Legacy MEDSearch

NOVEMBER 9, 2022

announced that over 1,200 patients have been treated with the Early Bird® Bleed Monitoring System, the first and only FDA-approved bleed detection system. The Early Bird was launched in 2019 following a De Novo classification by the U.S. Food and Drug Administration. Saranas, Inc.

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Pharmaceutical Technology

MAY 12, 2023

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. The US FDA granted breakthrough therapy designation to bentracimab in 2019. It was found to be well-tolerated, with only minor adverse events observed.

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European Pharmaceutical Review

SEPTEMBER 26, 2023

This recent decision by the EC follows approval of Tyruko ® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. Multiple sclerosis is a chronic condition with no cure at present and timely access to affordable, high-quality healthcare is therefore even more essential.”

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European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Small populations, paediatric patients, and the desire from patients and their caregivers to receive active therapy can make the conduct of randomised trials with placebo control untenable.

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Food and Drug Administration Patients Distribution FDA 112

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

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades. .

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Food and Drug Administration Medicine Food Government 107

Pharmaceutical Technology

DECEMBER 5, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also since granted the Great Britain marketing authorisation of Lupkynis to treat adults with active LN. Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN.

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Food and Drug Administration Physicians Competition FDA 59

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. billion by 2030. How has the gene therapy landscape evolved over the last several years?

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Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

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Pharmaceutical Technology

JULY 26, 2022

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of Novartis subsidiary Sandoz for natalizumab, a proposed first-ever multiple sclerosis (MS) biosimilar to reference medicine Tysabri. Natalizumab is developed by Sandoz’s collaboration partner Polpharma Biologics.

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Food and Drug Administration FDA Medicine Food 64

MedCity News

JUNE 16, 2023

Investors in 2022 appeared confident that the continued transformation of drug research and development protocols and the overall life sciences industry will not only include digital health solutions, but will even depend on them for data collection, analysis, patient engagement, and even their therapeutic properties.

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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. N) = number of approvals.

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European Pharmaceutical Review

OCTOBER 19, 2023

These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management. These diagnostics are also paired with therapeutics and act as an imaging biomarker to identify patients who may benefit from the paired therapies.

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Food and Drug Administration Side effects Manufacturing Doctors 87

MedCity News

JUNE 12, 2023

One of the fastest-growing frontiers of healthcare is Digital Therapeutics (DTx), which utilizes clinically tested software to prevent, treat, and manage a growing range of medical conditions. The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities.

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Food and Drug Administration Prescription Government FDA 83

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. About the author.

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Pharmaceutical Technology

MARCH 22, 2023

Healthcare providers are under pressure to address the growing issue of substance use disorders. A recent study in the Journal of the American Medical Association found that between 2015 and 2019 as high as one in eight deaths in the US could be attributable to excessive alcohol consumption.

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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

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 88

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

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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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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

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

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 2 The estimated annual healthcare costs associated with circulatory disease in the UK is £9 billion. percent of patients taking placebo. for placebo. 150 mg/dl [?

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Legacy MEDSearch

AUGUST 10, 2023

The device is intended as a companion test for qualified healthcare professionals (HCPs). The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure.

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Legacy MEDSearch

JANUARY 11, 2023

Micronoma , the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, announced that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA). When an imaging test (e.g., more LDCTs, PET-CT scans).

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FDA Food and Drug Administration Recruitment Patients 52

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 months for lecanemab and 5.5

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Food and Drug Administration Safety Patients Leads 76

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 84

Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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Food and Drug Administration Safety FDA Ethics 10

Evolve Your Success

FEBRUARY 7, 2023

He discusses why the future of the healthcare industry in the United States lies not in hospital buildings but in surgery centers. The patients like that their copay is lower. Patients have a lower copay. One in insurance, retail and healthcare that is still around. It’s the first drug-eluting heart stent in the world.

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