LEVO Health

FEBRUARY 24, 2021

The world shifted towards virtual events for safety but is now enjoying the accessibility and ROI it allows. Not only does social media allow healthcare facilities to connect with their patients and clients, but more importantly, it offers the opportunity to educate, provide better service, increase loyalty, and increase credibility. .

Healthcare 52

Healthcare Healthcare Marketing Media 52

European Pharmaceutical Review

JUNE 29, 2022

How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. How are regulatory guidelines adapting to this trend? References.

Ethics 84

Ethics Safety Manufacturing Medicine 84

Clarify Health

AUGUST 26, 2020

While many plans did not meet their minimum medical loss ratio (or MLR Target) for 2020, in three steps, payers can better position themselves to meet these targets in 2021. So with 2020 MRL targets slashed for many plans, what can they do to ensure they’re tracking in 2021? But first… What is a Medical Loss Ratio (MLR)?

Insurance 52

Insurance Medical Networking Management 52

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. First-in-human clinical trial for first RNA modifying enzyme inhibitor. Pre-clinical studies of STC-15.

Patients 84

Patients Safety Medical Pharmaceutical 84

European Pharmaceutical Review

DECEMBER 7, 2022

The Commission on Human Medicines (CHM), which endorsed the authorisation, advises ministers on the safety, efficacy and quality of medicinal products. In November 2021, the US Food and Drug Administration (FDA) authorised the emergency use of COVID-19 vaccine Comirnaty ® in children aged five to 11 years.

Food and Drug Administration 84

Food and Drug Administration Patients Side effects Medicine 84

pharmaphorum

JANUARY 27, 2023

Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the industry.

Patients 98

Patients Pharmaceutical Medical Physicians 98

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

Patients 106

Patients Transportation Retail Recruitment 106

Pharma Marketing Network

APRIL 27, 2021

Head of the Discovery Technology Center in Cambridge, Massachusetts, Head of Discovery Research in Ann Arbor, Michigan, and Head of Drug Safety R&D. The post Dr. Rod MacKenzie, 2020-2021 HBA Honorable Mentor appeared first on Pharma Marketing Network.

Medicine 52

Medicine Networking Safety Marketing 52

Pharmaceutical Technology

JANUARY 23, 2023

The term LN refers to a major predictor of poor prognosis in SLE patients, with inflammation of the kidney that encompasses diverse patterns of renal disease, including glomerular and vascular pathology. However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years.

Marketing 111

Marketing Safety Patients Pharmaceutical 111

European Pharmaceutical Review

OCTOBER 25, 2023

The device may be reassessed to ensure the performance and safety of the device is negatively impacted. The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs.

Medical 91

Medical Food and Drug Administration Manufacturing Safety 91

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 83

Healthcare Healthcare Electronics Safety 83

European Pharmaceutical Review

DECEMBER 6, 2022

In July 2021, the French temporary authorisation for use (Autorisation Temporaire d’Utilisation, ATU) programme was the subject of a major reform, initially published within the 2021 healthcare plan on the 14th December 2020 (Article 78 – La Loi de financement de la sécurité sociale , FSSL). Date of decision. AAP approval.

Patients 82

Patients Manufacturing Safety Healthcare 82

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

Patients 80

Patients Pharma Consulting Transportation 80

European Pharmaceutical Review

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. New hope for stomach cancer patients.

Patients 84

Patients Food and Drug Administration Side effects Safety 84

Pharmaceutical Technology

APRIL 3, 2023

Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinical research for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.

Insurance 98

Insurance Government Safety Patients 98

World of DTC Marketing

AUGUST 12, 2022

In the past 12 months, PhRMA and closely allied groups spent at least $57 million — $19 million of it since July — on TV , cable , radio , and social media ads opposing price negotiations, according to monitoring by the advocacy group Patients for Affordable Drugs. In 2021 alone, the top U.S.

Pharma 255

Pharma Retail Pharmaceutical manufacturing Pharmaceutical 255

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

SEPTEMBER 15, 2023

The study for Dercum’s disease evaluated the efficacy and safety of CBL-514 injections in twelve participants. In the Dercum’s disease patients who received the high-dose, 64.5 points,” stated Vivian Ling, CEO of Caliway Biopharmaceuticals, the company that developed the drug. percent and 54.7

Safety 118

Safety Marketing Medicine Pharmaceutical 118

European Pharmaceutical Review

JULY 28, 2023

About the SKYLARK trial There were 200 patients in the SKYLARK study, with 196 female patients between ages 18 to 45 who received the drug. Phase III ROBIN trial In 2021, Phase III results of the ROBIN clinical trial were published in the Journal of the American Medical Association (JAMA) Psychiatry.

Food and Drug Administration 88

Food and Drug Administration Food Safety FDA 88

European Pharmaceutical Review

MARCH 17, 2023

The clinical trial evaluated the safety and efficacy of efgartigimod in 167 patients. In gMG, an autoimmune disease, IgG autoantibodies disrupt communication between nerves and muscles and cause significant and potentially life-threatening muscle weakness.

