Over the past nine months, more than $7 billion in federal funding has poured into the BioHealth Capital Region aimed at the battle against COVID-19 and has shown a spotlight on the broad impact biopharma life science companies and academic institutions are making in the fight against the pandemic.

“The moons are aligned over the BioHealth Capital Region right now and people are beginning to see how important the region is in helping to address the research development and manufacturing needs to address this dreaded disease,” said Richard Bendis, president and chief executive officer of BioHealth Innovation.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Korro Bio, Inc., a biotechnology company developing single-base RNA editing therapies, today announced the appointment of Ram Aiyar, Ph.D., MBA, as its chief executive officer. Dr. Aiyar brings nearly 20 years of diverse experience across company-building, biotech and pharma to advance Korro’s innovative RNA editing platform to treat previously intractable diseases. He will also serve on the company’s board of directors.

“Ram is a proven leader with a track record of driving growth and advancing programs,” said Nessan Bermingham, Ph.D., co-founder and executive chair of Korro. “His broad business experience across the life sciences complements our existing leadership team. We look forward to working closely with him to pioneer the future of RNA editing for medicines.”

Well just to lighten the mood I have just seen on my BBC news app that the Oxford University? Astra Zenaca group have just announced that they have tested 43,500 people from here and abroad and they are claiming that it prevents 90% of people getting Covid. They also announced there was no safety issues with this vaccine. Could this help life to start to get back to normal, they say they are approaching the government to start rolling it out next month, lets just hope this is the light at the end of a very dark tunnel.

BioNTech, the German biotech which announced an apparent vaccine to coronavirus on Monday, is a classic European startup story: created by Turkish immigrants, funded by US and Asian investors and listed on the Nasdaq.

Along with pharma giant Pfizer, BioNTech is the first drug maker to show successful results from clinical trials of a coronavirus vaccine. Trials on thousands of volunteers found no serious safety concerns, meaning the companies will seek emergency use authorisation for the vaccine in the US later this month. 

Research parks and innovation districts historically have played important roles in development of innovation ecosystems in places like Silicon Valley, Boston, and North Carolina's Research Triangle.

The DC/Md/Va region has strong universities and Federal labs, with a growing set of innovation parks and incubation facilities. Learn how communities of innovation are growing in the DC region through new research parks and contributing to a fuller range of technology commercialization activities.

Novavax Inc. has the option to raise up to $500 million in a possible stock offering as it shepherds its Covid-19 vaccine candidate through clinical trials, juggles its seasonal flu vaccine program and sees its stock sustain dramatic highs.

The Gaithersburg biotech said it could offer up to 5.37 million shares of common stock based on its Nov. 5 closing price of $93.11, according to documents filed Tuesday with the Securities and Exchange Commission. That follows Novavax’s sale earlier this year of 3.4 million shares of common stock, which brought in $238.3 million in net proceeds.

In this conversation, Rachel King and Dr. Michelle McMurry-Heath share stories underlying their careers in scientific innovation, from the lab bench to government, consulting, and venture capital; and their experiences as one of the few women CEOs in biotechnology. 

https://www.thinkmedium.com

Qiagen NV QGEN, -2.76% shares rose in the extended session Wednesday after the Netherlands-based medical diagnostics company said it will begin selling a portable COVID-19 test in the United States. Qiagen shares rose 4% after hours, following a 0.9% rise in the regular session to close at $46.51. Called the “QIAreach SARS-CoV-2 Antigen Test,” the company said the test can process up to 30 swab samples to detect antigens of SARS-CoV-2, the virus that causes COVID-19, in people who are actively infected with the virus in up to 15 minutes. The test was developed by Qiagen in partnership with Australian digital diagnostics company Ellume. Qiagen said the QIAreach “will be particularly valuable when vaccines are introduced.”

Richmond, VA, Nov. 11, 2020 (GLOBE NEWSWIRE) -- The Center for Innovative Technology announced the appointment of Sean Mallon as Vice President for its Entrepreneurial Ecosystems Division.  The division is one of four recently created at CIT in its role as the operating arm for the Virginia Innovation Partnership Authority (VIPA). The other three divisions are Investment, Commercialization, and Strategic Initiatives.

