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JHU revises COVID-19 safety protocols ahead of spring semester | Hub

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Johns Hopkins University is revising its safety protocols ahead of the start of the spring semester as it prepares to resume a broad range of in-person academic, research, and other activities as safely as possible amid the surge in COVID-19 cases caused by the omicron variant, university leaders said Friday.

The most noticeable change is to the university’s masking requirement: JHU will now require the use of N95s, KN95s, or a combination of a cloth mask with a surgical mask. In other words, a cloth mask alone or a surgical mask alone will no longer meet the university’s mask requirement, wrote Stephen Gange, professor and executive vice provost for academic affairs; Jon Links, professor, vice provost, and chief risk officer; and Kevin Shollenberger, vice provost for student health and well-being and interim vice provost for student affairs in a message to the JHU community on Jan. 14.

 

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One Of America’s Richest Self-Made Women, Martine Rothblatt, Played Key Role In Week’s Historic Heart Transplant

https://en.wikipedia.org/wiki/Martine_Rothblatt

https://en.wikipedia.org/wiki/Martine_Rothblatt

When the University of Maryland Medical Center announced the first successful transplant of a heart that was grown in a genetically altered pig earlier this week, it notched a big win for one of America’s wealthiest self-made women.

Revivicor, a subsidiary of United Therapeutics–founded and led by Martine Rothblatt – supplied the heart that made the surgery possible. A former communications satellite lawyer who went on to cofound Sirius Satellite Radio, Rothblatt, 67,  has  been on a long journey to biotechnology success.  

Image: https://en.wikipedia.org/wiki/Martine_Rothblatt

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First pig-to-human heart transplant: what can scientists learn?

Surgeons at the University of Maryland Medical Center transplanted a genetically altered pig heart into David Bennett.Credit: University of Maryland School of Medicine

Surgeons at the University of Maryland Medical Center transplanted a genetically altered pig heart into David Bennett.Credit: University of Maryland School of Medicine

The first person to receive a transplanted heart from a genetically modified pig is doing well after the procedure last week in Baltimore, Maryland. Transplant surgeons hope the advance will enable them to give more people animal organs, but many ethical and technical hurdles remain.

“It’s been a long road to get to this point, and it’s very exciting we are at a point where a group was ready to try this,” says Megan Sykes, a surgeon and immunologist at Columbia University in New York City. “I think there’s going to be a lot of interesting things to be learned.”

Image: Surgeons at the University of Maryland Medical Center transplanted a genetically altered pig heart into David Bennett.Credit: University of Maryland School of Medicine

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Founder and Executive Chairman of Emergent BioSolutions Announces Retirement

emergent logo

emergent logo

GAITHERSBURG, Md., Jan. 14, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that Fuad El-Hibri, founder and executive chairman, has decided to retire effective April 1, 2022.

“Creating and leading Emergent has been the honor of my life, and it would not have been possible without the help of our incredible team,” said El-Hibri. “I want to thank everyone at Emergent, past and present, for helping advance our inspiring mission over the past two decades. I could never have imagined the number of lives we would impact, and I will forever be proud of our accomplishments. Emergent is on track to achieving its 2024 strategic plan goals and I have utmost confidence in the executive team under the leadership of Bob Kramer and the oversight of our highly experienced and capable board. While I have been looking forward to retirement after 23 years of service, I will be rooting from the sidelines as a fan, friend, and shareholder.”

 

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BioSpace: Cartesian Aims to Propel RNA Cell Therapy with Combinations

Cartesian Therapeutics Logo

Cartesian Therapeutics Logo

Published: Jan 07, 2022 By Gail Dutton  

Cartesian Therapeutics is developing non-permanent cell therapies that can be used soon after diagnosis and address a wide range of diseases beyond cancer. The biotech’s approach to cell engineering relies upon RNA rather than DNA to effect changes within the cells.  

The benefit, Cartesian President and CEO Murat Kalayoglu, M.D., Ph.D. told BioSpace, is that “our RNA approach, compared to a traditional DNA modification, offers an order of magnitude greater control over the therapeutic product and what happens when those cells are in the body.” A high level of control is important if cell therapy is to be used in the treatment of either front-line cancer or in indications where the choice isn’t between life and death.  

“RNA has a measurable half-life,” Kalayoglu explained, so cell therapies driven by RNA aren’t permanent. “The cells can’t proliferate out of control.” Consequently, Cartesian can develop cell therapy for newly diagnosed populations and for autoimmune, respiratory and inflammatory diseases, for example.  

