BioBusiness

Data released by the Cell and Gene Therapy Catapult (CGT Catapult) have shown that demands for specialist skills and investment in the cell and gene therapy industry in the United Kingdom are set to increase in the near future.

The innovative spirit of biotech startups is a driving force behind the development of new therapeutic products, but building a successful biopharmaceutical company from the ground up has its risks and challenges.

Nearly four decades after the first diagnosis, the fight to treat HIV/AIDs continues.

The acquisition of The Medicines Company and its investigational cholesterol-lowering therapy extends Novartis’ cardiovascular pipeline.

Catalent has named Mike Grippo as the new senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer.

The company celebrated 65-years of providing industrial vacuum cleaning systems to the market.

Legal experts in biopharmaceutical patent law shed some light on trends and recent news.

Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.

The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.

FDA report says drug shortages are underappreciated and patients pay a price.

The CPhI Pharma Index points to Germany as having consolidated itself into a leading pharma industry.

New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying risk to reduce costs.

The new joint venture, named Oerth Bio, will use Arvinas’ Protac technology to develop innovative new agricultural products. As part of its collaboration with Arvinas, Bayer is also using this technology to develop human therapeutics.

The companies are working together with Japanese clients to outline projects from early clinical stage up to commercial launch.

Colorcon Ventures looks to fund promising startups in drug manufacturing, delivery, and supply chain.

A new report by GlobalData projects 2.9% growth by 2028 for the hemophilia A and B market across the eight major world markets.

Roche has extended its offering period for the purchase of Spark to provide US and UK regulatory authorities with additional time to complete their review of the acquisition.

Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.

The editors welcome technical article contributions from biopharma industry experts.

Sponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.

Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.

South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.

Half a century after man first walked on the moon, space-based science is exploring benefits for Planet Earth.

Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.

Researchers in China are playing a role in advancing gene therapy development.

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.