Quality Systems

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Aviva Capital Partners and developer Socius are investing £1 billion to develop a cancer research and treatment center in Sutton, London.

The pharma industry is focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

SkyCell is working with Microsoft to incorporate SkyCell’s AI-powered supply chain solution into Microsoft Teams and Copilot.

Advancement of emerging therapies faces hurdles across all aspects and phases of drug development and manufacturing.

Advanced solutions are improving drug dissolution, absorption, and overall therapeutic performance.

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Josh Hoerner, general manager of Purisys, provides his perspective on FDA’s recommendations for acceptable intake limits for N-nitrosamine impurities.

New TCR-T cell therapies look promising in the treatment of haematological and solid tumours.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

The Act is the European Union’s plan to avert drug shortages.

Christian Cobaugh, Eswar Iyer, and Vincenzo Antignani go behind the headlines to discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old.

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

William Wainwright, business development manager at Iwata Label USA, discusses the practical security benefits of functional labels at INTERPHEX 2025.

The Omni ASCENT, officially launched at INTERPHEX 2025, is a next-generation off-site manufactured vertical utility solution aimed at optimizing the flexibility and efficiency of cleanrooms.

Pharmaceutical Technology® spoke with Will Gordon, senior vice president of Product Management, ArisGlobal, about how the geopolitical instabilities might impact the bio/pharmaceutical industry.

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about which trends from 2024 he expects to impact the bio/pharmaceutical industry in 2025.