Laks Pernenkil, Brian Feth, and Alex Philippidis go behind the headlines to discuss the impact of recent news, including FDA’s drug shortage list update, Nobel prize winners in microRNA and AI, and a big-potential research win for RNA editing.

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses how facilities used for solid dosage manufacturing may be retrofitted into sustainable cell and gene therapy production facilities.

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

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

The merger will create a specialty company, REGiMMUNE/Kiji TX, for regulatory T cells.

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.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Rather than relying on a myriad of different systems, the author proposes that a cloud-based solution can control and coordinate everything, allowing manufacturers to deftly respond when changes in labeling requirements arise.

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.

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

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 agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

Merck will deploy Mestag’s proprietary RAFT platform to investigate the pathogenic role that fibroblasts play in inflammatory diseases.

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.

For the pharmaceutical industry, drug formulation is a cornerstone, crucial for converting bioactive molecules into effective, stable, and patient-friendly medications.

Evonik won the CPHI Excellence in Pharma Award in the “Sustainability” category in recognition of its plant-based squalene, PhytoSquene, used in parenteral drug delivery applications.

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

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

Pharmaceutical Technology Europe spoke with John McQuaid, president and managing director at Almac Pharma Services, at CPHI Milan 2024, held October 8–10, in Milan, Italy, about how the pharmaceutical industry is growing and what might drive investment in the future.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

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.

Pharmaceutical Technology sat down with Niloufar Salehi, advisor at Eli Lilly & Company, to talk about the session she is moderating at AAPS PharmSci 360 2024, Symposium: An Accelerated Development of Poorly Soluble Drugs Using Predictive Tool.

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.