Biopharma News

Moderna has announced that it has entered a Memorandum of Understanding with the government of the Republic of Kenya to establish its first mRNA manufacturing facility in Africa.

Researchers at McGill University have made advancements with a novel method for growing synthetic bone tissue.

Genoox will use their genomic data platform to validate Element's AVITI system.

A consortium of nine development partners will support Biovac's expansion of its existing vaccine manufacturing plant capacity, while Biovac itself aims to raise funds to boost increased vaccine manufacturing capacity across Africa.

Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

Adagene has announced SAFEbody multi-target collaboration with Sanofi for novel masked immuno-oncology antibody candidates.

UCB has announced that it is extending its tender offer to acquire Zogenix.

EMA has recommended approval of Spikevax for children aged 6 to 11.

Johnson & Johnson has confirmed advancement of the nationwide opioid settlement agreement.

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.

Eli Lilly and Company are investing $700 million into a Boston-based facility for the newly announced Institute for Genetic Medicine.

Scottish Enterprise has awarded £20 million (US$27 million) to Valneva Scotland to advance vaccine development.

Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

Sanofi and GSK announce they are seeking regulatory authorization for COVID-19 vaccine.

Novavax announces the first doses of Nuvaxovid COVID-19 vaccine have begun shipping to European Union member states.

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.

The turnkey facilities will promote scalable vaccine production for an end-to-end manufacturing network for mRNA-based vaccines in Africa.

Health Canada authorizes Novavax COVID-19 vaccine for individuals 18 years of age and older.

The company has announced plans to establish a commercial presence in six European countries.

The commercialization and licensing deal will see Biogen commercialize Xbrane’s Xcimzane, a proposed biosimilar for CIMZIA (certolizumab pegol).

ONK will receive non-exclusive rights to Intellia’s proprietary ex-vivo CRISPR/Cas9 technology in the development of five allogeneic NK cell therapies.

ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

In an agreement with MaaT Pharma, Skyepharma will build MaaT a dedicated 1500-m² microbiome ecosystem therapies manufacturing site.

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

Eli Lilly and Company is investing $1 billion to establish a new manufacturing stie in Concord, N.C., to manufacture parenteral products and devices.

Eli Lilly and Company has entered into a research and collaboration agreement with Entos Pharmaceuticals to develop new therapeutics for treating neurologic disorders.