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."

Over the past nine months, more than $7 billion in federal money has poured into the BioHealth Capital Region in support of therapies, diagnostics, and vaccines against COVID-19. In that short time, the region has shown its importance in halting the spread of the ongoing pandemic.

At the 6th Annual BioHealth Capital Region Forum, COVID-19 was a central focus of attendees and panelists. One panel, Strength of Our Region: Combating Infectious Diseases, included representatives from four companies in the region that provided an overview of the region’s role in combating the novel coronavirus as well as other infectious threats. Company representatives from Novavax, Emergent BioSolutions, BioFactura, and Aperiomics pointed to the work conducted by their organizations in COVID, as well as other infectious diseases, including Ebola, influenza, RSV, and SARS. The panel was moderated by Karen Smith, chief medical officer of Emergent BioSolutions, who said she was struck early on in the pandemic that companies in the BioHealth Capital region battling the pandemic are “all in the same storm, just in slightly different boats.” She said they are all trying to figure out a solution to this pandemic but in different manners due to their areas of expertise.

ANNAPOLIS (WJZ) — A NIH initiative will fund a new Johns Hopkins center to research COVID-19 immunity as the pandemic continues to affect people of all ages.

The five-year grant will fund more than $2 million a year to the new Johns Hopkins Excellence in Pathogen to support the studies, to start immediately, the immune elements that determine whether people get mild or severe coronavirus after being exposed.

Image: https://baltimore.cbslocal.com - From Video

Greater Baltimore is one of few regions ideally suited to pioneer the future of digital health, an industry that will revolutionize healthcare as we know it. Companies in Greater Baltimore benefit from a rich ecosystem of healthcare assets that collectively provide every component necessary for digital health innovation: transformative research, specialized business incubation, access to funding, a talented workforce, and easily-accessible local and federal clients. The growing list of successes among Greater Baltimore's digital health companies and groundbreaking partnerships showcase tremendous potential for this industry to play a defining role in the Region and influence healthcare throughout the nation for decades to come. The pandemic has accelerated the development of digital health technologies.

ROCKVILLE, Md., Oct. 29, 2020 /PRNewswire/ -- Emmes today announced that the Montgomery County Chamber of Commerce has selected Emmes as the recipient of its 2020 Corporate Achievement Award.  Dr. Anne Lindblad, who recently retired as the company's president and chief executive officer, accepted the award at a virtual event hosted by the chamber on October 29.

According to Lowell Yoder, chairman of the Montgomery County Chamber of Commerce and M&T Bank's group vice president for the Greater Washington Market, "Over the years, Emmes has set high standards for financial performance, sound management, and sustained growth – while contributing significantly to our community along the way."

Leverage the only verified source of angel investment data to anticipate future trends with the Angel Funders Report 2020!

The Angel Funders Report 2020 is the only source of verified data provided directly by active angel investing groups. The report is based on information collected from a variety of ACA member groups, including some of the most active investing communities. It analyzes angel capital investments made during 2019, and features profiles and insights from leading angel investors and startup company executives. The Angel Funders Report 2020 also includes initial perspectives regarding the impact of the COVID-19 pandemic on the investing ecosystem.

The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZeneca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555).

The U.S. Department of Defense (DoD) disclosed yesterday that the Army this week awarded firm-fixed-price contracts of $312.5 million with Lilly (W911QY-21-C-0016) on Tuesday, and more than $286.9 million with AstraZeneca (W15QKN-21-C-0003) on Wednesday. The contracts, awarded by U.S. Army Contracting Command, cover an unspecified quantity of bamlanivimab to be made at a Lilly production site in Indianapolis; and 200 million doses of AZD1222 to be produced at AstraZeneca sites in West Chester Township, OH, and Albuquerque, NM.

