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April 21, 2021

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	Industry News

Agenus Submits Balstilimab Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer
Submission has been made for review under the accelerated approval pathway. read more »

Jackson Healthcare Saves Only U.S. Antibiotic Manufacturer of Amoxicillin; Purchases Out of Bankruptcy
Reopening of Facility and Resumption of Production to Combine experience and success of Jackson ... read more »

New Data for Genentech’s Ocrevus (ocrelizumab) Reinforce Significant Benefit on Slowing Disease Progression in Relapsing and Primary Progressive Multiple Sclerosis
85% of treatment-naïve, early-stage relapsing-remitting multiple sclerosis (RRMS) patients achieved ... read more »

	Infographic

Levels of Disinfectant Claims When Marketing a New Disinfectant
Whether you have an existing disinfectant or are looking to launch a new product into the market, the EPA requires several testing criteria to be met ... read more »

	Featured Articles

Microbial Considerations for the Selection of Aseptic Connectors The application of single-use, sterile and disposable technology is encouraged by regulators, as the draft to EU GMP Annex 1 indicates. Such ... read more »

Identifying Collapse in Freeze-Dried Products Via NIR Spectroscopy Aesthetic appearance is a Critical Quality Attribute (CQA) of a freeze- dried drug product and plays a key role in its release to the consumer. A ... read more »

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White Paper: Successfully Implementing Rapid Microbial Methods for Mycoplasma Detection
For the last several years, Bionique Testing Laboratories has been in a unique position to facilitate the adoption of rapid mycoplasma testing strategies by their clients. Predominantly cell therapy ... read more »

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