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

Food and Drug Administration 72

Food and Drug Administration Safety Food Patients 72

European Pharmaceutical Review

OCTOBER 23, 2023

An intravesical drug delivery system designed to provide sustained local release of gemcitabine into the bladder, has enabled 77 percent of bladder cancer patients (23 out of 30) to achieve a complete response (CR) in the Cohort 2 of the Phase IIb SunRISe-1 study. Sanofi-Janssen collaboration to advance novel E.

Pharmaceutical 89

Pharmaceutical Safety Patients Leads 89

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.

Side effects 52

Side effects Safety Medical Marketing 52

PM360

SEPTEMBER 7, 2023

However, Keri McDonough, Head, Patient Voice Consortium & Vice President, Medical and Scientific Strategy, Syneos Health , says that AI will only help so much in alleviating the “ burnout ” 3 or “ moral injury ” 4 many HCPs face. “To Of course, AI can also be used to help marketers better understand and serve patients.

Patients 111

Patients Physicians Healthcare Healthcare 111

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.

Education 98

Education Patients Digital Media Pharma 98

MedCity News

FEBRUARY 2, 2023

The percentage of respondents who know of a patient death being caused by nurses being assigned too many patients nearly doubled in the past seven years — from 22% in 2016 to 42% in 2023.

Patients 106

Patients Safety 106

Pharmacy Times

SEPTEMBER 12, 2023

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

Patients 49

Patients Safety Management 49

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.

Food and Drug Administration 81

Food and Drug Administration FDA Food Medicine 81

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 79

FDA Patients Electronics Medical 79

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).

Patients 98

Patients Food and Drug Administration Food Safety 98

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 92

Safety Medicine Government Medical 92

European Pharmaceutical Review

APRIL 5, 2024

I am particularly proud of these results given that there are currently no therapeutic treatments approved for patients with this disease,” Dr Holen explained. Study data was presented at the 2023 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.

Side effects 82

Side effects Safety Patients Leads 82

PM360

OCTOBER 13, 2023

HCPs need pharma, and pharma needs HCPs—so let’s make sure that this next chapter of engagement is one of partnership, in pursuit of the interest of patients.” Only 15% of prescribers think the drugs come at reasonable cost to patients or have decent insurance coverage eligibility.

Healthcare 59

Healthcare Healthcare Doctors Pharma 59

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 76

Healthcare Healthcare Electronics Safety 76

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 105

Safety Patients Medical Pharmaceutical 105

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 78

Patients Safety Medical Pharmaceutical 78

European Pharmaceutical Review

MAY 2, 2023

3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients. However, access to these medicines is not close to meeting patient demand, creating inequalities in the health prospects of those diagnosed with cancer. 1,2 In the EU, an estimated 2.7

Patients 94

Patients Medicine Marketing Medical 94

PM360

DECEMBER 14, 2023

A New Online Destination for HCPs HealthCentral Corporation , operator of leading digital platforms that serve patients living with chronic illness, their care partners, and health professionals, has announced the newest addition to its suite of HCP support sites: MedCentral.

Physicians 52

Physicians Pharma Medical Patients 52

Pharmaceutical Technology

DECEMBER 13, 2023

Odronextamab has demonstrated clinically meaningful efficacy and safety in patients with R/R FL and DLBCL.

Safety 52

Safety Marketing Patients 52

PM360

APRIL 7, 2023

Patient Pages: How Healthcare Costs Affect Insured Patients Today A new study shows an insured American with an employer-sponsored health insurance plan can expect to spend more than $320,000 (including insurance premiums and out-of-pocket costs) during his/her adult lifetime.

Healthcare 52

Healthcare Healthcare Insurance Physicians 52

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs).

Patients 69

Patients Food and Drug Administration Side effects Food 69

European Pharmaceutical Review

MAY 7, 2024

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. Johnson & Johnson’s Phase I study is assessing the safety and efficacy of TAR-210 as a delivery method for sustained, local release of erdafitinib into the bladder.

Food and Drug Administration 70

Food and Drug Administration Food Patients Safety 70

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 87

Safety Patients Physicians Medical 87

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.

Safety 84

Safety Pharmaceutical Patients Medicine 84

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 88

Safety Side effects Medicine Patients 88

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 85

Safety Leads Patients Pharmaceutical 85

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.

Food and Drug Administration 72

Food and Drug Administration Manufacturing Safety Transportation 72

European Pharmaceutical Review

JANUARY 16, 2024

Roche’s Tecentriq ® (atezolizumab) was first approved in Great Britain in August 2023. These data were presented at European Society for Medical Oncology (ESMO) in October 2023. The European Commission (EC) has approved the EU’s first PD-(L)1 cancer immunotherapy for subcutaneous injection.

Safety 89

Safety Medical Patients Marketing 89

European Pharmaceutical Review

JANUARY 8, 2024

The European Commission (EC) has now granted a marketing authorisation for biopharma company UCB’s treatment, as an add-on to standard therapy in patients who have this rare autoimmune condition. It is indicated as a subcutaneous, add-on to standard therapy in these patients.

Biopharma 88

Biopharma Medicine Healthcare Healthcare 88

European Pharmaceutical Review

JANUARY 9, 2024

TALZENNA the first and only PARP inhibitor licensed in the EU for use with XTANDI for patients with mCRPC, with or without gene mutations” The treatment is indicated for adults with metastatic castration-resistant prostate cancer (mCRPC) in individuals where chemotherapy is not clinically indicated.

Food and Drug Administration 77

Food and Drug Administration Safety Food Patients 77

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 102

Food and Drug Administration FDA Food Safety 102

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.

Food and Drug Administration 82

Food and Drug Administration Safety Food FDA 82

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.

FDA 96

FDA Safety Food Medicine 96

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.

Competition 92

Competition Marketing Safety Manufacturing 92

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.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

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.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

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 76

Food and Drug Administration Safety FDA Food 76