News

ISPE announced its 2020–2021 International Board of Directors during the virtual 2020 ISPE Annual Meeting & Expo on Nov. 6, 2020.

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

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

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.

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.

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

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 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.

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.

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.

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

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.

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

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

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.

Through the agreement, Takeda will handle securing the regulatory approvals before distributing the doses, while Moderna will supply the finished product.

FDA has granted priority review for the companies’ sBLA for Enhertu, an ADC for treating gastric cancers.

The complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality.

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS).

Novartis and Molecular Partners are collaborating on the development, manufacture, and commercialization of Molecular Partners’ anti-COVID-19 DARPin program.

The UK BIA Antibody Taskforce has identified differentiated antibody combinations that will be taken into development as COVID-19 antibody therapy candidates.

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

The new company will house more than 350 experts and will offer pharmaceutical, life sciences, food and beverage, and manufacturing solutions.