Image: Spc. Selena M. Castillo prepares to administer a flu vaccination on Fort Sill, Okla., Nov. 15, 2019. Spc. Castillo is a medic for 3rd Battalion, 2nd Air Defense Artillery Regiment, 31st Air Defense Artillery Brigade. The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZenca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555). (Photo By: Army Sgt. Amanda Hunt, U.S. Department of Defense)

Fina Biosolutions has been issued European patent No. 3099800, Expression and Purification of CRM Proteins and Related Proteins, and Protein Domains. The patent covers expression of the conjugate vaccine carrier protein CRM197 in our E. coli strain engineered to have an oxidative cytoplasm. FinaBio markets the E. coli expressed CRM197 under the name EcoCRM®.

The Glocal Innovation Life Sciences Meet-Up is run by the UK/Europe based #coffeebuddies online Thought-Leadership community. This is headed by Prof Tony Sedgwick and Graham Combe, and has an Agile Leaders Advisory Board of 18 life science innovation leaders and investors.

This Meet-Up has been inspired by huge advances in technology that allow us to connect, engage, inspire and entertain life science professionals from around the world. There are no boundaries for our abilities to connect and network with other global Thought-Leaders. We started with connecting our #coffeebuddies community with networks in Australia and NZ which is a phenomenal success. This event is the first in the series where we connect with the East Coast of the Americas.

WAKEFIELD, Mass. and FAIRFAX, Va., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, and George Mason University’s (Mason’s) National Center for Biodefense and Infectious Diseases (NCBID), today jointly announce completion of extensive laboratory testing supporting anti-SARS-CoV-2 activity of Brilacidin, a defensin-mimetic drug candidate, which is being developed as a potential COVID-19 treatment.

Research findings are being submitted for peer-review publication. A preprint, available for download at the link below, is in the process of being posted to bioRxiv.org.

When all the votes are cast and counted in this year’s momentous November 3 election, the results will have deep and potentially long-lasting impacts on numerous areas of society, including science. President Donald Trump and his challenger, former vice president Joe Biden, have presented vastly different visions for handling crucial issues—ranging from the deadly coronavirus pandemic to the damaging impacts of climate change and immigration policies.

Have you heard of a little thing called Covid-19? So has Big Pharma, and the race to develop a vaccine is on. It’s high-stakes geopolitical chess and every country and company involved badly wants to win, including Anglo-Swedish drugmaker AstraZeneca.

When Oxford’s Jenner Institute partnered with AstraZeneca on its vaccine candidate, ChAdOx1 nCoV-19, analysts scratched their heads. AstraZeneca is not a leader in vaccines, unlike its major UK competitor GlaxoSmithKline. It’s relatively small and has a tumultuous history. But if you look, the signs are there that AstraZeneca is building a blueprint to thrive as a 21st century pharma company.

What is BARDA Industry Day?

BARDA Industry Day is the annual meeting held to increase potential partner’s awareness of U.S. Government medical countermeasure priorities, interact with BARDA and ASPR staff, and network with public and private sector colleagues working in the Health Security space. This year,  BARDA Industry Day 2020 will be virtual and will feature one day of exciting speakers, breakout sessions, and valuable networking opportunities!

After posting positive results from a midstage test for its RNAi candidate back in the spring, Sirnaomics has grabbed a $105 million series D round.

The cash boost, co-led by existing investor Rotating Boulder Fund, new investor Walvax Biotechnology Co. Ltd. and Sunshine Riverhead Capital, will go toward the biotech seeking to push deeper into the clinic and one day follow rival and RNA pioneer Alnylam to regulatory approval.

The $105 million will be put toward that R&D process for its RNAi therapeutics, which are on tap to treat a diverse range of diseases including cancers, fibrosis diseases, metabolic diseases and viral infections.

