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Expiry dates guidance aligned with the United States Pharmacopeia. Given that public healthcare is centrally provided by government hospitals and clinics, prescribing practices are guided by the Ministry of Health Medicines Formulary and local formularies.
Indeed, in 2024, the Nobel Prize in Chemistry was awarded to the DeepMind team for their work on AlphaFold [ii] , an AI system that accurately predicts protein structures. AI models can predict molecular interactions and assist in designing novel compounds tailored to specific therapeutic goals.
Labels now emphasize the risks of higher doses and caution against abrupt discontinuation in dependent patients to prevent withdrawal and other harms. SHOW MORE The FDA intends to update opioid labels to highlight risks of addiction, overdose, and interactions, enhancing safety in pain management practices.
5 Phase 3 ECHO Trial: A New Frontline Option The approval was supported by data from the phase 3 ECHO trial (NCT02972840), presented at the 2024 European Hematology Association Hybrid Congress. June 21, 2024. Deaths were reported in 5 TN and 6 R/R patients. The trial enrolled 598 patients 65 years or older with TN MCL. Hemasphere.
The FDA approved nemolizumab in December 2024 for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not controlled by topical prescription therapies among individuals 12 and older. May 15, 2024. December 16, 2024. June 6, 2025.
At the same time, the NHC recommends that CMS avoid incorporating the MFP into ASP calculations, as doing so could depress reimbursement rates across both Medicare and commercial markets, compounding access risks and straining provider viability. A first priority is clarifying how providers should submit claims for drugs subject to the MFP.
Mounjaro was approved by the FDA in 2022, and by mid-2023 it was already widely used off-label for weight loss in the US. It wasnt until December 2024 that tirzepatide was authorised for weight management in the UK. In early 2024, UK searches for Mounjaro spiked significantlynearly a full year before its approval.
Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies. Still, providing accurate product labeling for these products—which properly conveys the risks of CRS and neurological toxicities—remains essential to ensuring patient safety. Last Updated November 11, 2024.
If approved, lumatperone’s expanded label could offer health care teams a valuable tool to improve stability, well-being, and real-world outcomes for patients with schizophrenia. 1-3 REFERENCES 1. Johnson & Johnson.
December 3, 2024. months progression-free survival in real-world RRMM patients, consistent with KarMMa trial results. July 10, 2025. Doi:10.1182/blood.2024026216 2024026216 3. Study shows comparable safety, efficacy of idecabtagene vicleucel in older patients. Pharmacy Times. Accessed July 15, 2025. July 10, 2025. Doi:10.1182/blood.2025029274
Image Credit: catalin | stock.adobe.com STARGLO Trial Overview Study Design and Population STARGLO was a global, randomized, open-label, phase 3 trial enrolling 274 patients across 62 centers in 13 countries. 011), respectively, with a cutoff date of June 17, 2024. 011), respectively, with a cutoff date of June 17, 2024.
This change mirrored a January 2025 FDA safety alert and label update that urged providers to consider genetic testing, inform patients of the risks, and discuss available options. billion in July 2024. Four others have been acquired, including Tobira Therapeutics, acquired by Allergan for up to $1.7
There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. August 8, 2024. Updated January 19, 2024. LinkedIn Workplace Learning Report 2024. American Oncology Network.
2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis. November 11, 2024. The trial’s primary objective was to evaluate the tolerability of OLC at its clinically effective doses (goal: serum phosphate ≤ 5.5 News release.
Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. 1-3 Detect-A-Dose Lid Label Covers. 4 Detect-A-Dose features a contrasting black and white pattern on the underside of its label to make missing doses for patients apparent to pharmacists.
The sBLA for glofitamab in combination with GemOx in R/R DLBCL was accepted by the FDA in December 2024. December 4, 2024. The dual targeting brings the T cell in close proximity to the B cell and then activates the release of proteins from the T cell that kill cancer cells. News release. Accessed July 18, 2025.
Its efficacy was evaluated in the 2 multicenter, single-arm open-label phase 2 clinical trials TRUST-I (NCT04395677) 3 and TRUST-II (NCT04919811). In TRUST-II, treatment with taletrectinib achieved a cORR of 62%, and as of October 2024 (the time of data cut-off), the median DOR was 19.4 Updated November 21, 2024.
Updated November 4, 2024. Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer with UGN-102: A single-arm, open-label, phase 3 trial (ENVISION). 4 REFERENCES 1. A phase 3 single-arm study of UGN-102 for treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (ENVISION).
The FDA has approved an updated label with a new recommended titration dosing schedule for donanemab-azbt (Kisunla; Eli Lilly and Company) for once-monthly amyloid-targeting therapy for adults that experience early symptomatic Alzheimer disease (AD). million individuals in the United States aged 65 and older.
