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These closures, compounded by the decline of independent pharmacies, create a critical gap in care. Image Maggie McCullough 12 June, 2025 pharmacy deserts Bookmark this Oncology ImmunityBio’s ANKTIVA & FDA Expanded Access: Transforming bl. These closures put medication access, affordability, and adherence at greater risk.
Robert Barrie June 24, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Compounded GLP-1RA medication has become a key revenue driver for Hims & Hers’ telehealth platform. Hims & Hers’ revenue has been soaring on the back of its compounded glucagon-like peptide-1 receptor agonist (GLP-1RA) sales.
Novo Nordisk is eyeing a cardiometabolic drug market future that is not purely dominated by incretins, after signing a $812m partnership with Deep Apple Therapeutics to access novel compounds for obesity and other diseases. Can pharma tariffs “Make America Manufacture Again”?
All pharma shipments must meet strict regulatory requirements that vary significantly between countries, for example Good Manufacturing Practice (GMP) guidelines, which are enforced by entities such as the FDA in the US. Tariffs and trade disputes are further compounding this challenge, affecting the cost structure of pharma businesses.
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. of the global market, valued at $39.3bn.
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.
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.
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. Sign up for our daily news round-up!
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.
This article appears in our free digital magazine Deep Dive: Market Access 2021. Compounding this problem is the fact that the healthcare sector is often glacial in its pace of change, while digital innovations are evolving rapidly every year. The post “A long way to go” for digital health reimbursement appeared first on.
Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. They employed hundreds of new salespeople to detail doctors and hospitals, spent millions on TV and magazine ads and handed out masses of free samples.
Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. A few innovators have shepherded this industry through these down years and managed to build impressive pipelines. Cell & Gene Therapy. Unlock Access to Member-Only Content. Company Name.
As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.
As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.
Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. Modernization of the FDA CDER Export Certificate Program.”
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA.
For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.
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