BioPharm International Editors

The company will use the acquisition to further its drug development pipeline in women’s healthcare.

Questions about safety and efficacy surround Putin’s announced approval of a COVID-19 vaccine with no supporting clinical trial results.

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

The expansion will involve using the facilities’ existing central utilities and labs to supplement its small-scale and large-scale assets.

The expanded facility will feature two new 40-L and 300-L manufacturing vessels, a capsule filling line, and six drying tunnels that will add more than 10 million doses per annum to the site.

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

PPD announced it will provide drug development services to advance Pfizer’s portfolio.

The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

The company’s SLIM technology has been a part of the company’s accelerated growth by offering enhanced R&D analytics.

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.

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.

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

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.

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.

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

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.

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

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

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