European Pharmaceutical Review

DECEMBER 15, 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of Vertex’s gene-editing therapy Casgevy for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia.

Medicine 95

Medicine Food and Drug Administration Food Patients 95

European Pharmaceutical Review

JANUARY 26, 2024

The US Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) as a treatment for children patients aged one to 11 years, weighing at least 15kg with eosinophilic esophagitis (EoE). This new authorisation by the FDA’s expands its initial approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40kg.

Medicine 87

Medicine Food and Drug Administration FDA Food 87

MedCity News

NOVEMBER 10, 2023

As the industry moves towards more personalized medicine, pharmacogenomics could play a key role in keeping patients healthier longer and in getting them viable treatments for their unique genetic profile.

Medicine 104

Medicine Patients Biopharma 104

European Pharmaceutical Review

SEPTEMBER 14, 2023

Rimegepant (Vydura) is the “first and only NICE-recommended medicine that can help alleviate the misery of acute migraines, and may be considered a step-change in treatment,” shared Helen Knight, Director of medicines evaluation at the National Institute for Health and Care Excellence (NICE).

Medicine 102

Medicine Patients Pharmaceutical 102

Pharmaceutical Technology

MAY 18, 2023

The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. The EMA set up a task force in 2016 in light of issues concerning medicine availability and supply chain.

Medicine 99

Medicine Specialization Networking Manufacturing 99

Fierce Pharma

AUGUST 24, 2023

mg dose bested placebo at reducing symptoms and physical limitations in patients with obesity and heart failure with preserved ejection fraction. The drug also led to greater improvements in exercise function and more weight loss versus a dummy drug, according to study results published in The New England Journal of Medicine Friday.

Patients 246

Patients Medicine 246

Fierce Pharma

AUGUST 31, 2023

In this interview, Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, discusses Jazz’s 20-year legacy and what it means to create an organization that is both patient-focused and a great place | Jazz Pharmaceuticals’ Chairman and CEO discusses the company’s longstanding history of bringing new medicines to patients with limited or no options.

Pharmaceutical 130

Pharmaceutical Patients Medicine 130

European Pharmaceutical Review

OCTOBER 9, 2023

This decision by the Scottish Medicines Consortium (SMC) relates to these patients who require therapy for VHL-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNETs), and for whom localised procedures are unsuitable or undesirable.

Medicine 90

Medicine Patients Healthcare Healthcare 90

pharmaphorum

JANUARY 17, 2023

Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify. Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool.

Medicine 97

Medicine Patients Transportation Healthcare 97

European Pharmaceutical Review

FEBRUARY 21, 2023

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. In this Q&A, EPR caught up with CEO James Short and Managing Director Arthur Wakeley from Celadon, to learn more about the company’s experience moving through, and progressing, the strict regulatory process for medicinal cannabis.

Medicine 131

Medicine Manufacturing Specialization Pharmaceutical 131

MedCity News

NOVEMBER 7, 2023

Baylor Medicine teamed up with Luna to launch a program expanding access to in-home physical therapy for patients in the Houston area. Luna, a provider of in-home physical therapy, has similar partnerships with more than two dozen health systems.

Medicine 111

Medicine Marketing Patients Healthcare 111

MedCity News

OCTOBER 23, 2023

For example, all models tried to justify race-based medicine when asked questions about calculating patients’ kidney function and lung capacity — two areas where race-based medicine practices used to be common but have since been scientifically refuted.

Medicine 103

Medicine Patients Healthcare Healthcare 103

Fierce Pharma

JUNE 5, 2023

One of the hottest topics shaping the world of pharmaceuticals and medicine is patient centricity. Victoria Summers, principal at ZS Associates, discusses one of the most pressing challenges facing the pharma industry today: patient centricity.

Patients 130

Patients Medicine Pharma Pharmaceutical 130

European Pharmaceutical Review

JULY 27, 2023

The first targeted therapy approved for paediatric patients with generalised myasthenia gravis (gMG) has been approved in the EU. This decision by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP). Soliris is administered intravenously every two weeks.

Medicine 87

Medicine Safety Patients Pharmaceutical 87

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

Medicine 93

Medicine Distribution Manufacturing Management 93

Pharmaceutical Technology

APRIL 24, 2023

Traditional medicine refers to the knowledge, skills and practices that indigenous and different cultures use to maintain health, encompassing forms such as herbal medicine, Traditional Chinese Medicine (TCM) and acupuncture. Studying the behaviour of animals can aid in drug discovery research too.

Medicine 105

Medicine Side effects Healthcare Healthcare 105

European Pharmaceutical Review

MAY 26, 2023

The Medicines and Healthcare products Regulatory Agency ( MHRA ) has announced that new international regulatory recognition routes for medicines will be established using approvals from the EU, Switzerland, US, Canada, Australia, Singapore and Japan.

Medicine 90

Medicine Manufacturing Patients Healthcare 90

MedCity News

MAY 10, 2023

Medical Affairs plays a critical role when it comes to driving adherence to evidence-based medicine (EBM) – the principle that clinical decisions should be informed by the best available scientific evidence, along with clinical experience and patient preference.

Medicine 114

Medicine Medical Patients Biopharma 114

PharmExec

FEBRUARY 1, 2024

Including patient and family feedback in our discussions will help shape our understanding of their perception of provided care and services and how we operate as a whole.

