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.

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.

Pharmaceutical Technology® sat down with Stefan Verheyden, Global Vice President Sales Pharma & Biopharma Solutions Injectables at Gerresheimer, to talk about the primary and secondary packaging solutions Gerresheimer and Bormioli Pharma will be showcasing at Pharmapack Europe 2025 in Paris, France from January 22–23.

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

Cytiva will combine its CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.

The company will be featuring its sustainable packaging solutions at the event in Paris on Jan. 22–23, 2025.

The two companies will be exhibiting together after Gerresheimer’s December 2024 acquisition of Bormioli.

Production is set to take place at Samsung Biologics’ Songdo, South Korea, site, and the agreement will run through December 2030, subject to change.

Pharmapack identifies biologic approvals, drug delivery advancements, GLP-1 generics, and the return of funding flow as drivers for a record year in 2025.

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

Lonza will work with Iconovo to develop spray-dried formulations for an intranasally delivered biologic using a reformulated biologic drug candidate for obesity.

Vanessa Almendro, Elliot Berger, Benjamin McCloud, and Turna Ray go behind the headlines to discuss their ‘wish list’ for the progression of trends in the bio/pharmaceutical industry.

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.

Through this global alliance, PackGene, Weill Cornell Medicine, and GC4K, an Australian non-profit, intend to deliver a custom-tailored gene therapy solution to treat hereditary spastic paraplegia type 56, a particularly rare neurological disease.

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

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.

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

Vanessa Almendro, Elliot Berger, Benjamin McCloud, and Turna Ray go behind the headlines to discuss 2024’s biggest trends in the pharmaceutical industry, as well as the unforeseen outcomes that took us by surprise.

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.

Using splicing technology, the new company aims to innovate safer and more effective RNA therapies for severe genetic diseases.

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.

With the new $94 million (€90 million) funding, the company will develop its pipeline of oral macrocycle drugs, nCycles, against validated biologic targets.