The Entrepreneurial Ecosystems Division was established to connect and leverage the expertise and infrastructure of Virginia-based partner organizations and will work with stakeholders to develop and strengthen programs that support entrepreneurs in all regions of the Commonwealth. As Division VP, Mallon’s responsibilities will include developing a backbone of statewide resources to assist regional ecosystems and ensure that all programs are inclusive to communities that have been historically under-represented in entrepreneurship and capital formation. Mallon will be based in CIT’s Richmond headquarters office.

The Universities at Shady Grove (USG) marks its 20th anniversary this year and the campus has launched a new chapter in its history with the appointment of Dr. Anne Khademian as USG's third executive director. Khademian, who joins USG after 17 years with Virginia Tech University, begins her tenure at a challenging time as USG and its partner universities grapple with the challenges of the COVID-19 crisis. But she is making rapid inroads in building strong relationships with colleagues and community leaders, and in laying out some of her initial priorities for advancing USG into the future. They include a continued focus on ensuring student success, and on strengthening the future of USG, which she sees as a unique asset for bolstering economic and workforce development in Montgomery County, the state of Maryland and throughout the D.C. metropolitan region.

The State Technology and Science Index (STSI) provides a benchmark for evaluating the knowledge economies of all 50 US states. The index compares each state’s capacity for achieving prosperity through scientific discovery and technological innovation, by performing a cross-sectional analysis of their rankings on key indicators using the latest available data from US federal government and private-sector sources.

The index is a composite of five sub-indexes, which cover a diverse range of topics: research and development (R&D) inputs, risk capital and entrepreneurial infrastructure, human capital investment, technology and science workforce, and technology concentration and dynamism. By comparing how states rank in these areas, the index assesses their capacities for generating new scientific ideas, as well as for commercializing technologies that contribute to firm expansion, high-skills job creation, and broad-based economic growth.

MENLO PARK, Calif., Nov. 12, 2020 /PRNewswire/ -- Talis Biomedical Corporation, a company dedicated to developing innovative molecular diagnostic tests for infectious diseases at the point of care, today announced it has strengthened its executive management team with the appointment of Rob Kelley as its first Chief Commercial Officer and Douglas Liu as Senior Vice President, Operations. Additionally, it has closed a new $126 million financing to support expansion of its operations and the commercial scale-up of the Talis One™ System and further expand the test menu. The Talis One System is a sample-to-answer, cloud-enabled, molecular diagnostic platform designed to provide rapid and highly accurate point-of-care tests for the detection of infectious diseases, including COVID-19.

The Biomedical Advanced Research and Development Authority (BARDA) is innovating in terms of how it will invest in projects, creating a new public-private partnership known as BARDA Ventures, based on the 21st Century Cures Act and venture capital methods.

As a result, BARDA seeks proposals from existing nonprofit partners to manage a long term health security fund no later than Dec. 8, 2020. That fund will be used to guarantee support for breakthrough technologies and new means of preparedness and response to health security threats. This, the organization hopes, will help its ability to stimulate innovation and promote disruptive technologies to close gaps in pandemic response and other healthcare preparedness.

Operation Warp Speed, the U.S. government's crash program to inoculate 300 million Americans against the coronavirus, includes a number of pharmaceutical partners like Emergent BioSolutions in Baltimore. CBS News correspondent David Martin toured one of Emergent's manufacturing suites where the company is producing two COVID-19 vaccines awaiting FDA approval. 

Novavax Inc. (NASDAQ: NVAX) said Monday it received a crucial status for its Covid-19 vaccine candidate as the pandemic drags on and coronavirus cases once again soar across the country.

The Gaithersburg company has earned fast-track designation from the Food and Drug Administration for NVX-CoV2373, a coronavirus vaccine candidate in late-stage development. It means the biotech can submit parts of its application on a rolling basis for a speedier review by the agency, and gives Novavax more direct and frequent access to the FDA.

Listen now on Apple https://apple.co/36iBbrp, Google https://bit.ly/32rZdiq, Spotify https://spoti.fi/2U7HEzs, and TuneIn https://bit.ly/3eOtb5i.