Medicine 52

Medicine Patients Pharma 52

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The regulatory approval was based on the data obtained from the placebo-controlled, double-blind PIONEER trial.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare Provider 98

Eversana Intouch

SEPTEMBER 14, 2023

Digital medicine is emerging as a revolutionary field that can transform the entire spectrum of healthcare, from proactive prevention to effective treatment of diverse medical conditions. Download POV

Medicine 90

Medicine Management Marketing Pharma 90

European Pharmaceutical Review

JANUARY 11, 2024

What are the key current challenges in the development of pain medicines? What is the present clinical landscape for pain management medicines, especially chronic pain? Pain management therapies: Pfizer’s migraine medicine recommended by NICE What are three current development trends for pain management treatments?

Medicine 83

Medicine Pharmacology Management Side effects 83

European Pharmaceutical Review

JULY 5, 2023

European Commission (EC) has granted approval for the label extension of cystic fibrosis medicine ORKAMBI ® (lumacaftor/ivacaftor) for children aged one to <2 years old. In these patients, the CFTR protein is not processed and trafficked normally within the cell. How does the oral cystic fibrosis medicine work?

Medicine 78

Medicine Transportation Medical Pharmaceutical 78

European Pharmaceutical Review

JULY 3, 2023

Data showed 51 percent of patients on 80mg of the small molecule treatment elafibranor achieved a cholestasis response compared with four percent on placebo. The Phase III trial enrolled 161 patients. A significant proportion of PBC patients are unable to benefit from existing therapies. There are 22.27

Medicine 90

Medicine Food and Drug Administration Food Patients 90

MedCity News

APRIL 11, 2023

Culturally competent behavioral health provider ReKlame Health is rolling out an in-home program for addiction medicine care in New York City.

Medicine 100

Medicine Patients 100

European Pharmaceutical Review

NOVEMBER 23, 2022

The European Medicines Agency (EMA) has established the Quality Innovation Expert Group (QIG) to aid innovative approaches for the development, manufacture and quality control (QC) of medicines, including new technologies, digitalisation, novel materials and novel devices for patients in the European Union (EU).

Medicine 104

Medicine Networking Manufacturing Training 104

Fierce Pharma

JANUARY 5, 2024

In fact, the research shows that those who were on semaglutide were less likely to have suicidal thoughts than patients on other diabetes and obesity meds.

Side effects 318

Side effects Medicine FDA Medical 318

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. As well as generic medicines Teriflunomide Accord and Teriflunomide Mylan (teriflunomide), indicated for the treatment of multiple sclerosis.

Medicine 98

Medicine Marketing Patients Safety 98

pharmaphorum

OCTOBER 28, 2022

In June, NHSE and NICE published details on the Innovative Medicines Fund, which will help improve patient access to cutting-edge medicines, with a particular focus on rare diseases, and ensure global pharmaceutical and biotech organisations continue to prioritise the UK as a launch destination. Angela McFarlane ?,

Medicine 107

Medicine Management Marketing Leads 107

Fierce Pharma

AUGUST 3, 2023

Jaclyn Bjorklund, 44, says that she also has been hospitalized on "several" occasions and that the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs.

Medicine 244

Medicine Sales Patients 244

Fierce Pharma

MARCH 14, 2024

After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy pact—this time centered on an adeno-asso | After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy (..)

Manufacturing 239

Manufacturing Medicine Patients 239

MedCity News

DECEMBER 19, 2023

It’s time to build the infrastructure needed to scale up inhaled gene therapies targeting cystic fibrosis, and to bolster investment that supports several key program components.

Medicine 131

Medicine Patients Biopharma 131

pharmaphorum

OCTOBER 12, 2022

He explains that bringing cutting-edge genomic therapies to market which could treat or cure life-threatening diseases can take up to 15 years and cost $2 billion – far too slow to match patients’ needs, and far too expensive on the healthcare system. “We The evolving field of genomic medicine.

Medicine 87

Medicine Patients Healthcare Healthcare 87

PM360

JUNE 26, 2023

Access to medicines have persisting and systemic differences across the globe and within countries. It is estimated that nearly two billion people globally do not have access to essential medicines. Traditionally, pharmaceutical companies have not prioritized emerging markets as part of their access strategy.

Medicine 98

Medicine Marketing Pharma Manufacturing 98

European Pharmaceutical Review

AUGUST 7, 2023

The US Food and Drug Administration ( FDA ) has approved Zurzuvae ( zuranolone ), the first oral medicine to treat postpartum depression (PPD) in adults. In Study 1, patients received 50mg of Zurzuvae or a placebo once per day for two weeks. Historically, treatment for PPD has been only available as an IV injection.

Medicine 78

Medicine Food and Drug Administration FDA Food 78

pharmaphorum

FEBRUARY 26, 2024

AstraZeneca has moved a step closer to EU approval of oral Factor D inhibitor danicopan in the EU, after the EMA’s human medicines committee, the CHMP, backed the drug as a treatment for residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria (PNH).

Patients 84

Patients Medicine 84

World of DTC Marketing

MARCH 28, 2021

IN BRIEF: Doctors are not required to treat obese patients who won’t do anything to lose weight but the problem is more than reminding patients they need to get exercise and drop pounds. But what about patients who make no effort to lose weight? Medicare and Medicaid patients specifically cost $61.8

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Doctors Patients Insurance Physicians 250