European Pharmaceutical Review

APRIL 18, 2024

percent success rates in patients with uncomplicated urogenital gonorrhoea (GC). EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in uncomplicated urogenital gonorrhoea.

Leads 97

Leads Safety Patients Pharmaceutical 97

European Pharmaceutical Review

APRIL 16, 2024

Novartis has released new data from the first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with the rare kidney disease IgA nephropathy (IgAN). Fabhalta was given a positive opinion from the CHMP of the EMA in March 2024, according to Novartis.

Food and Drug Administration 79

Food and Drug Administration Food Safety Medicine 79

European Pharmaceutical Review

DECEMBER 22, 2023

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

Food and Drug Administration 94

Food and Drug Administration Side effects Safety Food 94

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.” Like Stelara, the most serious known side effect of Wezlana is infection.

Food and Drug Administration 88

Food and Drug Administration FDA Side effects Safety 88

European Pharmaceutical Review

AUGUST 3, 2023

EPC’s new Cannabis flower monograph The new monograph Cannabis flower (Cannabis flower, monograph 3028) will be available next year in January 2024 with publication of the supplement 11.5. The monograph will enter into force several months later, in July 2024. 1 July 2024).

Medical 98

Medical Manufacturing Medicine Pharmaceutical 98

Clarivate

MAY 1, 2024

We took a look at these drugs’ impact on the medtech sector for our forthcoming report, Medtech Trends to Watch in 2024 , and found a more nuanced picture. These drugs could also enlarge the pool of candidates for major joint surgeries as patients become more physically active after achieving weight reductions, as Stryker has noted.

Side effects 59

Side effects Physicians Medical Patients 59

European Pharmaceutical Review

JANUARY 11, 2024

Ustekinumab biologic Once the European Supplementary Protection Certificate (SPC) for Stelara expires in July 2024, this will open up market entry as soon as possible for Uzpruvo, now that it is approved in Europe” Ustekinumab is a human IgG1κ monoclonal antibody (mAb). The EU ustekinumab market is worth €2.5

Competition 98

Competition Marketing Safety Manufacturing 98

European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. There were 381 Parkinson’s patients enrolled in the trial. and Joan A.

Food and Drug Administration 89

Food and Drug Administration Medicine Physicians Food 89

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 98

Medicine Safety Patients Pharmaceutical 98

European Pharmaceutical Review

AUGUST 24, 2023

Therefore “This could improve the overall safety and tolerability of risvodetinib.” “… compared to the capsules currently in use in the 201 clinical trial, the smaller tablets may overcome challenges patients have swallowing oral medication as a result of their disease.

Safety 87

Safety Medical Medicine Patients 87

European Pharmaceutical Review

NOVEMBER 13, 2023

First treatment for myelofibrosis with anaemia approved Steps to a novel EU approval of momelotinib If approved, momelotinib would be the only medicine in EU indicated for both newly diagnosed and previously treated myelofibrosis patients with moderate to severe anaemia that addresses splenomegaly and symptoms.

Safety 85

Safety Medicine Pharmaceutical Patients 85

European Pharmaceutical Review

MARCH 13, 2024

In the long-term extension FRONTIER 2 study , JNJ-2113 demonstrated sustained efficacy from Week 16 to Week 52, based on data presented at the American Academy of Dermatology (AAD) 2024 Annual Meeting. While safety results were consistent with previously reported data (FRONTIER 1), across JNJ-2113 treatment groups, 58.6

Safety 79

Safety Patients Pharmaceutical 79

European Pharmaceutical Review

NOVEMBER 17, 2023

The European Commission has approved Ebglyss (lebrikizumab) for atopic dermatitis patients 12 years and older with a body weight of at least 40kg, who are candidates for systemic therapy. The company said it will launch lebrikizumab in Germany, with further European rollout planned throughout 2024.

Safety 81

Safety Patients Management Leads 81

European Pharmaceutical Review

OCTOBER 25, 2023

The device may be reassessed to ensure the performance and safety of the device is negatively impacted. MHRA announced that it will publish its guidance in 2024. Since medical devices using machine-learning and artificial intelligence (AI) can require frequent updates, and therefore potentially lengthy reassessment for each change.

