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 78

Medicine Side effects Safety Pharmaceutical 78

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

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

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 85

Medicine Marketing Patients Safety 85

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 84

Patients Safety Medical Pharmaceutical 84

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 74

Food and Drug Administration Patients Safety Food 74

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 Electronics Patients 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

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 91

Recruitment Patients Media Management 91

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

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 79

Healthcare Healthcare Electronics Safety 79

PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety. Qualio surveyed 2,002 U.S. FDA Update.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52

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

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

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 96

Medicine Safety Patients Pharmaceutical 96

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

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

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 98

Patients Medicine Marketing Medical 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

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

Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration).

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 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

NOVEMBER 2, 2023

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.” billion in 2022, according to J&J’s financial results.

Food and Drug Administration 85

Food and Drug Administration FDA Side effects Safety 85

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

Impetus Digital

JULY 5, 2023

As of last year, i.e., 2022, the global healthcare cloud computing market was valued at $37.14 Cloud technology in healthcare has become critical in improving patient care and revolutionizing healthcare systems. Patients are more willing than ever to seek out greater healthcare services if their expectations are not met.

Healthcare 52

Healthcare Healthcare Patients Healthcare Provider 52

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

Food and Drug Administration 90

Food and Drug Administration FDA Pharmaceutical Food 90

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 88

Safety Patients Pharmaceutical 88

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 87

Medicine Side effects Safety Doctors 87

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 85

Distribution Healthcare Healthcare Medicine 85

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 84

Safety Patients Pharmaceutical Marketing 84

European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 Advancement of these oral medical devices is still in its infancy and further investigation is needed to ensure their effectiveness and safety in use for humans.

Food and Drug Administration 86

Food and Drug Administration Transportation FDA Medical 86

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 4 Amivantamab targets the extracellular portion of the EGFR and MET receptors.

Food and Drug Administration 89

Food and Drug Administration Safety Medicine Patients 89

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.

Patients 59

Patients Pharma Education Media 59

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 75

Food and Drug Administration Manufacturing Safety Transportation 75

European Pharmaceutical Review

DECEMBER 6, 2023

The first, the Phase III APPLY-PNH trial evaluated patients with residual anaemia (haemoglobin < 10 g/dL) despite prior anti-C5 treatment who switched to Fabhalta. percent of anti-C5-experienced Fabhalta patients responded versus 0 percent for anti-C5. Patients avoiding transfusion: The transfusion avoidance rate was 95.2

Food and Drug Administration 82

Food and Drug Administration Patients Physicians Food 82

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 79

Side effects Medicine Safety Marketing 79