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On May 25, 2025, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 22 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on the Manufacture of Oral Solid Dosage Forms (OSD).
s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry June 10, 2025 By Christopher Cole News Article The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond.
The discussion covered key aspects from the live Questions asked by the participants on the topic of oral liquid dosage form manufacturing. Jayakumar, President-Quality, Ajanta Pharma, and Abhijit S. Kulkarni, VP CQA, Lupin.
7] Liquid formulations hold strong potential, particularly for geriatric and paediatric populations, due to ease of administration and improved patient compliance. [8] 8] Cell and gene therapies have great potential to revolutionise treatments of major diseases like cancer, HIV, genetic disorders etc.
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The Indian Pharmaceutical Alliance (IPA) questions the reliance on the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) in the Ohio State University report titled, Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events.
As environmental concerns continue to intensify, the pressure on the pharmaceutical industry to reduce its overall environmental impact, particularly in final dosage forms, is growing proportionately. In March 2024, Lonza hosted its first digital Responsible Supplier Event which brought together more than 1,100 participants.
Treatment-related adverse events (AEs) included nausea (77.8% vs 10.8%, respectively), and major bleeding events (2.4% 5 Primary end points included safety, with secondary end points of overall response rate (ORR), progression-free survival (PFS), and duration of response. ORRs were 94.4% in the TN cohort (95% CI, 72.7%-99.9%)
Despite its proven efficacy, the conventional oral administration of lenalidomide presents challenges due to its short half-life and the high systemic exposure required to sustain therapeutic drug levels, which can lead to significant toxicities, particularly grade 3 or 4 hematologic adverse events (AEs).
Among the 37 practices that reported waste, 768 events were reported, leading to a total drug waste of $11,275,642.16. These events foster innovation, collaboration, and professional growth within the oncology pharmacy community. compared with $546,082.45 for the external mail-order pharmacies. Of that, $8,935,612.15 Subscribe Now!
Animal studies reveal dose-dependent hepatic responses to CBD, supporting the need for cautious monitoring even at consumer-relevant dosages. Pharmacists should review patient medication profiles, advise on appropriate dosage adjustments, and monitor for cumulative toxicity. of healthy adults, necessitating liver function monitoring.
Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.
link] Seasonal influenza vaccine dosage & administration. September 17, 2024. Accessed May 29, 2025. link] RSV vaccine guidance for older adults. August 30, 2024. Accessed May 29, 2025. October 16, 2024. Accessed May 29, 2025. link] US FDA approves BLA for Novavax’s COVID-19 vaccine. News release. May 19, 2025. Accessed May 29, 2025.
Generics are exact chemical copies of small-molecule drugs, with identical active ingredients, strengths, dosage forms, and routes of administration. A comprehensive review of 90 studies involving more than 14,000 patients demonstrated no increase in adverse events, immunogenicity, or loss of clinical effectiveness following a switch.
Both Hadlima and Hyrimoz share the same strengths and dosages and have no clinically meaningful differences from Humira when relieving patient symptoms. The most common reason for exclusion was the patient opting out of clinical follow-up with the specialty pharmacy team.
2 Guiding prescribers and patients through initiation of lumatperone, adjusting dosage amounts, and switching from other antipsychotics, emphasizing its favorable relapse reduction profile is key in preventing relapse.
HME in drug manufacturing typically employs corotated twin extruders and uses heat and pressure to create solid dosage forms, dispersing the active pharmaceutical ingredient within a molten polymer matrix, and forming a solid solution or amorphous solid dispersion. trillion economic impact in 2020.
By incorporating a patient's genetic profile into therapeutic decision-making, pharmacists can identify optimal drug choices and dosages while minimizing the risk of adverse events (AEs). Developed in partnership with InterSystems, the platform uses proprietary algorithms to personalize drug selection and dosage.
A group of experts will present an encore abstract titled " Prevalence of Dosage Modifications and Impact on Response Milestone Among Patients With CML Treated With Imatinib Using Real-World Data " at the 2025 Oncology Pharmacists Connect (OPC) meeting in Austin, Texas, from June 19 to 20.
