European Pharmaceutical Review

APRIL 17, 2024

Roche explained that additional data offered further evidence on the safety profile of OCREVUS SC injection. It was consistent with the safety profile of OCREVUS IV infusion, the findings revealed. No new safety signals were identified for OCREVUS SC.

Food and Drug Administration 66

Food and Drug Administration Safety Medicine Food 66

Pharmaceutical Technology

MARCH 30, 2023

Table 1: Medical product (drugs, devices, and diagnostics) safety budget, 2023 vs. 2024 Source: FDA; GlobalData © GlobalData Whether the proposal passes, and with what alterations, will depend on US Congress. Postmarket Safety Collaborative: +$10.1m to enhance the safety surveillance of adverse events.

Manufacturing 59

Manufacturing FDA Safety Pharma 59

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

APRIL 18, 2024

EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in uncomplicated urogenital gonorrhoea. GSK shared that the safety and tolerability profile of gepotidacin in this trial was consistent with data seen in Phase I and II trials.

Leads 95

Leads Safety Patients Pharmaceutical 95

PM360

FEBRUARY 8, 2024

It’s open-source design meets FDA requirements for safety and protection. Saatchi & Saatchi Wellness and TOM (Tikkun Olam Makers) The Prescription Paper Pill Bottle An innovative alternative to plastic, the Prescription Paper Pill Bottle is 100% compostable with no artificial glue and no toxic dye.

Prescription 52

Prescription Pharma Engineering Safety 52

European Pharmaceutical Review

APRIL 16, 2024

Pre-specified interim analysis results from the Phase III APPLAUSE-IgAN clinical trial were presented at the 2024 World Congress of Nephrology (WCN). Fabhalta was given a positive opinion from the CHMP of the EMA in March 2024, according to Novartis. Fabhalta ® (iptacopan) is a Factor B inhibitor of the alternative complement pathway.

Food and Drug Administration 77

Food and Drug Administration Food Safety Medicine 77

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

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 93

Food and Drug Administration Side effects Safety Food 93

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 86

Food and Drug Administration FDA Side effects Safety 86

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 97

Competition Marketing Safety Manufacturing 97

European Pharmaceutical Review

MARCH 5, 2024

This was communicated in a Letter to Industry (medical devices) published by the agency on 20 February 2024. Ensuring safety and efficacy of medical devices UK perspective Medical Devices/IVDs Regulatory Quality and Clinical Consultant, Shweta Agarwal, remarked on LinkedIn about a recent MedTech Regulatory Reform webinar by the MHRA.

Medical 80

Medical Manufacturing Food and Drug Administration Safety 80

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 85

Safety Medical Medicine Patients 85

European Pharmaceutical Review

MARCH 18, 2024

“Future studies will need to determine the durability of the long-term benefits and whether any safety issues could emerge, as well as how it might compare with deep brain stimulation.” Espay also stated that two additional subcutaneous delivery systems are also expected to be approved in 2024.

Food and Drug Administration 87

Food and Drug Administration Medicine Physicians Food 87

European Pharmaceutical Review

JANUARY 15, 2024

Previous research, including a 2022 paper published in JAMA Neurology , have highlighted the treatment’s potential to ‘dissociate’ efficacy from steroid safety concerns. We are working towards making Agamree available to patients in the UK in the second half-year 2024, after NICE completes its pricing review.

Medicine 97

Medicine Safety Patients Pharmaceutical 97

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 ICH M7(R2) 10 currently provides some guidance to establish AIs for mutagenic impurities.

Pharmaceutical 95

Pharmaceutical Food and Drug Administration Medicine FDA 95

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 87

Food and Drug Administration Medicine Medical Consulting 87

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. References Warning Letters. Internet} US FDA. cited2024Mar].

FDA 88

FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing 88

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 78

Safety Patients Pharmaceutical 78

European Pharmaceutical Review

NOVEMBER 13, 2023

According to GSK, the positive CHMP opinion is supported by data from the pivotal Phase III MOMENTUM study , which evaluated the safety and efficacy of momelotinib versus danazol for the treatment and reduction of key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population.

