Pharmaceutical Technology

FEBRUARY 3, 2023

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above.

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European Pharmaceutical Review

OCTOBER 19, 2023

One of the aspects of radiopharmaceuticals that is often overlooked is how complicated it is to develop a new agent, in terms of the complexity of drug design to realise a therapeutic candidate and the implementation of the clinical evaluations. This is not an effective strategy. Barrett at the Center for Gamma Ray Imaging.

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Pharmaceutical Representative Training

DECEMBER 28, 2021

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines.

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Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy.

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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. For milder cases, doctors have traditionally prescribed topical corticosteroids, vitamin D analogues, and retinoids. First in class.

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Medico Reach

OCTOBER 17, 2022

Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. Development Of Smart Implants And Augmented Reality (AR) In Orthopedic Technology. This focus on advanced implants also extends to smart technology.

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Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care. was founded by two doctors with a mission to “change cardiology with blood flow analysis.”

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Pharmaceutical Technology

JULY 28, 2022

The frequency of administration associated with a therapy is a critical factor that companies in this space focus on to fine-tune their chances of success in the wAMD market. Lower frequency of administration represents a significant alleviation of treatment burden and lower cost of treatment compared with standard of care.

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Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. ” This latest FDA clearance for the EyeArt v2.2.0

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Legacy MEDSearch

APRIL 26, 2023

Food and Drug Administration (FDA). Pulse’s FDA clearance means the company’s SphygmoCor technology can now be expanded to be used in decentralized clinical trials, remote patient monitoring, and for self-monitoring at home. Are you hiring?

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pharmaphorum

SEPTEMBER 28, 2022

Understanding these differences across diverse populations can help doctors and HCPs determine what medication and dosage best fit a patient. Food and Drug Administration (FDA). Martin is also the primary author of the pivotal FDA guidance document Collection of Race and Ethnicity Data in Clinical Trials.

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LEVO Health

OCTOBER 26, 2022

Food & Drug Administration (FDA) classifies medical devices. How the FDA Classifies Medical Devices. The FDA classifies medical devices into one of three classes based on their risks and regulatory controls: . They are not obligated to submit data or information to the FDA. .

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PM360

JUNE 24, 2024

This is partly due to the limited market potential for drugs in the space, but also due to the sheer volume of rare diseases: approximately 6,000–8,000 have been identified. The overarching theme: As with rare disease drug development, precision and personalization are key. Food & Drug Administration (FDA).

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pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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Medico Reach

OCTOBER 17, 2022

Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. Development Of Smart Implants And Augmented Reality (AR) In Orthopedic Technology. This focus on advanced implants also extends to smart technology.

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Pharmaceutical Technology

APRIL 13, 2023

DCTs in regenerative trials are restricted due to tighter controls of sample collection and administration of gene or cell therapy at home, such as stem cells, which can require injections into the spinal cord. However, there is still some use of remote patient monitoring technologies.

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Pharma Marketing Network

OCTOBER 1, 2024

This involves a combination of direct-to-consumer advertising, professional marketing to doctors and pharmacists, and educational campaigns. These representatives played a crucial role in educating doctors about new medications and their benefits.

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Nixon Gwilt Law

DECEMBER 16, 2021

So much so that we’ve recently welcomed 20-year Food and Drug Law veteran and FDA expert Mark Mansour, Esq., She also says, “Patients and providers alike are becoming more familiar with the concept that care management does not end in between doctor visits. to the Firm in part to address the influx of SaMD client needs.

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Pharmaceutical Technology

MAY 18, 2023

Other processes include direct-to-patient (DtP) shipments of drugs and other supplies to a patient’s home, as well as in-home care with mobile nurses. The DeTAP trial clearly demonstrates how using digital technology can increase and speed up clinical trial recruitment while also keeping the participant fully engaged.

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Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The post FDA grants approval for Amylyx’s Relyvrio to treat ALS appeared first on Pharmaceutical Technology.

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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.

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European Pharmaceutical Review

AUGUST 23, 2022

The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

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pharmaphorum

SEPTEMBER 13, 2022

Thanks to the dedicated efforts of doctors, patients, carers, and healthcare professionals, people diagnosed with blood cancer are now living longer, with a steady stream of more effective treatments entering the market each year. 2001– FDA green lights revolutionary treatments. 2002 – Emergence of CAR-T therapy.

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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. FDA UPDATE Aurlumyn (iloprost) injection by Eicos Sciences, Inc. Car T cells can help slow down aging by attacking senescent cells that multiply with age but don’t die off.

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Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. GlaxoSmithKline to pay $3bn in US drug fraud scandal. Department of Justice, 2020). link] Reuters.

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PM360

NOVEMBER 21, 2024

Adam with his family Greatest Achievements and Activism Adam said his greatest professional achievement is the launch of Keytruda, a prescription immunotherapy drug used to treat many types of cancer, which Merck manufactures and sells. Food and Drug Administration (FDA) approval.

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European Pharmaceutical Review

JANUARY 2, 2025

Here, collaboration between academic researchers, drug developers, and CDMOs will be key to making progress in identifying base modification strategies and leveraging them in therapeutic candidates. As of late 2024, the guidance is still under internal review by the FDA, so it remains unclear when or how the programme would be implemented.

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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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PM360

AUGUST 9, 2022

Brand Beat: Juul Fights FDA Ban. Shortly after banning Juul from selling its products, the FDA placed a hold on its decision in order to review the company’s case more closely. however, the company is required to prove to the FDA that their e-cigarettes in fact benefit the public. appeals court in Washington, D.C.,

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European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT. Q13 Continuous Manufacturing of Drug Substances and Drug Products.

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Cadensee

JULY 20, 2021

It's become the main thing that the doctors are looking at now. And did you know at the time that you were a trailblazer in this space? It broke the confines of you being a doctor learning healthcare, learning to be a medical profession and that stayed there; it just broke it all. Interview Transcription (mild edits).

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