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Friday, September 11, 2020

Verily nets FDA authorization for pooled COVID-19 testing

Verily has received a go-ahead from the FDA to begin pooled testing for COVID-19 to help scale up its screening efforts.

In addition, Google’s life-science-focused sister company also published guidance for others looking to adopt its sample collection methods and laboratory processes through a series of white papers. 

Pooled testing allows COVID-19 screeners to stretch their resources by grouping together individual samples before analysis and then only retesting each person individually if the larger mixture returns a positive result.

However, this requires sensitive hardware, as the collected samples may become diluted during the process and works best when the expected prevalence of the virus is low. The FDA authorized Verily to mix up to 12 samples at once at its coronavirus-dedicated testing laboratory launched last month in South San Francisco.

With a stated capacity of several thousand tests per day, the lab currently runs an adapted form of Thermo Fisher Scientific’s TaqPath RT-PCR testing kit for pooling COVID-19 samples, according to Verily pathology head Deb Hanks, and the lab plans to employ Roche’s Elecsys coronavirus antibody blood test as well.

The lab and both tests are primarily focused on providing Verily’s screening offerings aimed at individual workplaces, schools and other organizations.

The company’s white papers explore the scalability of its pooled testing approach as well as the evidence supporting different types of sample collection methods. Verily previously endorsed the use of mid-turbinate swabs, which can be used for self-collected nasal samples and are currently being employed by Verily’s partner Rite Aid at multiple pharmacy testing sites. Verily also published a paper on the pros and cons of different molecular testing methods for active COVID-19 infections.

https://www.fiercebiotech.com/medtech/verily-nets-fda-authorization-for-pooled-covid-19-testing

Needham upgrade lifts PerkinElmer; shares up

Needham has upgraded PerkinElmer (PKI +4.0%) to Buy from Hold with a $139 price target (17% upside), also adding the stock to his Conviction Buy list.

The analyst is impressed with the “strong operational performance” of the company’s Diagnostics segment as the company reported almost doubled earnings in Q2.

The company said that Q2 was the best quarter of profitability since the creation in 1999, with 28% adjusted operating margins, adjusted earnings was up over 50% and adjusted free cash flow by over 200% Y/Y.

The analyst adds that these trends “clearly” bode well for PerkinElmer’s performance in 2H of this year and into 2021.

The company saw a common ground from other analysts as well, with JPMorgan Chase increasing target price from $85 to $105 with a “neutral” rating. CFRA raised from “hold” rating to a “buy” rating. Stifel increased target price from $95 to $125 with “buy” rating.

https://seekingalpha.com/news/3613428-needham-upgrade-lifts-perkinelmer-shares-up-4

Shortage of Gilead’s remdesivir in U.S. appears over

Reuters National Post reports that, since July, U.S. hospitals have turned down about 1/3 of their allocated supplies of Gilead Sciences’ (NASDAQ:GILD) Veklury (remdesivir) for treating COVID-19 patients according to unpublished government statistics provided to Reuters by a U.S. pharmacists’ group.

Some hospitals are still buying the antiviral to beef up inventories in case the pandemic ramps back up this winter, but they say current supplies are adequate, in part because they are limiting use to severely ill patients. Six of eight hospital systems contacted by Reuters stated that they were not using the nucleoside ribonucleic acid polymerase inhibitor for moderately ill patients despite the FDA’s emergency use nod for the indication.

The U.S. Department of Health and Human Services (HHS) told hospitals and other healthcare organizations that state and territorial public health systems accepted ~72% of supplies offered between July 6 and September 8, according to Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists.

Government-led distribution of remdesivir will expire at month-end.

Some experts are unconvinced that remdesivir would benefit COVID-19 patients with moderate symptoms. Cleveland Clinic’s Dr. Adarsh Bhimraj is not “terribly impressed” with the study (supporting the drug’s use in this population) and remains “skeptical” about using remdesivir in patients with moderate COVID, especially given the price ($3,120/five-day course).

Another factor could be the alternative use of inexpensive corticosteroids in severely ill COVID-19 patients. Recent studies showed a mortality benefit compared to standard-of-care treatment.

https://seekingalpha.com/news/3613449-shortage-of-gileads-remdesivir-in-u-s-appears-over

Neurocrine/Voyager gene therapy shows sustained benefit in Parkinson’s

Neurocrine Biosciences (NBIX -3.8%) and Voyager Therapeutics (VYGR -1.5%) announced data from Phase Ib (PD-1101) three-year efficacy and safety study, demonstrating that a one-time treatment with NBIb-1817 (VY-AADC) showed sustained improvement in motor function including greater “On” time and reduction in the amount of medications in patients with Parkinson’s disease.

