PharmTech Group @PharmTechGroup
Bringing you the latest news, trends, and insight circulating the global pharmaceutical development and manufacturing industry. PharmTech.com UK + USA Joined February 2009-
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As @US_FDA refines its policy on complete response letters, affected companies are responding—praising the agency's commitment to transparency but remaining wary of potential inequities. hubs.li/Q03H6Slb0
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Experts discuss the state of the small molecule market amid challenges such as novel excipients, supply chain concerns, regulatory hurdles, artificial intelligence integration, and reliance on sustainable practices. Register now: hubs.li/Q03GyzZL0
Led by @OxfordVacGroup, the University of Oxford said it is lending its expertise to a strategic partnership with @EITOxford, whose cutting-edge AI innovation technology will be used for an ambitious new program of vaccine research. hubs.li/Q03G_fht0
PharmTech's September issue takes a look at how digital solutions help pharmaceutical manufacturers navigate the complex supply chain. hubs.li/Q03GK6PY0
Evonne Brennan previews some formulation topics discussed in the Pharma Fundamentals series, which aims to enhance learning for professionals in pharmaceutical drug development and manufacturing. hubs.li/Q03GH2gw0
Aficamten is currently under @US_FDA review, according to @Cytokinetics, with a PDUFA date of Dec. 26, 2025. hubs.li/Q03GzFqD0
EMA and WHO have collaborated for a decade, with WHO utilizing EMA’s scientific expertise to fulfill its mandate to improve access to safe and effective medicines. hubs.li/Q03Gy_Xp0
In this episode of the Ask the Expert video series, Susan J. Schniepp, RCA, talks to Piet Christiaens and Dennis Jenke, of Nelson Labs about extractables and leachables and the testing required for each. #asktheexpert hubs.li/Q03G12WK0
Nelson Labs is responding to growing demand for packaging and microbiological testing by expanding its laboratory space at its Wiesbaden, Germany, facility. hubs.li/Q03G0-nG0
Cereno Scientific says safer, disease-modifying therapies are urgently needed for this rare and progressive disease. hubs.li/Q03FYf_T0
Our latest episode of "Behind the Headlines" takes a look at the evolution of the biotech deal landscape given #trade and #tariff changes, with experts from Convey BIO and ClarityNorth Partners. hubs.li/Q03FQWZN0
The use of @GileadSciences' lenacapavir has been approved by EC in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35 kg (77 lbs.). hubs.li/Q03FK9CF0
The future of cell and gene therapy is here—are your protocols keeping up? Discover how vial adapters play a critical role in safe, accurate delivery. Want expert tips? Check out the link below to stay ahead. hubs.li/Q03Cr6yN0 #AdvancingMedicine #SafeDelivery
To find out how FDA’s new draft guidance on radiopharmaceuticals may impact the development of cancer treatments, PharmTech spoke with Michael Ritchie, chief commercial officer of Champions Oncology. #FDA #radiopharmaceuticals hubs.li/Q03Fj5ZW0
Adverse events associated with this #recall can be reported through @US_FDA's MedWatch program. hubs.li/Q03F1Kz20
Public consultation regarding the revision of the EU’s GMP guidelines Annex 11 and Chapter 4, along with the introduction of a dedicated Annex 22 on AI, is open until October 7, 2025. #EMA #GMPs hubs.li/Q03D_wvj0
J&J will be adding a 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC. #USmanufacturing #onshoring #drugdevelopment hubs.li/Q03DWxZJ0
Latest survey of professionals in bio/#Pharmaceutical industry garnered ~90 completions that reveal the profound impact on operations and supply chains! Dive into the full survey results here: pharmtech.com/view/biopharma… #SupplyChainsecurity #BioPharma #Tariffs #SupplyChain #Biotech
According to a US study cited by Iterum Therapeutics, among 150,000 US patients with uncomplicated UTIs in 2024, 57% of initial infections were resistant to at least one antibiotic class. hubs.li/Q03DJnCq0
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