Annovis Bio Positive Phase 2 Data - ANVS401 Improves Cognition in Alzheimer's

 Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced new results from a double-blind, placebo-controlled study of ANVS401, its lead drug candidate for the treatment of AD and PD. Patients treated with ANVS401 for 25 days showed statistically significant cognitive improvement as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11). The 11-part test is one of the most frequently used tests to measure impaired cognition in clinical trials for AD.

Dr. Maria L. Maccecchini, CEO of Annovis Bio, explained: "We previously reported that ANVS401 significantly increased speed, coordination and motor function in PD patients in this trial. We set up this study to measure the toxic cascade leading to nerve cell death and loss of function and its reversal in AD and PD. Since the study was powered to investigate changes in biomarker levels, not to demonstrate efficacy, we believe these results are that much more impactful."

https://finance.yahoo.com/news/annovis-bio-announces-positive-phase-120100640.html

EMA Positive on GSK-Vir Bio Sotrovimab For Early Covid

 Opinion based on the EMA’s Committee for Human Medicinal Products (CHMP) review of available data on sotrovimab (previously VIR-7831) for the early treatment of COVID-19 –

– EU member states can use the CHMP positive scientific opinion when making national decisions about the early use of sotrovimab prior to EMA marketing authorization –

– Discussions with global regulators regarding authorizations in additional countries continue to advance –

https://finance.yahoo.com/news/correction-ema-issues-positive-scientific-132600358.html

Japan to hold off on use of AstraZeneca vax despite OK

 Japan expanded a state of emergency to cover the southern island of Okinawa on Friday, as authorities approved two more coronavirus vaccines to speed a lagging inoculation campaign.

The newly approved vaccines, from Moderna Inc and AstraZeneca PLC, will join the one co-developed by Pfizer Inc and BioNTech SE in a vaccination drive that began in mid-February.

Earlier, media said the government would hold off on the use of AstraZeneca's vaccine because of concerns over blood clots and bleeding in some. The company said it was aware of the government's decision that its vaccine would not be immediately used.

"We'll do our utmost in working to ensure that all elderly people who seek vaccinations can get their two shots by the end of July," Economy Minister Yasutoshi Nishimura, who is leading the coronavirus response effort, told reporters.

Japan has vaccinated just 4.1% of its population, according to Reuters' global tracker https://tmsnrt.rs/3vbj5CE, the slowest rate among the world's larger, rich countries.

In contrast to some other Group of Seven (G7) nations that are beginning to end pandemic-busting lockdown measures, much of Japan remains under emergency curbs amid a fourth wave of infections.

On Friday, the government added Okinawa to its list of nine prefectures placed under the strictest emergency measures. They include Tokyo, where the Olympic Games are due to start in about two months.

JAPAN INC, PUBLIC FEARS OVER OLYMPICS

Fears that the Olympics would turn into a super-spreader event have persisted, ensuring opposition by the majority of the public to holding the Games this year.

A Reuters corporate survey https://jp.reuters.com/article/us-olympics-2020-japan-companies-poll/fretting-about-covid-most-japan-firms-say-olympics-should-be-cancelled-or-postponed-reuters-poll-idUSKCN2D12SZ published on Friday showed nearly 70% of Japanese firms also want the Games either cancelled or postponed.

https://finance.yahoo.com/news/6-japan-approves-more-covid-125009226.html

Therapeutic Solutions Develops Novel Stem Cell Therapy to Reduce Lung Scarring

  Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today new data and patent filing demonstrating that the FDA cleared drug, lithium carbonate, substantially augments the scar inhibiting activity of its licensed JadiCell™ universal donor stem cell therapy. Furthermore, the data reveals that the JadiCell™ was superior to other stem cells at inhibiting development of lung scarring in the bleomycin model of pulmonary fibrosis.   

"After patients recover from COVID-19 approximately one-third of those who were hospitalized develop long-term scarring of the lung,1" said Dr. James Veltmeyer, Chief Medical Officer of the Company. "There are no known treatments for this condition, and in some cases its progression leads to continuous deterioration in lung function.  We are currently developing the JadiCell™ for treatment of acute lung failure.  The data disclosed today suggests the possibility of expanding the use of JadiCell™ to address post-COVID lung failure, a condition which appears to be rising exponentially."

The use of JadiCells for treatment of lung pathology and COVID-19 is exclusively licensed and owned by Therapeutic Solutions International.  In an FDA double blind, placebo controlled clinical trial the JadiCell™ was successful at substantially improving survival in end-stage patients with COVID-19 associated acute lung failure2.  Specifically, treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), Serious Adverse Event-free survival (P = .008), and time to recovery (P = .03).  The Company plans to initiate a phase III pivotal registration trial and seek marketing approval for use of JadiCell in acute respiratory distress syndrome (ARDS) and other lung diseases.

