Legacy MEDSearch

DECEMBER 8, 2022

took a step towards its vision of transforming chronic care management with Polso , the company’s Remote Patient Monitoring (RPM) solution, achieving 510(k) clearance from the U.S. Food and Drug Administration (FDA). ChroniSense Medical Ltd. and globally. About ChroniSense Medical. About Rainbow Medical.

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FDA Patients Food and Drug Administration Medical 97

European Pharmaceutical Review

APRIL 17, 2024

Roche’s twice-yearly, 10-minute subcutaneous injection of OCREVUS ® (ocrelizumab) has shown significant promise for patients with either with relapsing or primary progressive multiple sclerosis (RMS or PPMS). percent had no relapse) in patients through 48 weeks of the treatment.

Food and Drug Administration 67

Food and Drug Administration Safety Medicine Food 67

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. clinical experts), and converting regulatory guidance into practical application.

Patients 52

Patients Food and Drug Administration FDA Safety 52

PM360

APRIL 18, 2023

Program sessions, centered around data quality and fit-for-purpose use, will delve into studies that showcase the utilization and effectiveness of RWE in healthcare decision-making. ISPOR 2023 is scheduled for May 7-10 with the theme, “Impacting Innovation, Value, and Healthcare Decision Making.”

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Food and Drug Administration Healthcare Healthcare Food 96

Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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Food and Drug Administration FDA Healthcare Provider Prospecting 119

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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Food and Drug Administration Transportation FDA Medical 88

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 used to prescribe antidepressants for patients but never considered psychiatry as a profession.

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Leads Pharma Food and Drug Administration Medicine 52

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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Food and Drug Administration Manufacturing Management Safety 80

Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. This approval marks a major milestone in the fight against Alzheimer’s, which is the sixth leading cause of death in the United States and affects over 5 million people.

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Food and Drug Administration FDA Consulting Food 52

Pharmaceutical Technology

APRIL 17, 2023

Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The company announced that Health Canada’s acceptance follows the acceptance by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

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Food and Drug Administration Government Medicine Food 64

European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose.

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Food and Drug Administration Side effects Medicine Food 84

Pharmaceutical Technology

MAY 12, 2023

SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.

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Food and Drug Administration Pharmaceutical FDA Specialization 52

European Pharmaceutical Review

AUGUST 11, 2023

Crizanlizumab is a once-a-month, humanised monoclonal antibody infusion, indicated for the prevention of recurrent vaso‑occlusive crises (pain crises) in sickle cell disease patients aged 16 years and above. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA).

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Marketing Food and Drug Administration Medicine FDA 83

Legacy MEDSearch

SEPTEMBER 16, 2022

the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Tasso technology has the power to bring healthcare anywhere, any time. Tasso, Inc., Trusted diagnostics made easy.

Medical 97

Medical FDA Food and Drug Administration Recruitment 97

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

Patients 52

Patients Food and Drug Administration FDA Safety 52

PM360

MARCH 22, 2024

Amor Vegas stated, “T cells have the ability to develop memory and persist in your body for really long periods, which is very different from a chemical drug. Think about patients who need treatment multiple times per day versus you get an infusion and then you’re good to go for multiple years.” National Healthcare Benchmark Database.

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Food and Drug Administration FDA Healthcare Healthcare 52

PM360

AUGUST 9, 2022

Following the annual American Society of Clinical Oncology (ASCO) conference, oncologists were asked how the data presented would impact their care of patients. Another 17% recommended mandating patient recruitment requirements and 14% would like to see the development of a diverse pool of investigators and staff.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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Food and Drug Administration Side effects Recruitment Safety 52

Legacy MEDSearch

MARCH 15, 2023

LIVMOR’s technology was commercially deployed within the VA Healthcare System in Dallas, Texas. In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. HeartBeam CEO and Founder.

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Food and Drug Administration FDA Recruitment Physicians 97

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.

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FDA Food and Drug Administration Recruitment Medical 95

Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.

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Food and Drug Administration FDA Prescription Food 52

European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

Medical 84

Medical Food and Drug Administration Pharmacology Medicine 84

PM360

MAY 2, 2023

Ardelis Health , a healthcare strategic marketing agency and consulting firm partnering with innovators that discover, differentiate, and launch important therapies, today announced the appointment of industry veteran Timmy Garde as Chief Growth Officer. “We I’m excited to join Ardelis and lead the next phase of our growth,” said Garde.

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Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. 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 healthcare subsidiary of Samsung Electronics Co.,

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FDA Food and Drug Administration Electronics Recruitment 92

Clarivate

JUNE 23, 2022

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. It targets mismatch repair deficiency, a biomarker seen in 25-30% of patients with endometrial cancer.

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Food and Drug Administration Marketing Doctors Patients 52

PM360

FEBRUARY 12, 2024

Created by The European Organization for Rare Diseases (EURORDIS) , this globally coordinated event brings together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers, and their families.

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Food and Drug Administration Patients Networking Medical 105

Legacy MEDSearch

MARCH 21, 2023

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc., The Lumicell DVS is not commercially available.

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Food and Drug Administration FDA Recruitment Medical 52

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. .

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

Pharmaceutical Technology

JUNE 2, 2023

Kicking off this year’s American Society of Clinical Oncology’s (ASCO) conference, Novartis has released data supporting the use of its CDK4/6 inhibitor Kisqali (ribociclib) as an adjuvant treatment for a group of early-stage breast cancer patients.

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Food and Drug Administration Healthcare Provider Patients Food 52

Pharmaceutical Technology

MAY 16, 2023

UniQure is selling a part of its royalty rights to the haemophilia B gene therapy Hemgenix (etranacogene dezaparvovec) to HealthCare Royalty and Sagard Healthcare for a gross purchase price of up to $400 million dollars. HealthCare Royalty is a royalty acquisition company. HealthCare Royalty is a royalty acquisition company.

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Food and Drug Administration Healthcare Healthcare Sales 52

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. Conversely, in the US, it has always been clear and regulated as a drug.

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Food and Drug Administration Manufacturing Medicine Pharma 98

Medico Reach

OCTOBER 17, 2022

What really matters are the orthopedic medical device trends that are already shaping the healthcare industry. Advancements in medical technology will always be a favorite topic of discussion when analyzing the healthcare sector. Healthcare executives are also looking into AR spinal surgical systems. Let’s dive right in!

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 76

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. Otsuka Medical Devices Co.,

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

pharmaphorum

OCTOBER 26, 2022

But two new non-steroidal topicals were introduced this year — Dermavant Science’s Vtama and Arcutis Biotherapeutics’ Zoryve — and each one solves a long-time problem plaguing millions of psoriasis patients. The approvals add two more options for psoriasis patients hoping to stay away from biologics as long as they can. First in class.

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Side effects Food and Drug Administration Patients Management 94

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. Early detection of sepsis is an invaluable capability for healthcare professionals.

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Food and Drug Administration FDA Recruitment Physicians 98