European Pharmaceutical Review

APRIL 17, 2024

Roche’s twice-yearly, 10-minute subcutaneous injection of OCREVUS ® (ocrelizumab) has shown significant promise for patients with either with relapsing or primary progressive multiple sclerosis (RMS or PPMS). percent had no relapse) in patients through 48 weeks of the treatment. No new safety signals were identified for OCREVUS SC.

Food and Drug Administration 93

Food and Drug Administration Safety Medicine Food 93

PM360

AUGUST 6, 2024

Unless patients have a voice right from product conception and design, new treatments could be poorly aligned with their needs, affecting take-up and commercial success. overcoming patient fear by emphasizing the scope for a better quality of life as more intrusive treatments are discontinued).

Patients 52

Patients Safety Medicine Pharma 52

European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD.

Manufacturing 145

Manufacturing Food and Drug Administration Engineering Safety 145

Pharmacy Times

FEBRUARY 15, 2024

The meeting provided a brief overview of California's new Stop Dangerous Pharmacies Act, the benefits of e-prescribing for improving patient safety and outcomes, and New Jersey's pilot program for anonymous dispensing of opioid antidotes from pharmacies.

Safety 57

Safety Patients 57

European Pharmaceutical Review

MAY 7, 2024

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. Johnson & Johnson’s Phase I study is assessing the safety and efficacy of TAR-210 as a delivery method for sustained, local release of erdafitinib into the bladder.

Food and Drug Administration 97

Food and Drug Administration Patients Food Safety 97

Nixon Gwilt Law

JUNE 24, 2024

The Digital Therapeutics Alliance Summit 2024 , held in Washington, D.C., One of the most compelling aspects of DTx is its potential to transform the patient-provider relationship. One of the most compelling aspects of DTx is its potential to transform the patient-provider relationship.

FDA 52

FDA Education Healthcare Provider Patients 52

Nixon Gwilt Law

JUNE 24, 2024

The Digital Therapeutics Alliance Summit 2024 , held in Washington, D.C., One of the most compelling aspects of DTx is its potential to transform the patient-provider relationship. One of the most compelling aspects of DTx is its potential to transform the patient-provider relationship.

FDA 52

FDA Education Healthcare Healthcare 52

European Pharmaceutical Review

MAY 8, 2024

A total of 13 patients were enrolled to receive three intravenous infusions of the monoclonal antibody treatment. Final findings from the Phase IIa atopic dermatitis trial are expected in Q3 2024. We are highly encouraged by the remarkable efficacy seen with a short four-week treatment period.

Safety 122

Safety Patients Medicine Medical 122

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 105

Leads Safety Patients Pharmaceutical 105

PM360

AUGUST 7, 2024

In June 2024, the FDA extended a Cooperative Research and Development Agreement (CRADA) to assess data quality in multicenter clinical trials using statistical modeling and ML. This can make it difficult to identify those which are likely to represent a real issue for participant safety or data integrity.

Safety 59

Safety FDA Management Medical 59

PM360

OCTOBER 8, 2024

The high-profile appointment follows the merger of Bioclinica DSS, MyMeds&Me and Commonwealth Informatics under the Qinecsa brand two years ago, and the recent addition of Insife to the group in Q1 2024. The business is supported by investment from Stanley Capital Partners.

Leads 52

Leads Safety Biopharma Management 52

European Pharmaceutical Review

MAY 14, 2024

Six-month Abeta positron emission tomography (PET) imaging results for ACI-24.060 are expected in Q2 2024. Furthermore, the 12-month Abeta PET data are expected in final quarter of 2024, Takeda confirmed. The post Takeda agrees to develop active immunotherapy for Alzheimer’s appeared first on European Pharmaceutical Review.

Safety 97

Safety Patients Pharmaceutical 97

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 98

Food and Drug Administration FDA Side effects Safety 98

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 97

Food and Drug Administration Food Safety Medicine 97

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 98

Food and Drug Administration Side effects Safety Food 98

European Pharmaceutical Review

APRIL 10, 2024

The small molecule anti-cancer treatment from Nurix Therapeutics is currently being investigated in a Phase I clinical trial in patients with relapsed or refractory B cell malignancies. The patient was given NX-5948 100mg once per day. The patient was given NX-5948 100mg once per day.

