INDIANAPOLIS, March 16, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has begun shipping the first allotment of its cobas® SARS-CoV-2 Test for COVID-19 (coronavirus) to a network of hospital and reference laboratories across the U.S. to enable automated, high-volume patient testing. Shipping of the initial 400,000 test kits began Friday, March 13, and will be completed this week. Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the guidelines of the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

The European Commission put out a call Friday for startups and small businesses which are developing technologies that could help combat the COVID-19 outbreak to apply for fast-track EU funding.

The push is related to a €164M pot of money that’s being made available for R&D via the European Innovation Council (EIC) — a European Union funding vehicle which supports the commercialization of high risk, high impact technologies.

GeneDx, a global leader in genomics and patient testing, is celebrating its remarkable 20th anniversary throughout the month of March.

The Gaithersburg, Maryland company has played an important role in the history of genetic sequencing and the rise of the BioHealth Capital Region as a global biohealth cluster. GeneDx was the very first company to commercially offer NGS (Next Generation Sequencing) testing in a CLIA (Clinical Laboratory Improvement Amendments) lab and has been at the leading edge of genetic sequencing and testing for two decades. The company’s whole exome sequencing program and comprehensive testing capabilities are world-renowned.

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Researchers at the Peter Doherty Institute for Infection and Immunity in Australia have mapped immune responses in a patient in response to COVID-19 infection, demonstrating the body’s ability to fight the virus and recover from the infection. The team tested blood samples taken from one of Australia’s first cases of COVID-19, at four different time points during the infection. “We looked at the whole breadth of the immune response in this patient using the knowledge we have built over many years of looking at immune responses in patients hospitalized with influenza,” said Oanh Nguyen, PhD, co-author of the researchers report, which is published in Nature Medicine.

Image: Outbreak response in action: Centers for Disease Control and Prevention (CDC) staff support the COVID-19 response in the CDC’s Emergency Operations Center (EOC). (CDC; photo credit James Gathany)

SAN DIEGO (March 17, 2020) – Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech partners, announced today that it has acquired MockV Solutions. MockV plays an important role in helping biopharma customers develop manufacturing processes that are free of viral contamination, leading to the production of safe biotherapeutics. The MockV acquisition, coupled with Maravai’s previous acquisition of Cygnus Technologies, expands Maravai’s leadership position in bioprocess impurity testing. Impurity testing is a critical step in the development and manufacture of biotherapeutic products.

Keeping angels and startups company while working from home! Great guests and great topics! The ZIDDANDFIZZ Show: Angels Talk Ziad Henry Moukheiber Faz Bashi hashtag#podcasting hashtag#podcasts

Hilden, Germany, and Germantown, Maryland, March 17, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced plans to dramatically ramp up global production capacity of RNA extraction kits that are used as part of workflows around the world to detect nucleic acid from SARS-CoV-2, the novel coronavirus that causes COVID-19.

QIAGEN has historically allocated global production capacity to manufacture RNA nucleic extraction reagents to supply about 1.5 million patient tests on a monthly basis. Now QIAGEN is ramping up production capacity for these reagents to support a level of more than 6.5 million patient tests a month by the end of April 2020 and over 10 million patient tests a month by the end of June 2020. A significant capacity expansion project is underway at sites in Europe and the United States to reach more than 20 million patient tests on a monthly basis by the end of 2020 to support the response to this global public health crisis.

Gaithersburg-based Emergent Biosolutions on Wednesday said it signed a second agreement in a week that will bring manufacturing of a coronavirus vaccine candidate to Baltimore.

The new agreement is with Vaxart, a San Francisco-based biotechnology company that is developing an experimental oral vaccine candidate that would be administered by tablet.

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ROCKVILLE, Md., March 18, 2020 /PRNewswire/ -- Cellphire, Inc., the global leader in long-term stabilization and storage of platelets, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to start a Phase 2 clinical trial of Thrombosomes in bleeding patients with thrombocytopenia.