What happens when you fund Black Founders? With $100K funding & support from Google for Startups Black Founders Fund, TruGenomix plans to further advance its efforts to bring earlier diagnosis & treatment for behavioral health disorders like PTSD to military, veterans, first responders, healthcare workers & trauma-exposed communities at large. This is why the initiative matters: https://goo.gle/2SqjS10

Scott Carmer, CEO of NexImmune, joins BioTalk to discuss his career in the BioHealth Capital Region, recent Milestones, and his Long-Term Vision for the company

Listen now via Apple https://apple.co/3kxdC3J, Google https://bit.ly/31FlUPB, Spotify https://spoti.fi/3kuVszD, or TuneIN https://bit.ly/2TqqD3f

Last week, the Department of Defense (DOD) announced a seven-year award of $87 million for a new Manufacturing USA institute: BioMADE. The BioIndustrial Manufacturing and Design Ecosystem (BioMADE) institute joins a network of 8 other DOD institutes, making for a total of 16 institutes supported across the federal government in the Manufacturing USA program. ASME has been a long-time supporter and advocate of the Manufacturing USA program.

Different geographies and jurisdictions play different roles in the global economy. Some specialize in what economists call “seedbed” functions—generating new products and firms, often through cutting-edge innovation. Others specialize in corporate functions by offering attractive environments for company headquarters or other management activities. Still others specialize in more routine production functions for goods or services, handling aspects of the work that involve less innovation and have lower skill requirements. Finally, some regions specialize in resource production tied to geographical endowments, such as minerals, arable land, or lumber.

In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look at COVID-19’s impact on Medicare telehealth. Other articles include: the next installment in the series of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for entrepreneurs; the Bayh-Dole Act turns 40; and the lack of public guidance available regarding COVID-19 related apps.

A few months ago, we all woke up to a new reality as COVID-19 changed everything. Personally, I shut down one of my startups while one of my portfolio’s startups boomed and a close friend — who had closed a large Series B in January — fired a third of her employees.

Then I saw community members rise to the occasion, taking action to help others, and governments acting faster than ever to enact bold and effective policy. Clearly, we are the ones we’ve been waiting for. It’s in our hands as a global community to shape how this will play out.

Rockville, Md.—Autonomous Therapeutics, Inc. (ATI), a rapidly growing antivirals company, has chosen Montgomery County’s Rockville, Maryland, for its new headquarters. ATI chose to relocate from New York City to take advantage of Rockville’s proximity to leading U.S. researchers, regulators, and funders. Their new 17,700 SF home at 1530 E. Jefferson Street is also in an Opportunity Zone, which offers an advantage for the company in attracting future investment.  

ATI is developing a suite of first-in-class “Therapeutic Interfering Particles” (TIPs) to prevent respiratory pandemics, including influenza and COVID-19. The company’s lead candidates include therapeutics that are designed to prevent infections by any coronavirus strain—from COVID-19 to the next pandemic. ATI has raised millions of dollars in capital from public and private partners to transition its antiviral candidates into first-in-human clinical trials.

It will support pediatric research at the health system.

The startup is now looking for a lead investor for its Series A round to fund the company’s go-to market roadmap.

Image: Sam Owen is founder and CEO of D.C.-based Otolith Labs ALEXANDRA WHITNEY PHOTOGRAPHY

Introduction

The UK formally left the EU on 31^st January  2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31^st December  2020. During this transition period the UK has continued to remain under EU pharmaceutical law.

From 1^st January 2021 the UK will be able to adopt an independent regulatory framework with the Medicines and Healthcare products Regulatory Agency (MHRA) positioned as the stand-alone regulator for medicines and medical devices.

Negotiations between the EU and UK are still ongoing to define the future relationship and with only a matter of months left before the end of the transition period there has been no formal agreement. For the pharmaceutical industry this presents numerous challenges as companies prepare to continue supply of medicines that comply with new legislation. The preferred outcome for many within the industry will be to implement a mutual recognition agreement for areas such as GMP certification, batch testing, etc. between the UK and EU.  It is unclear at this stage if an encompassing mutual recognition agreement is achievable so all involved parties should be preparing for a ‘no deal’ scenario and review existing guidance to understand risk exposure and mitigating actions.

