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2 Following Eli Lilly, in March 2025, Novo Nordisk launched NovoCare pharmacy as a direct-to-patient delivery option that allows patients to pay cash for semaglutide (Wegovy) in all available and approved dosages at $499 per month. mg and 15 mg vials of tirzepatide starting July 7, with shipments beginning in early August.
The primary outcomes included the number of individuals with HIV, the number of patients who experienced at least 1 adverse event (AE), and the number of participants who discontinued the study due to AEs. Investigators found that the rates of adverse events were similar for patients in the study drug groups and those in the placebo arm.
link] Recent Videos Related Content FDA Grants Expanded Interchangeability Designation to Yuflyma Ashley Gallagher May 23rd 2025 Article Adalimumab-aaty (Yuflyma) prefilled syringes and autoinjectors are now fully interchangeable with the reference product adalimumab (Humira) across marketed dosage forms and strengths.
Many people are turning to compounded versions of semaglutide for various reasons, such as costs and shortages of approved medications like Ozempic and Wegovy. While compounding alternatives might seem appealing, they lack the testing and quality control of their approved counterparts. Is compounded semaglutide safe?
In silico approaches for determination of ADMET properties have, therefore, become crucial to accelerating drug discovery and development efforts, allowing rapid evaluation of large numbers of compounds. “PK/PD
However, in many clinical settings, including hospital wards, a prescribed tablet strength may not be available, or a patient might have difficulty swallowing solid oral dosage forms. For some, well-developed compounding services provide patient-specific doses within hours.
Some are also approved to help lower the risk of heart disease and cardiovascular events in people with diabetes or obesity. However, the popularity of these medications has led to drug shortages , so some pharmacies make custom-made versions of semaglutide called compounded semaglutide , which are not FDA-approved.
Tablet Regular, chewable, delayed-release, or buffered oral tablets; or suppository What is the standard dosage? The degree of risk of these bleeding events is dependent on an individuals risk factors such as age and frequency of falls. Generic apixaban Brand Ecotrin or Bayer Aspirin What form(s) does the drug come in?
Combining venlafaxine and alcohol may compound this effect, which may become frustrating and affect relationships. Taking venlafaxine and alcohol together may lead to bleeding events, such as bruises, nosebleeds, or other internal bleeding problems. Drinking alcohol can also cause difficulties in sexual performance or satisfaction.
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.
Tablet Tablet What is the standard dosage? Conversely, telmisartan has approval for cardiovascular event risk reduction in patients who are at least 55 years old and at high risk of cardiovascular events. Mostly, they are drugs that compound one of the ARBs serious side effects. Is telmisartan or losartan more effective?
Erectile dysfunction isnt listed as a potential side effect on the Neurontin label, but one study from 2011 links gabapentin to sexual dysfunction, and a 2022 review of the FDA Adverse Event Reporting System found over 130 cases of gabapentin-induced erectile dysfunction over 10 years. But dont take a double dose if you forget.
Food and Drug Administration (FDA) to treat Type 2 diabetes and lower the risk of cardiovascular events and kidney problems in certain adults. Compounded medications Compounded drugs are medications made by altering, combining, or mixing ingredients tailored to meet a persons health needs. ml of 2 mg/0.85 ml of 5 mcg/ 0.02
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%)
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.
Note that while there are compounded versions of tirzepatide and semaglutide , these drugs are not FDA approved. Injection Ozempic and Wegovy: Injection Rybelsus: Oral tablet What is the standard dosage? Side effects will vary by drug and dosage. You may need a dosage adjustment and close monitoring. What is tirzepatide?
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).
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.
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
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.
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.
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.
Abuse Deterrent Pharma, LLC (ADP), has licensed the LIMITX technology from Acura Pharmaceuticals for a number of pharmaceutical compounds. It has been used frequently for manufacturing poorly soluble compounds. trillion economic impact in 2020. 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.
They have a team of highly skilled distribution professionals who can juggle efficacy and safety checks along with compounding as if they were conductors of a world-class symphony. We need people to coordinate and track prior authorizations, write persuasive appeal letters, and keep patients updated.
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.
Development Trends: Oncology at the Forefront Gene therapy currently ranks third among therapeutic focus areas, with 2151 compounds in development in 2024 ( Figure ). 2-4 In the United States, the FDA had approved 44 cell therapy products as of March 6, 2025. 6 CAR T-cell therapies continue to dominate the genetically modified space.
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.
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.
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.
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.
Hesperos, Psilera Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia Patrick Lavery June 9th 2025 Article The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.
Animal studies reveal dose-dependent hepatic responses to CBD, supporting the need for cautious monitoring even at consumer-relevant dosages. Clinical trials show low-dose CBD can cause significant liver enzyme elevations in 5.6% of healthy adults, necessitating liver function monitoring.
Improvements in clinical outcomes were observed, though thrombocytopenia and anemia were common adverse events. The phase 1 LIMBER trial evaluates INCB057643's safety, tolerability, and efficacy, focusing on spleen volume, symptom, and anemia responses.
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.
Rumore, PharmD, Esq, MS, LLM, FAPhA Key Takeaways The removal of tirzepatide and semaglutide from the FDA's shortage list impacts 503A compounders, requiring adherence to complex legal and regulatory frameworks. The definition of "essentially a copy" is pivotal, influencing compounding practices and legal interpretations.
The global biopharma industry is expected to increase at a compound annual growth rate of 8.97% from 2025 to 2030; this growth is suspected to result from a demand for targeted therapies, new alliances, and increased innovation (1).
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.
1 In response to this immense demand, coupled with high costs and accessibility issues, compounded alternatives have emerged as a seemingly pragmatic solution. However, these compounded GLP-1s are creating a significant, often underestimated, legal, reputational, and financial minefield for startups and the broader life sciences industry.
Repatha is a really important medication because it allows people to lower their dosages of the statins but still lowers their cholesterol, Dr. Tadwalkar explains. Taking a lower dosage may help to lower your risk of side effects from statins. This helped to reduce the risk of cardiovascular events, such as heart attack or stroke.
billion by 2034, exhibiting a compound average growth rate of 1.2% The future of mRNA vaccines and therapies The global mRNA therapeutics and vaccines market is estimated at US$64.5 billion in 2024 and is forcasted to reach US$71.7 during 2025–2034 (26).
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.
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