PharmaKure Gets Nod from MHRA to Trial Drug Targeting
Jan 10, 2024 · Clinical-stage UK-based pharmaceutical company, PharmaKure, has been granted Clinical Trial Authorization (CTA) from the United Kingdom’s regulatory body, the Medicines and Healthcare Regulatory Agency, to start a Phase IIa study to assess an oral combined drug for the treatment of mild cognitive impairment (MCI) as a result of Alzheimer’s Disease.
FDA Approves Pfizer’s Treatment for BRAF V600E-Mutant Non
On Oct 12, 2023, Pfizer announced that FDA approved BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) to treat adults with metastatic non-small lung cancer (NSCLC) with a BRAF V600E mutation.
The Basics of Aseptic Processing - PharmTech
Oct 2, 2021 · Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.
Phase III Results Show Balfaxar Non-Inferior to Kcentra in
Aug 13, 2024 · Results of a Phase III study (LEX-209) of the safety and efficacy of Balfaxar (prothrombin complex concentrate, human-lans), a blood coagulation factor replacement product made by Octapharma, have been published in JAMA Network Open, according to a press release from Octapharma USA on Aug. 12, 2024 (1,2).. The study investigated Balfaxar’s performance in the urgent reversal of acquired ...
CPHI Research Forecasts Growth for Biotech, Pharma Markets in …
Oct 8, 2024 · The 2024 CPHI Annual Report, a survey of more than 280 pharmaceutical industry executives from more than 40 countries, is forecasting an increase in biotech capital and fast-paced growth of outsourcing in 2025, according to a press release on Oct. 7, 2024 (1).
FDA Releases Draft Guidance on Sampling and Testing of In …
Jan 3, 2025 · FDA published a draft guidance document on Jan. 2, 2025 that provides considerations for complying with 21 Code of Federal Regulations (CFR) 211.110 (1).This specific section of the CFR focuses on production and process controls for sampling and testing of in-process materials and drug products.
Pharmaceutical Technology
Pharmaceutical Technology® sat down with Stefan Verheyden, Global Vice President Sales Pharma & Biopharma Solutions Injectables at Gerresheimer, to talk about the primary and secondary packaging solutions Gerresheimer and Bormioli Pharma will be showcasing at Pharmapack Europe 2025 in Paris, France from January 22–23.
Industry Outlook for 2025—Real-World Data - pharmtech.com
Dec 27, 2024 · The use of real-world data (RWD) and real-world evidence (RWE) has become a focus of pharmaceutical regulators in recent years. In December 2024, FDA’s Center for Drug Evaluation and Research announced a new Center for Real-World Evidence Innovation that will coordinate and promote the use of these data in regulatory decision making (1).
The Pros And Cons Of Single-Use Bioreactors - PharmTech
Oct 1, 2010 · Salavadi S. Easwaran. Technology Manager-PMT, at Merck Millipore, India. The willingness of the industry to use single‑use bioreactors is currently influenced by the criticality of the step, the value of the product and the time for product development and production.
Understanding the Impact of Annex 1 on Isolator Design
Nov 3, 2020 · Other important points when it comes to aseptic engineering design are cleaning and surface decontamination. With regard to surface decontamination by means of vH 2 O 2, all surfaces should be structured and designed so that the vH 2 O 2 reaches them quickly and completely. Dead spaces, areas with difficult accessibility, feed-throughs from the room into the isolator, screw connections, and so ...