Astellas Gains Three Cancer Drugs with $405M Potenza Buy

                                                                                          Issue # 2838 | December 18th, 2018      


















































































































































































News Alert



Astellas Gains Three Cancer Drugs with $405M Potenza Buy

Astellas has taken an option to acquire U.S. biotech Potenza Therapeutics after the companies spent more than three years working together on cancer immunotherapies. The Japanese pharma said the acquisition marks the successful outcome of a collaboration that began in 2015 to build a portfolio of novel immuno-oncology therapies. Astellas paid $164.6 million upfront to acquire Potenza, and shareholders will be eligible for additional payments totalling up to $240.1 million, depending on how clinical development progresses. The drugs that will be added to Astellas' portfolio include phase 1 drugs SP 8374/PTZ-201, an anti-TIGIT antibody immune checkpoint inhibitor and ASP 1948/PTZ-329, an anti-NRP1 antibody inhibiting T-regulatory cells. Learn More




FDA Approves Celltrion's Herceptin Biosimilar
 
The U.S. FDA has approved a BLA for Herceptin biosimilar Herzuma from Celltrion. In April, Celltrion received complete response letters from the FDA for Herzuma and Truxima rituximab-abbs, its Rituxan biosimilar. Celltrion said at the time the letters were directly related to the FDA's January warning letter describing GMP violations observed during a visit to Celltrion's manufacturing facility. Celltrion resubmitted the BLA for Herzuma in June, and in November the FDA approved a resubmitted BLA for Truxima to treat non-Hodgkin lymphoma. Teva has exclusive rights to commercialize both biosimilars in the U.S. and Canada. Learn More




Masco Group Acquires High Purity Division of MarCor

The Masco Group has acquired the High Purity division of MarCor, based in Burlington, Ontario, Canada. The new company, to be known as Stilmas Americas, will be the hub for selling, engineering, manufacturing and servicing Stilmas equipment in North America. The Masco Group has a presence in three continents. Its European headquarters is in Italy and it also has manufacturing and servicing operations in France and a commercial and service office in Russia. In Asia, it has an autonomous engineering and manufacturing facility in China, to serve the local market, while in North America an existing commercial and service office in Pennsylvania will be complemented by the newly acquired Canadian facility.  Learn More

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TED Alert

Why We Need to Treat Our Employees as Thoughtfully as Our Customers


Today's companies know everything there is to know about their customers and will stop at nothing to ensure that their experience is pleasant and meaningful. But what if they directed some of that same energy at understanding and engaging their employees? What are the potential payoffs for a better motivated, more loyal and imaginatively innovating workforce? Diana Dosik shares her experiences turning the tables of customer research and experience onto employees to create smarter and better companies. Learn More

Poll Alert

How respected is the U.S. by other countries today?
 



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Bioprocess Alert

Introduction to Viral Safety Part 5 - Detergent Inactivation


This video provides an introduction to the role of detergent inactivation as an element of viral safety.

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Event Alert

 

Controlled EGFR Ligand Display on Cancer Suicide Enzymes for Targeted Intracellular Delivery
 
Webinar - Tuesday, January 15th, 2019

The Best of BIOT awards are BIOT's annual recognition of excellent presentations given at the spring ACS National Meeting. The winners are selected based on audience and session chair voting. Each recipient is invited to give a webinar reprising the original presentation. 

In an effort to promote scientific discourse and connectivity throughout the BIOT community, this year, the webinars are provided free of charge. 


Resource Alert



Influence of Incident Wavelength and Detector Material Selection on Fluorescence in the Application of Raman Spectroscopy to a Fungal Fermentation Process

Raman spectroscopy is a novel tool used in the on-line monitoring and control of bioprocesses, offering both quantitative and qualitative determination of key process variables through spectroscopic analysis. However, the wide-spread application of Raman spectroscopy analyzers to industrial fermentation processes has been hindered by problems related to the high background fluorescence signal associated with the analysis of biological samples. To address this issue, we investigated the influence of fluorescence on the spectra collected from two Raman spectroscopic devices with different wavelengths and detectors in the analysis of the critical process parameters (CPPs) and critical quality attributes (CQAs) of a fungal fermentation process. Learn More

 
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Regulatory Alert



FDA Scraps 2013 Generic Drug Label Proposal That Could Have Exposed Manufacturers to Lawsuits

The U.S. FDA is backing off a 2013 proposal that could have opened generic drugmakers to potential lawsuits over the side effects of medications. This decision comes in the form of a statement from FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock noting that the regulatory agency has withdrawn its proposal for that rule, keeping the drug manufacturers safe from those kinds of lawsuits. Alert readers will recall that back in 2013 the FDA proposed the rule called Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Learn More

Discovery Alert



Biologists Turn Eavesdropping Viruses into Bacterial Assassins