In July 2019, Cellphire successfully completed a Phase I clinical trial of its lead product, Thrombosomes, a platelet-based freeze-dried hemostatic. Utilizing its patented technology to stabilize and freeze-dry platelets, Cellphire is developing next-generation therapeutics to treat bleeding patients. Standard liquid platelets only have a 5- to 7-day shelf life, making inventory management difficult and can lead to widespread platelet shortages during public health emergencies. By contrast, Thrombosomes have a 3-year shelf life.

Following up on the recent article Two Maryland Biotechs Partner to Bring Coronavirus/COVID-19 Vaccine Candidate into Clinical Trials, BioBuzz had the opportunity to speak with Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk.

Let’s start by having you provide a brief background on your role at Emergent.

I have been with the company for nearly 17 years, and have had the good fortune of working in and being responsible for many key parts of the business including manufacturing operations, quality assurance, regulatory affairs, product development, U.S. government program management, global operational excellence, global supply chain, medical and clinical affairs. In these roles I have spent a lot of time across Emergent’s sites and have been based in Lansing, Mich. – where I started – Gaithersburg, Md, and Winnipeg, Manitoba.

GAITHERSBURG, Md., March 18, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company, whereby Emergent has agreed to utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Development services will begin immediately, and upon Vaxart’s election, Emergent agrees to produce clinical material expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.

GERMANTOWN, Md. — German company Qiagen is racing to assemble new COVID-19 test kits. Already approved for use in Europe, Qiagen’s new kits are now getting assembled in their North American headquarters in Germantown, Maryland.

Image: Qiagen's North American headquarters in Germantown, Maryland Nathan Baca

Anthony Fauci, MD, Director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), offered hope to the thousands of people with confirmed cases of COVID-19, and the millions around the world whose lives have been disrupted by the pandemic caused by SARS-CoV-2, when he expressed to a congressional panel last week his hope that the first patients would be dosed with vaccines in development for the novel coronavirus “in a few weeks.”

MORRISTOWN, N.J., March 18, 2020 /PRNewswire/ -- In an ongoing series of research conducted by KMK Consulting, Inc. covering Innovation & Customer Value, GSK was ranked as the top company delivering superior customer value and sales force engagement, as well as delivering therapeutic innovation in the asthma market according to pulmonary disease specialists. The research was conducted in February 2020, using KMK's Rapid Pulse Survey platform. AstraZeneca, Genentech, and Novartis rounded out the top organizations driving innovation and customer value in this space.

Novavax and Emergent Biosolutions are not the only Maryland companies developing COVID-19 countermeasures. More than 15 local companies will meet virtually Friday to share their efforts.

Image: Maryland biotechs are coming together to build vaccines and diagnostic tests for COVID-19. CENTERS FOR DISEASE CONTROL AND PREVENTION

A massive effort is under way to develop a UK vaccine for coronavirus within months and make it available to save lives before the end of the year, the Guardian has learned.

Researchers at Oxford University, led by Prof Sarah Gilbert, are planning a safety trial on humans of what is expected to be the UK’s first coronavirus vaccine next month. Provided that it goes smoothly, they will move directly into a larger trial to assess how effective the vaccine is at protecting against the infection.

BALTIMORE (WJZ) — A Maryland company said it’s ready to manufacture multiple potential coronavirus vaccines.

Emergent BioSolutions manufactures drugs like Narcan and was involved in the Ebola response. Now, the Baltimore manufacturing facility will be involved with two companies hoping to develop a coronavirus vaccine.

“Our people certainly feel that level of responsibility and they’re giving it their all,” Emergent’s senior vice president Syed Husain said.

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Thirty innovators will compete on March 23, 2020 in a virtual showcase

WASHINGTON, March 19, 2020 /PRNewswire/ --  Thirty semi-finalists have been named in the annual "Make Your Medical Device Pitch for Kids!" competition presented by the National Capital Consortium for Pediatric Medical Devices (NCC-PDI).  The competition is adopting a virtual format for the March 23rd event to eliminate the need for travel or an in-person gathering due to the COVID-19 pandemic. Organized by nonprofit accelerator MedTech Innovator, contestants and judges will connect in online meeting rooms for the pitch presentations, which feature innovations in cardiovascular, orthopedic and spine, and NICU devices.