Patients 97

Patients Safety Pharmaceutical 97

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 115

Competition Marketing Safety Manufacturing 115

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.

Medicine 109

Medicine Safety Pharmaceutical Patients 109

European Pharmaceutical Review

SEPTEMBER 30, 2024

177 Lu-Dotatate has shown potential for extending progression-free survival for patients with the brain cancer meningioma, with results showing more favourable improvements compared to historical benchmarks. Participants (median patient age was 67), received a total of four infusions of 177 Lu-Dotatate every eight weeks.

Patients 64

Patients Safety Medicine Pharmaceutical 64

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

European Pharmaceutical Review

OCTOBER 26, 2023

The CTA is for a Phase IIa trial of PK051 in patients with mild cognitive impairment. The submission includes comprehensive data from pre-clinical studies and thorough safety assessments, PharmaKure noted. The clinical trial will involve 40 patients at a single site located in Motherwell, UK.

Safety 105

Safety Pharmaceutical Patients Medicine 105

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 98

Safety Medical Medicine Patients 98

European Pharmaceutical Review

JUNE 6, 2024

The new data is from the MYR204 study which investigated the efficacy and safety of the first-in-class entry inhibitor bulevirtide alone and together with PegIFN, in these patients with compensated chronic HDV infection. These findings were presented at the European Association for the Study of the Liver (EASL) Congress 2024.

Safety 98

Safety Patients Pharmaceutical 98

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 98

Safety Patients Pharmaceutical 98

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 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

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 98

Food and Drug Administration Medicine Physicians Food 98

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 98

Safety Patients Management Leads 98

European Pharmaceutical Review

JANUARY 5, 2024

“ Treatment with evenamide as an add-on to antipsychotics in treatment-resistant schizophrenia (TRS) patients has produced benefits that have never been reported before,” Ravi Anand, Newron’s Chief Medical Officer shared. This is compared to daily dosing, therefore helping to reduce the peak to trough variation patients can experience.

Food and Drug Administration 111

Food and Drug Administration Medical Safety Patients 111

European Pharmaceutical Review

OCTOBER 17, 2024

In August 2024, the European Commission approved EURneffy (adrenaline nasal spray) in the EU as the first needle-free emergency option to treat anaphylaxis. These factors may increase the likelihood that patients and caregivers carry it regularly. Poster Presented at the 2024 AAAAI Annual meeting, DC, US.

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

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 105

Medical Food and Drug Administration Manufacturing Safety 105

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). The data were presented at the 2024 Cure SMA Research & Clinical Care Meeting.

Safety 98

Safety Patients Leads Medical 98

European Pharmaceutical Review

JUNE 13, 2024

Significant reductions of treated bleeding episodes in haemophilia A In the FRONTIER 2 trial, treatment once-weekly and once-monthly with Mim8 provided a 97 percent and 99 percent reduction in treated bleeds in patients with no prior prophylaxis treatment, respectively. This was compared to prior coagulation factor prophylaxis.

Safety 98

Safety Patients Pharmaceutical 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 104

Safety Manufacturing Patients Medical 104

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 98

Safety Patients Pharmaceutical 98

PM360

JUNE 24, 2024

This fuels an enormous need for effective patient communication and education as new therapies move through the biopharma pipeline. Marketing to rare disease patient populations is equal parts opportunity and responsibility. audiences (direct-to-patient advertising rules are fundamentally different overseas).

Marketing 52

Marketing Patients Food and Drug Administration Digital Media 52

European Pharmaceutical Review

JUNE 25, 2024

The subcutaneous formulation was developed to offer patients an alternative twice-yearly treatment option, in addition to intravenous administration, Roche noted. The safety and efficacy of this administration method was comparable to the intravenous formulation. percent, over 48 weeks of treatment.

Medicine 111

Medicine Safety Medical Pharmaceutical 111