Another eight medications already authorized in the EU were recommended for extensions of various indications.

If the conditions prove optimal, 2025 could be a prosperous year for bio/pharma business deals.

AI regulations in healthcare are rapidly evolving, and one should consult with regulatory subject matter experts, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

The reduction is expected to be “substantially completed,” the San Diego-based company said, in the second quarter of 2025.

Pharmaceutical Technology® spoke with Andy Burns, vice president, MDI Business Development at Kindeva, about how sustainability requirements are impacting contract development and manufacturing organizations, specifically for the development and manufacture of inhalation drugs.

Pharmaceutical Technology® sat down with Adam Sherlock, CEO of Qinecsa, to discuss the changing political landscapes in the US and Europe and how that may affect the bio/pharma industry.

Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

Pharmaceutical Technology® spoke with Adam Sherlock, CEO of Qinecsa, about the industry trends of 2024, the future technology agenda, and M&A prospects in 2025.

Data from a Phase III study that evaluated lazertinib, in combination with amivantamab, in comparison to osimertinib as a first-line treatment resulted in the EC’s decision.

The company’s investments in Canada since 2023 have now resulted in the creation, or potential thereof, of 1200 new job positions.

Winners in this year's Pharmapack Awards include both commercial products and innovations that are shaping the future of pharmaceutical packaging.

One lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL is being recalled due to particulate matter found in a vial.

Brian Feth, Jonathan Grinstein, PhD, Beth Willers, and Laks Pernenkil go behind the headlines to discuss major news announcements made during the JP Morgan Healthcare Conference, a wave of new Medicare drug price negotiations, and more.

The collaboration will combine fully automated and digitalized technologies to reduce CGT manufacturing timelines to 2.5 days.

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.

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.

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.