BALTIMORE, Jan. 27, 2022 /PRNewswire/ -- CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today it has been awarded a $50,000 grant by the Children's Hospital of Philadelphia-based Pennsylvania Pediatric Medical Device Consortium ("PPDC") for its PUMA-G Peds System, a device designed to provide a safer way to place feeding tubes in children.

The PUMA System™ is a new category of minimally invasive devices, enabling ultrasound procedures in hollow organs of the body where previously it was impossible or unsafe to do so. The PUMA-G Peds System is being developed to allow ultrasound-based placement of gastrostomy tubes in pediatric patients as an alternative to traditional endoscopic or fluoroscopic procedures. Endoscopic procedures cannot "see through" tissue which can result in organ damage or other complications. Fluoroscopic procedures require the use of ionizing radiation which presents long term risk of cancer. The PUMA-G Peds System uses ultrasound to visualize tissue and organs in real time without ionizing radiation. It is designed to operate like the currently available adult PUMA-G System, with modifications to accommodate the pediatric patient population. 

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, Wednesday, January 26, 2022) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases today announces approval from the United States Food and Drug Administration (FDA) of KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

HILDEN, Germany, & GERMANTOWN, Md.--(BUSINESS WIRE)-- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has completed a U.S. government contract to equip public health laboratories across the country with the QIAcuity digital PCR system to monitor the spread of the COVID-19 pandemic by testing wastewater for the presence of SARS-CoV-2 pathogens.

QIAGEN has shipped more than 35 QIAcuity systems to state and local health laboratories as part of a multi-million-dollar contract with the U.S. National Institutes of Health (NIH) to supply COVID-19 instruments and consumables through the end of 2021.

The pandemic, now approaching year three in full force, has impacted nearly every facet of the life sciences’ job market. A talent shortage existed pre-pandemic and has only accelerated since then. For life sciences employers, finding and securing talent will continue to be a major challenge throughout 2022. 

At the University System of Maryland, January brings with it the chance to reflect on a year of accomplishment and anticipate a year of impact. Because, despite the challenges of the past several months, we’re still doing the work we were built to do. Our students are excelling. Our scholarship is making change. Our research is solving problems. Our service is improving lives.

This is a direct credit to the people of the USM. As COVID upended our academic enterprise and administrative operations, our people kept working harder, with a clarity of purpose and a devotion to mission that is, to me, breathtaking. The achievements and ambitions I share here honor their dedication.

The SEED Innovator Support Team helps NIH awardees build a business and explore their life science innovation's potential. Learn about the aspects of product development beyond the science of the awards. 

Regulatory & Business Development Consultations

Our business development, intellectual property, regulatory, and reimbursement experts meet with innovators focused on topics including:

• Optimizing formulation or manufacturing operations 
• Establishing an advisory board  
• Layering intellectual property protection 
• Preparing for regulatory interactions 
• Gathering evidence to support reimbursement value 
• Engaging with investors or strategic partners

Gaithersburg, Md., January 25, 2022 – Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, today announced that it has dosed the first patient in a Phase 1/2a multicenter clinical study evaluating Descartes-25 in patients with multiple myeloma.  To the company’s knowledge, Descartes-25 is the first off-the-shelf RNA cell therapy to enter clinical trials for any cancer and marks the company’s fifth FDA Investigational New Drug (IND) allowance in five years.  Descartes-25 is produced at Cartesian’s wholly owned cGMP manufacturing facility with the company’s proprietary RNA Armory® cell manufacturing platform.  This platform now includes an internally developed, Part 1271-compliant Master Cell Bank of human umbilical cord Mesenchymal Stem Cells (MSC) that was used to engineer Descartes-25.

Bill visits BioTalk to talk about being a serial entrepreneur, biotech executive, and their recent acquisition of Avidea Technologies.

Listen now via Apple https://apple.co/3fTySQM, Google https://bit.ly/3KDPMkh, Spotify https://spoti.fi/3rI7UB3, Amazon https://amzn.to/33DwOtH, or TuneIn https://bit.ly/3fS8C9f.

UKidney™ procedure data published in the American Journal of Transplantation; the first such data published in a peer-reviewed journal

UHeart™ recipient patient reaches a two-week milestone post-transplant

UThymoKidney™ procedure represents a historic first preclinical human model study

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (UT) (Nasdaq: UTHR), a public benefit corporation with a purpose to provide a brighter future for patients, announced today that the world's first recipient of an investigational genetically-modified xenotransplanted organ, UT’s UHeart™, reached a two-week milestone. University of Maryland School of Medicine (UMSOM) surgeons report continued post-operative cardiovascular improvement in the patient with normal organ function. In addition, the first peer-reviewed publication of a similarly gene-edited investigational xenograft, UT’s UKidney™, in a human preclinical model at the University of Alabama at Birmingham Marnix E. Heersink School of Medicine (UAB) was published yesterday in the American Journal of Transplantation.

