This week’s headlines include: Zika virus wipes out two types of brain tumors in mice, Access to Biosimilars in EU Expected to Continue to Outpace US and Canada, CAR-T therapy could be available to NHS patients this year, Breakthrough Therapy Designation Is Granted by FDA for Pfizer’s MenB Vaccine In Children, and U.S. court upholds dismissal of $200 million Merck verdict against Gilead.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:Biosafety Risk Mitigation Plan Overview“… Flu vaccine grown without eggs provided measurably better protection this season, FDA says,” the FDA reported that the approved cell-culture based influenza vaccine performed about 20 percent better than the standard egg-based vaccines. This is due to the fact that the viruses have to adapt to grow in the eggs and with this adaptation can come mutations that render the vaccine less effective… World Vaccine Congress has played a prominent role in educating biotech industry leaders on the latest research, innovations, and advocacy in vaccine development. This year’s World Vaccine Congress took place April 2 – 5 in Washington D.C., with 1000+ attendees, 250+ speakers, and 60+ exhibitors. According to a conference organizer, this year’s congress was both the largest and most successful event to date, with a ~25% increase in overall attendance…
Intensify process development steps and simplify transfer to GMP environment with new ÄKTA pilot 600 chromatography systemThe bioprocess industry is leaving the blockbuster era. The strive to shorten time to market is constant, which puts pressure on the entire drug development process from research to manufacturing. With more drugs in pipeline, biomanufacturers need flexibility, efficient changeovers, and accelerated scale-up and transfer to the next development phase… Download the cell harvesting technology selection guide and use the guide to compare the latest single-use harvesting technologies...
- The industry trends and recommended approach for the assurance of integrity of single-use systems
- Available solutions for the highest level of assurance of integrity of SUS
- A new integrity test for Allegro 2D biocontainer assemblies
Professional Training:3rd – 5th July 2018. Attendees will learn about the different technologies available for continuous processing steps including cell separation, filtration and chromatography. The three day course is focussed on practical hands-on work in the laboratory with small class sizes. Further information can be found at http://www.bcc.ch/continuous-d
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“The mosquito-borne virus Zika ignited fears around the world more than two years ago due to its link to children born with the brain malformation known as microcephaly. But a handful of cancer researchers see potential in exploiting the Zika virus’ ability to infect the brain. Among them is a team at the University of São Paulo in Brazil, which is reporting promising evidence that the virus may be useful in treating two types of childhood brain tumors…”
“Breakthrough Therapy Designation Is Granted by FDA for Pfizer’s MenB Vaccine In Children,” MD Magazine
“Drug giant Bristol-Myers Squibb is partnering with Illumina, the leading maker of DNA sequencing gear, to develop diagnostic tests that will pair with Bristol’s cancer drugs. One of the first tests will be for tumor mutation burden, a measure of how much a tumor’s DNA has changed compared to the patient’s healthy cells. Cancer drugs that target the immune system, like Bristol’s Opdivo (2017 sales: $4.9 billion) and Yervoy (2017 sales: $1.2 billion), may work better in patients where the tumor mutation burden is higher, because this may make the cancer easier for the immune system to “see…”
“A U.S. appeals court on Wednesday affirmed a ruling that pharmaceutical company Merck & Co dishonestly obtained patent rights and was not entitled to collect a $200 million infringement verdict it won against rival Gilead Sciences Inc…”