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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.
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.
Because there’s no generic version of Zepbound, the only other way tirzepatide can be purchased is if it’s compounded by a specialtypharmacy. Health insurance companies don’t usually cover compounded drugs because they’re not FDA approved. You may need more or less than that based on your prescribed 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.
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.
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.
This single-center, retrospective, observational study included data from electronic health records and specialtypharmacies from January 1, 2023, to June 1, 2024, with specialtypharmacy dispensing data specifically used to identify patients who had received Humira and a biosimilar during the study period.
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.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
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.
2,3 LIMBER is a phase 1, open-label, dose escalation study evaluating INCB057643 as a monotherapy at a dose escalation of 4 to 12 mg daily (part 1) or in combination with ruxolitinib at a dosage of 4 mg once daily and escalating to the maximum tolerated dose in part 1 (part 2). Subscribe Now!
Steqeyma provides a new dosage form and strength, enhancing treatment flexibility for young patients with chronic inflammatory conditions. The biosimilar demonstrated comparable efficacy and safety to Stelara in a phase 3 clinical trial, supporting its FDA approval.
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.
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.
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.
It will be interesting to see what dosage form these data prompt the future development of. It also introduces a question on how to optimize the PK/pharmacodynamic profile for protein degraders, such as cereblon E3 ligase modulatory drugs and proteolysis-targeting chimeras, which are a burgeoning area of therapeutic development.”
Generics are exact chemical copies of small-molecule drugs, with identical active ingredients, strengths, dosage forms, and routes of administration. Although generics and biosimilars offer lower-cost alternatives to brand-name drugs, they are not the same.
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 2 As a combination therapy, talquetamab and teclistamab show significant promise in the phase 1b/2 dose escalation and expansion in the RedirecTT-1 trial (NCT04586426).
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.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
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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