All News

eTheRNA Immunotherapies has entered into a strategic cooperation and product license agreement with China Grand Pharmaceutical and Healthcare Holdings to form a new joint venture company, Nanjong AuroRNA Biotech.

The grant will support the advancement of glycoengineering technology for plant-derived proteins developed by a University of Alberta scientist partnered with PlantForm.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

MHRA has granted a temporary authorization for emergency use to Pfizer and BioNTech for the mRNA vaccine against COVID-19.

The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products and cGMP suites for early-phase cGMP manufacture.

Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.

The added space will house a portion of its PVC, polyurethane, silicone, and additional plastic tubing products, as well as its AdvantaPure products.

Originally announced in March 2020, the acquired facility will be Bora’s first North American manufacturing facility and will serve as its North American headquarters.

The virtual assessments will address problems, issues, and questions customers have about their environments and operations.

The expansion is part of a new expansion initiative aimed at increasing flexibility, efficiency, and cost-effective production.

Behzad Mahdavi, PhD, will join a team of experts in the company’s Science and Technology Group to fast-track the adoption of new development and drug delivery technologies and manufacturing processes and techniques.

The companies have entered into a global collaboration and license agreement to develop zuranolone (SAGE-217) for major depressive disorder, postpartum depression (PPD), and SAGE-324 for essential tremor and other neurological disorders.

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

Dolomite Microfluidics and MilliporeSigma have begun a collaboration to release off-the-shelf microfluidic device kits for the fabrication of PLGA particles.

The new powerful, precise, and compact instrument can be retrofitted for point-of-care clinical testing at urgent care facilities, hospitals, or physicians’ offices.

The expansion of the companies’ partnership will integrate lead optimization efforts to advance cancer immune therapy drug discovery.

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

The companies have entered into an agreement for the technology transfer and clinical manufacturing of Mustang’s MB-107 lentiviral gene therapy program for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, in Europe.

The expansion will include a new 25,000-ft2 warehouse, a filling line for flexible plastic containers, a high-speed automated syringe fill line with the ability to fill up to 600 units per minute, and a high-speed automated visual inspection line.

The acquisition gives Merck a new Phase III COVID-19 therapeutic candidate, CD24Fc, a fusion protein that targets the innate immune system, in its pipeline.

The new super plant, being built in Incheon, South Korea, will have a total biopharmaceutical manufacturing capacity of 256,000 L.

The companies have formed a long-term manufacturing agreement to accelerate the global supply for Lilly’s COVID-19 antibody therapeutics.

The agreement follows a recent announcement that Sartorius plans to invest $100 million in Songdo, South Korea’s bio cluster.

The agreement will allow Roche to use CEVEC’s proprietary ELEVECTA technology, which is designed to enable fully scalable, high-performance AAV vector production in suspension bioprocesses.

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.

The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.

When administered together in clinical trials, casirivimab and imdevimab were shown to lessen COVID-19 hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.