PharmTech Europe News

Under an expanded agreement with J&J, Catalent Biologics will increase manufacturing capacity at its Anagni, Italy, site to accommodate the large-scale commercial supply of Janssen’s COVID-19 vaccine.

Provider of iPSC-derived cells, media, and characterization services, Axol Bioscience, has signed a merger agreement with Censo Biotechnologies, a cell biology CRO.

The Testa Center in Sweden provides access to equipment and expertise to help bridge the gap between biopharmaceutical discovery and industrialization.

I Holland, manufacturer of tablet tooling for the pharmaceutical and nutraceutical markets, has announced a number of appointments to form a new leadership team

The investments are expected to double Thermo Fisher’s manufacturing capacity while creating more than 1500 jobs at 11 manufacturing sites in the Americas, Europe, and Asia.

The expansion plans to increase Vectura’s DPI dosage form development, specifically its unit dose and multi-dose inhalers, and integrated device design and manufacturing for customer programs.

AstraZeneca has announced that the mass rollout of its COVID-19 vaccine has begun via the COVAX initiative.

Oxular has raised US $37 million in a financing round led by specialist life sciences investor, Forbion.

Arcline Investment Management has acquired ChargePoint Technology, strengthening its global presence.

A recent survey by SwedenBIO has demonstrated a major upswing in the Swedish life science industry.

EMA has recommended that Evrysdi be granted marketing authorization in the EU for the treatment of patients with certain types of SMA.

RDIF has announced that the Sputnik V vaccine for COVID-19 has been approved in Slovakia under the emergency use authorization procedure.

The EC has launched a structured dialogue aimed at gaining a better understanding of global medicines supply chains and to identify potential causes and drivers of vulnerabilities.

EMA's CHMP has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.

NICE has issued guidance recommending the use of TheraSphere Y-90 Glass Microspheres, from Boston Scientific, as a treatment for patients with HCC.

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

Salipro Biotech has been granted a European Patent for its novel method of direct extraction of membrane proteins and for the generation of libraries with Salipro particles.

PwC has teamed up with CPI on the Medicines Manufacturing Innovation Center to strengthen the UK’s position in advanced medicines manufacturing.

4D pharma has signed a clinical trial collaboration and supply agreement with Merck and Pfizer for Bavencio (avelumab).

Rentschler Biopharma will establish its manufacturing capability for advanced therapy medicinal products at the CGT Catapult site in Stevenage, UK.

Optibrium, software developer for drug discovery, has raised investment from Kester Capital, a private equity firm, for the development of its business.

Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.

The EC has granted Vico Therapeutics with orphan drug designation for its investigational antisense oligonucleotide therapy for the treatment of SCA.

Exscientia has formed a partnership with the ARUK-ODDI for the development of medicines targeting neuroinflammation to treat Alzheimer’s disease.

EMA has clarified its position on the European approval process of the Sputnik V vaccine.

Evonik has revealed plans for investment in the short-term expansion of its specialty lipids production, which are used with mRNA-based COVID-19 vaccines.

The recently formed scientific advisory board of Europital anticipates that a deficit in the clinical knowledge of smaller biotechs may lead to slow development in 2021.

The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.