
mRNA may be a modality whose chief advances are yet to come.

Mapping America’s Pharmaceutical Supply (MAPS) Act aims to establish a database including key information about critical drugs so supply chain weaknesses can be identified.

The program aims to aid submissions from external stakeholders and FDA staff.

Biogen’s acquisition of Reata will grant them access to Reata’s FDA-approved treatment for Friedreich’s ataxia.

AstraZeneca, via its subsidiary Alexion Pharmaceuticals, will purchase a portfolio of preclinical rare disease gene therapies from Pfizer in a deal worth up to $1 billion.

The guidance document outlines recommendations to limit potential carcinogenic risk.

The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.

Pandemic, PBM, and other policies on hold during the summer recess.

The expansion project is aimed to be completed in December 2024 and the new facility will be fully operational by 2025.

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

Roche will pay up to $2.8 billion for the rights to Alnylam’s RNA-based hypertension therapeutic.

Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solutions) is designed to treat Demodex blepharitis by directly targeting Demodex mites.

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.

The partnership is an extension of the collaboration from AbbVie and Scripps Research that was formed in 2019, according to the press release.

The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.

The framework is now expanded beyond COVID-19 vaccines and treatments.

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

Sanofi and Recludix Pharma’s deal centers on developing treatments for various immunological and inflammatory diseases.

WuXi STA’s new high-potency injectable line has an annual capacity of 12 million units.

Newly launched Crossbow Therapeutics will work to advance a novel class of antibody therapies for treating cancers.

Under a global license agreement, Bristol Myers Squibb and Evotec will advance the development of neurodegeneration pipeline assets.

The proposed spin-off of Sandoz into an independent entity has been approved by Novartis’ board of directors.

The partnership will see Flagship and Pfizer work to create a new pipeline of innovative medicines.

The expanded deal, now potentially worth more than $1.2 billion, will work to develop in vivo therapies, including sickle cell disease.

Novartis’ acquisition of biotech company DTx Pharma boosts its neuroscience pipeline and expands its capabilities in RNA-based therapeutics.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

The new drug may help vulnerable children resist RSV in the coming fall and winter season.

The goal for Upperton is to become fully operational by Q4 of 2023 for development and non-GMP manufacturing and a target start of GMP operations in January 2024.