Safety 84

Safety Medicine Pharmaceutical Patients 84

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 89

Medical Food and Drug Administration Manufacturing Safety 89

European Pharmaceutical Review

OCTOBER 23, 2023

RVT-3101 also demonstrated a favourable safety profile for all patients. “RVT-3101 has the potential to be the first therapy that offers both high efficacy and safety for people with IBD and the convenience of an at-home, subcutaneous administration” A Phase II clinical trial in Crohn’s disease is ongoing. “The

Safety 82

Safety Manufacturing Patients Medical 82

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

MARCH 23, 2023

” The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Detailed efficacy and safety results from the clinical trial will be presented in a future scientific forum. These results also validate the role type 2 inflammation plays in driving COPD in these patients.”

Safety 78

Safety Patients Pharmaceutical 78

European Pharmaceutical Review

NOVEMBER 17, 2023

The company said it will launch lebrikizumab in Germany, with further European rollout planned throughout 2024. The Phase III clinical development programme, which involved some 1,300 patients, also evaluated the safety profile of lebrikizumab. EC approval was based on three pivotal Phase III studies.

Safety 80

Safety Patients Management Leads 80

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

NOVEMBER 2, 2023

For instance, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) reported in January that due to manufacturing delays, production capacity issues and supply difficulties of antibiotics across most Member States, it was “closely monitoring” and responding to shortages.

Medicine 97

Medicine Manufacturing Pharmaceutical Safety 97

European Pharmaceutical Review

APRIL 2, 2024

At Roche, we see it as our ethical and environmental responsibility to support the use of alternative methods that prioritise animal welfare while ensuring the safety of our patients and the quality of our products. in the monographs for Water for Injection (0169) and Purified Water (0008) on 1 April 2024. on 1 January 2024.

Ethics 86

Ethics Manufacturing Marketing Networking 86

European Pharmaceutical Review

FEBRUARY 2, 2024

However, Biogen noted that while the move is not a result of safety or efficacy concerns, a “large portion” of the resources will be diverted in Biogen’s Alzheimer’s disease franchise. On 9 January 2024, Eisai confirmed that LEQEMBI was approved in China to treat Alzheimer’s.

Food and Drug Administration 73

Food and Drug Administration FDA Food Marketing 73

European Pharmaceutical Review

SEPTEMBER 12, 2023

A significant reduction of the risk of death by 41 percent was achieved with a better safety profile and a maintained quality of life,” commented Professor Benjamin Besse, Principal Investigator of the Atalante-1 clinical trial and Director of Clinical Research at Gustave Roussy Institute in France. months compared to 4.6

Safety 97

Safety Patients Pharmaceutical 97

Pharmaceutical Technology

APRIL 28, 2023

“We look forward to advancing our first candidate, THN391, into clinical trials, and expect to announce key safety and proof of mechanism clinical data by the end of 2024.” The grant includes preclinical research funding of $1m a year to advance the company’s Alzheimer’s disease programme into 2024.

Safety 52

Safety Medicine Leads 52

European Pharmaceutical Review

DECEMBER 8, 2023

The drug has shown promising efficacy and safety in a Phase Ib study for schizophrenia. The transaction is expected to close in the middle of 2024, subject to Cerevel shareholder approval, regulatory approvals, and other customary closing conditions. Emraclidine is a positive allosteric modulator (PAM) of the muscarinic M4 receptor.

Safety 91

Safety FDA Management Pharmaceutical 91

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 77

Patients Safety Medical Pharmaceutical 77

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. First distributed.

Distribution 86

Distribution Healthcare Healthcare Medicine 86

European Pharmaceutical Review

JULY 19, 2023

The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency have published recommendations for avoiding antibiotic shortages in the autumn/winter 2023-2024 season. These suggested actions have been developed through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).

Medicine 80

Medicine Manufacturing Safety Pharmaceutical 80

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 90

FDA Food and Drug Administration Medicine Food 90

Pharmaceutical Technology

JUNE 13, 2023

“We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.” The company stated that the Phase I/IIa trial will thoroughly evaluate the therapy’s clinical efficacy and safety.

Food and Drug Administration 59

Food and Drug Administration FDA Food Safety 59

European Pharmaceutical Review

FEBRUARY 13, 2024

Specification that positive control and negative controls should be included in the suitability test Utilising a new safety margin concept to determine the longest time to detection. The deadline to submit comments on the proposed chapter revisions on rapid microbiological methods is 31 March 2024.

Media 82

Media Safety Pharmaceutical Marketing 82