Drug Development

WuXi Biologics and WuXi STA have established a joint venture company named WuXi XDC to provide contract development and manufacturing of bioconjugates, including antibody-drug conjugates.

The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceutical space.

Biogen and Capsigen have entered into a strategic research collaboration to engineer novel AAV capsids to deliver gene therapies that address the underlying genetic causes of various central nervous system and neuromuscular disorders.

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

Through the collaboration, MiNA will use its saRNA platform to research up to five targets selected by Lilly to address diseases across Lilly's key therapeutic focus areas.

Sterling Pharma Solutions and OncoTEX have entered into a clinical development agreement for the manufacturing of OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.

The collaboration, which has been in place since 1998, will focus on drug discovery, translational medicine research, and pharmaceutical development.

Eli Lilly and Company has partnered with leading diabetes tech firms to offer app compatibility with insulin smart pens to streamline diabetes management with automated data collection.

Vectura and Inspira Pharmaceuticals have joined forces to develop a potential inhaled therapy for COVID-19.

This new collaboration between Vyant Bio, Ordaōs Bio, and Cellaria mitigates risk in the drug discovery process using artificial intelligence and in-vitro “avatar” clinical trials.

AMRI will increase R&D and manufacturing capabilities for orphan and rare disease products.

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

Applying a QbD approach helps address excipient variability and other quality features.

Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.

Aprecia and Glatt investigate manufacturing technologies to widen the formulation design space for oral delivery.

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

As face masks start to come off, bio/pharma’s COVID-19 battle goes on.

Merck has entered into non-exclusive voluntary licensing agreements with five Indian generic drug manufacturers for the development of molnupiravir, an investigational, oral antiviral agent for the treatment of non-hospitalized patients with confirmed COVID-19.

Since launching the partnership, Evotec and Bristol Myers Squibb have established a pipeline of novel first-in-class targeted protein degradation projects, two of which have transitioned into lead optimization.

DCAT’s annual bio/pharmaceutical development and manufacturing business event, DCAT Week, will take place virtually from July 12–16, 2021, with the in-person even postponed to March 20–24, 2022 in New York City.

Vertex and CRISPR have amended their collaboration agreement to include the development, manufacture, and commercialization of CTX001, an investigational CRISPR/Cas9-based gene editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia.

Biogen UK has announced that the UK’s MHRA and the EC have granted marketing authorization for the subcutaneous (SC) formulation of Tysabri (natalizumab).

Catalent plans to add cryogenic capabilities to its facility in Philadelphia, which will strengthen its ability to cryogenically preserve cell therapies and other biological materials.

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.

Intensified and distributed manufacturing approaches create flexible, local capacity.

Topical drugs are attractive to patients, but these complex products pose challenges for formulators.

Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.

Despite its importance in drug development, dissolution testing still has some limitations, but advances in automation and real-time monitoring are producing promising results.

Smart, accurate, science-based messaging is needed to advance bio/pharma science.