European Pharmaceutical Review

FEBRUARY 26, 2024

At its February 2024 meeting, the EMA’s human medicines committee (CHMP) recommended the extension of marketing authorisations for six treatments, and positive opinions for the approval of ten medicines. CHMP meeting highlights: January 2024 The post CHMP meeting highlights: February 2024 appeared first on European Pharmaceutical Review.

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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.

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European Pharmaceutical Review

JANUARY 10, 2023

In 2024, Pharmapack Europe, the two-day exhibition and conference for pharma’s drug delivery and packaging industry will introduce two brand new zones to the flagship event. The post Pharmapack Europe to launch two new zones in 2024 appeared first on European Pharmaceutical Review.

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PharmaTech

SEPTEMBER 9, 2024

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

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Eversana Intouch

MARCH 13, 2024

Our team is on the ground at SXSW 2024, and as we navigate through the bustling streets of downtown Austin, Texas — where the magic of immersive brand experiences dress the streets — we can’t help but feel the pulse of innovation surrounding us. It’s time for a change. Ready to chat with our experts?

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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

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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.

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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.

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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.

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European Pharmaceutical Review

JUNE 27, 2024

References [link] [link] The post Drug approval roundup – May/June 2024 appeared first on European Pharmaceutical Review.

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Food and Drug Administration Food Patients Marketing 64

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.

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Pharmacy Times

OCTOBER 28, 2024

Results demonstrating safety and efficacy in those with anemia in non-dialysis dependent chronic kidney disease and anemia in dialysis-dependent chronic kidney disease were presented at the 2024 American Society of Nephrology Kidney Week.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Prescription Pharma Engineering Safety 52

Nixon Gwilt Law

JUNE 24, 2024

The Digital Therapeutics Alliance Summit 2024 , held in Washington, D.C., One frequently overlooked or misunderstood pathway for DTx products is the FDA's “enforcement discretion” framework, allowing DTx applications that pose low risk to patient safety enter the market prior to undergoing a 510(k) or de novo approval process.

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Nixon Gwilt Law

JUNE 24, 2024

The Digital Therapeutics Alliance Summit 2024 , held in Washington, D.C., One frequently overlooked or misunderstood pathway for DTx products is the FDA's “enforcement discretion” framework, allowing DTx applications that pose low risk to patient safety enter the market prior to undergoing a 510(k) or de novo approval process.

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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).

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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.

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Food and Drug Administration FDA Side effects Safety 98

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.

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Pharmacy Times

SEPTEMBER 10, 2024

Presentations highlighted the potential of tarlatamab in treating solid tumor cancers.

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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.

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Food and Drug Administration Side effects Safety Food 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.

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Food and Drug Administration Patients Food Safety 97

Pharmacy Times

SEPTEMBER 17, 2024

The efficacy and safety profiles of CAR T-cell and bispecific antibody therapies have led to their investigation in earlier lines of therapy, with several new treatments in development.

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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.

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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

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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.

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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

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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.

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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.

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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.

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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.

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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.

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