Real estate investment trusts (REITs) have done an excellent job creating outsized wealth for their investors over the years. From 1972 through the end of last year, REITs generated an average annual total return of 13.3%, which outperformed the S&P 500's 12.1% total return. Those higher long-term returns mean REITs have turned small initial investments into big-time paydays at a faster pace than the S&P 500.

New Enterprise Associates Inc., one of the world’s largest venture capital firms, is in talks to sell a minority stake in itself, according to people with knowledge of the matter.

The Silicon Valley firm has held discussions with several potential investors, said the people, who requested anonymity because the talks are private. No deal has been reached, and it’s possible one won’t materialize. Representatives for NEA didn’t immediately respond to requests for comment.

Image: NEA’s Scott Sandell Photographer: David Paul Morris/Bloomberg

Johns Hopkins moved up a spot to No. 10 in the annual U.S. News & World Report Best Global University Rankings released today, a year after moving up to No. 11 from No. 12 in the 2020 rankings.

Johns Hopkins also ranks among the top 10 universities in the world in 15 subject areas and among the top 20 in 19 subject areas. Ten new subject area rankings were added to the list this year, bringing the total to 38.

Image: https://hub.jhu.edu

In a long-awaited meeting on America’s crash program to deliver vaccines against the Covid-19 coronavirus, leaders of the program reviewed the measures they have taken to assure the effectiveness and safety of the vaccines. The U.S. Food and Drug Administration convened a panel of independent vaccine experts to ask questions during the Thursday online session. The meeting was designed to reassure the public on the integrity and transparency of the FDA’s vaccine oversight, as the agency has wrestled with political pressure and pockets of public vaccine hesitancy.

MARSEILLE, France, Oct. 23, 2020 (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that AstraZeneca (LSE/STO/Nasdaq: AZN) has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors (“IO-pretreated”). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

She said the Rockville research company is set to grow and details Covid’s larger impact on research.

Image: Dr. Christine Dingivan took over as president and CEO of Rockville contract research organization Emmes at the end of September. COURTESY EMMES

The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new chief medical officer.

Marshall joined as a consultant to Oxford spinout Vaccitech in the summer, but she now jumps on board full time. This comes two months after it nabbed U.K. government funding for a COVID-19 vaccine it thinks can improve on first-generation prospects, including the AstraZeneca vaccine it helped develop.

Image: Vaccitech's headquarters in Oxford, England (Jun via Flickr/CC-by-SA 2.0)

America’s long-term economic growth demands a stepped-up commitment to promoting the innovation impact of the nation’s top-tier universities and other research institutions.

For research institutions themselves, this commitment means prioritizing research, empowering great researchers, building efficient and outcomes-focused technology transfer operations, instilling cultures of innovation and entrepreneurship, and engaging with surrounding business and innovation communities. For America as a whole, it means funding more research resources and paying more attention to the worldwide competition for human talent, including high-skilled immigrants.

BLUEPRINT FOR ECONOMIC RECOVERY BEYOND THE TRIANGLE: Most experts agree Raleigh and Durham are well positioned for a strong recovery from the pandemic, but what about the areas well beyond the Triangle's core?

A new report released Wednesday from RTI International is meant to address that very question. The Innovation Corridor Blueprintincludes 12 areas of focus for leaders and stakeholders to tackle in a 100-mile radius around the Triangle. Topics range from digital infrastructure and affordable housing to biohealth technology and addressing systemic racism.

Image: An illustration of the Raleigh-Durham skylines. SEANPAVONEPHOTO

By Brian Darmody 

Seventy-five years ago, Vannevar Bush, an electrical engineer who directed government research during the Second World War, authored Science—The Endless Frontier. His report called for a centralized approach to government research, which led to the creation of the National Science Foundation in 1950 and is credited as a path breaking roadmap for US science policy.  

Over the next 75 years, the federal government invested billions of dollars of research, creating the world’s leading research universities, while places like Stanford University and state of North Carolina launched research parks; tech transfer programs stimulated by the Bayh-Dole Act flourished; and reforms in SEC regulations created the venture capital sector. 

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