News

The agreement provides Novo Nordisk with full access to Emisphere’s Eligen SNAC technology, which will boost Novo Nordisk’s portfolio of oral therapeutics.

The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.

Interim efficacy data suggests the Pfizer/BioNTech has an efficacy rate above 90%.

Through the acquisition, Merck will gain access to VelosBio’s lead investigational candidate, VLS-101, an antibody-drug conjugate that targets receptor tyrosine kinase-like orphan receptor 1.

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to EMA for expanded use of the SC formulation of Darzalex.

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

ACG has acquired a significant stake in IQGEN-X, a Mumbai-based start-up contract research organization (CRO).

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

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.

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

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

The company is investing $64.5 million to open new facilities in Germany and Japan to expand its overall capacity.

PerkinElmer will have the opportunity to strengthen its portfolio of automated life sciences discovery and applied genomics solutions by including Horizon’s gene editing and gene modulation tools.

Through the acquisition, Sanofi will have access to Kiadis’ proprietary platform, which uses natural killer cells from a healthy donor to make products for a wide range of patients across several indications.

In the wake of its efforts to develop a COVID-19 vaccine candidate, the company has secured two additional properties in the Gaithersburg, MD area.

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

Nostrum Laboratories is recalling Metformin HCl Extended Release Tablets because of NDMA above the acceptable daily intake limit.

Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies.

Pierre-Alain Ruffieux has been named Lonza’s new CEO, taking over for Albert Baehny who has been serving as CEO ad interim since November 2019.

A virtual ribbon cutting, tour, and panel discussions were hosted on Oct. 29, 2020 to announce the opening of BioCentriq on the campus of the New Jersey Institute of Technology in Newark, NJ.

The transaction is set to be completed during the fourth quarter of 2020.

FDA, US Customs and Border Protection, and the US Immigration and Customs Enforcement, Homeland Security Investigations signed a Memorandum of Understanding to prevent illegal drug imports from entering the US through International Mail Facilities.

The agency, in response to an executive order, published a list of essential medicines, medical countermeasures, and critical inputs that should be available at all times in an adequate amount to serve patient needs.

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

FDA published guidance for submitting standardized study data in electronic format.