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Despite observational evidence, causation is not established, necessitating further research on dosage effects and neurocognitive outcomes. The inconsistency underscores the need for further research, particularly prospective studies that control for dosage and assess neurocognitive outcomes over time.
1 "[Meloxicam injection] demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management," Ron Scarboro, chief executive officer at Azurity Pharmaceuticals, said in a press release.
After learning of his diagnosis, our relationship shifted from small talk at school events to detailed discussions in an infusion center setting about chemotherapy, immunotherapy, clinical trials, alternative medicines, and anticipated adverse effects.
As of now, supply for this coming season matches last year’s total dosage, with production expected to continue. Expanded manufacturing capacity for the upcoming season Now, the Sanofi-AstraZeneca partnership has resulted in tripled production capacity, along with twice the number of manufacturing facilities.
Limitations included open-label design and dosage constraints, but the multicountry approach enhanced generalizability and external validity. All patients underwent a 20-week correction period for dosage titration and Hb correction, which was followed by an 8-week evaluation for efficacy assessments. 1 REFERENCES 1.
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In addition, the dosage [of 2000 IU per day] used in the research is far below the target dose for correcting vitamin D deficiency, which is usually 50,000 IU per week,” Carvalho-Pessoa said in a news release. 1,2 “Even with a small sample of participants, it was possible to observe a significant difference in the response to chemotherapy.
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More than 30,000 patients have been treated with CAR T cell therapies, with studies including an analysis of BMS presented recently showing that most serious adverse events occur within the first two weeks of infusion. Sign up for our daily news round-up! Give your business an edge with our leading industry insights.
Selection of an appropriate OTC analgesic should take into consideration various patient factors, including the patient’s overall health status, current medical conditions, and medication profile, as well as patient preferences, which are often influenced by dosage form, required dosing intervals, and cost of OTC medication.
However, this approach often results in increased systemic exposure, which in turn can lead to a higher incidence of adverse events and toxicities. Historically,” Jarrett explains, “overcoming these physiological defenses has required delivering drugs at high concentrations.
Steqeyma provides a new dosage form and strength, enhancing treatment flexibility for young patients with chronic inflammatory conditions. Common adverse events include nasopharyngitis, upper respiratory infection, and headache in plaque psoriasis, with additional events in Crohn disease and ulcerative colitis.
Improvements in clinical outcomes were observed, though thrombocytopenia and anemia were common adverse events. 3 The most common treatment-emergent adverse event (TEAE) was thrombocytopenia in 46% of the population, of which 26% were grade 3 or higher. Grade 3 or higher anemia occurred in 20% of patients.
Despite high-grade adverse events, the dual-targeting approach offers promising outcomes, especially for patients with prior anti-BCMA CAR-T therapy. The investigators assessed a total of 90 patients who received talquetamab at a dosage of 0.8 mg/kg once every 2 weeks plus teclistamab at a dosage of 3.0 mg/kg every 2 weeks.
Conducted at City of Hope, the retrospective chart review focuses on overall survival, event-free survival, remission rates, and treatment durability. These events foster innovation, collaboration, and professional growth within the oncology pharmacy community.
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News All News Bio/Pharma News Publications All Publications PharmTech PharmTech Europe Resources Marketplace ICH Q9 Revision: A Comprehensive Resource on Quality Risk Management Peer-Reviewed Research PharmTech Products Pharma Insights Sponsored Podcasts Sponsored Videos Sponsored eBooks Whitepapers Webcasts Multimedia All Videos Ask the Expert Behind (..)
Compounding, by definition, involves customizing medications to meet individual patient needs, such as altering dosage forms or removing allergens. This all leads to an increased risk of adverse events, like contamination, incorrect dosages, or unexpected side effects, simply because production can vary wildly.
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Image credit: Cynthia | stock.adobe.com The Battle Over GLP-1 Compounding We are witnessing the most significant events in compounding history play out as some of the challenges to GLP-1 compounding are addressed in court. The discussion underway gets to the very essence of compounding itself. 6 API, active pharmaceutical ingredient.
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