BioPharm International Editors

The companies will use Ajinomoto’s AJICAP proprietary site-specific bioconjugation technology for the development of Bright Peak’s Immunocytokines.

Mikael Hagstroem has been named as the company’s new CEO.

The companies will work together to determine the impact on autologous and allogeneic cell therapies by combining Kytopen’s proprietary Flowfect technology for non-viral cell engineering with other steps in the manufacturing process.

The companies will aim to establish clinical and commercial supply agreements for Plus Therapeutics’ RNL-liposome drug product at the appropriate stage of development.

The fund will focus on emerging life science companies with novel platforms and methods to improve therapeutic outcomes and those with technologies that support science research, development, and manufacturing.

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

Roche has revealed the positive topline results from it Phase III trial assessing the investigational antibody cocktail of casirivimab and imdevimab in high-risk non-hospitalized COVID-19 patients.

EFPIA and Vaccines Europe urge the avoidance of any reactionary measures that could disrupt the production and delivery of COVID-19 vaccines.

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.

FDA has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol in ways that violate the Federal Food, Drug, and Cosmetic Act.

The new facility, which is expected to be operational by spring 2025, will feature 8 x 20,000-L bioreactors with the potential to add further 24 x 20,000-L bioreactors based on market demand.

Cybin will use Catalent’s Zydis orally disintegrating tablet technology for the delivery of its novel deuterated tryptamine, CYB003, a potential therapy for treatment-resistant psychiatric disorders.

Mecart has achieved FM-4880 and FM-4882 certification of its cleanroom wall and ceiling panels from the FM Approvals certification organization.

BIA has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and GMOs.

Patrick D. Walsh will take over the role from Walter J. Kaczmarek III, who is stepping down as CEO.

Under an expanded agreement with J&J, Catalent Biologics will increase manufacturing capacity at its Anagni, Italy, site to accommodate the large-scale commercial supply of Janssen’s COVID-19 vaccine.

Using the capabilities of Pharma Waldhof, one of Aceto’s facilities in Düsseldorf, Germany, the company plans to provide customers with access to raw materials, tested products for pharmaceutical cell culture applications, and cell culture media ingredients.

Sana will be authorized to use the iPSC cell lines from FUJIFILM Cellular Dynamics for the research and development, clinical and commercial manufacture, and commercialization, of the cell therapies derived from the lines.

The transaction is set to close during the first half of 2021 and is expected to enhance drug substance and drug product capabilities for WuXi.

The companies will collaborate at BioCentriq’s GMP facilities to produce Tevogen’s proprietary COVID-19 targeted T cells.

The companies will use capacity at IDT previously reserved for Takeda’s dengue vaccine candidate, TAK-003, to manufacture Janssen Pharmaceutical’s single-shot COVID-19 vaccine.

The companies will combine combining Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen aimed at treating HIV.

Precompetitive efforts of the members of the IQ Consortium have demonstrated that collaboration from a global bio/pharma village is essential to serve patients.

Sagent Pharmaceuticals is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL) to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product.

Lonza will provide a manufacturing suite at its facility in Houston, TX, for the clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate.

The acquisition will expand the antimicrobial and antiviral testing capabilities of Sotera’s Nelson Labs business in the US.

WuXi will produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.

This agreement enhances GSK’s investment in cell and gene therapy manufacturing in the UK for clinical trials.

Through the acquisition, Takeda will have access to Maverick’s T-cell engager COBRA platform, along with its development portfolio.

CRB decided to integrate the groups to further focus on end-to-end design and construction organization in order to expand project execution and improve its client and employee experience.