Pharmaceutical Technology Editors

Thermo Fisher Scientific’s QualTrak is tailored for biologics development.

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided.

FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.

FDA approved Stemline Therapeutics’ elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris.

Pharmapack Europe experts expect smaller and medium European packaging companies to grow or be acquired.

AstraZeneca and Thermo Fisher will collaborate to develop a solid tissue and blood-based companion diagnostic test for osimertinib.

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

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

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.

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

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.

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.

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.

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.

Agilent’s $725 million investment is designed to double its capacity to produce APIs.

The BioProfile FAST CDV is a fully automated viable cell density and viability analyzer.

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

Pfizer and Gero have partnered to discover potential therapeutic targets for fibrotic diseases using machine learning technology.

The collaboration between AbbVie and Anima Biotech will combine Anima's mRNA Lightning technology platform with AbbVie's extensive expertise in oncology and immunology.

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

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.

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.

The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy.