BioBusiness

The Alliance for Regenerative Medicine’s (ARM) report highlights major trends and metrics from the 2018 second quarter in the regenerative medicines sector.

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

CPhI Korea to feature zone for finished dosage formulation drug products.

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

This article highlights 15 years of changes in biopharmaceutical manufacturing.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

Strategic restructuring is designed to position GE Healthcare as a pure-play healthcare company.

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

A new report released at the BIO International Convention shows that the US bioscience industry has had a $2-trillion economic impact and has accelerated venture capital investment and job growth.

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.

Madison Dearborn Partners will acquire a majority ownership position in CDMO Alcami.

By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

Takeda expands its global and therapy base with announced acquisition of Shire.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

While technology promises advances for healthcare, a skilled workforce is needed to deliver on the potential.

Global investment firm Advent to acquire and invest in Sanofi’s European generics business, Zentiva, to boost its position in European market.

The transaction is part of Merck KGaA’s strategy to actively shape its product portfolio and focus on innovation-driven business.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.