NBIb-1817 reduced average “Off” time (times when the medication stops working and symptoms recur) by up to -1.91 hours and improved average “On” time without troublesome dyskinesia by up to +2.23 hours after three years across three cohorts.

In addition, 14 out of 15 patients treated with NBIb-1817 continued to show an improvement in disease staging after three years, as assessed by the modified Hoehn & Yahr scale.

These new data, along with two-year data from another open-label Phase Ib trial, PD-1102, were presented at the MDS Virtual Congress.

On the safety front, NBIb-1817 was well-tolerated in both studies, with no study drug-related serious adverse events reported. The most common adverse events reported were headache, hypoesthesia, and musculoskeletal pain (in PD-1101), and upper respiratory tract infection, headache, nausea, and depression (in PD-1102).

The company plans to re-initiate enrollment in registrational RESTORE-1 Trial of NBIb-1817 later this year, after the enrollment was paused amid COVID-19.

NBIb-1817 is an investigational gene therapy product designed to deliver the AADC gene directly in brain cells where it can convert levodopa to dopamine.

https://seekingalpha.com/news/3613401-neurocrine-voyager-gene-therapy-shows-sustained-benefit-in-parkinsons

Nano-X adds to blistering post-IPO pace

Israeli affordable imaging gear maker Nano-X Imaging Ltd. (NNOX +20.1%) has been a top gainer since its U.S. debut on August 21 at $18. Shares are currently exchanging hands at $58.13, up three-fold.

The company has a grand vision called 1x1x1 aimed at deploying enough systems (Nanox ARC) worldwide that every person on the planet has access to at least one medical imaging scan each year.

The feasibility of 1x1x1 is enabled by a low-cost x-ray source it has developed based on a digital microelectromechanical system semiconductor cathode, thereby avoiding the extreme heat required for the traditional method of generating electrons with a single filament paired with an analog cathode.

3D images can be uploaded to end-to-end imaging services software Nanox CLOUD where they can be reviewed, annotated, reported and billed.

It originally filed for FDA clearance for a single-source version of Nanox ARC in January. In March, the agency requested additional information (major deficiency letter). It expects to submit the requested information and test data this quarter. It expects to file an additional 510(k) application next quarter for a multiple-source version of the system which will be the one it commercializes. If all goes well, market launch will commence in H1 2021 with a goal of installing at least 1,000 devices by year-end. It forecasts an installed base of 15,000 systems by 2024 (prospectus, pages 1-2).

Two days ago, it announced a distribution deal for its equipment and testing services in Mexico.

https://seekingalpha.com/news/3613352-nano-x-adds-to-blistering-post-ipo-pace-up-20

Biofrontera AG plans mediation to resolve legal disputes

Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company” or the “Biofrontera-Group”), an international biopharmaceutical company, today has reached a mutual agreement with Mr. Wilhelm K.T. Zours and Deutsche Balaton AG on the key elements of a mediation agreement. The completion of the mediation agreement is expected today.

Within the framework of the mediation process, which is to commence shortly, an experienced and renowned mediator will be called in to find solutions for the settlement of disputes as well as disagreements on personnel and strategic corporate matters.

Mr. Zours is chairman of the supervisory board and majority shareholder of Deutsche Balaton AG and is as such an indirect major shareholder of the Company. Between the Company on one side and Deutsche Balaton AG together with other companies in which Mr. Zours holds a majority interest on the other side, various legal disputes are pending in Germany and one legal dispute in the USA.

https://finance.yahoo.com/news/biofrontera-ag-plans-mediation-resolve-113300991.html

Over 1B to get Russia’s COVID-19 vaccine in 2020-2021

Russia’s sovereign wealth fund said on Friday that more than one billion people would receive its COVID-19 vaccine “Sputnik-V” in 2020-21, the Interfax news agency reported.

The Russian Direct Investment Fund (RDIF) has already signed two deals to export the vaccine abroad and on the Brazilian state of Bahia on Friday agreed to conduct Phase III clinical trials of the vaccine.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-tar/more-than-1-billion-people-to-get-russias-covid-19-vaccine-in-2020-2021-ifax-cites-rdif-idUSKBN2621YI