European Pharmaceutical Review

NOVEMBER 6, 2023

IZERVAY ( avacincaptad pegol intravitreal solution) induced a year-over-year reductions in the rate of geographic atrophy lesion growth in patients with geographic atrophy secondary to age-related macular degeneration (AMD) in a Phase III trial, Astellas Pharma has announced. Astellas to accelerate ocular disease treatments with $5.9

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Food and Drug Administration Safety Food Patients 101

European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

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Food and Drug Administration FDA Food Medicine 98

European Pharmaceutical Review

OCTOBER 19, 2023

These findings presented at the 2023 European AIDS Conference (EACS 2023) were based on the ongoing Bictegravir Single Tablet Regimen (BICSTaR) study. First paediatric EC approval of HIV drug The post EACS 2023: Gilead shares real-world evidence for Biktarvy® appeared first on European Pharmaceutical Review.

Safety 104

Safety Food Physicians Medical 104

pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.

FDA 97

FDA Patients Electronics Medical 97

European Pharmaceutical Review

FEBRUARY 7, 2023

A wave of important legislative changes is anticipated in the EU in 2023 making this year one of the biggest for the EU regulatory landscape governing the life sciences industry in recent times. As a key priority action under the ACT EU initiative, EU regulators plan to establish a multi-stakeholder platform (MSP) in 2023.

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European Pharmaceutical Review

NOVEMBER 25, 2022

STC-15, a first-in-class ribonucleic acid (RNA) modifying enzyme inhibitor, has been dosed in the first patient in a clinical trial, making it the first molecule targeting an RNA methyltransferase to enter clinical development. We anticipate presenting results from our Phase I study in 2023.” Pre-clinical studies of STC-15.

Patients 98

Patients Safety Medical Pharmaceutical 98

Pharmaceutical Technology

JUNE 8, 2023

The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS).

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Patients Food and Drug Administration Food Safety 98

PM360

DECEMBER 14, 2023

Empowering patients with comprehensive information about their health and medical conditions is a critical step towards fostering their active involvement in healthcare decisions. And pharma marketers can play a crucial role in helping to deliver the right education to patients.

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Education Patients Digital Media Pharma 98

European Pharmaceutical Review

OCTOBER 11, 2023

Late-breaking data from Roche’s Phase III OCARINA II study have revealed that OCREVUS® (ocrelizumab) subcutaneous injection was comparable to IV infusion in providing near-complete suppression of MRI brain lesion activity over 24 weeks, for relapsing or primary progressive multiple sclerosis (RMS or PPMS) patients.

Safety 111

Safety Patients Medical Pharmaceutical 111

European Pharmaceutical Review

NOVEMBER 7, 2023

The treatment is being evaluated in patients with upper GI adenocarcinomas. The new Phase II data, in addition to existing studies, add to evidence that domvanalimab has a differentiated safety and tolerability profile relative to published data from studies with Fc-enabled anti-TIGIT antibodies.

Safety 114

Safety Patients Physicians Medical 114

Pharmatutor

JANUARY 23, 2023

Pharmacovigilance - Indian view of 2023 admin Tue, 01/24/2023 - 12:26 Pharmacovigilance is the process of monitoring and assessing the safety of medications after they have been approved and are on the market.

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Side effects Safety Medical Marketing 52

European Pharmaceutical Review

MAY 2, 2024

It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023. According to the MHRA, artificial intelligence offers “improved efficiencies”, enabling patients in the UK to safely access medical products earlier.

Safety 115

Safety Medicine Government Medical 115

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. 3 Moreover, digital platforms can be tailored to the needs of patients and healthcare professionals, offering accessible, trustworthy and up-to-date information on medicines precisely when required.

Healthcare 98

Healthcare Healthcare Safety Electronics 98

European Pharmaceutical Review

NOVEMBER 19, 2024

This new collaboration is set to further improve safety and efficacy of radiopharmaceuticals. For example, targeted radioligand therapy has shown promise for eligible patients with prostate cancer. “Radioligand therapies hold transformative potential for certain forms of cancer.”

Food and Drug Administration 52

Food and Drug Administration Manufacturing Food Safety 52

European Pharmaceutical Review

NOVEMBER 16, 2023

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. No significant safety concerns were identified during the trials.

Safety 114

Safety Side effects Patients Medicine 114

European Pharmaceutical Review

OCTOBER 20, 2023

In a long-term extension study, Eli Lilly and Company’s biologic lebrikizumab enabled almost 80 percent of patients with moderate-to-severe atopic dermatitis (eczema), who continued monthly maintenance dosing for up to two years, to maintain fully or almost complete skin clearance for this period.

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Safety Pharmaceutical Patients Medicine 105

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

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Food and Drug Administration Manufacturing Safety Transportation 97

European Pharmaceutical Review

OCTOBER 18, 2023

Ardelyx’s first-in-class oral treatment is indicated to reduce serum phosphorus in adults with chronic kidney disease ( CKD ) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant to phosphate binder therapy.

Food and Drug Administration 119

Food and Drug Administration FDA Food Patients 119

Pharmacy Times

SEPTEMBER 12, 2023

Empowering technicians can enhance overall pharmacy management and promote a culture of patient safety.

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Patients Safety Management 49

European Pharmaceutical Review

JUNE 27, 2023

This follows FDA clearance of the Investigational New Drug (IND) application, enabling expansion to the US of the ongoing Phase Ib/II ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.

