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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. Kennedy Jr.
Pharmacists are well positioned to perform drug interaction checks, counsel patients on adherence and administration, and coordinate supportive care, including prophylaxis for infections (eg, granulocyte colony-stimulating factor, vaccines).
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.”
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.
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. Subscribe Now!
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. Although generics and biosimilars offer lower-cost alternatives to brand-name drugs, they are not the same.
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.
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.
Nanoparticles have attracted particular attention, including those based on lipids, polymers (natural and synthetic), lipid-polymer hybrids, dendrimers, inorganic materials (metals, magnetic compounds, carbon nanotubes, silica-based systems, etc.).
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.
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.
billion right now, but projects it to reach $7 billion by 2035 given a compound annual growth rate of 13%. A study by Roots Analysis values the ADC manufacturing market at $1.79 Patients can’t wait.
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.
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.
Research has reported that fear of needles constitutes about 20-50 per cent among children and 20-30 per cent among adults globally; often leading to missed vaccinations and delayed treatments. How does the company collaborate with pharma and vaccine companies to optimise efficacy of medicines with this delivery system?
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.
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).
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 (..)
link] Recent Videos Related Content Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics Cheryl Barton June 24th 2025 Article mRNA technologies offer great promise in immunotherapy and non-immunogenic applications. Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs Paul L. link] Haigney, S. PharmTech.com.
cancer and vaccines), and non-immunogenic applications (e.g., cancer and vaccines), and non-immunogenic applications (e.g., Several types of mRNA-based vaccines have emerged, namely non-replicating linear mRNAs (NRM), self-amplifying mRNAs (saRNAs), and circular mRNAs (circRNAs). Types of messenger RNA (mRNA)-based vaccines.
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.
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 (..)
Sharing knowledge, exploring investments Key Takeaways Abu Dhabi signed MoUs with BI, Sanofi, and Abbott to expand vaccine R&D, local pharma production, and digital health capabilities. BI’s OpnME platform access aims to enhance Abu Dhabi’s clinical research by providing compounds, networks, and collaboration tools. Press Release.
When it comes to vaccines and other high-value biologics, it is essential that effective formulations go hand in hand with safe delivery. This also has clear advantages in healthcare settings, particularly when it comes to vaccines. In general, a prefilled syringe is clearly preferred for vaccines.”.
Supply chain challenges are compounded by the broader global picture, such as the war in Ukraine, the great resignation, and natural disasters. The extraordinary scenario of producing vaccines for a global pandemic led to a well-documented shortage of vials, stoppers, and syringes, and finding a solution is no easy task.
For the past two years, I was a territory manager in Philadelphia and Delaware where I was responsible for calling on general practice accounts, selling various products, anything from IV lines, flea, tick, and heartworm products to vaccines to capital equipment. So more of the overall drug side of things. And that’s what led me to Epicur.
Combination use : The FC found that a generic manufacturer’s single-compound product would induce infringement of claims to a combination therapy (see here ). Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use.
Who are allowed to dispense or compound any poison for use in medical treatment? When the sample concentration is subtherapeutic yet patient is responding well, is dosage adjustment necessary? Post dosage adjustment of sodium valproate, how long should we wait at least prior to TDM reassessment?
While BioNTech is best known for co-developing the first approved mRNA vaccine with Pfizer, the company continues to invest heavily in mRNA research targeting various solid tumors and infectious diseases. billion (1). billion (1). Implications of RFK Jr.’s
s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry Christopher Cole June 10th 2025 Article The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond. Implications of RFK Jr.’s Implications of RFK Jr.’s
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.
Peter Hotez, a vaccine scientist and professor and dean at the National School of Tropical Medicine at the Baylor College of Medicine (BCM), shared an article on more than 30 million (three crore) children aged between 12 and 14 years having received the first dose of the Covid-19 vaccine, according to Mansukh Mandaviya, the Union Health Minister.
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