Legacy MEDSearch

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. per eligible Medicare patient case.

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Pharmaceutical Technology

OCTOBER 7, 2022

The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk. Simultaneously, the companies have signed a securities purchase agreement under which Sanofi will procure $35m of Provention’s common stock on teplizumab, obtaining FDA approval. .

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World of DTC Marketing

JULY 5, 2022

There isn’t one method to get people exercising; it will take an approach for every healthcare provider to communicate the importance of exercise. Pharma websites provide the prescription that can help people overcome health problems but too often, they ignore the patient’s responsibility to lose weight and exercise.

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World of DTC Marketing

SEPTEMBER 17, 2020

IN SUMMARY: American healthcare is failing. Not only has the FDA become a political pawn but almost half the population is now obese. While there are lots of reasons for this the silence of healthcare providers is a huge reason. My diet has changed to more chicken and fish and less red meat and high fattening foods.

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Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Ancora Heart , Inc., An estimated 6.5 million U.S. million U.S.

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Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. million people in the UK and 2.7

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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. Direct-to-physician (DTP) advertising: DTP advertising is advertising that is directed to healthcare providers.

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PM360

MARCH 22, 2024

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.” Polycystic Kidney Disease is a genetic condition that results in cysts on the kidneys which grow and often result in kidney failure by the time the patient is in their late 40s or 50s.

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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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Pharmaceutical Technology

DECEMBER 5, 2022

Incyte could also grant a potential licence to CMS for other topical formulations of ruxolitinib to treat ailments, such as vitiligo and atopic dermatitis, in the future, for patients in mainland China, Hong Kong, Macau, Taiwan and some Southeast Asia nations.

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Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. And, if there are concerns, the pharmacist can call their healthcare provider to develop a plan.

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Nixon Gwilt Law

APRIL 22, 2024

Valid: Confirms that DSIs are scientifically and statistically sound, providing reliable predictions based on the data and methodologies employed. Effective: Ensures that DSIs achieve their intended outcomes, improving clinical decision-making and patient care. Pro Tip: We are in a moment of transition.

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Pharmaceutical Technology

MARCH 22, 2023

Healthcare providers are under pressure to address the growing issue of substance use disorders. The device received Breakthrough Device Designation from the US Food and Drug Administration (FDA) in December 2020 as no standard of care for the condition existed.

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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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European Pharmaceutical Review

SEPTEMBER 2, 2022

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

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European Pharmaceutical Review

NOVEMBER 8, 2022

There are also several pending bills that seek to lower drug costs by means other than price regulations, including: 1) deterring the delay in FDA approval of drug applications caused by sham ‘Citizen Petitions’. Citizen Petitions before the FDA. 562 would permit the FDA to deny the petition if either of these factors were satisfied.

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Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1. 2] Figure 1.

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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

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. Asthma control improvement and safety profile were consistent with previous clinical trials.

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MedCity News

JUNE 12, 2023

The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities. Combined, DTx and DCTs improve patient recruitment, retention, and access, allowing researchers to pull from underserved communities, including rural populations.

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Pharmaceutical Technology

JANUARY 16, 2023

AstraZeneca has announced that its Tezspire (tezepelumab) received approv al from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the EU for self-administration in severe asthma patients aged 12 years and above.

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Pharmaceutical Technology

NOVEMBER 15, 2022

Pfizer’s Paxlovid ( nirmatrelvir and ritonavir) treatment comprises a twice-daily three-pill antiviral regimen for five days designed to treat adult patients with Covid-19 by preventing the virus from spreading within the body. In Q3 Pfizer earned $7.5 The frequency of targeted symptom recurrence after symptom resolution was assessed.

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Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma.

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Clarify Health

NOVEMBER 9, 2022

But are they doing enough to make a significant impact and accurately reflect the diverse patient population? Deloitte research recently discovered it delivers three key advantages: Safety and effectiveness: Clinical trial participants must reflect the patient population likely to use a new drug. Current FDA guidance.

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Clarify Health

NOVEMBER 9, 2022

But are they doing enough to make a significant impact and accurately reflect the diverse patient population? Deloitte research recently discovered it delivers three key advantages: Safety and effectiveness: Clinical trial participants must reflect the patient population likely to use a new drug.

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PM360

NOVEMBER 21, 2022

allowing users to analyze their real-time glucose monitoring data even more fully as well as send it to their healthcare providers right from their smartphones. Telehealth companies such as Mindbloom, Nue Life, and Wondermed are offering the delivery of ketamine products to patients’ homes for treatment of psychiatric conditions.

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Cadensee

JULY 20, 2021

He is one of the first advocates for patient centric health care more than a decade ago when patient opinions and requests were not part of the equation in the system. Uri founded and continues to contribute insights through his digital magazine, e-Pochonder and is one of the first advocates for patient centric health care.

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