Click here to read more via BioSpace.

Institute for Bioscience and Biotechnology Research Receives $16.8M Investment from the National Institute of Standards and Technology

Institute for Bioscience and Biotechnology Research Logo

Institute for Bioscience and Biotechnology Research Logo

Fri, Jan 14, 2022  

New Cooperative Agreement to Aid in the Development of Therapeutics and Vaccines, Improve Access to Medication  

The Institute for Bioscience and Biotechnology Research (IBBR) announces a newly funded five-year cooperative agreement with the National Institute of Standards and Technology (NIST) headed by the Co-Directors of IBBR, Dr. David J. Weber (PI) and Dr. John Marino (NIST). This award provides more than $3.3 million each year to support groundbreaking research, including technology and standards development that will impact vaccine and therapeutic discovery and development, and to improve access to life-saving treatments for addressing other crucial health challenges.  

IBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore and NIST. Research born out of this new cooperative agreement will be applied to accelerating the development and manufacturing of new pharmaceutical and vaccine approaches including cell and gene therapies and mRNA vaccines.  This type of bioscience and bioengineering research will enable robust and rapid responses to pandemics and help remove obstacles to care and treatment related to rare childhood diseases and complex cancers.  

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Unblock research bottlenecks with non-profit start-ups

Mouse neurons imaged using a method similar to one being developed as a high-throughput tool by a focused research organization. Credit: P. W. Tillberg et al./Nature Biotechnol.

Mouse neurons imaged using a method similar to one being developed as a high-throughput tool by a focused research organization. Credit: P. W. Tillberg et al./Nature Biotechnol.

It takes more than a great idea to accomplish a great project. Our research and experience have convinced us that many worthy projects wither or are never launched because neither academic laboratories, start-up firms nor government facilities can support them.

This applies particularly to projects that would produce public goods, such as data sets or tools, that could make research faster and easier. Few research-enabling projects will be commercially viable enough to attract venture capital.

Image: Mouse neurons imaged using a method similar to one being developed as a high-throughput tool by a focused research organization. Credit: P. W. Tillberg et al./Nature Biotechnol.

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Cartesian Aims to Propel RNA Cell Therapy with Combinations | BioSpace

Cartesian President and CEO Murat Kalayoglu, M.D., Ph.D./Courtesy Cartesian Therapeutics

Cartesian Therapeutics is developing non-permanent cell therapies that can be used soon after diagnosis and address a wide range of diseases beyond cancer. The biotech’s approach to cell engineering relies upon RNA rather than DNA to effect changes within the cells.

The benefit, Cartesian President and CEO Murat Kalayoglu, M.D., Ph.D. told BioSpace, is that “our RNA approach, compared to a traditional DNA modification, offers an order of magnitude greater control over the therapeutic product and what happens when those cells are in the body.” A high level of control is important if cell therapy is to be used in the treatment of either front-line cancer or in indications where the choice isn’t between life and death.

Image: Cartesian President and CEO Murat Kalayoglu, M.D., Ph.D./Courtesy Cartesian Therapeutics  

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South Korea Ministry of Food and Drug Safety Approves Novavax COVID-19 Vaccine – Jan 12, 2022

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novavax-logo

— Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) is the first protein-based COVID-19 vaccine granted approval in South Korea

GAITHERSBURG, Md., Jan. 12, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited, a vaccine business subsidiary of Korea-based SK Group, today announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved a Biologics License Application (BLA) from SK bioscience for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. Nuvaxovid™, Novavax’ COVID-19 vaccine also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and will be manufactured and marketed in the country by SK bioscience.

“Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank our partners at SK bioscience for their commitment to this public health challenge and the MFDS for its thorough assessment of our data as we look forward to helping address major obstacles to controlling the pandemic through the additional option of our protein-based vaccine.”

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Chain Drug Review Pharmacy Outlook: Ronald Piervincenzi, USP

Ronald Piervincenzi

Ronald Piervincenzi

January 10, 2022 by Ronald Piervincenzi  

The COVID-19 pandemic made the last year both an extraordinary and challenging time to work in health care. Development, distribution and administration of new vaccines, treatments and preventatives moved at a pace never before experienced. Pharmacists and other health care practitioners were called to the front lines of a mass vaccination effort, working to balance safety, speed and a plethora of daily demands in caring for patients and working to save countless lives. Manufacturers, regulators, pharmacists and other care providers demonstrated how cross-sector collaboration could rapidly transform cutting-edge innovation into the new standard of care, including an expanding scope of practice for many pharmacists.  

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