Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. We are committed to continuous improvement to optimize the clinical utility of the Swoop® system while driving commercial adoption across leading institutions globally. Hyperfine, Inc., Hyperfine, Inc.

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Food and Drug Administration FDA Recruitment Food 98

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.”

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European Pharmaceutical Review

AUGUST 1, 2022

The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said. The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team.

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Pharmaceutical Technology

JUNE 27, 2022

The transaction is focused on Epizyme’s lead asset, Tazverik (tazemetostat), a chemotherapy-free EZH2 a inhibitor. In 2020, the US Food and Drug Administration (FDA) granted accelerated approval for the drug.

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Food and Drug Administration FDA Food Patients 59

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. NaviBot is subsidiary of MicroPort MedBot. About MicroPort MedBot Shanghai MicroPort MedBot (Group) Co.,

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Food and Drug Administration Recruitment Medical Food 98

Pharmaceutical Technology

MAY 16, 2023

In June 2020, CSL Behring announced plans to acquire exclusive global rights for the development and commercialisation of Hemgenix from UniQure. billion in milestone payments, per the June 2020 announcement. The standard of care involved factor replacement therapy where patients receive infusions that replenish their Factor IX levels.

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Food and Drug Administration Healthcare Healthcare Sales 52

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication?

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Food and Drug Administration Safety Patients Medicine 89

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 96

Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. months compared with patients treated with standard-of-care chemotherapy.

Food and Drug Administration 59

Food and Drug Administration Sales Patients Food 59

Clarivate

MAY 21, 2024

Given its clinical robustness and patient relevance, OS is universally accepted by regulators and health technology assessment (HTA) bodies alike [2] [3]. Measurement of OS is also susceptible to confounding, particularly when involving multiple lines of therapies, patient crossover, and the occurrence of non-cancer related deaths.

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Food and Drug Administration Patients Consulting Marketing 52

Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). The InTandem name reflects both the synchronization inherent in the device’s mechanism of action and the partnership formed between patient and device. The burden on patient functioning is also profound. MedRhythms also unveiled the brand name for MR-001: InTandem.

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European Pharmaceutical Review

DECEMBER 28, 2023

Following their introduction, these therapies have moved to early lines of treatment, but unfortunately, a significant number of patients are not cured with these approaches. As a result, when the patient’s lymphoma relapses after treatment with chemotherapy, BV and CPIs, there are no effective treatment alternatives for these patients.

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Food and Drug Administration Patients Safety Medical science 84

European Pharmaceutical Review

NOVEMBER 4, 2022

Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. tumour effects. The importance of taxanes in oncology.

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Food and Drug Administration FDA Pharmaceutical Patients 79

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

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Food and Drug Administration Manufacturing Engineering Pharmacology 75

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs. N) = number of approvals.

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Medicine Food and Drug Administration FDA Healthcare 98

Pharmaceutical Technology

MARCH 22, 2023

Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death. 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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Food and Drug Administration Healthcare Healthcare Medical 52

European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Some countries have blocked parallel trade to prevent supplies from depleting.

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Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. However, there is still some use of remote patient monitoring technologies.

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Food and Drug Administration Electronics Healthcare Healthcare 52

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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Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. References Drugs@FDA: FDA-Approved Drugs.

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Food and Drug Administration Medicine FDA Marketing 52

pharmaphorum

SEPTEMBER 28, 2022

Martin Mendoza, PhD, director of health equity and health science policy for the All of Us Research Program at the National Institutes of Health (NIH), tells pharmaphorum about the programme and how it will accelerate research for the benefit of all patients. In March 2020, when the pandemic hit, we had to pause in-person recruitment.

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European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

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Manufacturing Pharma Food and Drug Administration Safety 83

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. The patient centricity movement has been building momentum in recent years. Building relevance.

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Patients Food and Drug Administration Medicine Pharma 83

World of DTC Marketing

MARCH 17, 2022

What treatment works in one patient may not work in another but we have to keep trying to beat cancer anyway we can. But it’s’ still the leading cause of cancer deaths. 9, 2020, by the Breast Cancer Research and Treatment journal. ” There is also the issue of medical debt of surviving cancer patients.

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Food and Drug Administration Medical Ethics Patients 255

Pharmaceutical Technology

JUNE 21, 2023

CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). In the study, Hemgenix reduced or eliminated the need for prophylactic treatment in 94% of patients. Hemgenix is the first and only gene therapy approved for haemophilia B.

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Patients Food and Drug Administration Engineering Sales 98

Pharmaceutical Technology

JANUARY 16, 2023

In October last year, CARsgen submitted a new drug application (NDA) for CT053 to China’s National Medical Products Administration (NMPA). The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019.

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Nixon Gwilt Law

DECEMBER 16, 2021

Partner Carrie Nixon seconds that by predicting “increasing adoption by providers of care management services like Remote Patient Monitoring, Behavioral Health Integration , and Chronic Care Management to improve outcomes for patients.” serves as the lead of NGL’s busy RPM Practice. Kaitlyn O’Connor, Esq.,

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Healthcare Healthcare Food and Drug Administration Ethics 52

European Pharmaceutical Review

JULY 13, 2023

However, even as science advances, there remain patients who still need new treatment options. By re-engineering existing approaches that have already shown clinical promise, there is potential to bring further benefit to the patient community in its fight against cancer.

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Engineering Food and Drug Administration Safety Patients 85

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 percent and 14.3

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European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics.

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Food and Drug Administration Manufacturing Safety Pharmaceutical 87

European Pharmaceutical Review

JUNE 28, 2022

According to the World Health Organization (WHO), CVDs are the leading cause of death worldwide accounting for 32 percent of global deaths in 2019 (approximately 17.9 percent of patients taking empagliflozin for around 14 months were hospitalised for heart failure or died of cardiovascular causes, compared with 24.7 for placebo.

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Food and Drug Administration Medicine Patients FDA 91

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. We’ve learnt that innovative therapies, like Zolgensma, require equally inventive access pathways so that as many patients as possible benefit from treatment.

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Food and Drug Administration Government Healthcare Healthcare 69

Pharmaceutical Technology

JUNE 30, 2022

The country also offers timely patient recruitment due to a population of nearly 4 million, many of whom are treatment-naïve. More than 100 clinical trials were initiated in Georgia from 2020 to 2021, with the majority from international sponsors and a focus on managing Phase II-III multinational trials. Room to grow.

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Pharmaceutical Technology

APRIL 24, 2023

Having steadily risen over the last two decades, 2020 saw more approvals for biopharmaceuticals, often termed as biologics, than any other year in the last decade, according to GlobalData analysis. These attributes make some biologic drugs, especially monoclonal antibodies more specific and targeted in their treatment.

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Manufacturing Food and Drug Administration Biopharma Sales 52

World of DTC Marketing

APRIL 7, 2022

Obesity costs our health care system $147 billion per year, yet there is a movement underway to tell HCPs not to weigh patients during routine visits. The seventh leading cause of death in the United States, diabetes costs $327 billion in medical costs and lost work and wages. Launch prices of new cancer drugs in the U.S.

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World of DTC Marketing

AUGUST 25, 2020

grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals. For the first time, I am now in fear of FDA drug approvals.

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Food and Drug Administration FDA Ethics Prescription 188