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© 2023 MJH Life Sciences and BioPharm International. All rights reserved.
© 2023 MJH Life Sciences™ and BioPharm International. All rights reserved.
This compilation allows readers to adjust their thinking to appreciate the full impact certain select technologies will make on the industry by 2026.
The testing of new convecdiff membranes shows this material to be well suited for lab- and commercial-scale bind-and-elute applications.
Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.
Biologic drug development requires relevant bioassays to measure and help predict cellular response.
Affinity chromatography resins must perform well under mild elution conditions yet withstand robust cleaning and sanitization protocols.
Efforts to optimize the ideal blend of technology and best practices that are needed to protect and deliver time- and temperature-sensitive biologic therapies, vaccines, and cell and gene therapies continue to evolve.
Health crises, political tension, and budget concerns were major challenges.
January 30, 2023
FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.
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.
January 26, 2023
Agilent will work with Quest Diagnostics to distribute the ctDx FIRST test.
deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.
The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.
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.
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.
January 20, 2023
The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.
The partnership led to Asimov licensing its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients.
January 19, 2023
The merged company will operate under the name Ayala Pharmaceuticals and will target the development and commercialization of Ayala’s lead program, AL102, for the treatment of desmoid tumors.
January 18, 2023
Recently, 2seventy bio announced the initiation of a strategic partnership with JW Therapeutics aiming at the collaboration being the development of 2seventy bio’s MAGE-A4 cell therapy in mainland China, Hong Kong, and Macao.
Snapdragon Chemistry concentrates in API batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges.