Industry News

Martin Smyth, senior vice-president of Go-To-Market Strategy at MasterControl, discusses gaps in digitalization in the pharma industry.

Alessandro Zannini, sales director, engineering division, Stevanato Group, discusses artificial intelligence and digitalization in the pharma field.

Mariano Mattei, vice-president of cybersecurity and CISO for Azzur Group, goes in depth about cybersecurity in the pharma field.

Emily Moran, senior vice-president of vector manufacturing and supply chain at The Center for Breakthrough Medicines, talks about manufacturing processes for viral vectors in the cell and gene therapy space, and more.

Michael Blackton, senior vice-president of technical operations at Elektrofi, speaks about comparability in cell and gene therapy.

Phil Challis, vice-president of product development at eTheRNA, discusses four of the major challenges in working with mRNA therapeutics.

Aspect Biosystems and Novo Nordisk A/S have announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics.

The leaked study summary found that Carvykti (ciltacabtagene autoleucel) reduced disease progression by 74%.

The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.

SAB Biotherapeutics has received both breakthrough and fast track designations from FDA for its lead antibody drug candidate for treating influenza.

Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.

Moderna and Merck reported that a combination therapy involving pembrolizumab and an mRNA demonstrated a 44% reduction in recurrence or death in cancer patients compared to non-combination treatments.

Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.

Integrated systems combine functions.

Under this partnership, the two companies will develop bioprinted tissue therapeutics for diabetes and obesity.

The construction will expand Catalent’s clinical supply facility in Schorndorf, Germany.

Forecyte Bio has opened a new GMP facility in Shanghai just two months after its sister site in the United States.

The new site will include state-of-the-art cleanroom facilities, laboratories, R&D, and office spaces.

The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11.

A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

If approved, Johnson & Johnson would pay $8.9 billion to resolve all current and future claims in its ongoing talc litigation.

FDA aims to address mounting criticisms of its accelerated approval pathway.

Lonza and ABL Bio are collaborating on the development and manufacture of bispecific antibody product.

A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience.

FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.

Roche and Lilly will collaborate on the development of Roche Diagnostics’ Elecsys Amyloid Plasma Panel.