Pfizer Launches Biosimilar Version of Amgen's Epogen

                                                                                          Issue # 2815 | November 15th, 2018      



















































































































































































News Alert



Pfizer Launches Biosimilar Version of Amgen's Epogen

Pfizer has announced the U.S. launch of its third biosimilar product, creating a new market threat to Amgen's Epogen and Johnson & Johnson's Procrit. Retacrit, a copycat of both Epogen and Procrit, gained U.S. FDA approval in May with initial shipments of the drug having went out to U.S. wholesalers earlier this week according to Pfizer. The leading biopharma has priced its drug at 57% lower than Procrit and 33% lower than Epogen. This is expected to result in a reduction in sell price for both branded biologics as they look to maintain market share that amounted to roughly $1B in sales each last year. Learn More




Allergan Loses Appeal Over Validity of Restasis Patents

Allergan's patents on its blockbuster eye drug Restasis are invalid, a U.S. appeals court ruled this week. Without issuing a formal opinion, the U.S. Court of Appeals for the Federal Circuit in Washington affirmed a trial court decision that the patents are invalid, in a victory for Teva, Akorn and Mylan. The court ruling came a week after it heard arguments on the case. Allergan had been counting on the patents to block generic competition until 2024; all other patents on the drug have since expired. Restasis brought in $1.5 billion last year, or 9.2 percent of the company's revenue. It's the second-biggest money-maker behind the wrinkle treatment Botox. Learn More




Samsung BioLogics Stock Suspended, Fine Issued and Advised to Dismiss CEO
 
South Korea's Financial Services Commission has ruled that Samsung Biologics "intentionally" violated accounting rules in 2015, a year ahead of its IPO. For its part, Samsung BioLogics has denied wrongdoing, citing an agreement with its U.S. partner as the reason for valuing its stake in Samsung Bioepis at fair market value rather than at book value. As a result of the ruling, trading of the company's stock has been suspended indefinitely while authorities decide whether to delist the firm. The regulator has also imposed a $7 million fine and advised the company to dismiss its current chief executive. However, Samsung has made clear that it intends to fight the ruling in court. Learn More

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What I Learned Serving Time for a Crime I Didn't Commit


In 2011, Teresa Njoroge was convicted of a financial crime she didn't commit -- the result of a long string of false accusations, increasing bribe attempts and the corrupt justice system in her home in Kenya. Once incarcerated, she discovered that most of the women and girls locked up with her were also victims of the same broken system, caught in a revolving door of life in and out of prison due to poor education and lack of economic opportunity. Now free and cleared by the courts of appeal, Njoroge shares how she's giving women in prison the skills, tools and support they need to break the cycle of poverty and crime and build a better life. Learn More

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Lab Culture and Media Prep


In this video the presenter addresses a key element of upstream bioprocessing, lab culture and media prep.

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High Productivity Harvest - Intensify Harvest and Displace Clarification in Fed Batch Cell Culture
 
Live Webinar - Thursday, November 15th 2018

High Productivity Harvest (HPH) is a novel application developed by Repligen that enables you to harvest a fed batch bioreactor in a fully sterile manner while eliminating both centrifugation and depth filtration. A 0.2µm filtered, closed system and single step process using the XCell™ ATF System, HPH can significantly increase yields above industry standards and generate a sterile clarified batch harvest ready for batch or continuous chromatography.

This webinar will demonstrate how HPH works, present initial results of up to a 2-fold increase in protein production, and how you can apply HPH specific to your product need or facility design.

 
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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. Learn More

 
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Regulatory Alert



Pazdur, Marks and Woodcock Discuss What's Coming at the FDA 

Three of the U.S. Food and Drug Administration's (FDA) directors - Richard Pazdur, Peter Marks and Janet Woodcock - took the stage this week at Prevision Policy's Biopharma Congress to discuss all things FDA - from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers. The views they shared on everything from real-time review to manufacuring practices and more can be found at RAPS. Learn More

Discovery Alert



Synthetic DNA-Delivered Antibodies Protect Against Ebola in Preclinical Studies

Scientists at The Wistar Institute and collaborators have successfully engineered novel DNA-encoded monoclonal antibodies (DMAbs) targeting Zaire Ebolavirus that were effective in preclinical models. Study results, published online in Cell Reports, showed that DMAbs were expressed over a wide window of time and offered complete and long-term protection against lethal virus challenges. DMAbs may also provide a novel powerful platform for rapid screening of monoclonal antibodies enhancing preclinical development. Learn More

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Abzena Investing $20M Into Expansion of Manufacturing Capacity
 
Abzena CEO Dr. Jonathan Goldman has announced that the biotech has augmented its existing 500L scale biologics equipment with a $20 Million investment into two new manufacturing suites at 500 L and 2000 L scale in a new GMP facility in San Diego, which will be equipped with Sartorius single use bioreactors. Abzena's existing focus on cell line development is strengthened with a new ambr 15 automated high throughput bioreactor in Cambridge, UK, and existing synthetic chemistry capacity is increased with build out of a fully equipped multifume hood laboratory in Pennsylvania.

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