Praduman Jain, known to colleagues as “PJ,” is CEO and Founder of Vibrent Health and the Principal Investigator of the Participant Technology Systems Center of the National Institutes of Health Precision Medicine Initiative, the All of Us Research Program, for which the PTSC received a $75 million grant in 2017 and an additional award in 2020 with initial first-year funding of $39 million to build a national platform for health research and health management insights for 1 million people across the U.S. for at least 10 years.  Jain is also the Chair of the Security Board of the Committee on Access, Privacy & Security for the NIH All of Us Research Program; a member of the Roundtable on Genomics and Precision Health at the National Academies of Sciences, Engineering, and Medicine; an invited external expert for eMERGE & Beyond, The Future of Electronic Medical Records and Genomics program of the Division of Genomic Medicine, National Human Genome Research Institute; and an external advisory board member for iTHRIVE – a Virginia Clinical and Translational Science Award.

Biopharma and Life Science companies in the BioHealth Capital Region are known for their work with cutting edge technologies such as gene and cell therapies. Those strengths were on display at the 6th annual BioHealth Capital Region Forum.

The Strengths of our Region: Cutting Edge Therapies panel, which was moderated by Mark Cobbold, vice president of Discovery in Early Oncology at AstraZeneca, brought together leaders from three other companies to discuss their disruptive pipelines, the strength of the region and challenges brought by the COVID-19 pandemic. Cobbold touted the work performed by the three companies joining him on the panel, Cartesian Therapeutics, Adaptive Phage Therapeutics, and Ziel Bio. Pointing to the work being done by those three companies and AstraZeneca, Cobbold said they are representative of why the BioHealth Capital Region has become one of the most successful BioHubs in the United States.

If you’ve ever kept track of your steps or the quality of your sleep, you’re familiar with wearable sensor technology apps. It’s a big deal in the fitness and wellness space, but did you know it could help older adults remain independent as they age?

In 2007, Ashkan Vaziri, Ph.D.and a few friends started a company called BioSensics to execute their vision for technology to help older adults age in place. More than a decade later, the company’s success — spurred in part by small business funding from the National Institute on Aging (NIA) at the National Institutes of Health — has led to a partial acquisition by electronics retailer Best Buy and to a continuing pipeline of innovative research projects.

Keeping kids safe at home is more important than ever – including safely storing medicines. Especially, as many families are living a new normal with children spending more time at home due to the pandemic.

Every hour in the United States, 5 children under age 6 are rushed to emergency departments for medication poisonings, many due to unsafe storage practices. There has been a 142% increase in prescribed medications over the past two decades. At the same time, an aging population and drastic increase in three-generation households, kids living with their parents and grandparents, are likely contributing to approximately 200,000 children visiting emergency departments each year due to adverse drug events.

Johns Hopkins University launched its popular COVID-19 map on Jan. 22 — just 2 days after the first person in the United States was diagnosed with the novel coronavirus.

Exactly 8 months later, Healio and others cited the university’s COVID-19 dashboard on Sept. 22 when reporting that the U.S. had surpassed 200,000 deaths from COVID-19.

Image: https://www.healio.com

This year, more than ever before, we’ve seen just how important it is for us all to stay connected and work together to build a stronger biotech ecosystem. In the face of great adversity, the biotech community has risen to the challenge and formed new collaborations and partnerships to innovate and rapidly develop new medicines and tools to help us beat this pandemic. 

That’s why we decided that this year was the right time to launch the first annual BioBuzz Awards.  This is an opportunity for us all to revisit the accomplishments of the past year and recognize the leaders and companies in the region who are doing great things to build a stronger BioHealth Capital Region across Maryland, DC and Virginia, and are making an impact on human health.

Exact Sciences said today it has agreed to a pair of acquisitions designed to create a diagnostics powerhouse across multiple cancers.

In the larger acquisition, Exact Sciences said it agreed to acquire blood-based diagnostics developer Thrive Earlier Detection for up to $2.15 billion in cash and stock. Exact Sciences also said it completed a $410 million cash acquisition of Base Genomics, adding Base’s DNA methylation analysis technology, designed to detect cancer at its earliest stages.

