Pharmaceutical Technology

APRIL 24, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. We look forward to our upcoming meeting with the FDA on 1 May 2023 to discuss our planned Phase III clinical programme for XORLO.”

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Food and Drug Administration FDA Pharmacology Food 52

pharmaphorum

OCTOBER 26, 2022

The sensor communicates with an app on a smart device, which can send a warning to the patient and trusted contacts, allowing them to take action to try to prevent seizures and avoid injury that might occur during an attack. mjn-SERAS already has a CE mark in Europe and is currently in clinical testing, with results due in 2023.

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Pharmacology Patients Sales Healthcare 62

pharmaphorum

DECEMBER 22, 2022

Regulators in the US and EU have started a review of Pfizer’s S1P receptor modulator etrasimod for people living with moderately-to-severely active ulcerative colitis (UC), with decisions expected in the first halves of 2023 and 2024, respectively.

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Pharmacology Safety Patients Marketing 52

pharmaphorum

SEPTEMBER 26, 2022

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. It was first launched in the US in 2008.

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Pharmacology FDA Pharma Marketing 52

Legacy MEDSearch

OCTOBER 13, 2022

Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns from patients. It was developed to address the variability in pain from patient to patient and to help patients optimize and maintain long-term pain relief and improved quality of life. market launch planned for early 2023.

FDA 52

FDA Food and Drug Administration Recruitment Pharmacology 52

European Pharmaceutical Review

MARCH 11, 2024

In fact, a study published in 2023 in The Lancet HIV revealed that women and men with HIV at age 40 had an average of 39 and 37 years of life left, respectively – only a few years less than that of the general population – if they started antiretroviral therapy (ART) after 2015. Internet] 2023. References 1. World Health Organization.

Medicine 85

Medicine Pharmacology Healthcare Healthcare 85

pharmaphorum

JANUARY 16, 2023

The present article focuses on opportunity, the unmet need which lies at the heart of better healthcare provision, and two areas of growth and opportunity: Point of Care Diagnostics, and the new pharmacotherapy classes which will commercialise for the first time in 2023.

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FDA Healthcare Healthcare Medicine 79

European Pharmaceutical Review

FEBRUARY 14, 2024

Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles. 2023; 28(2):860 The post Navigating the unique CMC challenges of oral anaerobic live biotherapeutics appeared first on European Pharmaceutical Review. Gullifa G, Risoluti R, Mazzoni C, et al.

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Food and Drug Administration Manufacturing Engineering Pharmacology 71

European Pharmaceutical Review

MARCH 6, 2024

The facility will also have capacity to conduct non-clinical pharmacology studies for detailed characterisation of its first-in-class development candidates, according to Ariceum. Internet] European Pharmaceutical Review, Issue 3 2023. 1 References Jaafar-Thiel. Meeting rising demands of a new radiotheranostic era. cited 2024Mar].

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Pharmaceutical Technology

MARCH 17, 2023

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. Companies are testing the use of digital platforms along with pharmacological treatments. The potential cost of these approaches is also an obstacle.

Prescription 111

Prescription Pharmacology Pharma Medical 111

Rep-Lite

JUNE 28, 2023

According to recent statistics, the global medical technology market is projected to reach a staggering US$570.70bn in 2023. This rapid growth is driven by advancements in medical technology, an aging population with increasing healthcare needs, and the constant pursuit of improved patient outcomes.

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Medical sales Medical Sales Medical sales reps 52

European Pharmaceutical Review

JANUARY 18, 2024

The company predicted this will be “driven by an increase in the patient share of dual orexin receptor antagonists (DORAs)”. billion by 2023, driven by the launch of Merck’s Belsomra and Eisai’s lemborexant (E-2006). billion across the 7MM up to 2032, GlobalData’s predicted in a report published in December 2023.

Marketing 85

Marketing Sales Pharmacology Pharma 85

European Pharmaceutical Review

DECEMBER 11, 2023

The first approved ASO was designed for injection directly into the eye for the local treatment of cytomegalovirus (CMV) retinitis in immunocompromised AIDS patients. Known linkers in the RNA field are used to bond together the two pharmacologically active molecular entities and can be applied to multiple oligonucleotide modalities.

Pharmacology 77

Pharmacology Safety Engineering Medical 77

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

Food and Drug Administration 71

Food and Drug Administration Safety Patients Leads 71

Pharmaceutical Technology

DECEMBER 16, 2022

This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology. Post-Covid return and challenges.

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Pharmacology Pharma Pharmaceutical Manufacturing 105

Pharmaceutical Technology

NOVEMBER 3, 2022

The Australian Department of Health and Aged Care published a similar statement on August 25, stating that tenecteplase shortages will likely affect the country until the end of 2023. And patients can die when we do not have these readily available,” he says. Dobutamine is used in the acute treatment of heart failure.

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Medicine Manufacturing Pharmacology Healthcare 111

Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds. But these treatments have their own limits.

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Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

JUNE 15, 2023

Combined with pharmacologic and biologic insight, Confo Therapeutics’ platform allows the company to develop a multi-indication drug candidates pipeline with the aim of transforming therapeutic outcomes for patients living with severe illnesses.

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Pharmacology Medicine Sales Leads 52