Bayer appeals $20M Roundup ruling to California Supreme Court

Bayer (OTCPK:BAYRY -0.9%) is asking California’s Supreme Court to review a decision awarding $20.5M to a groundskeeper who claimed the company’s Roundup weedkiller caused his cancer, arguing the ruling was at odds with federal law and settled legal principles.

Bayer says the July decision by the California Court of Appeal affirming a 2018 jury verdict would be relied upon by other courts handling cases over the herbicide.

The original $289M jury award eventually was whittled down to $20.5M but it was not vacated.

Bayer also wants the high court to determine whether a manufacturer of a federally approved herbicide can be liable under state law for failing to provide a cancer warning when the federal regulator determined federal law does not permit that warning.

The case is separate from Bayer’s June agreement to pay up to $10.9B to settle nearly 100K lawsuits in the U.S. claiming that Roundup caused cancer.

https://seekingalpha.com/news/3610534-bayer-appeals-20m-roundup-ruling-to-california-supreme-court

Google, Apple build COVID-19 notifications straight into phones this month

Google (GOOG +0.9%, GOOGL +0.8%) and Apple (AAPL +2.8%) are building a COVID-19 notification system straight into smartphones – eliminating the need for a separate app, and ramping up a new weapon in the effort to track exposure to the novel coronavirus.

Future versions of iOS and Android will feature the new system that previously required an app made by a public health authority.

But now the system will use Bluetooth signals from phones that have opted in to find out how closely and for how long two phones were near each other, without collecting location or identity data, according to the companies.

A user that tests positive for COVID-19 would generate a push notification to other participating phones saying they may have been exposed to the virus.

The ability to opt in to the system without installing a separate app is expected to increase adoption of an approach that depends on a large network to work correctly.

The new software is coming in iOS 13.7 for iPhones, due out Tuesday, and in Android updates coming out this month.

https://seekingalpha.com/news/3610528-google-apple-building-covidminus-19-notifications-straight-phones-this-month

Quest under pressure on dustup in Florida over COVID-19 testing issues

Quest Diagnostics (DGX -2.7%) is down on average volume on the heels of a tweet from the Florida Department of Health taking the company to task over, what appears to be, a dump of a large number of overdue COVID-19 test results. Governor Ron DeSantis has ordered all state executive agencies to sever ties with the reference lab effective immediately.

Specimen collection sites in the U.S. have complained about the slow turnaround of results from contracted diagnostic labs, not just Quest, since delays undermine intervention efforts on people who test positive. Labs cite supply chain issues preventing timely procurement of essential supplies to run the tests.

LabCorp (LH -1.3%) and OPKO Health (OPK -4.2%) are down in sympathy.

https://seekingalpha.com/news/3610527-quest-under-pressure-on-dustup-in-florida-over-covidminus-19-testing-issues

Sanofi, Regeneron: Kevzara fails in late-stage COVID-19 trial

Shares of Sanofi SNY, -1.09%SAN, -1.10% were up 0.9% in premarket trading on Tuesday after the drugmaker said that the rheumatoid arthritis drug Kevzara failed a Phase 3 clinical trial testing the therapy as a treatment for severely ill COVID-19 patients. Sanofi and Regeneron Pharmaceuticals Inc. REGN, -4.71%, its commercial partner for Kevzara, said they do not plan to conduct additional studies testing the drug as a COVID-19 treatment. Regeneron’s stock was down 1.4% in premarket trading on Tuesday. In the early days of the pandemic, there was interest in testing rheumatoid arthritis drugs like Kevzara and Roche Holding AG’s ROG, +0.72% Actemra in coronavirus patients; however, studies so far have failed to demonstrate that these drugs can lessen the severity of disease, shorten hospital stays, or reduce death. Roche said in July that Actemra had failed in a late-stage clinical trial testing the drug in hospitalized COVID-19 patients.

https://www.marketwatch.com/story/sanofi-regeneron-kevzara-fails-in-late-stage-covid-19-trial-2020-09-01

‘Likely’ cause of coronavirus reinfections

Researchers at the University of Nevada in Reno reported what they say is a likely case of SARS-CoV-2 reinfection in a 25-year-old man who tested positive for the virus on April 18 and again on June 6. The findings were published as a preprint study in The Lancet on Aug. 27. (A preprint is the preliminary publication of research that has not yet been peer-reviewed but has become a common way to disseminate medical findings during the evolving COVID-19 pandemic.) Scientists have also reported one-off instances of reinfection in individuals outside the U.S. in recent weeks, notably in Hong Kong. Media outlets have also reported that Belgium and The Netherlands have had cases of reinfection. The patient in Nevada had tested negative twice between the positive tests. He was hospitalized when he tested positive the second time. When the researchers in Nevada sequenced the virus samples, they said there were “two genetically distinct SARS-CoV-2 viruses,” which they say “strongly supports that reinfection with SARS-CoV-2 can occur.”

https://www.marketwatch.com/story/researchers-in-nevada-report-likely-case-of-coronavirus-reinfection-2020-09-01

FDA acepts 3 supplemental applications from Vertex for expanded use of CF meds

The FDA has accepted for review three supplemental marketing applications from Vertex Pharmaceuticals (NASDAQ:VRTX) seeking expanded labels for cystic fibrosis (CF) meds  TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO (tezacaftor/ivacaftor and ivacaftor) and KALYDECO (ivacaftor) to include additional rare CFTR mutations.

The filings may also allow certain CF patients who are currently eligible for KALYDECO to become eligible for SYMDEKO or TRIKAFTA and certain people currently eligible for SYMDEKO may become eligible for TRIKAFTA.

The agency’s action date is December 30.

https://seekingalpha.com/news/3610448-fda-accepts-three-supplemental-applications-from-vertex-for-expanded-use-of-cf-meds

Co-Diagnostics to launch respiratory virus panel

Ahead of the flu season and in response to the ongoing coronavirus pandemic, Co-Diagnostics (CODX -0.6%) will launch a new respiratory virus panel designed to test and differentiate influenza A, influenza B and COVID-19.

The company says demand for its RT-PCR tests like Logix Smart COVID-19 remains “significant.”

The stock was one of the top pandemic-related gainers before the recent sell-off. Shares rocketed almost 35-fold from the end of 2019 to a high of $30.99 on August 3. The stock is now exchanging hands at $10.92, down 65% since then. 

https://seekingalpha.com/news/3610471-co-diagnostics-to-launch-respiratory-virus-panel