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Roche

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization

By News Archive

Roche

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).

 

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Coronavirus vaccine news boosting Gaithersburg s Novavax Washington Business Journal

Startups developing tech to combat COVID-19 urged to apply for fast-track EU funding | TechCrunch

By News Archive

Coronavirus vaccine news boosting Gaithersburg s Novavax Washington Business Journal

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.

 

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GeneDx Celebrates 20 Year History as Pioneer In Genetic Sequencing and Testing · BioBuzz

By News Archive

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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.

Image: https://biobuzz.io

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Study Shows How Mild Coronavirus Infection is Beaten by Immune Response

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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)

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MockV Maravai

BHI portfolio company MockV Solutions led by David Cetlin acquired by Maravai LifeSciences

By News Archive

MockV Maravaidavidlarge 150x150SAN 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.

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QIAGEN dramatically ramping up global production capacity for RNA extraction kits for use in detection of SARS-CoV-2 coronavirus

By News Archive

Qiagen Logo

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.

 

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Emergent Biosolutions will manufacture Vaxart’s experimental coronavirus vaccine in Baltimore – Technical.ly Baltimore

By News Archive

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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.

Image: https://technical.ly – Courtesy photo

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Cellphire

Cellphire Begins Phase 2 Trial of Thrombosomes® in Bleeding Thrombocytopenic Patients

By News Archive

Cellphire

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.

 

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In Conversation Sean Kirk Emergent BioSolutions BioBuzz

In Conversation: Sean Kirk, Emergent BioSolutions · BioBuzz

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In Conversation Sean Kirk Emergent BioSolutions BioBuzz

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.

 

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