Patrick Lavery

Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

The 1200-square-meter facility that is planned will enhance analytical development and testing capabilities to support scale-up of products for customers.

This investment is additional to and separate from £11 million that was announced in the fall of 2024 for creating new jobs and expanding Almac’s global analytical services capabilities.

The collaboration will leverage Thermo Fisher’s Accelerator Drug Development stable of solutions, which was launched in the fall of 2024.

Kloxxado was approved by FDA in 2021 for emergency treatment of opioid overdose, and Emergent also distributes the FDA-approved over-the-counter treatment Narcan.

Although specifics about the milestone were not immediately provided, Scribe is eligible to receive more than $1.2 billion for certain research, development, regulatory, and commercial benchmarks.

The transaction adds a pipeline of early-stage drug candidates against high-value targets to Telix’s portfolio, along with other novel targets currently in the discovery stage.

This is the latest facility launch for BioDuro, following a kilogram laboratory and compound management center, both on the same site, in October 2024.

CNP-104 is a biodegradable nanoparticle that previously received fast track designation from FDA in January 2022, which would eventually make it eligible for accelerated approval and priority review.

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The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.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