European Pharmaceutical Review

JULY 18, 2022

Phase III results from the explorer7 study presented at ISTH 2022 in London, UK, revealed an 86 percent reduction in treated spontaneous and traumatic bleeds for haemophilia A or B patients with inhibitors on concizumab prophylaxis. Patients received Mim8 once weekly at different dose levels to target drug plasma levels of 1 ?g/ml,

Safety 98

Safety Patients Leads Medical 98

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

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

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

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

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

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

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

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

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

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.

Patients 130

Patients Education Retail Pharma 130

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

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

Clarivate

OCTOBER 10, 2022

Clarivate oncology experts share key takeaways from the 2022 ESMO Congress and their expected impact on the drug treatment landscape and patients. Read on to for insights from our analysts on: Global highlights from ESMO 2022. Key ESMO 2022 highlights from Mainland China. Seven global highlights from ESMO 2022.

Marketing 52

Marketing Safety Patients Competition 52

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

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 121

Healthcare Healthcare Patients Doctors 121

Pharmaceutical Technology

SEPTEMBER 14, 2022

This week, at the European Society of Medical Oncology (ESMO) Congress 2022 researchers presented encouraging updates on immunotherapies in the field of cervical cancer. Positive data with checkpoint inhibitor combinations in particular garnered attention for their potential in broader patient groups. Phase I/II Checkmate-358 trial.

Food and Drug Administration 59

Food and Drug Administration Patients FDA Pharmaceutical 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 98

Healthcare Healthcare Safety Electronics 98

PM360

DECEMBER 14, 2022

In its latest venture into the healthcare arena, Amazon is reaching out directly to the consumer via its soon-to-be-launched Amazon Clinic , a virtual health service for patients to see licensed clinicians about common medical issues. The services are cash pay only at this point.

Manufacturing 52

Manufacturing Medical Healthcare Healthcare 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

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.

Recruitment 88

Recruitment Patients Media Management 88

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

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

OCTOBER 8, 2024

The company is the only pure-bred pharmacovigilance specialist, providing comprehensive, independent pharmacovigilance services as well as advanced tools and technology-powered solutions that address companies’ most complex product safety needs. The business is supported by investment from Stanley Capital Partners.

Leads 52

Leads Safety Biopharma Management 52

Pharma Marketing Network

JANUARY 5, 2022

Customers – HCPs and patients alike – want seamless experiences and don’t want to wait for what they need or be bounced around from one person to another. What have you learned in 2021 that you’ll be putting into practice in 2022? The post Data-Driven Decision Making – Business as Usual in 2022?

Pharma 52

Pharma Marketing Sales Government 52

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

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

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

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

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

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 Pharmaceutical Patients 105

European Pharmaceutical Review

JUNE 5, 2024

These findings from GSK reflect outcomes from 42 patients with mismatch repair deficient (dMMR) locally advanced rectal cancer who finished the treatment. GSK highlighted that the first 24 patients demonstrated “a sustained clinical complete response, with a median follow-up of 26.3 months was observed”.

Safety 98

Safety Patients Manufacturing Medicine 98

European Pharmaceutical Review

JANUARY 22, 2024

Market growth factors Pharmaceutical extractable and leachable (E&L) testing services The heightened and increasing demand for biopharmaceutical medicines has resulted in greater demand for E&L testing in drug safety , such as when mitigating cross-contamination risks, the report highlighted. percent in 2022.

Marketing 52

Marketing Safety Medicine Pharmaceutical 52

Pharma Marketing Network

JANUARY 5, 2022

Customers – HCPs and patients alike – want seamless experiences and don’t want to wait for what they need or be bounced around from one person to another. What have you learned in 2021 that you’ll be putting into practice in 2022? Having the data is table stakes, but having the data is only the foundation. “It

Pharma 52

Pharma Marketing Sales Government 52

European Pharmaceutical Review

JUNE 10, 2024

New five-year data from Genentech (a member of the Roche Group)’s open-label extension of the pivotal Phase II FIREFISH study confirm the sustained efficacy and safety of Evrysdi ® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA). Roche released three-year data from the SUNFISH study in March 2022.

Safety 98

Safety Patients Leads Medical 98

Impetus Digital

JUNE 8, 2022

In recent years, the biotech industry has been trending toward personalized medicine, which is a form of treatment that is tailored specifically for each patient. Under the new program, oncologists can submit real-time data from patients undergoing treatment, which helps the agency assess the safety and efficacy of the medicines faster.

Medicine 52

Medicine FDA Leads Distribution 52