Safety Update: New Sorbitol-Containing IV Remsima Formulation
Key Points: A new liquid infusion formulation of Remsima (infliximab) has been introduced in Europe as a 100 mg and 350 mg concentrate for infusion. Unlike the original powder form, the new concentrate contains sorbitol (45 mg/mL)ema.europa.eu. Because patients with hereditary fructose intolerance (HFI) cannot safely metabolize sorbitol, this formulation must not be given to HFI patientsema.europa.eu. Even […]
PRIME: priority medicines
What is the PRIME scheme? The PRIME (Priority Medicines) scheme is a regulatory support programme established by the European Medicines Agency (EMA). It is designed to enhance support for the development of medicines that target an unmet medical need, by providing early and intensified interaction with developers, so that promising therapies can reach patients more […]
EMA partners with content creators to promote safe and responsible use of GLP-1 medicines
What the announcement says The EMA has launched its first social-media campaign to raise awareness of the safe and responsible use of GLP-1 receptor agonist medicines. European Medicines Agency (EMA)Key points: Why this step is important Several reasons why EMA’s initiative is both timely and significant: For someone in the healthcare or medical-store business (such […]
First Treatment Recommended for Rare Immunoglobulin-Related Autoimmune Disease
In September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended extending the indication of Uplizna® (inebilizumab) to include treatment of active Immunoglobulin G4-related disease (IgG4-RD) in adults. European Medicines Agency (EMA) IgG4-RD is a rare, chronic autoimmune disorder in which the body’s immune system attacks its own tissues, leading […]
Inside PRAC (Sept 2025): What EMA’s Safety Experts Decided, and What That Means for You
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) met from 1-4 September 2025. Their role: monitor the safety of medicines in the EU, assess risk signals, recommend actions, and ensure the benefit/risk of drugs remains favorable. Here are the key takeaways from the meeting, plus deeper insight into why they matter. Key Decisions & […]
EMA backs first low-carbon propellant for a licensed inhaler: what’s changing with Trixeo/Riltrava Aerosphere, and why it matters
The headline On July 25, 2025, the European Medicines Agency (EMA) announced that it recommended a change in the propellant for two pressurised metered-dose inhalers (pMDIs) used in COPD—Trixeo Aerosphere and its duplicate product Riltrava Aerosphere. The current hydrofluorocarbon (HFC) propellant HFA-134a will be replaced with HFO-1234ze(E), a low-global-warming-potential (GWP) alternative. EMA highlights that this […]
EMA CHMP Spotlight: July 21–24, 2025 Meeting Highlights
1. New Medicines Recommended for Approval The EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed promising therapies and issued positive opinions for 13 new medicines, including treatments targeting rare, life-threatening, or underserved conditions.European Medicines Agency (EMA) Notable approvals: 2. Biosimilars & Generics: Expanding Access The CHMP also issued positive opinions for four biosimilars […]
Syfovre (pegcetacoplan) — “Slowing the Fade: The First Approved Drug to Slow Geographic Atrophy — Promise, Patents, and Problems”
Below is an in-depth, evidence-based article on Syfovre (active substance pegcetacoplan) that covers: developer and regulatory status, the IP/patent picture, the drug’s benefits, limitations, and the main safety concerns that arose in clinical trials and post-marketing. Key source material is the EMA EPAR/CHMP pages, the OAKS and DERBY Phase-3 trials, Apellis product information, and regulatory […]
Comirnaty — “mRNA on the Frontline: How Tozinameran Changed Vaccination”
Executive summary (one line) Comirnaty (tozinameran, BNT162b2) is the Pfizer–BioNTech mRNA COVID-19 vaccine that transformed pandemic response through very high clinical efficacy, rapid global rollout, and an adaptable mRNA platform — but it brought a complex patent landscape and rare, important safety signals (notably myocarditis/pericarditis and allergic reactions) that regulators continue to monitor. European Medicines […]