The Biotechnology Innovation Organization (BIO) provides a glimpse of economic development in the biosciences ecosystem at the state and regional levels. The report, which was developed in partnership with the Council of State Bioscience Associations (CSBA), was released as an industry analysis in the wake of the COVID-19 pandemic and its impact on the overall economy. 

UMBC has received a $900,000 grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to develop and implement a new, short-term biomanufacturing training program. Four universities, all classified as minority-serving institutions (MSIs), received funding for similar programs, designed to meet critical national workforce needs. 

Image: Charmaine Hipolito ’20, and Titina Sirak ’20, right, alumni of UMBC’s TLST program at The Universities at Shady Grove, speak with visitors at a celebration for the opening of USG’s new Biomedical Sciences and Engineering Building in November 2019. Photo by Marlayna Demond ’11 for UMBC.

Proof-of-concept of exosomes manufacturing in scale-X™ bioreactor to demonstrate advantages of intensified and integrated platforms. RoosterBio to leverage scalable, continuous bioprocessing technologies to deliver regenerative therapies at reduced timelines and costs, improving access for patients.  

FREDERICK, MD. (PRWEB) JANUARY 20, 2022

Univercells Technologies, a leading provider of novel biomanufacturing technologies for flexible and scalable viral production, announces today a strategic partnership with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and hMSC bioprocess systems. This partnership will optimize manufacturing of extracellular vesicles (EVs) using scalable and continuous bioprocessing technologies to propel the commercialization of regenerative therapies at affordable costs.  

Time for a Concerted Effort to Explore Manufacturing in Microgravity Environments

Space is emerging as the next frontier for advanced manufacturing. The market alone for biomanufacturing in space is expected to reach nearly $3 billion by the mid-2030s. Similar microgravity markets exist in other engineering and technology areas.

Accordingly, the administration and Congress need a coordinated effort to take advantage of the incredible opportunity of manufacturing at scale in the microgravity environment. As a recent gathering of corporations, federal agencies, scientists, and engineers examining biomanufacturing in space noted: “The formation of a public-private consortium is needed to further prioritize opportunities, de-risk space-based research and development (R&D) and guide the translation of results into commercial applications on Earth.”

So, you just had a $5 billion venture capital year. Now what? With the final numbers for Q4 finally in, we can say with certainty that DC had a record-breaking year for investment across the board. To the tune of $4.9 billion, venture capital sang in 2021, with deals growing larger as the year went on.

For some scale, note that the DMV raised just under $2 billion in all of 2020, meaning it more than doubled its dollars in a year. It’s not alone in the bump, though. Nearby Baltimore had its best (albeit much smaller) year in recent history at $768 million and Philadelphia did, too, with a casual $8 billion raised.

Image: (Photo by Flickr user, used via a Creative Commons license)

A life sciences building in downtown Bethesda seemed like a slam dunk when StonebridgeCarras and Donohoe Cos. first proposed it in 2018. The site at 8280 Wisconsin Ave. was located close to the National Institutes of Health, the largest source of life sciences funding in the country, and in an urbanized core primed to attract a vibrant millennial workforce.

Image: Bisnow/Jon Banister A view looking down Wisconsin Avenue in Bethesda with Carr’s The Wilson and The Elm development in the background.

The University of Maryland has again ranked among the top 10 research institutions in the National Science Foundation’s (NSF) Higher Education Research and Development (HERD) Survey, placing 10th among public institutions in research and development (R&D) spending and 16th overall nationally for Fiscal Year 2020.

Center will expand Orgenesis’ Point of Care (POCare) Platform Capabilities in Maryland GERMANTOWN, Md., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, and The Johns Hopkins University, today announce the next phase of their collaboration. This new phase involves construction of a cell and gene therapy processing facility for point of care treatment of patients at Johns Hopkins which is planned to start in Q2 2022 and is expected to be operational in Q2 of 2023.

Construction of the new POCare Center, also known as the Maryland Center for Cell Therapy Manufacturing, has been funded in part by a $5 million grant from the State of Maryland. The new state-of-the-art 7,000-square-foot facility has been designed to meet U.S. Food and Drug Administration standards and provides Johns Hopkins clinicians and researchers with a more streamlined path to treat patients and take promising and novel treatments from the lab to patient trials. This path will enable local capacity for processing of clinical therapeutics at the point of care, rather than having to outsource clinical trial cell and gene therapy manufacturing to third parties.

