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.

Patients 122

Patients Medical Safety Healthcare 122

European Pharmaceutical Review

JULY 26, 2022

It is not intended for direct use in patients. Tecvayli was supported through EMA’s PRIority MEdicines (PRIME) scheme and its application was reviewed under an accelerated timetable to enable faster patient access to this medicine. This product was designated as an orphan medicine during its development.

Medicine 105

Medicine Marketing Patients Safety 105

European Pharmaceutical Review

OCTOBER 25, 2022

AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) combination therapy has been approved in the US for adult patients with unresectable hepatocellular carcinoma (HCC). Phase III trial results found that three years post-treatment, 31 percent of patients given the drug combination were still alive. p=0.0035).

Food and Drug Administration 111

Food and Drug Administration Patients Safety Physicians 111

European Pharmaceutical Review

NOVEMBER 14, 2022

These products are used in some types of surgery to help patients recover quicker from the effects of the muscle relaxant. CHMP’s safety update. Read highlights from the CHMP’s September 2022 meeting. The post EMA human medicines committee (CHMP) highlights, November 2022 appeared first on European Pharmaceutical Review.

Medicine 98

Medicine Side effects Safety Pharmaceutical 98

European Pharmaceutical Review

SEPTEMBER 21, 2022

Enjaymo (sutimlimab) for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease, a rare autoimmune disorder characterised by the premature destruction of red blood cells. Safety update. 11 medicines for indication extension. Adapted vaccines Comirnaty Original/Omicron BA.1

Medicine 98

Medicine Marketing Patients Safety 98

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.

Side effects 115

Side effects Patients Marketing Safety 115

European Pharmaceutical Review

OCTOBER 6, 2022

The approval redefines the pool of patients to be optioned for Enhertu (fam-trastuzumab deruxtecan-nxki), a modified HER2-directed antibody drug conjugate (ADC). Now, they may be eligible for a HER2-targeted therapy, significantly increasing the number of patients who could have improved outcomes.”. Every year 2.3

Food and Drug Administration 97

Food and Drug Administration Patients Safety Food 97

European Pharmaceutical Review

OCTOBER 1, 2022

A Phase III trial from Shanghai Henlius Biotech is the first study to suggest that the programmed cell death (PD) 1 receptor immune checkpoint inhibitor Hansizhuang (serplulimab) plus chemotherapy can markedly improve survival for extensive-stage small cell lung cancer (ES-SCLC) patients. A follow-up after 12.3

Patients 98

Patients Safety Medical Pharmaceutical 98

European Pharmaceutical Review

JANUARY 17, 2023

A Phase IIa pilot trial of CER-001 showed for the first time in a human pilot trial, that recovery of a normal protein apolipoprotein A-I (apoA-I) level in patients stop the cytokine storm and improve clinical outcomes. CER-001 is the only natural recombinant apoA-I for septic patients at high risk of acute kidney injury (AKI).

Patients 98

Patients Safety Pharma Medicine 98

European Pharmaceutical Review

AUGUST 30, 2022

Based on the results, Pfizer said it intends to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for RSVpreF “in fall 2022”. However, there are currently no prophylactic or therapeutic options for this group of patients. Approximately 37,000 patients have been enrolled to date, receiving 120?g

Patients 98

Patients Food and Drug Administration Safety FDA 98

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Today, we still can’t easily discern whether a patient took their pill or not and the reason why. Michael Oleksiw.

Medical 105

Medical Patients Electronics Healthcare 105

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

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). This data led to the US approval for initial treatment of R/R LBCL in April 2022 and European Union approval in October 2022.

Safety 145

Safety Patients Pharmaceutical 145

MedCity News

OCTOBER 16, 2023

Called Microsoft Fabric, which was rolled out broadly in May, the announcement on October 10 marks the availability of Fabric’s capabilities specifically for the healthcare vertical – to clinicians, administrators but perhaps, most importantly, to patients. Lungs hyperinflated to clear. No pneumothorax or pleural eltusion.

Healthcare 126

Healthcare Healthcare Patients Doctors 126

pharmaphorum

SEPTEMBER 14, 2022

As will be discussed at the 2022 DPharm annual conference in Boston, IQVIA, a global clinical research organization, surveyed more than 6,400 participants across the U.S. Leveraging patient perspectives. Sponsors need to take on the role of educating patients as to the value of clinical research to the trial participant.

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Recruitment Patients Media Management 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

Pharma Marketing Network

MAY 3, 2023

However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

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

JANUARY 16, 2023

According to 2022 data gathered by the World Health Organization (WHO), there are around 24 million schizophrenia patients. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder.

