
Incyte and MorphoSys have revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tafasitamab, an anti-CD19 antibody.

Incyte and MorphoSys have revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tafasitamab, an anti-CD19 antibody.

The UK BioIndustry Association has stated its support of a government led funding initiative, Future Fund, which will support innovative companies in the United Kingdom that will help to ensure the country’s leading position in science, innovation, and technology.

Biopharmaceutical company, Atriva Therapeutics, has announced, in a May 28, 2020 press release, that it will develop ATR-002, an oral small molecule, for treatment of patients with moderate-to-severe COVID-19 that require hospitalization in a Phase II study.

Merck will acquire Themis Bioscience and collaborate with IAVI and Ridgeback Bio on COVID-19 vaccines and therapies.

Merck will use Themis’s vector platform to develop a vaccine to prevent COVID-19.

The new facility in County Mayo includes an ISO class 7 cleanroom for the manufacturing of single-use systems.

The company has received a $288,000 grant from the COVID-19 Therapeutics Accelerator, part of the Bill & Melinda Gates Foundation, to support a clinical study in Sub-Saharan Africa to find a treatment for COVID-19.

CordenPharma and Moderna extended a strategic manufacturing services agreement for the supply of lipid excipients to be used in Moderna’s vaccine against SARS-CoV-2.

Advent manufactured the vaccine doses for the Phase 2/3 clinical trial.

The companies have entered into a partnership worth more than $231 million to provide GSK with added capacity to manufacture and supply its biopharmaceutical therapies.

The White House looks to bring in credible experts for its Operation Warp Speed initiative to advance therapies and vaccines to combat the coronavirus pandemic.

The company announced that participants have enrolled in a Phase 1/2 clinical trial of its COVID-19 vaccine candidate, NVX‑CoV2373, a prefusion protein made using Novavax’s proprietary nanoparticle technology.

Funding from the US government could lead to 300 million coronavirus vaccine doses by October 2020.

CanSinoBIO will license-in Precision NanoSystems' proprietary RNA vaccine platform technology while the latter leads the development of the RNA vaccine formulation.

The companies have formed a collaboration to develop a novel human recombinant protein as a therapeutic candidate against COVID-19.

The Trump Administration has awarded a hefty contract to a new pharmaceutical manufacturing consortium to produce in the United States all components of certain critical medicines needed to combat COVID-19.

This latest round of funding adds 14 new technology projects, workforce development, and Global Health Fund projects to NIIMBL's portfolio.

Participants in two dosing cohorts in Moderna’s mRNA-1273 study reached or exceeded neutralizing antibody titers generally seen in convalescent sera.

Biopharmaceutical companies and federal agencies have been working overtime and assuming considerable risk to be able to supply billions of doses of any safe and effective preventive.

Ori Biotech is partnering with manufacturers and materials suppliers to develop an automated system for cell and gene therapy manufacturing.

The International Coalition of Medicines Regulatory Authorities held a virtual meeting of regulators from around the world to discuss policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic.

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met on May 13, 2020 to discuss measures the European Union is taking to ensure the availability of medicines during the COVID-19 pandemic.

The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective.

Vibalogics is contracted to manufacture Janssen's COVID-19 candidate vaccine at its GMP-accredited facility in Cuxhaven, Germany.

Leadership was announced for the US government’s Operation Warp Speed program, which aims to deliver COVID-19 vaccines, therapeutics, and diagnostics.

Michelle McMurry-Heath will assume the role of BIO president and CEO on June 1, 2020 after Jim Greenwood, who has led the organization since 2005, retires from the positions.

A temporary restraining order was entered against Xephyr LLC, doing business as N-Ergetics requiring the company to immediately stop distributing colloidal silver products.

The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.

The Center for iPS Cell Research and Application Foundation and the Cell and Gene Therapy Catapult have announced the launch of a new collaborative research project that will focus on induced pluripotent stem cell characterization.

Santen Pharmaceutical has concluded a licensing agreement with jCyte for the development, registration, and commercialization rights to jCell, an investigational retinitis pigmentosa therapy, in Japan, Asia, and Europe.