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Patients Pharmaceutical Safety 
European Pharmaceutical Review
OCTOBER 10, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed that according to new safety data, SPRAVATO ® (esketamine nasal spray [NS]) has demonstrated superior efficacy compared to quetiapine extended-release (Quetiapine XR) for treatment-resistant depression (TRD). Patients were 1.21 However, 82.6 However, 82.6
109 
European Pharmaceutical Review
JULY 12, 2023
Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. The analysis is the largest safety evaluation to date of any microbiota-based live biotherapeutic.
98 
European Pharmaceutical Review
SEPTEMBER 22, 2022
EBT-101, a CRISPR-Cas9 gene editing system delivered by adenovirus-associated virus vector serotype 9 (AAV9) has been administered to the first individual in a Phase I/II trial designed to establish its safety and efficacy. As a result, HIV can persist in tissue reservoirs for years.
145 
European Pharmaceutical Review
SEPTEMBER 25, 2023
The post Achieving pharmaceutical drug traceability compliance appeared first on European Pharmaceutical Review.
105 
Pharma Marketing Network
JULY 27, 2022
The patient care team supplies an abundance of information, although sifting through brochures and online resources can be daunting for the patient and their caregiver. 1 The marketer’s goal is to design easy-to-follow patient guidelines while conforming to med-legal language. Meeting Patients Where They Are.
130 
European Pharmaceutical Review
MAY 29, 2024
The safety and tolerability of rationally-designed live bacterial product (LBP) BMC128 combined with nivolumab has shown initial positive trends in non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC), new data from an ongoing Phase I clinical trial suggests.
98 
European Pharmaceutical Review
MAY 20, 2024
3 Significant unmet needs The path to diagnosis of a rare disease is complex, taking on average five to eight years from the onset of symptoms before a patient receives an accurate diagnosis. Even with a diagnosis, patients continue to face barriers to care. Engaging with patients and caregivers is key to addressing these challenges.
122 
European Pharmaceutical Review
JANUARY 29, 2024
1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.
111 
World of DTC Marketing
JANUARY 8, 2021
At the time, pharmaceutical giant Pfizer and its partner BioNTech—which now have the other US-authorized COVID-19 vaccine—had inked a deal with the US government to supply doses at $19.50 Pharmaceutical companies are in business to make money, and if taxpayers have to pay the bill well, then so be it. So let’s be real.
266 
European Pharmaceutical Review
MARCH 8, 2024
Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. Therefore, to achieve this, quality by design offers a systematic approach to development, the authors stated.
European Pharmaceutical Review
APRIL 18, 2024
What are the three main challenges of monitoring pharmaceuticals in the environment? Andreas Häner (AH): Roche, along with other pharmaceutical companies, acknowledges concerns about pharmaceuticals in the environment (PiE). A well-designed wastewater sampling plan will ensure that representative samples are collected.
World of DTC Marketing
APRIL 12, 2021
QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. We need a 21st-century approach that puts patient safety first. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).
European Pharmaceutical Review
SEPTEMBER 21, 2023
Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments.
European Pharmaceutical Review
DECEMBER 18, 2023
After eight weeks of treatment, patients’ depression severity scores dropped by an average of 19.1 A second study led by Yvan Beaussant from the Dana-Farber Cancer Institute that gathered input from patients in the trial during exit interviews. Participants involved in the trial had moderate to severe depression scores at baseline.
World of DTC Marketing
DECEMBER 29, 2020
A key consideration is funding – public and private cash has been poured into the race for a Covid vaccine, pushing aside the usual financial concerns facing pharmaceutical companies. All vaccines go through clinical trials to test safety and effectiveness. That’s a hell of an incentive.
307 
Pharmaceutical Technology
JANUARY 6, 2023
While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.
115 
Pharma Marketing Network
JULY 19, 2023
For pharmaceutical companies, this means aligning sponsorships with causes that are related to health and wellness. This could include sponsoring research into new drugs and treatments, providing educational resources about health conditions, or supporting patient care programs.
European Pharmaceutical Review
OCTOBER 12, 2023
September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. While the data was based on responses from 292 manufacturers across all sectors, the outcomes are applicable to pharmaceutical manufacturing. Meath opened last month.
European Pharmaceutical Review
DECEMBER 4, 2023
The (bio)pharmaceutical industry is currently facing numerous hurdles in its path to high-efficiency production that are more complex and pressing than ever before. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety. principles.
Pharma Marketing Network
DECEMBER 31, 2024
Table of Contents Sr# Headings 1 Introduction: The Pharma Marketing Challenge 2 Building a Winning Pharma Marketing Strategy 3 The Role of Branded Drug Campaigns 4 Innovating for Future Success Introduction: The Pharma Marketing Challenge Marketing pharmaceuticals is no small feat.
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.
114 
Pharma Marketing Network
JULY 19, 2023
Content Marketing as a Sales Driver: Unlocking Your Business Potential in the Pharmaceutical Industry Content marketing is a long-term strategy that can help businesses of all sizes generate leads, increase brand awareness, and drive sales. In the pharmaceutical industry, content marketing can be particularly effective for driving sales.
98 
European Pharmaceutical Review
JUNE 13, 2024
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. To date, six patients with Stargardt disease have been dosed in the Phase I/II clinical trial.
145 
European Pharmaceutical Review
JUNE 30, 2023
A collaborative approach to advancing adoption of RMMs EPR ’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry. The post In Depth Focus QA/QC Microbiology/RMM 2023 appeared first on European Pharmaceutical Review.