Wednesday, February 02, 2022, 12:00pm - 01:30pm

Winning over a hospital Value Analysis Committee or “VAC” is a must for companies targeting hospital customers.

What does it take?

Who makes up VACs?

Case studies, lecture format + Q/A time.

Wednesday, February 2, 2022 12pm – 1:30pm EST

via webinar

To learn more click here.

Jonny’s back! Despite the continuation of COVID -19 through 2021, 2021 was a spectacular year for venture fundraising.  Investment in every healthcare sector set records, and most experienced record IPO activity as well. 

With pullback in both investments and public market performance in late 2021, what will 2022 have in store? Jon will provide his unique insights into 2021s market performance and his crystal ball predictions for 2022,

The Developing and Accelerating Age-Tech and Digital Health Solutions webinar series, hosted by NIA’s Small Business Program, offers research entrepreneurs and biotech small business owners insights and best practices for digital health and age-tech solutions. The Understanding the Fundamentals of the Longevity Economy Market session provides guidance on developing and positioning your solutions, defining customer market segments, understanding reimbursement pathways, and creating a profitable and impactful business model.

https://www.youtube.com/watch?v=IcbPXa0_NOY

One month after being acquired in a $40 million deal by U.K.-based Vaccitech plc, the team that was formerly part of Avidea Technologies continues to advance its SNAPvax platform into the crucible of clinical trials in about one year.

Privately-held Avidea is developing next-generation T cell immunotherapies for the treatment of cancer and autoimmune diseases. The company’s immunotherapies are driven by its polymer-drug conjugate technology platform, SNAPvax, which is designed to co-deliver multiple antigens and immunomodulators in nanoparticles of precise, programmable size and composition.

Image: https://biobuzz.io/

DNA or RNA-based diagnostic tests for infectious diseases are critical in modern medicine. The current gold standard for COVID-19 detection is testing SARS-CoV-2 viral RNA by quantitative reverse transcription Polymerase Chain Reaction (RT-qPCR). This method involves patient sample collection with a nasopharyngeal swab, storage of the swab in a universal transport medium during transport to a testing site, RNA extraction, and analysis of the extracted RNA sample. Collected patient samples, in addition to the possible presence of SARS-CoV-2, also contain inhibitors for downstream enzymatic reactions, RNA degrading enzymes (e.g., RNase), and magnesium and calcium ions that are required for RNase activity. Active RNase in the patient sample can reduce the amount of SARS-CoV-2 RNA in the sample; so, the RNA needs to be extracted for analysis.

Dr. David Hackam and his lab are utilizing human stem cell technologies to tackle the leading cause of death and disability in premature infants, necrotizing enterocolitis (NEC), as well as other chronic intestinal conditions that affect children and adults. As the Chief of Pediatric Surgery at Johns Hopkins University and Surgeon-in-Chief of Johns Hopkins Children's Center, Dr. Hackam knows firsthand the complicated neonatal surgery and the devastating long-term effects that result from NEC.

Prize Competition for Maternal Health

NIBIB launched the NIH Technology Accelerator Challenge (NTAC) series of prize competitions to stimulate the design of new diagnostic technologies to transform public and global health and to accelerate the full development of those products for use in low-resource settings. This iteration of NTAC intends to award cash prizes for innovative diagnostic technologies to help improve maternal health by diagnosing conditions related to maternal morbidity and mortality. Pregnancy and childbirth complications are a major global health problem resulting in the deaths of more than 800 women and 7,000 newborns each day. Contributing to the high rates of maternal morbidity and mortality in low-resource settings is the lack of low-cost diagnostics that operate at the point-of-care and are capable of detecting and differentiating common conditions during antenatal and intrapartum periods of pregnancy. Therefore, the intended purpose of NTAC: Maternal Health is to spur and reward the development of low-cost, point-of-care molecular, cellular, and/or metabolic sensing and diagnostic technologies integrated with a digital platform to guide rapid clinical decision-making, improve patient outcomes, and ultimately prevent maternal morbidity and mortality.

Monoclonal antibodies (mAbs) have proven effective for the treatment of ebolavirus infection in humans, with two mAb-based drugs Inmazeb™ and Ebanga™ receiving FDA approval in 2020. While these drugs represent a major advance in the field of filoviral therapeutics, they are composed of antibodies with single-species specificity for Zaire ebolavirus. The Ebolavirus genus includes five additional species, two of which, Bundibugyo ebolavirus and Sudan ebolavirus, have caused severe disease and significant outbreaks in the past. There are several recently identified broadly neutralizing ebolavirus antibodies, including some in the clinical development pipeline, that have demonstrated broad protection in preclinical studies.

Image: https://www.frontiersin.org

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.

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

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

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.”

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.

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.  

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.

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  

-- 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."

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.