News

Be The Match BioTherapies Launches CRO Services for Cell and Gene Therapy

January 31, 2023

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

Scientific Laboratory Supplies Acquires C&M Scientific

January 31, 2023

Scientific Laboratory Supplies’ acquisition of C&M will bolster the company’s scientific calibration, maintenance, and validation offerings.

FDA Seeks to Simplify COVID-19 Vaccination Program

January 30, 2023

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

FDA Releases Research Roadmap for Biosimilars Pilot Program

January 27, 2023

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.

Agilent and Quest Diagnostics to Collaborate on Lung Cancer Diagnostic

January 26, 2023

Agilent will work with Quest Diagnostics to distribute the ctDx FIRST test.

Amgen, Illumina, and Nashville Biosciences Announce Genome Sequencing Agreement

January 26, 2023

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

USPTO Issues Notice of Allowance for Zika Vaccine Patent

January 26, 2023

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

Takeda Strikes $1.13 Billion Deal for Hutchmed Colorectal Cancer Treatment

January 23, 2023

Takeda will pay approximately $400 million upfront for the exclusive worldwide rights to Hutchmed’s fruquintinib, a tyrosine kinase inhibitor, outside of China.

FDA Rejects Accelerated Approval for Lilly’s Alzheimer’s Drug

January 23, 2023

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

FDA Issues Guidance on Development of Drugs for Monkeypox

January 23, 2023

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.