Image: Exact Sciences has announced a pair of acquisitions totaling up to $2.5+ billion intended to broaden its cancer diagnostics technology and test offerings. The company has agreed to acquire blood-based diagnostics developer Thrive Earlier Detection for up to $2.15 billion in cash and stock, and has completed its $410 million cash purchase of Base Genomics, adding Base’s DNA methylation analysis technology. (Exact Sciences) 

“Somewhere past the pandemic” celebrates the 30-year partnership between The National Institutes of Health and The Children's Inn in caring for the children and young adults who participate in clinical research to help make new treatments and cures possible. Thank you, NIH Director Dr. Francis Collins, for recognizing this milestone with an original song! #INNitfor30

Image: https://www.linkedin.com - From Video

The rapid availability of effective medical countermeasures against chemical exposures, from either accidents or chemical weapons attack, is critical in the treatment of their acute health effects following exposures.

The ReDIRECT Program is a new initiative from the Biomedical Advanced Research and Development Authority (BARDA) which aims to identify existing, commonly available therapeutics that can be used to save lives during a chemical emergency.

The Small Business Innovative Research (SBIR) program provides grant or contract funding to small businesses seeking to commercialize innovative technologies. With $3.2 billion allotted to SBIR each year, there are twelve different agencies that have set aside SBIR funding. One agency is Health and Human Services which provides funding through the National Institutes of Health (NIH). NIH has three grant funding proposal deadlines a year. The next deadline is January 5, 2021. On the NIH/SBIR website, NIH states that the electronic submission process for grants can take from six to eight weeks, so this is a reminder to start now. Below are five key tips to help small businesses in their NIH SBIR electronic submission process.

Novavax (NASDAQ:NVAX) announced on Wednesday that it has reached an agreement to provide the Australian government with 40 million doses of its COVID-19 vaccine candidate, NVX-CoV2373, if it earns approval from health regulators. Two early clinical trials of the vaccine candidate were run in Australia, and so far, the results have been positive.

The small biotech has had notable success at finding governmental buyers for its coronavirus vaccine: Novavax has signed direct supply deals with the United States, the United Kingdom, and Canada, and through its distribution partnerships has arranged to supply NVX-CoV2373 to Japan, India, and South Korea as well.  

GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company’s rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. Novavax has secured two additional properties in Gaithersburg, Maryland to support the Company’s immediate need for additional laboratory and office space for manufacturing, R&D and business operations.

The Company currently has a large pivotal Phase 3 trial underway in the UK with another slated to begin in the United States and Mexico in November, as well as several Phase 2 trials ongoing and in the planning phases around the globe. Novavax has also created a global production network to enable manufacturing and rapid distribution across the U.S., Asia and Europe if and when its COVID-19 vaccine is approved for use. The Company also reported positive Phase 3 data for its influenza vaccine candidate, NanoFlu, earlier this year. Novavax has received $2 billion in funding for its COVID-19 vaccine efforts, including up to $1.6 billion from the U.S. government to help address the global pandemic and up to $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

Through a partnership with NIH, D.C. virtual reality startup Floreo is expanding from autism spectrum disorder to attention deficit hyperactivity disorder.

Image: Floreo's platform allows kids to practice skills such as pointing or eye contact, with a linked tablet for parents to follow along. COURTESY FLOREO

Sep 05, 2020 (IssueWire via COMTEX) -- San Diego, Sep 5, 2020 (Issuewire.com) - Jaan Biotherapeutics ("JBT"), announced that it has been awarded a Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute, part of the National Institutes of Health under Award Number R43HL154884. Under the Phase I grant, JBT intends to advance its lead cardiac muscle regeneration viral delivered drug, JBT-miR2 through preclinical testing in large animals. The first indication of JBT-miR2 is for the treatment of Ischemic Heart Disease (IHD), the single largest cause of death of both men and women in the Western World.

JBT-miR2 is a first in class viral delivered microRNA inhibitor that reprograms cardiac muscle cells to divide within the damaged heart, and repair the heart muscle after permanent heart muscle injury, for example following a heart attack.

