Biopharma News

Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.

Moderna’s COVID-19 vaccine candidate can be distributed using widely available vaccine delivery and storage infrastructure.

PhoreMost and Oxford Biomedica have entered into a discovery collaboration for the development of next-generation chimeric antigen receptor T-cell therapies.

Apeiron Biologics has selected Domainex to advance the development of inhibitors for the E3 ubiquitin ligase Cbl-b.

FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.

Interim efficacy data suggests the Pfizer/BioNTech mRNA-based vaccine has an efficacy rate above 90%.

Lonza has inaugurated its first ADC payload manufacturing suite at the Visp, Switzerland site.

ProteoNic has licensed its protein expression technology, 2G UNic, to Gilead Sciences.

Sanofi’s Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham, MA was named the Overall Award winner at the ISPE virtual annual meeting.

Samsung Biologics has adopted Solentim’s cell seeding and cell metric platforms at its new R&D center in San Francisco, CA.

Mogrify’s new technology platform, EpiMOGRIFY, can predict cellular switches important for determining cell identity, cell maintenance, directed differentiation, and cell conversion.

With the presentation of research supporting the use of PTA technology, BioSkryb also launched its ResolveDNA platform for commercial use at ASHG 2020, held virtually on Oct. 27–30, 2020.

NanoMab Technology has signed heads of terms with a supplier of Tungsten-188/Rhenium-188 generators, OncoBeta.

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

Gilead’s antiviral drug Veklury is the first approved treatment in the US for COVID-19.

Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.

Joerg Ahlgrimm has left Lonza and is now leading The Discovery Labs’ mission to establish a powerhouse for cell and gene therapy development and manufacturing in the Philadelphia area.

Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.

The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.

The company was selected because of its nucleic acid platform which, when combined with virotherapy, has the potential to treat liver cancer by using a lipid nanoparticle delivery system.

Branching out from roots in industrial biotechnology, Riffyn Data Systems (and its CEO Tim Gardner) is taking the message of data-driven process improvement to biopharma.

The new VirusExpress lentiviral production platform increases dose yields and reduces process development time for cell and gene therapies.

The new facility at the company’s San Diego, CA, site will be for late phase and commercial CGMP manufacturing.

The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.

Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.

The partnership aims to provide a platform of hiPSC-based assays, drug discovery technologies, high-throughput screening, and high-content screening.

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.