Biopharma News

Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.

Norwegian clinical-stage immunoncology company, Lytix Biopharma, has entered into a clinical collaboration with US-based Iovance Biotherapeutics.

The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.

Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.

The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.

Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.

The company will invest $24 million into its Inchinnan, Scotland, site to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell-culture media.

Breaking with tradition, a compounding facility won for overall operational excellence, while biopharma facilities took home awards in various categories.

The new facility is 15,000 ft2, which includes 8000 ft2 of lab space and 7000 ft2 of office space.

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.

The therapy received positive results in a randomized, double-blind, placebo-controlled clinical trial in 34 adults with proven celiac disease.

The new location was established to ensure uninterrupted support for clients’ trials in both the United Kingdom and Europe if the UK leaves the European Union on Oct. 31, 2019, especially in the event of a no-deal Brexit.

Nonacus has revealed the launch of its new capture kit, ExomeCG, which has been designed to simplify molecular and cytogenomics data generation and interpretation.

GammaDelta Therapeutics has unveiled the formation of a new spin-out company, Adaptate Biotherapeutics, aimed at developing antibody-based therapies that modulate gamma delta T-cells.

On Tuesday, Nov. 5, 2019, Karima Yadi from Becton Dickinson & Co. will present the challenges of using, and necessity for, shorter needles and integrated systems with high viscosity drugs, such as biologics, to improve the patient experience at CPhI Worldwide.

The long-term agreement gives CombiGene the authority to manufacture and commercialize the drug if it is approved after clinical studies.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.

The collaboration aims to reduce “vein-to-vein” time for patients and to optimize manufacturing and supply operations.

MilliporeSigma will now be the first company to make acoustic technology available for cell therapy manufacturing.

The new facility raises production capacity by an additional 19,100 m2 and creates 200 new full-time jobs.

The collaboration focuses on baculovirus/Sf9 expression system for Prevail's pipeline of novel AAV9-based gene therapy programs neurodegenerative diseases.

GSK invested $139 million to its Rockville, MD site to support demand for Benlysta.

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 agreed to a multi-year research and development collaboration that will focus on AI empowerment and exploration.

The new incubators are set to be operational starting in 2021.

GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.

Under a new co-development license agreement, Boehringer Ingelheim and Inflammasome Therapeutics aim to develop novel therapies for retinal diseases.

The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche’s Rituxan.