Patrick Lavery

The AI Lab was launched almost exactly three years ago and has produced several programs so far, at least one of which achieved its first scientific stage gate 40% faster than the teams originally forecasted.

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

The transaction, which was first announced in September 2024, expands Phillips Medisize’s inhalation drug delivery capabilities.

The system is Hapman’s first major product launch since 2008, following a year of intensive R&D that builds upon the company’s eight decades of tubular drag conveyor expertise.

The treatment for ATTR in certain adults with polyneuropathy had just been recommended for approval across the European Union and had gained regulatory approval in the United States at the end of 2023.

A new laboratory will be built in Oss, while additional capacity and capabilities will be added to the Bioanalytical Center of Excellence in Assen.

In this podcast episode, we discuss trends in dosage forms, specifically oral solid dosage, as viewed by five industry experts who recently exhibited at CPHI Milan.

Pauline Janssen of DFE Pharma gave a presentation on the utility of analyzing big data sets to better understand and diagnose variability in the production process.

The laboratory is on the same site as BioDuro-Sundia’s new Compound Management Center, which was launched earlier in October 2024.

Vyalev, also known as Produodopa, has been approved in 35 countries, with more than 4200 patients having started treatment.

The agreement follows Agilent’s acquisition of Canada-based CDMO BIOVECTRA in July 2024.

The Cambridge-GSK Translational Immunology Collaboration builds on an existing scientific relationship between the biopharma company and the university, with the aim of improving outcomes for patients.

As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.

Wainzua had been previously approved for use by patients with ATTRv-PN in the United States, under the brand name Wainua.

Redica Systems has been assisting pharmaceutical companies in determining GMP quality risks at their manufacturing sites, and with AI, it has a relatively new addition to its toolbox.

Xiao-Yan Cai, PhD, co-founder and CEO of Accurant Biotech, discussed collaborative efforts that must be undertaken between companies, and across scientific disciplines, to work together on continuing to develop medicines to save lives.

The design of the center prioritizes integration of the entire supply chain, with the end goals of accelerating product development and autonomous production capacity in alignment with EU priorities.

The global CRDMO said its clients would be able to expedite R&D processes, thereby reducing costs and potentially leading to accelerated discovery of new candidate therapies.

SK pharmteco will be the preferred manufacturing partner for AVG-101, AaviGen’s lead gene therapy product.

Five speakers discussed the impact of the COVID-19 pandemic, the rise of artificial intelligence, more women in leadership tracks in the industry, and various emerging technologies.

Rafael Ferrer, interim chief business officer at Acino, talked about his company's recent efforts to reach customers in Africa, the Middle East, and most recently, Latin America.

Enzene Biosciences CEO Himanshu Gadgil talked about fully connected continuous manufacturing's role in providing equity for biotech companies that may not normally be able to afford such services.

Michelle Logan, vice president of the drug product division for Thermo Fisher Scientific, talked about expanding capability to better serve customers in the OSD market.

European biotechs have had a strong year in 2024, causing those in the United States to increasingly look to them for innovation.

James Hamilton, president of Sharp Sterile, discussed innovation in products associated with sterile manufacturing and industry trends that are driving growth.

The introduction of Accelerator Drug Development follows expansions of sites in Cincinnati, Ohio, and Bend, Ore., earlier in 2024 to enable R&D, manufacturing, and testing.

When the expansion is completed, Piramal expects manufacturing capacity to be increased by the first quarter of 2027 from 104 product batches per year to more than 240.

The stand at booth 4A41, carried over from last year in Barcelona, will be constructed of white honeycomb cardboard and linoleum, with material waste generated during production repurposed into seats and tables.

The group’s IMA Life division will present a robotic fill/finish solution that was awarded Best in Show at INTERPHEX 2023.

The tubes are designed to provide an aluminum-free packaging solution for select pharmaceutical, dental, and ophthalmic products.