Manufacturing

FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.

Cellafa Bioscience, an Astellas-Yaskawa joint venture, uses Maholo robotic automation and AI to standardize cell therapy manufacturing, targeting GMP compliance within two years and global expansion.

In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.

Executives leading the commercialization of cell and gene therapies are informing how the industry approaches everything from manufacturing strategy to physician education.

During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.

Generics Bulletin reviews global regulatory developments across the world.

In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.

When it comes to predicting the future for generic GLP-1s, Sandoz CEO Richard Saynor believes that “everyone’s asking the wrong questions,” pointing to the importance of manufacturing capacity and ability to supply the, rather than the potential market size, as the key factor.

CRDMOs, CDMOs and GCCs are driving partnering and invigorating the wider ecosystem as India moves up the innovation value chain. CRDMOs are moving well beyond traditional outsourcing roles, a new report shows.

Axplora made waves with a recent announcement that the API specialist’s total investments for 2025 would exceed €100m. Anant Barbadikar, co-president of the firm’s PharmaZell business unit, explains how the firm’s strategy is evolving and why he believes the future of pharma remains small-molecule.

Buoyed by the milestone AbbVie deal, Glenmark expects to “pay down” its debt and is also changing certain legacy practices as it seeks to ascend the value chain to become more of a branded company.

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.