105 
European Pharmaceutical Review
JULY 5, 2024
Following the Labour Party’s win yesterday in the UK 2024 General Election, industry representatives have voiced their opinions on what this could mean for the future of the pharmaceutical industry under the new government. EU pharmacovigilance is stronger with the UK, and UK research is stronger with the EU.”
98 
European Pharmaceutical Review
JUNE 28, 2024
An innovative oral small molecule GLP-1 receptor agonist enabled patients to obtain an average weight loss of 4.9 HUADONG MEDICINE, via its subsidiary Hangzhou Zhongmei HuaDong Pharmaceutical CO. According to the trial data, the dose range of 10mg to 600mg for HDM1002 offered good safety and tolerability. percent to 6.8
105 
European Pharmaceutical Review
FEBRUARY 27, 2024
While she is stepping down from her current role, Dame June shared that she still hopes to contribute] “to patient safety and public health in other ways” “It has been an enormous privilege to have led the MHRA through a time of change which is unprecedented in UK medical products regulation.
111 
European Pharmaceutical Review
MAY 8, 2024
A total of 13 patients were enrolled to receive three intravenous infusions of the monoclonal antibody treatment. The post Potential best-in-class antibody shows “remarkable efficacy” in atopic dermatitis appeared first on European Pharmaceutical Review. Final findings from the Phase IIa atopic dermatitis trial are expected in Q3 2024.
122 
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.
105 
World of DTC Marketing
MAY 19, 2021
SUMMARY: “You’re spending all this money to make sure you make money rather than spending money to… help patients,” the California congresswoman told AbbVie’s, Richard Gonzalez. A “critical part” of pharmaceutical company AbbVie ‘s success is “face-to-face” interaction, CEO Richard Gonzalez explained in an Aug.
181 
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.
98 
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
105 
European Pharmaceutical Review
JANUARY 25, 2023
For patients who experience little benefit from existing antidepressants, the potential for rapid and durable relief from a single treatment, as shown in this trial, is very promising,” shared Dr David Erritzoe Clinical Psychiatrist at Imperial College London and Chief Investigator of the Phase I/IIa study. “For
133 
European Pharmaceutical Review
MAY 2, 2024
According to the MHRA, artificial intelligence offers “improved efficiencies”, enabling patients in the UK to safely access medical products earlier. Implications of AI regulation for data integrity The post MHRA publishes strategy on AI regulation appeared first on European Pharmaceutical Review.
115 
World of DTC Marketing
JUNE 8, 2021
The Financial Times said , “Michael Carome, director of the health research group at Public Citizen, said, “these costs to patients, to their families, are just not justified based upon what we know about this drug”. There are no efficacy data to clearly demonstrate this drug helps patients. Nowhere to be seen.
207 
European Pharmaceutical Review
JANUARY 5, 2024
Utilising an add-on therapy for treatment-resistant schizophrenia (TRS) Newron Pharmaceuticals SPA has reported significant final, one-year results from its clinical trial 014/015, evaluating evenamide as an add-on therapy to antipsychotics in treatment-resistant schizophrenia (TRS).
European Pharmaceutical Review
MARCH 21, 2023
fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment compared to standard of care (SOC). In the study, Yescarta had a safety profile that was consistent with previous studies. Yescarta demonstrated a 2.5-fold
145 
European Pharmaceutical Review
JANUARY 15, 2024
“In addition to its anti-inflammatory efficacy, both the EMA and the MHRA recognise the benefits of treatment with Agamree for bone health and growth,” Dr Shabir Hasham, Chief Medical Officer of Santhera Pharmaceuticals shared. Patients did not experience a significant reduction of bone mineralisation in the spine after 48 weeks. “We
105 
European Pharmaceutical Review
NOVEMBER 13, 2023
First treatment for myelofibrosis with anaemia approved Steps to a novel EU approval of momelotinib If approved, momelotinib would be the only medicine in EU indicated for both newly diagnosed and previously treated myelofibrosis patients with moderate to severe anaemia that addresses splenomegaly and symptoms.
109 
European Pharmaceutical Review
JUNE 16, 2023
With the adoption of digital technologies gaining traction in many industries, pharmaceutical companies must take advantage of digitalisation within its research and development (R&D) sector. Using digital means we can streamline communications, facilitate better patient engagement, and ultimately improve retention rates.
111 
European Pharmaceutical Review
NOVEMBER 29, 2023
Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. percent of patients were cystectomy-free at 36 months. Additionally, 53.8 percent, 36.6 percent and 34.2
European Pharmaceutical Review
APRIL 18, 2024
percent success rates in patients with uncomplicated urogenital gonorrhoea (GC). EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in uncomplicated urogenital gonorrhoea.
105 
European Pharmaceutical Review
NOVEMBER 21, 2022
The first-in-human gene therapy trial for heart failure patients with preserved ejection fraction (HFpEF) has been approved by the US Food & Drug Administration (FDA). HFpEF patients suffer from reduced ventricular relaxation and associated dysfunctional hemodynamics. Heart failure with preserved ejection fraction.
European Pharmaceutical Review
DECEMBER 12, 2023
Casgevy (exagamglogene autotemcel) a cell-based gene therapy, is approved for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises (VOCs). With Casgevy, the patients’ own CD34+ cells are modified to reduce BCL11A expression in erythroid lineage cells.
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