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). “FDA clearance is an important validation of our technology.

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European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. This authorisation of BEQVEZ is based on results from the pivotal Phase III BENEGENE-2 study.

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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.

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pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

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World of DTC Marketing

NOVEMBER 24, 2021

needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S. SUMMARY: The U.S.

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Nixon Gwilt Law

APRIL 22, 2024

That said, the flurry of regulatory policymaking and legislation, congressional hearings and inquiries, and industry stakeholder organization around the development and deployment of healthcare AI portends major developments in the coming years. HIPAA is the pantheon of healthcare data privacy regulation in the U.S. HIPAA What is it?

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European Pharmaceutical Review

MARCH 27, 2024

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). Merck/MSD stated that WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

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Legacy MEDSearch

OCTOBER 30, 2023

Medinol today announced United States Food and Drug Administration (FDA) approval for the EluNIR-PERL drug-eluting stent (DES) for the treatment of coronary artery disease. EluNIR-PERL builds upon the proven performance and clinical data of the EluNIR DES system. For more information, see www.medinol.com.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Food and Drug Administration Medical Patients FDA 73

Legacy MEDSearch

SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. This action is part of the FDA’s ongoing effort to ensure the safe and effective use of blood lancets in the home and health care settings. Tasso technology has the power to bring healthcare anywhere, any time.

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Medical FDA Food and Drug Administration Recruitment 97

European Pharmaceutical Review

AUGUST 29, 2023

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes.

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Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment.

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Food and Drug Administration Patients Side effects Medicine 52

Legacy MEDSearch

OCTOBER 24, 2023

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. “The FDA’s Breakthrough Device Designation is a testament to the potential of our technology to address a critical unmet need in interventional cardiology,” said Dr. . Are you hiring?

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Pharmaceutical Technology

JUNE 20, 2023

The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity. In the US and Europe, the drug has received orphan drug status to treat Duchenne muscular dystrophy (DMD).

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Food and Drug Administration FDA Prescription Medicine 98

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Patients should be scared. In other words, money over safety.

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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. ED affects approximately 18% of men in the US.

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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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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.

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Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ 505(b)(2) new drug application (NDA) for a ready-to-use oncology injectable, PEMRYDI RTU. Amneal Pharmaceuticals claimed that PEMRYDI RTU is the first and only ready-to-use presentation of pemetrexed for injection. “By

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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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Pharmaceutical Technology

APRIL 20, 2023

The US Food and Drug Administration (FDA) has approved Roche ’s Polivy (polatuzumab vedotin-piiq), along with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP), to treat certain types of previously untreated diffuse large B-cell lymphoma (DLBCL) in adult patients.

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Food and Drug Administration FDA Food Safety 52

Legacy MEDSearch

NOVEMBER 14, 2022

Xironetic, an early-stage healthcare technology company, today announced its IntraOpVSP augmented reality (AR) visualization software for complex surgeries has received clearance from the U.S. Food and Drug Administration (FDA). Food and Drug Administration cleared the software for use in 2022.

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Food and Drug Administration FDA Recruitment Food 52

Legacy MEDSearch

SEPTEMBER 18, 2023

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites. CereVasc, Inc., Carl Heilman, M.D., Are you hiring?

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Food and Drug Administration FDA Patients Recruitment 52

Legacy MEDSearch

JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

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Pharmaceutical Technology

APRIL 28, 2023

Otsuka America Pharmaceutical and Lundbeck have received approval from the US Food and Drug Administration (FDA) for a new drug application for Abilify Asimtufii (aripiprazole) to treat schizophrenia or for maintenance monotherapy treatment of bipolar I disorder in adult patients.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Biosimilars are key to making healthcare more affordable and accessible.

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Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. the healthcare subsidiary of Samsung Electronics Co., the healthcare subsidiary of Samsung Electronics Co., About NeuroLogica.

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FDA Food and Drug Administration Electronics Recruitment 92

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.

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Food and Drug Administration Safety Medicine Food 66

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

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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.

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FDA Food and Drug Administration Recruitment Medical 95

European Pharmaceutical Review

DECEMBER 7, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Comirnaty ® , the Pfizer/BioNTech COVID-19 vaccine for infants and children aged six months to four years in Great Britain. The acceptance was based on a randomised, placebo-controlled study that has enrolled approximately 4,700 children five to 11 years of age.

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Food and Drug Administration Patients Side effects Medicine 81

Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. This type of advertising is often used to raise awareness of a new drug or to promote a new indication for an existing drug.

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Legacy MEDSearch

OCTOBER 3, 2023

ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100).

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Legacy MEDSearch

JUNE 9, 2023

Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). At present, patients with long blockages of the superficial femoral artery (SFA) have limited treatment options. million Americans are affected by PAD.

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FDA Patients Food and Drug Administration Recruitment 52

European Pharmaceutical Review

OCTOBER 19, 2022

The US Food and Drug Administration (FDA) has awarded a total of $38 million in the form of 19 new grants and two new contracts, to facilitate the upcoming four years of clinical trials and regulatory tools for rare diseases. FDA Commissioner Dr Robert M.

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Pharmaceutical Technology

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. The post US FDA accepts Sandoz’s BLA for biosimilar denosumab appeared first on Pharmaceutical Technology.

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