News

The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.

Global pharmaceutical company, Advanz Pharma, has closed its acquisition of specialty pharmaceutical company, Correvio Pharma.

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

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

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.

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

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.

A network-based supply chain approach has the potential to improve resilience and performance.

The 60,000-ft2 facility will work in conjunction with the company’s Kakegawa, Japan, clinical supply facility to serve local and global biotech and pharmaceutical companies.

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.

All ReFIBE wipes are laser-cut with heatsealed edges and cleanroom laundered to lessen the amount of releasable particles and fibers.

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

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

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

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.

US manufacturers focus on preparing capacity while vaccines and treatments for COVID-19 are being developed and tested.

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

HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.

Evonik opened a new facility for GMP manufacturing of bioresorbable polymers and excipients for pharmaceutical and medical applications in Birmingham, AL.

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

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

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.

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.

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.

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