In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.
Vienna to host BIO-Europe 2025, connecting top biopharma companies for collaborations and pipeline development.
The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, and how manufacturers can incorporate process models into control strategies.
Alvin Jogasuria, ProBio; Matthew Lunning, University of Nebraska Medical Center; and Carl Schoellhammer, DeciBio, go behind the headlines to discuss the need for doing more with less.
The dispute shines a light on the vulnerability of long-established drugs to renewed safety scrutiny: Even when causal evidence is lacking, observational findings can influence policy and public perception.
Pfizer gains access to Metsera’s oral and injectable obesity candidates, underscoring innovation in drug development and scalable manufacturing.
Advances in digital technologies offer effective data handling for bio/pharma manufacturing.
In a three-part series, the author explores the potential use of agentic AI in pharmaceutical R&D.
Advancements for novel cancer therapies are booming. This video takes a look at some of the latest efforts in the cancer research and therapy arena.
EMA states the new variations guidelines will streamline lifecycle management and make processing variations quicker.
While plastics have revolutionized pharmaceutical packaging, that evolution within the industry has come at a cost.
In the first-ever “Two-Minute Mysteries: BioPharma Stories,” Agilent’s Ken Boda shares the mystery of a low reading.
The week's pharma news includes FDA warnings for Lilly and Novo, new drug approvals for MASH and edema, and a look ahead at CPHI Europe.
CDC panel shifts vaccine policy by discouraging combined MMRV shot for young children due to increased febrile seizure risk.
In this exclusive Drug Digest video, Steve Barr from SK pharmteco and Prasad Raje from LGM Pharma explore how supply chain pressures, sustainability, and AI adoption are reshaping small molecule development and excipient use in pharma.
Finalists for CPHI Frankfurt Pharma Awards 2025 showcase innovation in drug development, advanced manufacturing, and future industry leaders.
The company, under parent ICE Pharma, will celebrate its past achievements, present its expertise and plans for the future, and unveil a “100 Years” logo.
Pharmaceutical Technology® spoke with Todd Sprouse, associate director, Analytical Services, and Erik Feldmann, PhD, principal technical advisor, Client Solutions & Proposals, both with Cambrex, to find out more about the challenging situation.
Dan Williams, CEO of SynaptixBio emphasizes how small biotechs are using genetic research and partnerships to accelerate rare disease innovation in the final installment of his interview.
The Phase IIa study will test HTL0039732 in combination with immunotherapy to boost responses in resistant solid tumors and broaden treatment choices.
The company has expanded its CDMO offerings in recent years, adding to decades of experiences in solutions such as moisture management.
Misleading promotions of GLP-1 and compounded semaglutide products are drawing renewed regulatory scrutiny over risk disclosure and safety messaging.
Corstasis Therapeutics plans to launch the product in the United States in the fourth quarter of 2025.
Novo Nordisk’s Wegovy will be competing with Madrigal Pharmaceuticals’ Rezdiffra in the metabolic dysfunction-associated steatohepatitis arena.
UK pharma small- and medium-sized enterprises face funding and R&D barriers. Improved tax relief and targeted incentives are vital to keep UK innovation competitive.
The 2024 edition of the annual conference, held in Milan, attracted more than 59,000 professionals from across the bio/pharmaceutical landscape.
This potential shift has profound implications for regulatory strategy, transparency, and internal quality systems, directly impacting the core concerns of industry professionals.
Pharma embraces AI for quality, supply chain, and training; navigates FDA compliance; and develops new treatments like an epinephrine nasal spray.
The two organizations are collaborating on an integrated translational biology platform for the development of radiopharmaceuticals.
Bram Baert, global head of Regulatory Affairs at Lonza CHI, gives his perspective on the impact of the EC’s decision on the use of TiO2 in drug products.