Medicine 91

Medicine Safety Consulting Patients 91

European Pharmaceutical Review

OCTOBER 20, 2022

The drug (14.2mg estetrol and 3mg drospirenone) is the first oral combined contraceptive containing a new, synthetic natural oestrogen to be offered to patients in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) granted a UK licence for the product in 2021.

Safety 82

Safety Consulting Medicine Healthcare 82

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment Medical 98

European Pharmaceutical Review

FEBRUARY 22, 2023

This ‘quick-approval, quick-withdrawal from the market’ utilised in accelerated approval can benefit both industry and patients alike. Furthermore, certain drugs awarded accelerated approval have subsequently been proven inefficacious or not safe in impacted patients. 2021; 22(7): 3464. Commonwealth Fund [cited 2023Jan].

Food and Drug Administration 77

Food and Drug Administration FDA Safety Food 77

European Pharmaceutical Review

AUGUST 28, 2023

In the Phase III extension trial ORION-8 , inclisiran in addition to statin therapy provided consistent LDL-C reduction beyond six years in patients with atherosclerotic cardiovascular disease (ASCVD), increased risk of ASCVD or heterozygous familial hypercholesterolemia (HeFH).

Food and Drug Administration 97

Food and Drug Administration Consulting Patients Food 97

European Pharmaceutical Review

OCTOBER 9, 2023

A new drug, part of a class of chemicals called potassium-channel openers, has demonstrated potential in offering relief to patients with focal epilepsy. Comparatively, patients given a placebo had on average 18 percent fewer seizures during the treatment phase of the trial, which lasted eight weeks.

Side effects 94

Side effects Recruitment Safety Medicine 94

European Pharmaceutical Review

NOVEMBER 22, 2022

The application is supported by results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcoritamab in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL). EPCORE NHL-1 Trial of epcoritamab .

FDA 87

FDA Food and Drug Administration Safety Food 87

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 79

Food and Drug Administration Manufacturing Safety Transportation 79

Pharmaceutical Technology

APRIL 18, 2023

The US Food and Drug Administration (FDA) has granted approval for the expanded indication of AbbVie ’s Qulipta (atogepant) as a preventive treatment for chronic migraines in adult patients. Qulipta received the FDA’s approval to treat episodic migraine in adults in September 2021.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

NOVEMBER 14, 2022

In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells. All five patients achieved remission after three months. MSCs and CAR-Ts for lupus.

Side effects 144

Side effects Patients Manufacturing Safety 144

Pharmaceutical Technology

FEBRUARY 16, 2023

Accord US received exclusive rights for developing and marketing HLX02 in Canada and the US in 2021. It is now approved in more than 30 countries and benefitted more than 100,000 Chinese patients. More importantly, we prioritise the needs of patients.”

Food and Drug Administration 52

Food and Drug Administration FDA Safety Biopharma 52

European Pharmaceutical Review

OCTOBER 31, 2022

AbbVie has announced that the European Medicines Agency (EMA) has validated its Marketing Authorisation Application (MAA) for epcoritamab, a bispecific antibody (bsAb) for adults with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after more than two lines of systemic therapy, offering patients a potential new therapy option.

Food and Drug Administration 86

Food and Drug Administration Medicine Food Safety 86

pharmaphorum

SEPTEMBER 9, 2022

It also marks the first move by Kry beyond the primary care category, where it provides virtual GP consultation services to millions of patients across various European countries, into tools for the treatment and prevention of chronic diseases. Novo Nordisk recently predicted its obesity sales could reach $3.7 billion in 2025.

Pharmacology 95

Pharmacology Patients Management Consulting 95

pharmaphorum

JULY 19, 2022

Approval is based on the TRuE-V1 and TRuE-V2 studies, which showed that around 30% of patients treated with ruxolitinib cream twice daily achieved 75% or more improvement from baseline in the facial vitiligo area scoring index at 24 weeks, significantly more than in a control group.

FDA 96

FDA Side effects Sales Safety 96

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). More than 90% of patients who received treatment with odevixibat were pruritus responders.

Food and Drug Administration 52

Food and Drug Administration FDA Transportation Prescription 52

European Pharmaceutical Review

JUNE 16, 2023

Pharmacovigilance and machine learning Applications of ML include analysing social media posts for safety insights, extracting information from clinical narratives in electronic health records (EHRs) and integrating data sources with multiple analytical approaches to provide richer insights. Bate et al.

Safety 90

Safety Electronics Medicine Government 90

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

NOVEMBER 15, 2022

According to IGBA, the World Health Organization ( WHO) Biosimilars Guideline has been a useful tool for health authorities to boost international regulatory convergence and consistency of terminology when evaluating biosimilars, by approving quality, safe and efficacious biosimilar medicines for patients who otherwise would have lacked access.

Medicine 90

Medicine Safety Healthcare Healthcare 90