European Pharmaceutical Review

MAY 29, 2023

A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. This medicinal product has potential to diagnose this cancer in high risk patients in early stages and for patients with suspected recurrence.

Medicine 98

Medicine Marketing Leads Safety 98

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 111

Pharmaceutical Safety Patients Leads 111

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 Physicians Food Medical 104

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

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 98

Food and Drug Administration FDA Food Medicine 98

Pharmacy Times

DECEMBER 8, 2023

In an interview at the 2023 San Antonio Breast Cancer Symposium, Ana Ferrigno Guajardo, MD, discussed research into the safety and efficacy of taxane-based chemotherapy use in pregnant patients with breast cancer.

Safety 26

Safety Patients 26

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 118

Patients Safety 118

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

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 82

FDA Patients Electronics Medical 82

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.,

Patients 52

Patients Medical Safety Recruitment 52

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

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

OCTOBER 12, 2023

September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. Therefore, this investment is supporting the sector to better deliver the changing needs and preferences of patients. Meath opened last month. Comment below to share your thoughts or reach out to us on social media.

Pharmaceutical manufacturing 104

Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharma 104

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

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

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

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.

Medical 117

Medical Government Marketing Medicine 117

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 96

Patients Food and Drug Administration Side effects Food 96

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 105

Patients Medicine Marketing Medical 105

Pharmacy Times

JUNE 26, 2024

These findings build off research from March 2023 that demonstrated efficacy and safety of renizgamglogene autogedtemcel in patients with sickle cell disease.

Patients 26

Patients Safety 26

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 98

Side effects Safety Patients Leads 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

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

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

Medicine 52

Medicine Manufacturing Safety Consulting 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

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 97

Food and Drug Administration Manufacturing Safety Transportation 97

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 105

Safety Pharmaceutical Patients Medicine 105

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

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

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

Pharmaceutical Technology

JUNE 13, 2023

At the European Hematology Association (EHA) Congress, June 8–11, 2023, updated results were presented from the Phase l KOMMET-001 study establishing a recommended Phase ll dose (RP2D) for Kura Oncology’s menin inhibitor ziftomenib. Thus, targeting menin may be an effective strategy for patients with high unmet needs.

Patients 52

Patients Sales Competition Safety 52

European Pharmaceutical Review

JUNE 13, 2024

In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation. Ocugen plans to expand the OCU400 clinical trial in the second half of 2024 to include patients with LCA, contingent on favourable results from the Phase I/II study and alignment with regulatory agencies.

Manufacturing 145

Manufacturing Food and Drug Administration Engineering Safety 145

European Pharmaceutical Review

DECEMBER 26, 2023

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. These challenges predominantly surround scalability, stability, regulatory compliance and access to patients.

Manufacturing 98

Manufacturing Safety Patients Competition 98

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.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment FDA 98

PM360

MAY 15, 2023

The companies will also use generative AI to design mRNA medicines with optimal “safety and performance.” Both companies hope that the partnership will enable them to make significant advancements in drug discovery and ultimately improve patient outcomes.

Safety 52

Safety Healthcare Healthcare Electronics 52

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