Food and Drug Administration 122

Food and Drug Administration FDA Competition Pharma 122

PM360

OCTOBER 27, 2022

Patients with DEB experience extensive skin erosions in response to minor injuries or frictions, such as rubbing or scratching. At its root, the missing or mutated gene in DEP patients disrupts the normal functioning of Collagen VII (COL7), a protein that plays a crucial role in adhesion of epidermis to the dermis.

Safety 104

Safety Patients FDA Medical 104

Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. In March 2022, the US Food and Drug Administration approved the IND application for SM17 to treat asthma. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

Food and Drug Administration 109

Food and Drug Administration Food Safety Medical 109

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

Patients 98

Patients Healthcare Healthcare Marketing 98

Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The approval of Tzield, a first-in-class therapy, adds an important new treatment option for certain at-risk patients,” says an FDA spokesperson.

Patients 98

Patients FDA Medicine Education 98

pharmaphorum

AUGUST 16, 2022

Dosing considerations dependent on your disease indication, route of administration and patient group for improved safety. Hear the latest insights and case studies to optimize your prediction of PKPD, accurate dosing regime and immuno-modulation of LNP for long-term patient safety and potency. And much more!

Pharmacology 52

Pharmacology Safety Networking Patients 52

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

European Pharmaceutical Review

OCTOBER 21, 2022

The safety profile observed in the extension study was consistent with safety data for the vaccine. No deaths or other Safety Adverse Events (SAE) considered related to vaccination were observed. No deaths or other Safety Adverse Events (SAE) considered related to vaccination were observed.

Safety 105

Safety Patients Pharmaceutical Marketing 105

European Pharmaceutical Review

JANUARY 15, 2024

The medicine is indicated in patients who are four years of age and over, independent of the underlying mutation and ambulatory status. Previous research, including a 2022 paper published in JAMA Neurology , have highlighted the treatment’s potential to ‘dissociate’ efficacy from steroid safety concerns.

Medicine 105

Medicine Safety Patients Pharmaceutical 105

European Pharmaceutical Review

AUGUST 5, 2022

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. 10/02/2022. 10/02/2022. 10/02/2022. First distributed.

Distribution 98

Distribution Healthcare Healthcare Patients 98

Pharmaceutical Technology

SEPTEMBER 13, 2022

Presentations at the ESMO Congress 2022 have demonstrated the critical importance of therapy sequence, with astounding results for neoadjuvant ICI use in melanoma and microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colorectal cancer (CRC). The use of neoadjuvant ICI therapy remained largely unexplored.

Patients 69

Patients Physicians Safety Pharma 69

Pharmaceutical Technology

APRIL 21, 2023

Nonetheless, the agency did not require further efficacy and safety data in the application. The type II FLT3 inhibitor could also be used as continuation monotherapy post consolidation in this set of adult patients. The median OS in patients on quizartinib was 31.9 AML makes up 23.1% of total leukaemia cases globally.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

European Pharmaceutical Review

SEPTEMBER 20, 2022

“Over the past 15 years and the experience from clinical practice has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference products and are therefore interchangeable,” commented EMA’s Executive Director, Emer Cooke. This was substantiated by safety data of over one million patient-treatment years.

Medicine 98

Medicine Side effects Safety Doctors 98

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.

Safety 105

Safety Patients Pharmaceutical 105

European Pharmaceutical Review

OCTOBER 31, 2022

The Pharmacovigilance Risk Assessment Committee (PRAC) , the European Medicines Agency (EMA)’s safety board, has confirmed it recommends the withdrawal of Marketing Authorisation Application (MAA) for amfepramone obesity medicines, to prevent more patients being at risk of serious side effects. Risks of amfepramones.

Side effects 98

Side effects Medicine Safety Marketing 98

European Pharmaceutical Review

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. 7 The frequency of these issues prompts the question of why the Indian regulatory authorities are not policing this area of GMP and patient safety more effectively.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Food 105

Pharmaceutical Technology

OCTOBER 31, 2022

Hoffmann-La Roche (Roche Canada) has received approval from Health Canada for Actemra IV (tocilizumab for injection) vials to treat Covid-19 patients. The regulator has recommended a single intravenous infusion of an 8mg/kg dose of Actemra given over 60 minutes for adult Covid-19 patients.

Patients 105

Patients Safety Medicine Medical 105

European Pharmaceutical Review

DECEMBER 5, 2022

Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor type I (ACVR1), which could help myelofibrosis patients with anaemia. Patients were randomised at 2:1 to receive either momelotinib or danazol (n=130 and n=65, respectively).

Food and Drug Administration 97

Food and Drug Administration Marketing Food Medicine 97

European Pharmaceutical Review

JUNE 16, 2023

According to Maximize Market Research , new technologies are expected to boost the clinical trials market between 2022 to 2029, especially as the industry and patients are shifting towards digitalisation approaches and personalised medicines.

Safety 111

Safety Electronics Recruitment Patients 111