News Archive

Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the first patient was dosed in a randomized, doubleblind Phase II clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab (IPH5401), in COVID-19 patients with severe pneumonia.

The primary objective of this investigator-sponsored trial, named FORCEa , is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).

Since the enactment of the CARES Act, the Small Business Administration and U.S. Department of the Treasury have continually updated the rules governing the Paycheck Protection Program (PPP) through formal rulemaking and less formal guidance. In some cases, these rules and guidance have contradicted the plain language of the Act itself.

The PPP, of course, is designed to provide businesses and nonprofits with 500 or fewer employees (subject to certain notable exceptions) access to 2 months of payroll for their employees in light of the economic uncertainty brought on by the COVID-19 Pandemic.

The National Institutes of Health today announced a new initiative aimed at speeding innovation, development and commercialization of COVID-19 testing technologies, a pivotal component needed to return to normal during this unprecedented global pandemic. With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing. At the same time, NIH will seek opportunities to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability. NIH will work closely with the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority (BARDA) to advance these goals.

Image: https://www.nibib.nih.gov

Gilead Sciences’ closely-watched COVID-19 drug candidate remdesivir outperformed placebo in a clinical trial sponsored by the NIH’s National Institute of Allergy and Infectious Disease (NIAID), the agency announced today—the first clinical study launched in the U.S. of a therapeutic for the virus.

NIAID released preliminary data showing that the study met its primary outcome of statistically significant improvement in time to recovery by Day 29. Patients who were treated with remdesivir showed a median time to recovery of 11 days compared with 15 days for those who received placebo—a 31% faster time to recovery.

Gilson and QIAGEN have entered into a strategic partnership that will provide researchers the ability to limit operator-dependent variation in their manual nucleic acid extraction results and improve the traceability of their workflows.

This agreement brings together two influential leaders in the life science industries: Gilson, a global manufacturer of sample preparation technology, and QIAGEN, a leading global provider of molecular diagnostics and sample preparation technologies.

This collaboration will integrate Gilson’s TRACKMAN® Connected digital bench tools and QIAGEN’s manual nucleic acid extraction kits to create consistency between collaborators, increase confidence in their execution of extraction protocols, and improve traceability at the bench.

Personal Genome Diagnostics, the venture-backed developer of a novel diagnostic kit for genomic profiling of different cancers in lab settings, has received clearance from the U.S. Food and Drug Administration for its PGDx elio tissue complete test.

The test’s approval is another step forward for precision therapies that rely on an understanding of the unique genomic profile of an individual patient’s tumor, according to the company.

Image: Image Credits: Ed Uthman / Flickr (opens in a new window)under a CC BY 2.0 license.

BALTIMORE–(BUSINESS WIRE)–Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio™ tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner. By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

BALTIMORE, Md., April 27, 2020 /PRNewswire/ — LifeSprout, a privately-held regenerative medicine company founded with technology licensed from Johns Hopkins University, has closed a $28.5 million Series A financing. The company is using proceeds to support clinical development of novel therapeutic products from its Regenerative Matrix platform.

The financing was led by Redmile Group, LLC, with new institutional investors Nexus Management, LP, Emerald Development Managers, LP, and the Abell Foundation joining the syndicate.

“We are delighted to complement the lead investment from Redmile with a strong cadre of Maryland-based and international investors,” stated Sashank Reddy, MD, PhD, co-founder of LifeSprout. “The early, visionary investments made by the Maryland Stem Cell Research Fund and others made this new financing possible.”

Gentian AS, a Norwegian company, with its US office at BioHealth Innovation in Rockville, Maryland is seeking collaborators to investigate if two of the biomarkers in their portfolio, cystatin C (FDA510(k) cleared) and plasma calprotectin (US research only), could potentially be useful for detection of the severely affected COVID-19 patients.

High mortality and long hospitalization are consequences of the severe cases with COVID-19 pneumonia. Gentian therefore believes that it is important to identify biomarkers that can aid in early, rapid and effective identification of the severely affected patients.

Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.