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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. Industry groups have also raised serious concerns. BIO President and CEO John F.
When it comes to vaccines and other high-value biologics, it is essential that effective formulations go hand in hand with safe delivery. An example is the ability of a patient suffering from venous thrombosis to perform their own injections of heparin – an anticoagulant often packaged in a prefilled syringe.
In a vote of 5 to 1 on Thursday, members of the Advisory Committee on Immunization Practices (ACIP) voted to recommend against influenza vaccine containing the preservative thimerosal. The recommendations include all US adults as well as recommending pregnant women also receive a thimerosal-free vaccine for influenza.
Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.
How will RFK Jr’s American dream for vaccines play out? Reports Contract Injectable Packaging Trends in the Bio/Pharma Industry Data Insights The gold standard of business intelligence. The planned 160,000ft² facility will focus on aseptic production and includes areas for material preparation and compounding.
In March 2025, Novo Nordisk discounted the cost of all doses to $499 per month to competitively price its prized asset against cheaper compounded alternatives. Compounded semaglutide is a personalised weight loss medicine, which is chemically identical to branded alternatives.
It's cognitive behavioral therapy packaged as a digital experience. I've even seen VR experiences, so it can be packaged in any type of digital experience. Areo Nazari, PharmD: PDTs are digital or software-based treatments that are approved by the FDA to treat disease.
How will RFK Jr’s American dream for vaccines play out? The projected growth of the cell and gene therapy market GlobalData estimates that the cell and gene therapy market will achieve global sales of $76.03bn by 2030, up from $5.88bn in 2023, with a compound annual growth rate (CAGR) of 44% over the seven years analysed.
503b Dispensing 503b dispensing can help your pharmacy grow by offering sterile compounded products WITHOUT being a sterile compounder. Compounding Services Compounding isnt just for niche needs anymore. Common Compounds to Offer: Hormone replacement therapy (HRT) Pediatric formulations Dermatology compounds (e.g.,
Package insert. FDA approves tablet formulation of BeOne's BRUKINSA for all approved indications. News Release. Released June 11, 2025. Accessed June 11, 2025. BeiGene USA, Inc.; Accessed June 11, 2025.
According to a report by Research Nester, the global aseptic packaging market is projected to reach a revenue of $35 billion by 2033 and is estimated to reach a compound annual growth rate (CAGR) of 10 percent between 2023 and 2033. According to the report, European production has grown by approximately 5.4
I presented on planning and executing and designing fill lines, RABS, Isolators, and transfers – along with the differences between processing potent compounds versus non- potent compounds. When I started attending and speaking at the ISPE Aseptic Conference in the 2000s, I came to grow and learn. Learn More & Register.
In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. Ahmed et al.
There are many examples of clinical revenue, such as MTMs, annual wellness visits, LTC consulting, food sensitivity testing, travel vaccines, and more. Just like they want their packages fast and efficiently, your patients want their healthcare fast and convenient and are willing to pay for it!
It is important to note that, for the purpose of subcutaneous biologics market analysis, the biologics were segregated into antibodies , nucleotides, proteins and vaccines. The below figure presents the distribution of subcutaneous biologics based on initial approval year and type of biologic.
According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.
The myasthenia gravis (MG) market across the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK and the US) is poised to grow at a compound annual growth rate of 5.3% Credit: Vitalii Vodolazskyi via Shutterstock. billion in 2024 to $10.3 Give your business an edge with our leading industry insights.
As Part of Europe’s leading Injectable conference series, we will assess innovations in drug product formulation and biologics, new technologies in device design and the use of long-release injectable compounds. There is a rising demand for vaccines, insulin, and many modern medicines used to treat cancer and other chronic diseases.
“The future manufacturing of APIs for our medicines includes compounds with highly complex synthesis, requiring next generation technologies and capabilities that can respond quickly and nimbly to rapidly-changing clinical and commercial needs,” said Pam Cheng, AZ’s executive vice president of global operations and IT.
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. Its technology platforms are built to enhance immunogenicity while maintaining low-dose efficiency—a key factor for scalability and safety.
Department of Health & Human Services (HHS) expanded pharmacy technicians roles to include administering vaccines and point-of-care testing during the COVID-19 pandemic. This includes counting, measuring, and packaging medications, as well as labeling and organizing them for distribution. RELATED: COVID-19 tips for pharmacists 9.
In addition, we took the Board on tours of Vetter’s facilities for sterile products and through all the production steps: compounding to fill-finish to automated visual inspection and secondary packaging. Most Board members were able to attend in person, and we had very productive Board and Executive Committee sessions.
Food and Drug Administration that compounding pharmacies must stop selling obesity medicines more cheaply than the companies that developed them. Packages valued at less than $800 that enter the U.S. For more than a year there has been demand for cheap Chinese-made powders, exacerbated by limited health insurance coverage in the U.S.
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Burke, PhD. 1 September 2022.
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.
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.). link] org/10.1016/j.jddst.2023.104724
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.
4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™
Research and development highlights from the research period include the company’s work with Mirati Therapeutics in developing methods to determine torsion rotational energy barriers of the clinical compound, MRTX1719, which is being developed for use as an inhibiter to MTAP-deleted cancers. Assays to support mRNA-based Covid-19 vaccines.
In a new CDC report, investigators found that there was no connection between thimerosal in vaccines and autism or other neurodevelopmental conditions. Thimerosal is a mercury-containing compound that has been widely used as a preservative in some biological and drug products since the 1930s.
CSPC will use its AI-powered drug discovery platform, which uses the technology to analyse the binding patterns of target proteins with existing compound molecules. The AI models work out targeted optimisation, advancing small molecules with the best developability. Give your business an edge with our leading industry insights.
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 warnings encompassed various forms of lack of compliance in the agency’s view, including product mislabeling, false or misleading claims on packaging, and shortfalls in current good manufacturing practice (CGMP) standards found during laboratory inspections. Implications of RFK Jr.’s Implications of RFK Jr.’s
The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.
This includes companies providing on-demand drug deliveries, alternative packaging solutions, or other personable entreaties to entice customers to get their medications filled at their location. Pharmacists by and large are still on the bench (though now vaccinating as well) and pushing their drug filling process to meet metrics.
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.
Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. Pharmacists must adapt to new tools, ensuring safe medication distribution through improved literacy and teamwork. 1-3 Detect-A-Dose Lid Label Covers.
The race to produce a vaccine which could protect the world against COVID-19 brought the topic of diversity in clinical trials, or lack of it, into sharp focus. Vaccines approved for public use require comprehensive RCTs to establish their safety and efficacy. The pandemic brought imbalances into sharp focus. About the authors.
Promotion Ideas: Allergy Relief Bundles: Combine antihistamines, nasal sprays, and eye drops in a discounted package. Travel Health Packages: Create kits with motion sickness pills, pain relievers, and mini first-aid supplies. Partner with local schools to distribute flyers promoting your vaccination services.
Compounded GLP-1RAs have completely disrupted pricing frameworks for Wegovy and Mounjaro, what happens now? Price differences are especially pertinent with these weight loss drugs, which are officially called glucagon-like peptide-1 receptor agonists (GLP-1RA), due to the emergence of compounded alternatives in the past few years.
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