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deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.

Amgen, Illumina, and Nashville Biosciences Announce Genome Sequencing Agreement

The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.

USPTO Issues Notice of Allowance for Zika Vaccine Patent 

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.



FDA Issues Guidance on Development of Drugs for Monkeypox

Vetter significantly increases its sustainability ranking by achieving gold status in EcoVadis ranking. 

Vetter Wins Gold in EcoVadis Ranking

The guidance provides examples of required and recommended information in the Dosage and Administration section.

FDA Publishes Guidance on Labeling Drugs and Biological Products 

The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

FDA Signs Mutual Recognition Agreement with Swiss Confederation 

The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. 

Pharmacovigilance Risk Assessment Committee Meeting Highlights

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person. 

Spectrum Laboratory Products Issues Recall of Epinephrine USP Bulk API Due to Discoloration

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Updated REMS Document for Prescription, Biological Drug Product

The definitive agreement will give AstraZeneca global rights to CinCor’s portfolio of cardiorenal disease treatments.

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