PharmTech Europe News

Eisai has announced an expansion of its manufacturing operations at its Hatfield production plant in the United Kingdom to meet global demand.

Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.

Almac Sciences has been granted an award by the COVID-19 Therapeutics Accelerator for the development of an efficient and scalable production process for remdesivir.

Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.

The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.

EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.

The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

The agency marked the annual European Antibiotic Awareness Day with the launch of a social media campaign highlighting the prudent use of antibiotics.

Apeiron Biologics has selected Domainex to advance the development of inhibitors for the E3 ubiquitin ligase Cbl-b.

AstraZeneca has received approval for Calquence (acalabrutinib) to be used as a treatment of chronic lymphocytic leukemia (CLL) in adults within the European Union (EU).

PhoreMost and Oxford Biomedica have entered into a discovery collaboration for the development of next-generation chimeric antigen receptor T-cell therapies.

Analysis from the CPhI Annual Report has revealed that the global contract services sector is benefitting from a switch toward COVID-19 manufacturing and clinical-stage contracts; however, mega-cap pharma innovation is slowing outsourcing.

Vifor Pharma and Angion Biomedica have signed a license agreement that will see the commercialization of late-stage product, ANG-3777.

Optibrium has entered into a cheminformatics collaboration with MSD (known as Merck & Co. in the United States).

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to EMA for expanded use of the SC formulation of Darzalex.

ProteoNic has licensed its protein expression technology, 2G UNic, to Gilead Sciences.

ACG has acquired a significant stake in IQGEN-X, a Mumbai-based start-up contract research organization (CRO).

Lonza has inaugurated its first ADC payload manufacturing suite at the Visp, Switzerland site.

Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS).

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

The UK BIA Antibody Taskforce has identified differentiated antibody combinations that will be taken into development as COVID-19 antibody therapy candidates.

NanoMab Technology has signed heads of terms with a supplier of Tungsten-188/Rhenium-188 generators, OncoBeta.

Pfizer has announced that FDA has accepted for filing and granted priority review designation for a new drug application and EMA has accepted the MAA for abrocitinib.

Novartis and Molecular Partners are collaborating on the development, manufacture, and commercialization of Molecular Partners’ anti-COVID-19 DARPin program.

The third part of the CPhI annual report has predicted a significant amount of pressure will be placed on bioprocessing networks should COVID-19 biologics gain approval.

JSR Life Sciences has increased its European footprint with a new expanded facility in Switzerland, that will combine the company’s two affiliates in one campus.

EC has granted orphan drug designation to Pharming Group for its treatment of activated phosphoinositide 3-kinase delta syndrome, leniolisib.