3 neoCARHP was a multicenter, open-label, randomized, noninferiority phase 3 trial (NCT04858529) that compared the efficacy and safety of TCbHP with THP in the neoadjuvant setting. If caught early, the cancer can often be treated and cured, according to Cleveland Clinic. Gao HF, Li W, Wu Z, et al. J Clin Oncol. doi:10.1200/JCO.2025.43.17_suppl.LBA500
In general, choosing a product that has broad spectrum on the label, covering both UV-A and UV-B rays and containing 20% zinc oxide, for her children will be optimal, especially for more sensitive areas of the skin. Updated August 9, 2024. August 28, 2024. August 28, 2024. June 21, 2024. Accessed May 12, 2025.
TAI-SHAN5 is a phase 1, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of DZD8586 in patients with B-NHL. Updated July 23, 2024. Updated August 20, 2024. 1 Birelentinib has demonstrated favorable clinical benefit across multiple clinical trials.
EDQM has been promoting the use of alternative tests and removed the RPT in June 2024 from Ph. In July 2024, the United States Pharmacopeia (USP) announced it was permitting the use of non-animal-derived reagents for endotoxin testing (3).Susan July 26, 2024. Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs Paul L.
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.
The CARTITUDE-1 trial reported a 98% overall response rate and significant progression-free survival, but experts urge caution in labeling cilta-cel as a cure. 1 Image Credit: LASZLO | stock.adobe.com However, despite these promising data, experts are cautious about labeling the therapy a cure. Updated April 2, 2024.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines Feliza Mirasol April 30th 2024 Podcast In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
The planned 160,000ft² facility will focus on aseptic production and includes areas for material preparation and compounding. How will RFK Jr’s American dream for vaccines play out? Find out more Ground preparation work for the new site commenced in April after obtaining the building permit.
In the randomized, open-label, multicenter phase 3 NATALEE clinical trial (NCT05306340), ribociclib (Kisqali; Novartis) plus endocrine therapy, a nonsteroidal aromatase inhibitor (NSAI), significantly improved invasive disease-free survival among individuals with HR-positive (HR+) and HER2-negative (HER2-) early breast cancer. March 20, 2024.
1 To evaluate how temperature information is stored in the mouse brain, researchers designed a thermoregulatory Pavlovian conditioning experiment using engram labeling technology, which is a physical change in the brain that accounts for a specific memory. 1 The study included trained mice in context A at 21 °C and in context B at 4 °C.
In 2024, the FDA granted datopotamab a breakthrough therapy designation for patients with NSCLC based on data from the TROPION-Lung05 and TROPION-Lung01 trials that have since led to the agent’s accelerated approval. December 9, 2024. AstraZeneca. Accessed June 23, 2025. Pharmacy Times. June 19, 2025. Accessed June 23, 2025.
The pulmonary arterial hypertension (PAH) market is forecast to grow at a compound annual growth rate (CAGR) of 2.0% Symptoms such as fatigue, breathlessness, and chest pain are frequently misattributed to more common conditions, delaying intervention and compounding disease burden. Credit: Green Apple via Shutterstock.
It remains active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations. Updated December 13, 2024. September 14, 2024. ClinicalTrials.gov identifier: NCT05384626. Accessed July 21, 2025. J Clin Oncol.
to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 7] A recent report from 2024 found that fluoride exposure is associated with lower IQ in children, which has brought the issue of fluoridation front and center again (the U.S.
Ross Law July 10, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The global oncology market is set to grow at a compound annual growth rate (CAGR) of 24.5%. Image credit: CI Photos / Shutterstock. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
The endometriosis market across the seven major markets (7MM*) is forecast to increase at a compound annual growth rate (CAGR) of 10.3 million in 2024 to $2.5 per cent from $938.0 billion in 2034, forecasts GlobalData. Beyond therapeutic innovation, increased awareness of endometriosis is contributing to the higher diagnosis rates.
Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. Identification threshold: 10 ppm Qualification threshold: 20 ppm The FDA’s deadline for submitting comments on its draft guidance is 26 February 2024.
BCPS, BCIDP Article Posted October 2024, First Released in the October 2024 IDstewardship Newsletter 1. Read all about this in the product label here. More information on ganciclovir in the label here. Authored By: Timothy P. Gauthier, Pharm.D., Well, maybe not. Products can impact stability.
This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products. We have 95 expiring in March 2024.)
The negotiations over the treaty are being hosted through the World Health Organization (WHO), with plans to officially adopt a binding agreement sealed by the United Nations health agency’s member countries in May 2024. The UN Special Rapporteur on contemporary forms of racism, E.
Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use. 2017 Malaysia Patient Safety Goals 2.0,
billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%. Specifically, across all the major classes there are significant developments, label updates, and biosimilar launches that are driving their growth. billion in sales in 2019, increasing to $136.2
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