Medical 90

Medical Food and Drug Administration Manufacturing Safety 90

European Pharmaceutical Review

FEBRUARY 8, 2024

RIDGELINE 105, evaluated the safety and efficacy of the vanza triple in children with cystic fibrosis between six and 11 years old with at least one mutation responsive to triple combination CFTRm. Vertex confirmed that full data set from these studies will be presented at medical meetings later in 2024.

Food and Drug Administration 88

Food and Drug Administration Medicine Medical Consulting 88

European Pharmaceutical Review

MARCH 23, 2023

Key data from the BOREAS Phase III trial, the first out of two Phase III trials in the Dupixent ® (dupilumab) development programme, has shown that o f 939 adult patients, 30 percent experienced reduction in moderate or severe acute chronic obstructive pulmonary disease (COPD) exacerbations over 52 weeks.

Safety 80

Safety Patients Pharmaceutical 80

European Pharmaceutical Review

SEPTEMBER 12, 2023

The immunotherapy activating tumour specific T-cells, off-the-shelf, neoepitope-based vaccine Tedopi ® was evaluated in HLA-A2 positive patients with advanced or metastatic NSCLC in monotherapy in third line NSCLC with secondary resistance to immune checkpoint inhibitors, in the Phase III clinical trial Atalante-1. percent versus 27.5

Safety 98

Safety Patients Pharmaceutical 98

European Pharmaceutical Review

MARCH 4, 2024

Final data from the Phase IIIb SMART study of Zolgensma ® (onasemnogene abeparvovec) highlighted its safety and efficacy in children weighing ≥ 8.5kg to ≤ 21kg, with a mean age of 4.69 Findings from the study demonstrated that most children maintained motor milestones throughout the one-year study.

Patients 79

Patients Safety Medical Pharmaceutical 79

Pharmaceutical Technology

SEPTEMBER 6, 2022

It also boosts the drug’s safety, tolerability and efficacy. By 2024, doxorubicin is anticipated to have a market size of $1.38bn and is extensively utilised as a part of the standard of care in various types of cancers. . This approach aids the therapy to be activated mainly in the tumour, sparing healthy tissue from exposure.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Food 98

European Pharmaceutical Review

OCTOBER 23, 2023

Clinical evidence for RVT-3101 RVT-3101 has been investigated in the TUSCANY-2 Phase IIb study in patients with moderate to severe ulcerative colitis. RVT-3101 also demonstrated a favourable safety profile for all patients. The transaction is expected to be completed in Q4 2023 or in Q1 2024, Roche noted.

Safety 83

Safety Manufacturing Patients Medical 83

European Pharmaceutical Review

JANUARY 10, 2024

A lymph node-targeted cancer vaccine has shown potential to prevent relapse of KRAS-mutated pancreatic and colorectal cancers in patients who have had surgery, according to a Phase I trial led by US researchers. Patients were given no more than 10 doses of the ELI-002 cancer vaccine targeted toward KRAS G12D and G12R mutations. “It

Specialization 86

Specialization Patients Training Safety 86

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. First distributed. 84 capsules. 10/02/2022. Batch number. Expiry date. 84 capsules.

Distribution 87

Distribution Healthcare Healthcare Medicine 87

European Pharmaceutical Review

DECEMBER 20, 2023

The FDA’s Priority Review designation acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the US,” Garraway added. The study involves patients aged 1 to 55 years who are allergic to peanuts and at least two other common foods.

Food 95

Food Food and Drug Administration FDA Patients 95

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. It is to be hoped that this will be addressed by an update of the ICH M7(R2) guidance during 2024. Thus, NDSRIs could be generated endogenously.

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine FDA 96

European Pharmaceutical Review

SEPTEMBER 29, 2023

Clinical efficacy of the serotonin 1a receptor antagonist for major depressive disorder Studied in over 5,000 patients, Exxua has demonstrated an overall acceptable safety profile, with no significant adverse effect on weight, blood pressure, heart rate or liver function.

