Pharmaceutical Technology Editors

The new manufacturing company has been launched under the Defense Production Act to produce APIs in the US.

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

Vico Therapeutics has raised $31 million (€27 million) in a Series A financing round, which the company will use to further advance its Antisense OligoNucleotides lead platform.

PCI Pharma has announced the creation of a new clinical center of excellence in Western Europe at its site in Berlin, Germany.

EMA has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.

EMA's CHMP has adopted a positive opinion for Dapivirine Vaginal Ring for women in non-EU countries where HIV disease burden is high.

Pharmapack Europe 2021 has been rescheduled after a careful review by the event organizers with key stakeholders.

Avacta Group has expanded its partnership with Daewoong Pharmaceutical to include Affimer molecules that target viruses, such as coronavirus.

The transaction is expected to be completed during the fourth quarter of 2020.

Sangamo will receive a $75 million upfront license fee payment and will be eligible to earn up to $720 million in other development and commercial milestone payments, including up to $420 million in development milestones and up to $300 million in commercial milestones.

Celltrion Healthcare has announced that the EC has granted marketing authorization for its subcutaneous formulation of Remsima (infliximab, CT-P13).

Sterling Pharma Solutions has signed a deal with Moleculin Biotech to support the development of WP1122, a potential COVID-19 treatment.

Following a review, CPhI Japan has been postponed until April 14–16, 2021 to ensure positive business conditions and greater attendance.

DuPont Nutrition and Biosciences has entered into a research collaboration in microbiome science with the Center for Advanced Biotechnology and Medicine at Rutgers University.

ABPI has issued its response to the recently published report and recommendations from the International Trade Committee on the impacts of COVID-19 on international trade.

The companies will combine Intravacc’s OMV delivery platform with S-proteins with Celonic’s CHOvolution mammalian cell expression system to produce B and T-cell responses against SARS-CoV-2.

The acquisition gives LGM access to Nexgen’s manufacturing and warehouse distribution facilities and a pilot plant.

The companies will utilize Avid’s upstream and downstream process development and drug substance manufacturing services in conjunction with Argonaut’s parenteral drug product fill-finish services for the delivery of CGMP parenteral drug products for use in clinical studies.

The approval comes after positive results were met in a single-arm, open-label study that resulted in FDA Breakthrough Therapy Designation for the one-time therapy.

The UK government is committing a further £100 million (US $127 million) to ensure that there is capability to manufacture a successful COVID-19 vaccine at scale in the UK.

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

Stevanato Group and Colanar have signed an agreement for lab scale fill/finish capabilities to study container closure systems at Stevanato Group’s US TEC in Boston, MA.

An LIMS system enables a COVID-19 testing center for employees at their workplace.

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.

Pending approval of the Pfizer and BioNTech mRNA-based vaccine candidate against SARS-COV-2, the companies will supply the US government with an initial 100 million doses.

CMIC Bio will offer contract development and manufacturing organization services for biopharmaceutical drug substance.

The Acryl-EZE II works to extend Colorcon’s aqueous enteric systems by providing applications for tablets and multi-particulate dosage forms with increased enteric protection.

The project will focus on providing a faster route to clinical studies for AstraZeneca’s potential COVID-19 vaccine, AZD1222.

Catalent has unveiled plans to invest in a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France.

The UK government has secured early access to 90 million COVID-19 vaccine doses from the BioNTech/Pfizer alliance and Valneva.