrics or any meaningful lead-gen metrics. In addition, the FDA seems to be looking at NDAs in terms of REAL outcomes. Pharma is losing people who have a passion and excellent knowledge on how to market to patients. This has to be reversed.

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Marketing Sales pitches Pharma Media 196

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.

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FDA Recruitment Medical Management 52