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Food and Drug Administration Safety FDA Food 105

pharmaphorum

AUGUST 1, 2022

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023.

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FDA Safety Patients Doctors 105

European Pharmaceutical Review

JUNE 29, 2023

The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Achievement of the first dose in human patients is a “milestone” for AI-driven drug discovery and drug development , stated Feng Ren, PhD, co-CEO and Chief Scientific Officer of Insilico Medicine.

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Food and Drug Administration Safety Recruitment FDA 98

Pharmaceutical Technology

JANUARY 10, 2023

The approval of Tzield, a first-in-class therapy, adds an important new treatment option for certain at-risk patients,” says an FDA spokesperson. The drug’s potential to delay clinical diagnosis of T1D may provide patients with months to years without the burdens of disease.”. Developing sufficient testing infrastructure.

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Patients FDA Medicine Education 98

European Pharmaceutical Review

JANUARY 20, 2023

In the letter, the FDA specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Lilly confirmed that the Phase III trial included more than 100 patients treated with donanemab.

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FDA Food and Drug Administration Safety Medicine 98

European Pharmaceutical Review

JANUARY 11, 2024

billion, so biosimilar competition could significantly expand patient access to this biologic therapy within the fields of gastroenterology, dermatology, and rheumatology, according to STADA and Alvotech. The EU ustekinumab market is worth €2.5 In this region, STADA already has six biosimilars approved in this market.

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Competition Marketing Safety Manufacturing 115

European Pharmaceutical Review

OCTOBER 22, 2024

The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). Introduction of this framework was originally announced by the MHRA in January 2023. [The

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Medicine Manufacturing Safety Consulting 89

European Pharmaceutical Review

SEPTEMBER 18, 2023

The first and only treatment for anaemic patients with myelofibrosis has been approved by the US Food and Drug Administration (FDA). While transfusions are often required, more than 30 percent of patients will discontinue treatment due to anaemia.​

Food and Drug Administration 98

Food and Drug Administration Safety FDA Food 98

Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). Rexulti is an atypical antipsychotic.

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FDA Safety Food Patients 96

European Pharmaceutical Review

APRIL 17, 2023

In December 2022, Prometheus announced positive results for PRA023 from two studies of the monoclonal antibody: ARTEMIS-UC , a Phase II study evaluating safety and efficacy in patients with moderate to severely active UC APOLLO-CD , a Phase IIA study evaluating safety and efficacy in patients with moderate to severe CD.

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Safety Patients Pharmaceutical 105

Pharmaceutical Technology

MAY 2, 2023

The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA). The European Medicines Agency (EMA) has also validated the Type II variation application for Reblozyl.

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Food and Drug Administration FDA Safety Prescription 98

European Pharmaceutical Review

SEPTEMBER 4, 2023

. “Fabry disease brings a multitude of complex symptoms and, since one therapy may not suit all, it is vital that patients have additional treatment options available to them.” Data highlighted by Chiesi noted that the efficacy and safety profile of pegunigalsidase alfa was drawn from the outcomes of a clinical trials programme.

Medicine 98

Medicine Safety Patients Medical 98

European Pharmaceutical Review

MARCH 26, 2024

.” Moderna reveals optimistic data for influenza-COVID-19 vaccine A promising mRNA vaccine What the clinical data showed Findings from the NextCOVE Phase III pivotal trial showed that mRNA-1283 facilitated a higher immune response in patients against both the Omicron BA.4/BA.5 Moderna’s Spikevax XBB.1.5-adapted

Safety 110

Safety Leads Patients Pharmaceutical 110

European Pharmaceutical Review

OCTOBER 6, 2023

For example: higher patient compliance, easier administration and greater convenience. Data from Moderna’s mRNA-1083 Phase I/II trial The ongoing Phase I/II clinical trial is evaluating the safety and immunogenicity of mRNA-1083 compared to a standard dose of the influenza vaccine Fluarix, in adults aged 50-64.

Safety 105

Safety Pharmaceutical Manufacturing Patients 105

European Pharmaceutical Review

OCTOBER 30, 2023

Atamyo Therapeutics ’ one-time gene therapy for fukutin-related protein (FKRP) limb-girdle muscular dystrophy Type 2I/R9 (LGMD2I/R9) has enabled clinical trial patients to experience symptom relief, as well as a correction of centronucleation. Moreover, no unexpected safety signal for the gene therapy was identified in the LGMD2I/R9 study.

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Food and Drug Administration Safety Food FDA 98

European Pharmaceutical Review

APRIL 10, 2025

This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products. The PFAS regulatory challenge As a result, in the EU, a joint PFAS Restriction Proposal under REACH was submitted in 2023, aiming for a full ban on all PFAS by 2028/2030.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 59

Legacy MEDSearch

MAY 1, 2023

the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. of patients compliant with once daily treatments at 12 months. BlueWind Medical, Ltd.,

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Patients Medical Safety Recruitment 52

European Pharmaceutical Review

OCTOBER 18, 2023

Data from the Phase III PROTECT clinical trial , presented at the 2023 Annual ISPAD Conference, showed that superior beta cell preservation was observed compared to placebo. While no new safety signals were identified, Sanofi stated the study’s key secondary endpoints did not meet statistical significance.

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Medicine Safety Patients Medical 111