Hosting Online Event Leadership Summit, Thursday, March 19 @ 1 pm EST

WASHINGTON, March 19, 2020 /PRNewswire/ -- VIVA Creative, a leading Metro DC live events producer and creative agency, is helping companies quickly move canceled events online. VIVA became a leading producer of online and virtual events post 9/11, and again during the global financial crisis. Today, the company brings expertise in audience engagement and communication in times of restricted travel.  As several brands and event organizers are canceling or postponing major meetings due to COVID-19, VIVA is offering immediate solutions. 

The biopharma industry spent $90 billion on R&D in 2016, a figure that represents about 20% of total sales. Despite this significant financial investment by the industry and splashy media headlines, how much, or little, is healthcare really digitizing?

During the 2020 JP Morgan Healthcare Conference, a panel of senior executives, including Brent Saunders, chairman, president and CEO of Allergan, Tariq Shaukat, president of industry product and solutions for Google Cloud, and Sara Nayeem, MD, partner at New Enterprise Associates, joined me to share their perspectives and insights on how biopharma and medtech companies are driving digital health.

Despite the serious impacts of the coronavirus, MIPS is continuing its normal business activities, although we have moved many of our operations online. Our upcoming round of proposals are due May 1 at 5 p.m. We continue to work with the Maryland business and academic communities to support your efforts to develop technology products and services. Now is an excellent time to develop new products in order to have them ready for market when the U.S. economy begins to recover in the not-too-distant future.

Sterling, Virginia-based biotech company Aperiomics has launched a new test that can detect COVID-19.

Founded in 2014, the company uses genomic analysis and machine learning to detect known pathogens from a sample of any nature in just one test. Aperiomics reports that its Xplore-PATHO tech can accurately identify nearly 40,000 microorganisms including over 12,000 clinically relevant pathogens.

Image: An Xplore-COVID-19 testing kit from Aperiomics - Courtesy Photo

The US Food and Drug Administration has approved a coronavirus test that can deliver a COVID-19 diagnosis in 45 minutes.

The test, made by California-based Cepheid, got emergency clearance on Saturday, eight days after the agency gave fast-track approval for a test by Roche, which can diagnose the novel coronavirus within three hours.

Not long ago, American entrepreneur and President of Lung Biotechnology PBC, Martine Rothblatt, was told her aspiration of converting conventional helicopters to electric power was impossible.

Fast forward to 2018 and not only is it a possibility but it’s also a reality – a reality that has granted Rothblatt along with her "dream team" – Tier 1 Engineering (USA) and test pilot, Captain Ric Webb of OC Helicopters (USA) – an official Guinness World Records title for Farthest flight by an electric helicopter (prototype).

Image: https://www.guinnessworldrecords.com

NEEDHAM, Mass., March 23, 2020 /PRNewswire/ -- For biopharma companies faced with increasing demand for new biologics, cell and gene therapies, and drug products, Thermo Fisher Scientific is investing more than $475 million in new capabilities and capacity in 2020. This investment, in addition to those made in 2019, brings the total investment over two years to approximately $800 million across the company's pharma services business.

"We've invested strategically to ensure that lack of capabilities, capacity or supply is never a reason medicines are delayed in reaching patients," said Mike Shafer, president, Thermo Fisher's pharma services business. "Our offering can provide solutions at all points along the pathway to commercialization, whether it's an emerging biotech working on vaccine for a novel virus or a high-volume pharmaceutical manufacturer delivering necessary drugs at scale."

TERLING, Va., March 20, 2020 /PRNewswire/ -- Aperiomics, a biotechnology company deploying advanced technologies to identify the root causes of infectious disease, announced today it is now offering a test for the novel coronavirus.

