Pharmaceutical Technology Editors

Leo Pharma, medical dermatology specialist, has announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for tralokinumab.

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

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

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

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

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.

CPhI Worldwide have announced that the 2020 event will be organized in accordance with new global biosafety measures, Informa’s AllSecure health and safety standard, to ensure hygiene and safety of event attendees.

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.

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

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

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

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.

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

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

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

A new clinical and commercial partnership expands Experic’s presence while providing PCI with advanced powder-filling equipment.

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

The center will offer expertise in fill-finish optimization and analytical testing.

The company is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, because of the detection of N-Nitrosodimethylamine.