Five Prime Cutting Staff by 20% to Focus on Clinical Programs

                                                                                          Issue # 2851 | January 16th, 2019      

























































































































































News Alert



Five Prime Cutting Staff by 20% to Focus on Clinical Programs

Five Prime Therapeutics is cutting its headcount by 41 employees, roughly 20 percent. This corporate restructuring will eliminate positions in research, pathology and manufacturing in an effort to reduce operating expenses by upwards of $10 million. These monies will be used to support clinical-stage programs expected to report key data later this year. Alert readers will recall that BMS paid $350M upfront to Five Prime in 2015 to partner on the oncology drug cabiralizumab. Learn More


 

Pfizer Halts Development of Five Preclinical Biosimilar Assets

Pfizer this week made public plans to halt the development of five preclinical biosimilar assets, though the company will continue to market three biosimilars and develop five other biosimilars in mid- to late stage development. Joining a handful of other companies - from Boehringer Ingelheim to Momenta to Sandoz and more -- in exiting the US biosimilar space in some shape or form.  Pfizer's exit reiterates the view by many that the need exists to raise questions about the viability of the US biosimilar market as a whole.  Learn More




FDA Approves Record-Breaking 59 Novel Drugs in 2018

The past year proved to be a big one for the U.S. FDA and the approval of novel drugs. Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler's diarrhea, migraine headaches and more. Over the past 190 years, the FDA has averaged an approval of 33 novel drugs each year, with 2018 having the highest number. In 2017, the FDA approved 46 novel drugs, but only 22 in 2016. Learn More

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Business Model Innovation: Beating Yourself at Your Own Game


It seems as though Uber upended the taxi industry in less time than it takes to drive across Manhattan at rush hour. How did they do it, and what can legacy companies learn from their example? Business transformation expert Stefan Gross-Selbeck distills the unique qualities of today's most successful start-ups and shares strategies for replicating this spirit of hyper-innovation and disruption in any business. 

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What is the likelihood of elections in your country being tampered with?
 



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Batch Culture


This video, which has 65,000+ views, provides an informative explanation of the principles and practices associated with batch culture.

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Single Use Manufacturing Within the Bristol-Myers Squibb Manufacturing Network - Preparing for Commercial Production 
 
Webinar - Thursday, January 17th, 2019

Presented by Lance Marquardt, Associate Director Upstream Processing, Bristol-Myers Squibb

This webinar will provide an overview of the current use of single-use manufacturing within the Bristol-Myers Squibb manufacturing networks and planned future state.  The challenges in implementing single-use manufacturing for commercial production will be discussed.  Comparisons will be made to the implementation of past improvements and the plans for future improvements, such as continuous processing.


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A Systematic Mass-Transfer Modeling Approach for Mammalian Cell Culture Bioreactor Scale-Up

A mathematical mass-transfer model was developed based on the mass balance of gas exchange in cell culture bioreactors. The model combines the bioreactor mass transfer properties and mammalian cell metabolic parameters to predict the cell culture process oxygen demands and carbon dioxide accumulation in bioreactors. With the guidance of the mass-transfer model, a CHO cell culture process to produce a therapeutic antibody was successfully scaled up from 2-L to 1500-L bioreactor directly without intermediate steps. The process performances and product quality attributes demonstrate good robustness and consistency between small and large scales. This mass-transfer model provides a more systematic and reliable approach for mammalian cell culture bioreactor scaling up.


 
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FDA Approves Record-Breaking 59 Novel Drugs in 2018