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

European Pharmaceutical Review

JUNE 28, 2024

According to the trial data, the dose range of 10mg to 600mg for HDM1002 offered good safety and tolerability. Twenty-eight days of continuous dosing within the dose range of 50-400mg revealed that HDM1002 had “good” safety and tolerability. HUADONG MEDICINE, via its subsidiary Hangzhou Zhongmei HuaDong Pharmaceutical CO. percent to 6.8

Safety 105

Safety Medicine Pharmaceutical Patients 105

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 93

Food and Drug Administration Safety Medicine Food 93

European Pharmaceutical Review

JUNE 28, 2024

Furthermore, issues such as data accuracy, completeness and security impact product quality, regulatory compliance and ultimately patient safety. This Guide To has been sponsored by: The post Guide to Data Integrity 2024 appeared first on European Pharmaceutical Review. Interested?

Biopharma 52

Biopharma Manufacturing Safety Pharmaceutical 52

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 105

Leads Safety Patients Pharmaceutical 105

European Pharmaceutical Review

MAY 8, 2024

By uniquely targeting the OX40 receptor without depleting T cells and with its long half-life, IMG-007 presents a best-in-class potential to not only minimise safety risks associated with T cell depletion, but also provide patients with a more convenient dosing regimen.” “We

Safety 122

Safety Patients Medicine Medical 122

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

PharmaTech

SEPTEMBER 9, 2024

Webinar Date/Time: Wed, Oct 2, 2024 9:00 AM EDT

Safety 52

Safety 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

MAY 7, 2024

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. These data for the drug delivery system for erdafitinib were featured at the 2024 American Urological Association (AUA) Annual Meeting.

Food and Drug Administration 97

Food and Drug Administration Patients Food Safety 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 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 97

Food and Drug Administration Food Safety Medicine 97

Pharmaceutical Technology

NOVEMBER 20, 2024

The Phase III BROOKLYN trial saw HeFH patients randomly assigned in a 2:1 ratio to receive either obicetrapib or a placebo for 52 weeks.

Safety 52

Safety Patients 52

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.

Medicine 109

Medicine Safety Pharmaceutical Marketing 109

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

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 98

Safety Patients Pharmaceutical 98

European Pharmaceutical Review

SEPTEMBER 26, 2024

On the back of this success, the 12th PharmaLab Congress will again be held on site in Düsseldorf/Neuss from 25-27 November 2024. For the first time, PharmaLab 2024 will host a European conference on biosassays and potency assays. In 2022 and 2023, PharmaLab attracted more participants to Düsseldorf/Neuss than ever before.

Pharmaceutical 52

Pharmaceutical Pharmaceutical products Safety 52

European Pharmaceutical Review

MAY 29, 2024

The safety and tolerability of rationally-designed live bacterial product (LBP) BMC128 combined with nivolumab has shown initial positive trends in non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC), new data from an ongoing Phase I clinical trial suggests.

Patients 98

Patients Safety Medicine Medical 98

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 26, 2023

The submission includes comprehensive data from pre-clinical studies and thorough safety assessments, PharmaKure noted. Upon MHRA approval, the company plans to initiate a Phase IIa clinical trial to evaluate the multi ascending dose, safety and tolerability of PK051,” stated Dr Bob Smith, Clinical Director at PharmaKure.

Safety 105

Safety Pharmaceutical Patients Medicine 105

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 104

Safety Manufacturing Patients Medical 104

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

JANUARY 25, 2024

Safety thresholds Due to “the variety of chemical species and the enormous capability of modern analytical techniques in detecting trace amounts of chemicals”, manufacturers and applicants do not need to identify all detected leachables for safety qualification, according to the guidance.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Manufacturing 98

European Pharmaceutical Review

APRIL 10, 2024

The brain penetration of NX-5948 coupled with the clinical activity and safety profile presented to date, suggests a potential role in the treatment of B-cell lymphomas and chronic lymphocytic leukaemia involving the [central nervous system] which are notoriously difficult to treat.

Patients 97

Patients Safety Pharmaceutical 97

European Pharmaceutical Review

JUNE 25, 2024

The safety and efficacy of this administration method was comparable to the intravenous formulation. This one-year data for OCREVUS SC was presented in April this year at the 2024 American Academy of Neurology (AAN) Annual Meeting. Findings showed non-inferior levels of subcutaneously administered OCREVUS in the blood.

Medicine 111

Medicine Safety Medical Pharmaceutical 111

Pharmacy Times

JULY 18, 2024

Safety and efficacy findings on Lomecel-B will be presented at the upcoming 2024 Alzheimer’s Association International Conference, which will be held July 28 to August 1.

Safety 55

Safety 55

Pharmacy Times

JULY 29, 2024

An extension of a long-acting cabotegravir study shows safety prior to and during pregnancy in cisgender women, with full results being presented at the 2024 International AIDS Conference.

Safety 55

Safety 55

PM360

DECEMBER 14, 2023

If losing weight or just getting more fit is on your agenda for 2024 then you may be looking at investing in some new exercise gear. The latest iteration, the WalkingPad G1 ($799), adds side handrails for users who may prefer the extra safety or support while walking, running, or jogging.

Training 52

Training Safety Manufacturing Marketing 52

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

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

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

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.

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Distribution Healthcare Healthcare Patients 98

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 98

Food and Drug Administration Medicine Physicians Food 98

Pharmacy Times

DECEMBER 11, 2024

Komal Jhaveri MD, FACP, shares that the combination of imlunestrant plus abemaciclib further improved progression-free survival compared to imlunestrant alone.

Safety 48

Safety 48

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 98

Safety Patients Management Leads 98

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].

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