FDA 92

FDA Food and Drug Administration Medicine Food 92

European Pharmaceutical Review

JANUARY 24, 2024

The therapy has potential to enable these patients attain normal serum AAT levels via monthly rather than weekly dosing. By inhibiting neutrophil elastase, an enzyme responsible for lung tissue damage, INBRX-101 could help lower inflammation and prevent further decline in lung function in AATD patients, Sanofi noted.

Safety 52

Safety Patients Pharmaceutical 52

European Pharmaceutical Review

FEBRUARY 29, 2024

For Rare Disease Day 2024, Biogen’s Vice President and Head of the Neuromuscular Development Unit, Dr Toby Ferguson, spoke with EPR about the current rare disease landscape, including highlighting recent developments in treating Friedreich’s ataxia.

Medicine 70

Medicine Patients Recruitment Training 70

European Pharmaceutical Review

MARCH 14, 2024

This month, new data from Novo Nordisk has revealed that semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD). Up to fifty percent of IgAN patients progress to end-stage renal disease, requiring dialysis or transplant.

Food and Drug Administration 93

Food and Drug Administration Side effects Leads Patients 93

PM360

APRIL 22, 2024

relies on the industry’s ability to understand, accept and manage change throughout 2024 and beyond. In an understandably conservative industry, where patient safety is the priority, the adoption of new technology and processes can be slow, particularly if their effectiveness and value are poorly understood. Clinical Research 2.0

Education 52

Education Management Recruitment Safety 52

European Pharmaceutical Review

MARCH 14, 2024

This month, new data from Novo Nordisk has revealed that semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD). Up to fifty percent of IgAN patients progress to end-stage renal disease, requiring dialysis or transplant.

Food and Drug Administration 93

Food and Drug Administration Side effects Leads Patients 93

European Pharmaceutical Review

AUGUST 9, 2023

The Bruton’s tyrosine kinase (BTK) inhibitor was evaluated in patients with symptoms inadequately controlled by H1-antihistamines. Approximately 60 percent of patients are inadequately controlled with antihistamines alone. The pharmaceutical company announced that it plans to submit to global health authorities in 2024.

Safety 69

Safety Medical Patients Pharmaceutical 69

European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The FDA’s target action date is the second half of 2024. The study enrolled 513 patients.

Food and Drug Administration 89

Food and Drug Administration Manufacturing Safety Medicine 89

Pharmaceutical Technology

MAY 30, 2023

Amplo CEO Dr Patricio Sepulveda stated: “Amplo is thrilled to collaborate with UC-Davis in the development of AMP-201, addressing the critical unmet needs of patients suffering from ColQ CMS. “By By combining the power of Amp-101 and AMP-201, we are confident in our ability to revolutionise the lives of CMS patients.”

Safety 97

Safety Patients Leads Pharmaceutical 97

Pharmaceutical Technology

JUNE 16, 2023

This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology. Due to this, adjunctive treatments are used as part of a patient’s treatment regimen.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

Pharmaceutical Technology

MAY 25, 2023

It will be offered to patients in prefilled syringe and autoinjector administration options. Celltrion USA chief commercial officer Tom Nusbickel stated: “Yuflyma offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

pharmaphorum

JANUARY 4, 2023

More than 30 years after it was first formed, Geron is on the cusp of bringing its first product to market, after imetelstat hit the mark in a phase 3 trial in patients with myelodysplastic syndromes (MDS). “True innovation is a lot harder than it sounds,” he said. “And this isn’t the ultimate victory lap today. .”

Safety 98

Safety Marketing Patients Pharma 98

Pharmaceutical Technology

JULY 18, 2022

There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. The DPP-1 inhibitor is being investigated in the Phase III ASPEN trial (NCT04594369), which is expected to read out in March 2024, but Phase II data already suggests that this agent has a good safety and efficacy profile.

Marketing 59

Marketing Safety Management Patients 59