News

MicrofluidX has raised £1.4 million (US$1.7 million) in seed funding, which it will use to develop its novel cell bioprocessing technology for cell and gene therapy.

A UK BioIndustry Association industry-led vaccine manufacturing group has welcomed a recent announcement by the government of the UK, that it will receive £14 million (US$17.3 million) in investment to rapidly scale up the development of vaccines for COVID-19.

The vaccine will be based on a ReiThera-proprietary simian adenoviral vector with strong immunological potency and low pre-existing immunity in humans.

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.

The approval was based off of positive results from a Phase III study that showed patients 70 years or younger treated with the BTK inhibitor lived longer without disease progression.

Bayer will provide CAD $1.5 million (USD$1 million) toward two studies to evaluate its chloroquine and interferon beta-1b combination therapies.

Catalent Biologics increased capacity at its Bloomington, IN Facility.

US government and industry partners will coordinate to bring the most promising COVID-19 vaccine and treatment candidates to clinical trials.

With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.

The phase-II, randomized, double-blind, placebo-controlled trial will study the efficacy and safety of the live biotherapeutic in 90 individuals with COVID-19 symptoms.

The company will build an additional commercial-scale, contract manufacturing facility for viral vectors and gene therapies near its existing site in Carlsbad, CA.

The report outlines the company’s approaches to product quality, safety, environmental sustainability, and diversity and inclusion.

Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.

Biopharmaceutical company, TScan Therapeutics, has entered into a collaboration agreement with Novartis that is aimed at the discovery and development of novel T-cell receptor (TCR) therapies for solid tumors.

The Commission of Human Medicines Expert Working Group has concluded that there is insufficient evidence to link ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), with susceptibility for contracting COVID-19 or worsening symptoms.

Dutch company HALIX has announced it is joining a consortium of partners that are all under the guidance of the University of Oxford to provide good manufacturing practice (GMP) manufacturing services for a COVID-19 vaccine.

The lab is expected to open in April 2020 and will increase the company’s capacity for diagnostic testing of rare genetic diseases along with its COVID-19 capabilities.

Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.

Sanofi and GlaxoSmithKline (GSK) have revealed that they are joining forces to develop an adjuvanted vaccine using their respective technologies that can be used to fight COVID-19.

AstraZeneca has announced it will be commencing a randomized, global clinical trial to assess the efficacy and safety of Calquence (acalabrutinib) in treating the exaggerated immune response of patients with COVID-19.

The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.

ISPE’s Facility of the Year Awards for 2020 go to bio/pharma companies in eight award categories, including two winners in the new Social Impact category.

With the acquisition, Orgenesis will combine TamirBio’s ranpirnase antiviral platform with its Bioxome technology.

Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs.

The companies announced they are entering into a strategic collaboration under which Blackstone will provide up to $2 billion to fund Alnylam’s RNAi drugs to treat a range of diseases.

The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.