Aperiomics' Xplore-COVID-19™ test is available nationwide today and the company has already begun taking orders for the test. With the ability to process up to 1000 coronavirus tests per week, Aperiomics can provide test results within 48 to 72 hours of receiving a sample. The tests, which can be ordered for patients at a cost of $250 per sample, utilize a PCR technique designed to identify specific genetic markers within the coronavirus using samples obtained via throat swabs. This test utilizes existing sample collection, DNA extraction, and PCR identification technologies.

As more cases of COVID-19 are being reported and leaders seek tests and treatments, biotech companies are stepping up efforts to develop new tests and treatments.

That includes Maryland, where life sciences companies are working on vaccines, therapeutics and diagnostics. They’re also seeking to share what they’re working on and offer up resources: On Friday, Maryland Life Sciences is putting together a call with more than 15 companies where they’ll look to connect and share needs.

Rich speaks with VIVA Creative • Business Development & Strategic Partnerships. Image:

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Cargo ships are huge polluters—in 2015, as they traveled the ocean delivering everything from smartphones to bananas, they emitted more than 200 million metric tons of CO2, roughly as much as the entire country of Vietnam. Unlike cars, which can easily be replaced with electric versions, ships are harder to decarbonize. But a relatively simple intervention from a new type of underwater robot can help significantly shrink emissions.

Image: Semcon - https://www.fastcompany.com

Executive Director of the Universities at Shady Grove, Stewart L. Edelstein, Ph.D., joins BioTalk to discuss his career, USG, and its role in the BioHealth Capital Region

Dr. Stewart Edelstein joined the Universities at Shady Grove (USG) as Executive Director in 2002 and in 2007 was named to the dual title of Associate Vice Chancellor for Academic Affairs for the University System of Maryland (USM).

USG is a regional campus of USM that offers both undergraduate and graduate degree programs from nine partner universities. During Dr. Edelstein’s tenure, USG expanded its number of participating universities, as well as the breadth and depth of its academic programs, and enrollment has grown significantly, to more than 3,000 students. The campus’s capacity for future enrollment growth has doubled with the recent opening of a new Biomedical Sciences and Engineering Education Facility, which is expanding degree and certification offerings in healthcare, engineering, biosciences, computer science and other areas.

The BioHealth Capital Region Forum Planning Committee has made the difficult decision to postpone our 6th annual BioHealth Capital Region Forum that was scheduled for April 14th and 15th at AstraZeneca. We believe the health and safety of all participants is of paramount importance. Following the most recent reports from the CDC, the WHO, and the state of Maryland’s ban on gatherings of 250 people or more, we have made this decision.

In accordance with state and federal recommendations to combat COVID19, BioHealth Innovation has modified the EIR Feedback Sessions for the near future to take place by videoconference only.   There now are a couple openings tomorrow (3/18).  To participate in this session, please register using this link www.tinyurl.com/EIRfeedback feedback and send your ppt presentation including the top 3 topics on which you would like feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. by 2 p.m. 3/17/20.  The next sessions are scheduled to take place by videoconference on 4/22 and 5/27.

The Bill & Melinda Gates Foundation is teaming up with Wellcome and Mastercard to form the COVID-19 Therapeutics Accelerator, a $125 million effort to help find potential treatments for the coronavirus epidemic and future threats.

The accelerator will bring together the World Health Organization, pharmaceutical companies, biotech firms, government, and other philanthropic groups to develop therapies for COVID-19.

Image: Mark Suzman. (Gates Foundation Photo)

U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons. Contrastingly, biologic drugs are larger and more complex molecules, for example proteins, viruses, and living cells such as CAR-T cells.

OSLO, NORWAY, March 10, 2020 – CEPI, the Coalition for Epidemic Preparedness Innovations, today announced the expansion of its COVID-19 vaccine portfolio. CEPI will be investing a further $4.4 million in partnering agreements with Novavax, Inc. and The University of Oxford to rapidly develop vaccine candidates against COVID-19. This brings CEPI’s total investment in COVID-19 vaccine R&D to $23.7 million.