BioPharm International Editors

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.

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 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.

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.

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 companies have signed a Statement of Intent with Gavi to make 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine available for distribution.

Delivery will commence over the course of two months following the EUA and the government will have the ability to purchase up to 650,000 additional vials of the treatment through June 30, 2021 based on product availability and medical need.

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

The Direct-to-Patient services include Pharmacy-to-Patient, Depot-to-Patient, and Clinical Site-to-Patient services.

The companies will work to provide development strategy consultations, system-building, and clinical trial operations, while lessening development time and reducing risk by centralizing project tasks between companies.

Under the partnership, Catalent has ordered visual inspection machines from Stevanato Group to install at its Bloomington, IN and Anagni, Italy facilities to support customer programs.

Bayer will own the rights to AskBio’s AAV-based gene therapy platform, its intellectual property portfolio, and an established CDMO.

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

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

The name change touches on the company’s AI and machine learning proficiencies, while including the expansion of the company’s mission to serve additional regulated industries including animal health, cosmetics, medical devices, specialty chemicals, nutraceuticals, and food and beverage.

The 6th-generation Eclipse FFF system handles analytes such as proteins, polymers, viruses, gene vectors, and liposomal drug nanoparticles.

200 employees will be hired by the end of 2020, with 300 more planning to be hired by 2023.