BioBusiness

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.

In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.

Catalent will manufacture products for Bristol-Myers Squibb while adding sterile biologics fill/finish and oral solids manufacturing and packaging capacity.

The acquisition will boost Merck’s pipeline for cancer, fibrosis, and autoimmune disease therapeutics.

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

Paul Hudson, formerly CEO of Novartis Pharmaceuticals, has been tapped to succeed Olivier Brandicourt as CEO of Sanofi.

The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.

Nanobiotix has launched Curadigm, a spinoff company that will specialize in developing a nanotechnology platform for healthcare applications.

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.

New offering from Catalent targets integrated development and manufacturing of biologic drugs.

The company says it will work with payers to create payment options for its recently approved gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), priced at $2.125 million.

Catalent expands gene therapy capabilities with $1.2-billion acquisition of Paragon Bioservices.

MilliporeSigma event scheduled to recognize biotech challenges and support development potential.

This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

Pharma delivers a positive message with renewed efforts to eradicate malaria.

Expansion at GSK’s Hamilton, MT site is designed to boost vaccine production capacity.

Catalent’s acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.

The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.

With the spin-off, Alcon will operate as a standalone company, and Novartis will focus on its core innovative medicines.

While it may not be getting easier, biopharma patent protection is at least becoming more predictable.

Promoting patient compliance with drug regimens extends beyond the formulation laboratory.

A $1.7-billion acquisition CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.

Alcami Biologics formed to meet market demands for biological drug development services.

Richard Francis will step down as CEO of Sandoz, effective March 31, 2019.