ROCKVILLE, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NASDAQ:REXN) (“Rexahn”) announced today that at its special meeting of stockholders held on November 2, 2020, Rexahn’s stockholders approved all of the proposals presented, including: (i) the issuance of shares of Rexahn common stock pursuant to the Agreement and Plan of Merger and Reorganization, dated June 17, 2020, as amended, by and among Rexahn, Razor Merger Sub, Inc. and Ocuphire Pharma, Inc. (“Ocuphire”) and the change of control of Rexahn resulting from the merger; (ii) a reverse stock split of Rexahn common stock, at a ratio of one new share for every 3 to 5 shares outstanding, with such final ratio to be approved by Rexahn’s board of directors; (iii) changing the name of Rexahn from “Rexahn Pharmaceuticals, Inc.” to “Ocuphire Pharma, Inc.”; (iv) the adoption of the Ocuphire Pharma, Inc. 2020 Equity Incentive Plan; and (v) the issuance of shares of Rexahn common stock upon the exercise of warrants to be issued in the pre-merger financing and the issuance of additional shares of Rexahn common stock that may be issued following the closing of the pre-merger financing.

GAITHERSBURG, Md.--(BUSINESS WIRE)--Neuraly, Inc., a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease. NLY01 is also being evaluated in patients with Parkinson’s disease in a Phase 2 trial initiated in February 2020.

“Initiation of this Phase 2 study in Alzheimer’s disease represents an important milestone in the ongoing advancement of NLY01,” said Seulki Lee, Ph.D., President and Chief Executive Officer of Neuraly. “Alzheimer’s has proven to be a particularly challenging disease to address therapeutically. We believe that targeting neuroinflammation via this novel mechanism of action represents a compelling pathway with the potential to be a disease-modifying agent for both Alzheimer’s and Parkinson’s disease.”

Three Emmes employees were among the co-authors of the recent report, "Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults."  The employees are Jim Albert, lead project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician.

In its role as the statistical and data collection and coordination center, Emmes managed development of the statistical analysis plan and performed all data analysis. 

MADISON, Wis. and CAMBRIDGE, Mass., Oct. 27, 2020 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS) and Thrive Earlier Detection Corp. (“Thrive”), a healthcare company dedicated to incorporating earlier cancer detection into routine medical care, today announced they have entered into a definitive agreement under which Exact Sciences will acquire Thrive for cash and stock consideration of up to $2.15 billion. The transaction was unanimously approved by both companies’ Boards of Directors and is anticipated to close during the first quarter of 2021, subject to regulatory approval and the satisfaction of other conditions.

Combining Thrive’s pioneering early-stage screening test, CancerSEEK, with Exact Sciences’ best-in-class scientific platform, clinical organization, and commercial infrastructure will establish Exact Sciences as a leading competitor in blood-based, multi-cancer screening. Thrive, with an early version of CancerSEEK, has conducted a first-of-its-kind 10,000-patient, prospective, interventional study in a real-world clinical setting. In this landmark study, using its mutation and protein biomarker approach, CancerSEEK achieved promising results detecting 10 different types of cancer, including seven with no recommended screening guidelines, with very few false positives. Bringing together highly complementary scientific approaches and the strengths of both organizations, Exact Sciences expects to develop a more accurate test and accelerate the widespread adoption of this potentially life-saving advancement.https://d-1827656436805240469.ampproject.net/2010132225002/frame.htmlAd

Image: https://biobuzz.io

ROCKVILLE, Md., Oct. 27, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will receive a milestone payment of $80.0 million from Novartis AG based upon the achievement of $1.0 billion in cumulative net sales of Zolgensma. REGENXBIO expects to recognize this revenue in the third quarter of 2020.

"Zolgensma is a transformative, one-time gene therapy for the treatment of pediatric patients with SMA, a debilitating and potentially deadly disease, and the first approved gene therapy based on REGENXBIO's NAV Technology. We believe that this achievement provides further validation of the broad potential of NAV Technology to improve the lives of patients in need," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO.  "We are pleased to have contributed to a therapy that has impacted the lives of over 700 patients with SMA and their families around the world."