European Pharmaceutical Review

APRIL 13, 2023

Psychedelic research: evaluating the fast-evolving regulatory roadmap Psychedelics: the position in Europe The EMA’s recent letter confirms that as of 17 February 2023 in the EU, 6 there were: 11 ongoing clinical trials in EU with psilocybin for a range of central nervous system conditions four ongoing trials with MDMA one trial with LSD.

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European Pharmaceutical Review

JULY 19, 2023

The data “are compelling, particularly the significant improvements observed in both depressive and anhedonic symptoms,” stated Dr Roger S McIntyre, FRCPC, Professor of psychiatry and pharmacology, University of Toronto and Executive Director of the Brain and Cognition Discovery Foundation in Toronto, Canada.

Pharmacology 98

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European Pharmaceutical Review

JANUARY 18, 2024

billion by 2023, driven by the launch of Merck’s Belsomra and Eisai’s lemborexant (E-2006). GlobalData’s Analyst covering Neurology and Ophthalmology, Thomas Parker, MPharmacol, predicted that Belsomra would lead the market by 2023. billion across the 7MM up to 2032, GlobalData’s predicted in a report published in December 2023.

Marketing 98

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Pharmaceutical Technology

MARCH 17, 2023

Companies are testing the use of digital platforms along with pharmacological treatments. But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging.

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Pharmaceutical Technology

MAY 11, 2023

Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US. The regulator accepted and gr anted priority review for the sNDA in January 2023.

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Pharmaceutical Technology

APRIL 24, 2023

We look forward to our upcoming meeting with the FDA on 1 May 2023 to discuss our planned Phase III clinical programme for XORLO.” Oxypurinol, a xanthine oxidase inhibitor, has key pharmacologic characteristics that are ideal for administration in ADPKD patients.

Food and Drug Administration 52

Food and Drug Administration FDA Pharmacology Food 52

pharmaphorum

OCTOBER 26, 2022

mjn-SERAS already has a CE mark in Europe and is currently in clinical testing, with results due in 2023. The platform has been developed with support from the EU’s European Institute of Technology Health (EIT Health) and funding from the Horizon 2020 programme, along with industrial and academic partners.

Pharmacology 64

Pharmacology Patients Sales Management 64

pharmaphorum

NOVEMBER 1, 2022

Date: 8 – 9 February 2023. In 2023 we will see the return of SAE’s RNA Therapeutics conference to a live in-person event, showcasing an update on mRNA therapeutic applications, coupled with an industry outlook of the field. Director, Clinical Pharmacology. 14th Annual RNA Therapeutics. Location: London, UK. Website: [link].

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European Pharmaceutical Review

DECEMBER 11, 2023

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. Brain pharmacology of intrathecal antisense oligonucleotides revealed through multimodal imaging. Bennett CF, Krainer AR, Cleveland DW. 2019 ;42:385-406. JCI Insight.

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Safety Pharmacology Engineering Medical 98

Impetus Digital

AUGUST 2, 2024

Looking back at 2023 , AI for drug discovery saw both wins and losses. Specifically, AI can help with data mining and integration, predictive modeling and virtual screening, network pharmacology and systems biology, clinical trial optimization, safety and toxicity prediction, and decision support.

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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.

Pharmacology 52

Pharmacology FDA Marketing Pharma 52

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.

Pharmacology 52

Pharmacology Safety Patients Marketing 52

European Pharmaceutical Review

JULY 18, 2024

This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. 2023; 3 Tsuchikama et al. She also heads three of Ipsen’s specialised functions that support the entire pipeline from discovery through to lifecycle management. 2023;15(1) Shastry et al.

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Food and Drug Administration Engineering Pharmacology Side effects 59

European Pharmaceutical Review

JANUARY 13, 2025

2023; 11 (17), 6510-6522. Pulmonary Pharmacology & Therapeutics. 2023; 33:5. 2023; 33(1): 24. References Carbon Impact of Biotech & Pharma Report: Collective Action Accelerating Progress to the UN Race to Zero. Internet] My Green Lab: San Francisco California. Cited 2024August]. Green Innovation. 2024; 85: 1-9.

Medicine 52

Medicine Pharmaceutical Manufacturing Government 52

Legacy MEDSearch

OCTOBER 13, 2022

market launch planned for early 2023. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy , an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 90,000 patients globally. this quarter, with a broad U.S.

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FDA Food and Drug Administration Recruitment Patients 52

European Pharmaceutical Review

JULY 4, 2024

Regulatory pathways in the EU The EU regulatory framework is, unsurprisingly, similar to that in the UK (as the UK framework derives from the EU Directives) and consists of the Traditional Use Scheme and full MA.

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

JANUARY 31, 2025

She holds a MSc in Pharmacology. Marechal-Jamil has led European and International advocacy efforts across a wide range of topics: market access and health policies, and regulatory and scientific frameworks. References 1. Key Figures on Biosimilar medicines (2024). Internet] Biosimilar Medicines Group, Medicines for Europe. Internet] IQVIA.

Medicine 52

Medicine Competition Marketing Patients 52

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.

Pharmacology 52

Pharmacology Medicine Sales Leads 52

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. Look for programs that offer courses in sales and marketing, healthcare management, biology, pharmacology, or medical technology.

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Medical sales Sales Medical Medical sales reps 52

pharmaphorum

JANUARY 26, 2023

2023 is set to usher in a new era of genomics, and here are five areas where we should see significant advances. The post A new dawn of the genomic age: five areas set to be transformed in 2023 appeared first on. Such innovations are driven by the rapid evolution of genomics technologies that has taken place in recent years.

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European Pharmaceutical Review

OCTOBER 27, 2022

Ahead of the world’s largest pharma event, CPHI Frankfurt – hosted at the Frankfurt Messe (1-3 November, 2022) – part i of the CPHI Annual Report looks ahead at the opportunities for biologics outsourcing and contract manufacturing organisastions (CMOs) in 2023. In the report some 50.4 percent in 2021).

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Clarivate

OCTOBER 7, 2024

They became integral to physiological and pharmacological research during the 19th century and started to be systematically used for drug development during the 20th century. Food and Drug Administration, 2023). Clinical Pharmacology and Therapeutics, 104(6), pp. Food and Drug Administration, 2023. Organogenesis, 19(1).

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Food and Drug Administration Pharmacology Food Engineering 52

European Pharmaceutical Review

MAY 2, 2023

He received an MD from the Georg August University of Göttingen and completed a postdoctoral Master’s in Medical Sciences Clinical Pharmacology at the University of Glasgow. cited 2023 Apr 4]. 2019 [cited 2023 Apr 4]. cited 2023 Apr 4]. cited 2023 Apr 4]. cited 2023 Apr 4]. 2023 [cited 2023 Apr 4].

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Patients Medicine Marketing Medical 105

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.

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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.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

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 97

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. Innovation will power the market.

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Prior to joining Novimmune in 2002, she was Head of Immunology and Preclinical Pharmacology at the Serono Pharmaceutical Research Institute, a Senior Scientist and then Head of Immunology at the Glaxo Wellcome Research Institute in Geneva, and a Scientific Member of the Basel Institute for Immunology. 2023 AD/PD Conference.

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Food and Drug Administration Safety Patients Leads 97

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. But these substitutions do not come without complications, as these drugs can vary in their pharmacologic properties, states Page.

Medicine 111

Medicine Manufacturing Pharmacology Leads 111

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.

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