CorMedix up as FDA says no advisory meet required for Defencath application

• CorMedix shares climb 14% in premarket, after the company said the FDA has decided to cancel the Antimicrobial Drug Advisory Committee meeting tentatively scheduled for January 14, 2021, to discuss the marketing application for Defencath, to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter-related bloodstream infections.
• The company was notified that based on the agency’s ongoing dialogue with CorMedix, discussion at an advisory committee is not needed, and it will continue to work on the application with the company during the remainder of the review cycle.
• Agency's action remains February 28, 2021.
• https://seekingalpha.com/news/3637495-cormedix-surges-fda-says-no-advisory-meeting-required-for-defencath-application
  
  

Gilead lenacapavir meets primary endpoint in mid-stage HIV study

• Gilead Sciences announced top-line results from Phase 2/3 CAPELLA trial evaluating lenacapavir (GS-6207), a capsid inhibitor, in heavily treatment-experienced people with multidrug resistant HIV-1 infection.
• The study found that 88% of participants receiving lenacapavir (n=21/24) experienced at least 0.5 log (66%) reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as compared with 17% on placebo.
• Additionally, the lenacapavir group achieved a statistically significant greater mean change in viral load versus placebo.
• Lenacapavir was generally safe and well-tolerated, with no serious adverse events related to study drug observed and no study drug discontinuations.
• Following the 14-day functional monotherapy period, all participants are offered open-label lenacapavir added to an optimized background regimen in an ongoing maintenance period of the study evaluating the subcutaneous administration of lenacapavir every six months as well as the safety and efficacy of lenacapavir in addition to an optimized background regimen at Weeks 26 and 52.
• https://seekingalpha.com/news/3637488-gileads-lenacapavir-meets-primary-endpoint-in-mid-stage-hiv-study
  

FDA authorizes first at-home rapid COVID-19 test

• The FD has issued an emergency use authorization (EUA) to the single-use COVID-19 diagnostic test kit from Lucira Health, a California manufacturer.
• The Lucira COVID-19 All-In-One at home test kit provides rapid results. To date, the Agency has authorized nearly 300 tests for coronavirus.
• The test allows users age 14 and older to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed in 30 minutes as lights labeled positive or negative.
• The test is currently authorized for prescription use only.
• https://seekingalpha.com/news/3637350-fda-authorizes-first-home-rapid-covidminus-19-test
  

AbbVie gains after BMO Capital points to positive pipeline

• BMO Capital Markets starts off coverage initiated on AbbVie (NYSE:ABBV) with an Outperform rating on what it calls a positive risk/reward profile.
• The firm is also positive on AbbVie's pipeline of drug products.
• "Very strong execution with Skyrizi/Rinvoq in immunology, along with very solid performance with Imbruvica/Venclexta and underappreciated hematology/oncology pipeline, has now been combined with Allergan's key growth platforms in aesthetics and neuroscience all providing much greater portfolio diversification. Positive physician feedback and our sensitivity analysis on valuation suggest good risk/reward at current levels."
• https://seekingalpha.com/news/3637456-abbvie-gains-after-bmo-capital-points-to-positive-pipeline
  

Pfizer (PFE), BioNTech (BNTX) vaccine is 95% effective in final analysis

• COVID-19 vaccine in development by Pfizer and BioNTech is 95% effective, according to the final clinical trial data.
• And application for emergency authorization with be submitted "within days".
• https://seekingalpha.com/news/3637409-pfizer-pfe-biontech-bntx-vaccine-is-95-effective-in-final-analysis
  

Besides Dog Ownership, Grocery Delivery Raises COVID Risk

A new study found a couple of surprising results related to COVID-19 risk: Owning a dog raises one's chances of contracting the virus as much as working in an office — and having groceries delivered doubles the risk of actually buying them in person.

Walking a dog raises the risk of catching the coronavirus by 78%, according to the study conducted by the University of Granada and the Andalusian School of Public Health in Spain. It was conducted on 2,086 people, 41% of whom were between 40 and 54, the Daily Mail reported.

It is not known whether dogs picked up the virus from surfaces and transmitted them to to their owners or caught the virus then infected their owners, but researchers suggested pets also social distance when in public.

It was unclear why grocery delivery doubled the risk.

"In the midst of a pandemic and in the absence of an effective treatment or vaccine, preventive hygiene measures are the only salvation, and these measures should also be applied to dogs, which, according to our study, appear to directly or indirectly increase the risk of contracting the virus," said Professor Cristina Sánchez González, who was involved in the study.

https://www.newsmax.com/newsfront/dogs-groceries/2020/11/17/id/997540/

Restaurant groups sue Michigan to block dine-in restaurant ban

Michigan’s latest dine-in ban at restaurants and bars is headed to court as the Michigan Restaurant and Lodging Association is demanding a judge block the ban.

The MRLA filed the lawsuit on Tuesday, Nov. 17, just hours before the three-week ban goes into effect at midnight Wednesday. A pair of restaurant and hospitality companies – Suburban Inns and Heirloom – are also plaintiffs in the lawsuit against Michigan Department of Health and Human Services Director Robert Gordon.

The lawsuit is filed in U.S. District Court, Western District of Michigan.

“Director Gordon’s decision to effectively shutter restaurants for a second time this year – this time with no safety net of federal stimulus dollars to soften the blow to already ailing operators and employees – will absolutely lead to a catastrophic economic fallout,” plaintiffs argue in the lawsuit.

Gordon can “prohibit the gathering of people” during an epidemic, under state law.

Michigan restaurants were closed for dining in starting in March when COVID-19 hit Michigan, but reopened with restrictions in June. Masks were required except when eating and drinking, tables were limited to six people and buildings were limited to 50% of their capacity.

While the MRLA pushed for more than 50% capacity in the late summer months, state lawmakers didn’t budge.

In an unsuccessful attempt to compromise, the MRLA said it would support a 25% capacity limit and 10 p.m. curfew instead of closing dine-in seating altogether. Takeout and outdoor dining are still available – but even some forms of outdoor dining aren’t allowed.

There are 54 active COVID-19 outbreaks tied to restaurants and bars right now, accounting for 5.5% of all outbreaks. Only long-term living facilities, schools, manufacturing/construction and health care settings have more.

The MRLA projects 6,000 restaurants could shutter by spring if there’s a prolonged closure and no federal aid. It also expects 40% of restaurants to close temporarily during this time and 250,000 Michigan employees in the industry to be laid off.

https://www.mlive.com/public-interest/2020/11/restaurant-groups-sue-michigan-ask-court-to-block-dine-in-restaurant-ban.html