BioPharm International Editors

The company is planning on adding up to 1.5 million sq. ft. of cGMP distribution space for COVID-19 shipments.

Valneva will manufacture the Sabin vaccine strains for clinical trials in its manufacturing facility in Solna, Sweden, using Batavia’s process.

Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.

Catalent will provide vial filling and packaging capacity to AstraZeneca at its manufacturing facility in Anagni, Italy, for the large-scale commercial manufacturing of the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate.

Oxford Biomedica, has signed a collaboration agreement with the not-for-profit organization, the Vaccines Manufacturing and Innovation Centre, to provide the UK with its first strategic vaccine development and advanced manufacturing capability.

According to a report from commercial law firm, Hill Dickinson, there is general support by the public of the United Kingdom that vaccine regulations should be relaxed in light of the current COVID-19 pandemic.

The Biomedical Catalyst has been relaunched, meaning that innovative biotech companies will have the opportunity to access a share of £30 million (US$38 million) in grant funding.

The companies have entered into a collaboration agreement to develop and commercialize three of Genmab's early-stage investigational bispecific antibody product candidates.

The candidates will be used by the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

The companies have entered into a development and manufacturing agreement for Anthos Therapeutics’ abelacimab for treating thrombotic disorders.

Catalent will use its GPEx cell line development technology to create a cell line expressing the recombinant VLP at its Madison, WI facility.

The investment will increase production lines for bulk drug substance and will add a fill/finish production line to the site.

The news comes after the company received its FDA registered ISO 13485 as a CDMO.

The agency published guidance to clarify its enforcement of distribution of drug samples for drug marketing during COVID-19.

The 120-day pilot program was set up to help reduce the availability of unapproved opioids illegally offered for sale online.

The agency has added a COVID-19 innovation resource page and an education resources page to its website.

Siemens and Exyte partner for fast-track construction of modular, automated, digitalized biopharmaceutical facilities.

Novavax announces DoD contract to produce 10 million doses of COVID-19 vaccine candidate.

The European Commission is pledging EUR 300 million (US$339 million) to Gavi for vaccines for infectious diseases, in addition to an earlier pledge of more than EUR 1.5 billion (US$1.7 billion) made on May 4, 2020.

SiO2 Materials Science has received $143 million from the US government to accelerate capacity scale-up of its advanced primary packaging platform.

The protocol on Northern Ireland (NI) once Brexit has been completed has received mixed opinions in industry, according to various press releases.

The European Commission has granted marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for Darzalex (daratumumab) subcutaneous formulation to treat adults with multiple myeloma.

The collaboration will focus on novel therapeutics targeting RNA-modifying proteins for cancer treatment.

Johnson & Johnson’s Janssen Pharmaceutical Companies has received a positive opinion in Europe for its two-dose Ebola vaccine regimen.

The investment will give the company the opportunity to accelerate the development of proprietary boron-10 target drugs while it develops its neutron beam accelerator technology for Boron Neutron Capture Therapy.

CordenPharma announces expansion of lipid excipients supply for coronavirus vaccine scale up.

The company worked with Eurofins Lancaster Laboratories to conduct independent extractables testing that involved eight solvents tested over a 21-day exposure time frame.

The VIA Capsule from Cytiva is a liquid nitrogen-free cryogenic shipment system designed to transport cell therapies.

Agreements with the PolyPeptide Group and AGC Biologics will scale up production of the Novavax Matrix-M adjuvant.

The new vaccine would be made with a Newcastle disease virus vector that expresses the immunogenic spike protein of SARS-CoV-2