News

Lower levels of an active ingredient may result in unexpected pregnancies.

BlueRock will be responsible for the global development and commercialization of therapeutic candidates emerging from this collaboration.

Under a manufacturing agreement, Northway Biotech will develop a manufacturing process for iTolerance’s fusion protein in development for regenerative therapy.

Waters XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies.

Kiefel’s new machine is designed to form, fill, and seal up to 6,000 infusion, parenteral nutrition, or dialysis bags per hour.

The nasal-spray drug can be used to reverse the effects of opioid overdose.

Laboratories are focusing on more automated processes while also trying to maintain an efficient, safe, and personalized experience with each analytical test.

Only a significant joint effort across the supply chain will help to make healthcare more sustainable and reduce the impact of climate change on global health.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

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.