Drug Development

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.

In-vitro and in-silico tools can help predict in-vivo outcomes for low-solubility drugs formulated as spray-dried dispersions.

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

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.

The move to continuous manufacturing and Pharma 4.0 is resulting in a more data-driven approach to bio/pharma development. Enabling this approach are innovative data systems that can help users improve product quality while facilitating audit-trail review. First used with chromatography, they are now being applied to mass spectrometry.

Hovione has successfully completed the Phase II clinical trial of its ophthalmic formulation of minocycline, Meizuvo.

An integrated CMC provider can help smaller companies to streamline development timelines and reduce project management complexity when compared with multi-provider models.

The Testa Center in Sweden provides access to equipment and expertise to help bridge the gap between biopharmaceutical discovery and industrialization.

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.

Basic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.

Continuus Pharmaceuticals is building the first GMP facility using integrated continuous manufacturing technology for end-to-end production of small-molecule APIs and finished dosage forms.

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

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

Without an independent approval pathway for novel excipients, true pharmaceutical innovation could be stymied.

Various strategies to improve bioavailability are being continuously evaluated, affording greater commercial prospects for the future.

FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.