Deals, Development and Manufacturing

Technical services and regulatory affairs consulting group, Diamond Pharma Services, has announced its acquisition of PharmaCentral-a pharmacovigilance services and medical affairs business based in Dublin, Ireland.

The vaccine will be based on a ReiThera-proprietary simian adenoviral vector with strong immunological potency and low pre-existing immunity in humans.

Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.

Bayer will provide CAD $1.5 million (USD$1 million) toward two studies to evaluate its chloroquine and interferon beta-1b combination therapies.

The companies will collaborate on the discovery and development of next-generation drug and engineered cell therapies focused on natural killer cells.

Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.

Medical dermatology company based in Denmark, Leo Pharma, has entered into a license agreement with two Eastern-Asian companies for the development and commercialization of FB825, a novel atopic dermatitis and allergic asthma drug candidate.

Dutch company HALIX has announced it is joining a consortium of partners that are all under the guidance of the University of Oxford to provide good manufacturing practice (GMP) manufacturing services for a COVID-19 vaccine.

Biopharmaceutical company, TScan Therapeutics, has entered into a collaboration agreement with Novartis that is aimed at the discovery and development of novel T-cell receptor (TCR) therapies for solid tumors.

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.

Late-stage pharmaceutical company based in San Diego, MEI Pharma, and Japanese drug discovery company, Kyowa Kirin, have entered into a global license, development, and commercialization agreement for ME-401.

AstraZeneca has announced it will be commencing a randomized, global clinical trial to assess the efficacy and safety of Calquence (acalabrutinib) in treating the exaggerated immune response of patients with COVID-19.

Sanofi and GlaxoSmithKline (GSK) have revealed that they are joining forces to develop an adjuvanted vaccine using their respective technologies that can be used to fight COVID-19.

With the acquisition, Orgenesis will combine TamirBio’s ranpirnase antiviral platform with its Bioxome technology.

Through the agreement, Arrakis will receive an upfront payment of $190 million in cash and will have the potential to receive preclinical, clinical, commercial, and sales milestone payments and royalties for any resulting products.

The companies announced they are entering into a strategic collaboration under which Blackstone will provide up to $2 billion to fund Alnylam’s RNAi drugs to treat a range of diseases.

The partners have formed a joint venture to produce muscle-derived mesenchymal stem cells as a source of exosomes and other cellular products to develop related therapies and advance clinical trials.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

Horizon Discovery has announced that it has expanded its cell-based clustered regularly interspaced short palindromic repeats (CRISPR) screening services to include primary human B cells, which complements the T cell screening service.

Belgian biopharmaceutical company, UCB, has successfully completed its acquisition of Ra Pharmaceuticals, which is now a wholly-owned subsidiary of the company.

Second Genome will use its Microbiome Analytics Platform throughout the collaboration to identify novel biomarkers associated with clinical response to Gilead’s investigational medicines.

The partnership, led by Takeda and CSL Behring, will focus on developing a hyperimmune immunoglobulin against COVID-19.

The companies will collaborate on research and development solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.

N4 Pharma will be undertaking a proof-of-concept research project using a COVID-19 DNA plasmid to demonstrate the ability of its delivery system, Nuvec, to collaborative partners developing DNA or RNA vaccines.

As COVID-19 rapidly spreads, the bio/pharma industry is committing significant efforts to fast track development of therapies.

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

The companies are entering into a partnership to develop fully human neutralizing antibodies targeting SARS-CoV-2 to prevent or treat COVID-19.

Daiichi Sankyo has entered into a partnership with Ultragenyx Pharmaceutical for the use of Ultragenyx’s proprietary AAV-based gene-therapy manufacturing technology.

The partnership will focus on the development of up to five novel protein replacement and mRNA therapies.

ProBioGen will facilitate the development of Immunogenesis’ monoclonal antibody candidate and will be responsible for manufacturing the drug at its new facility in Berlin, Germany.