"There are at least 660,000 patients suffering from post-COVID lung fibrosis if you look at the CDC statistics reporting over 2,000,000 COVID-19 related hospitalizations,3" stated Famela Ramos, Vice President of Business Development for the Company. "To our knowledge Therapeutic Solutions International is the only Clinical Stage Cell Therapy company aggressively addressing not only the acute lung failure associated with COVID-19, but also its long-term consequences."

https://www.prnewswire.com/news-releases/therapeutic-solutions-international-develops-novel-stem-cell-based-therapy-to-reduce-lung-scarring-potential-solution-to-post-covid-19-lung-deterioration-301296796.html

U.S.-Canada border closure extended to June 21

 The current closure at the U.S.-Canada border will remain in place for all non-essential travel until June 21.

Public Safety Canada made the announcement this morning on its official Twitter.

According to officials, the restrictions also apply to travel to Canada from countries other than the U.S. Certain exemptions do apply, Public Safety Canada says.

Congressman Brian Higgins released a statement following the announcement saying he’s disappointed in the decision to keep the border closed for another month.

“It is truly unacceptable at this point to have another 30-day extension with no further exceptions for those vaccinated, no goals or targets outlined to expand crossings, no reciprocal allowances for family reunification, and no plan,” Higgins said. “We have made great strides in fighting the pandemic, and we need to make progress on reopening the border. That is essential to both families that have been separated for way too long and to our binational economies.”

Congressman Chris Jacobs also responded to the extension today saying:

“This indefinite closure of the US – Canada border is unacceptable. To continue to do this for over a year without a plan for heartbroken families and anxious homeowners represents a failure of leadership. Vaccines are rolling out; the United States especially has done the work to tame the pandemic and reopen our nation. There is no excuse to willfully continue this uncertainty that has plagued citizens living on both sides of the border. We know how to reopen safely and have proven we are able to do so – the President, the Prime Minister, and respective federal officials need to develop and implement a metric-based, binational plan to reopen the US – Canada Border as soon as possible.“

The border first closed to non-essential travel last March at the beginning of the pandemic.

https://www.wivb.com/news/local-news/buffalo/western-new-york/u-s-canada-border-closure-extended-to-june-21/

Brooklyn Nets offer playoff tickets to incentivize COVID-19 vaccinations

 Mayor Bill de Blasio hopes that the Brooklyn Nets’ upcoming participation in the NBA Playoffs can give the city an assist in its efforts to vaccinate more New Yorkers.

While wearing a Nets jersey and hat, the mayor announced Tuesday that the city and the Nets were teaming up.

“The Nets are now going to be joining the battle against COVID with a mobile vaccination site right outside Barclays Center,” the mayor said at a news conference announcing the offer.

According to the Nets, the new vaccination site will only be available the day of and the day before home games. The mobile vaccination site will actually be set up across the street from the Barclays, at 143 Flatbush Avenue.

The Nets’ offer is in line with some of the other giveaways announced in recent weeks. The Mets and the Yankees announced earlier this year that they would offer free tickets to an upcoming game to those vaccinated at their respective stadiums on specific dates.

But the Nets’ offer is different in that the tickets the team is offering would be to a playoff game, as opposed to a regular season game.

“I feel like it’s giving the fans a little more of a present,” Nets fan Joshua Foster said about the ticket offer.

“It will be a big incentive for people,” said Debra Hamilton, another Nets fan.

NBA playoff tickets can be expensive and, according to prices listed online Tuesday, currently retail for at least $115.

NY1 spoke to one young fan, who was not old enough to get the shot herself but could still see the appeal of the offer:

“If they get free tickets, they won’t have to pay for it. So if they don’t have to pay for it, they’ll save up more money,” said Mackenzie Jordan, who was attending a Liberty game with her mother at Barclays Center on Tuesday.

Another difference with the Nets’ offer is that some people who are already vaccinated can still qualify for the raffle to attend a playoff game for free. The Nets are opening up the offer to those already vaccinated, but only if they live in one of 33 neighborhoods that city’s Task Force on Racial Inclusion and Equity previously found were disproportionately impacted by the coronavirus pandemic.

“The Nets, and the whole NBA, to their great credit, are focused on social justice, are focused on attacking the disparities that we learned during the COVID crisis,” the mayor said.

https://www.ny1.com/nyc/all-boroughs/coronavirus/2021/05/19/nyc-covid-vaccinations-nyc-covid-vaccination-site-near-barclays-center-brooklyn-nets-offer-playoff-tickets

Elliott Management could force out GSK CEO Walmsley, investor warns

 Speculation is mounting GlaxoSmithKline’s CEO Emma Walmsley may pay the price for the company’s lacklustre performance, after the dreaded activist investor Elliott Management built a stake in the struggling pharma.

GSK is fast becoming thought of as the UK’s other pharma company following Pascal Soriot’s successful turnaround of AstraZeneca – but according to press reports some investors are losing patience with Walmsley’s efforts to revive the firm.

It’s unclear how Elliott Management, run by billionaire Paul Singer, will proceed but it’s thought that the investor could push out Walmsley or call for the separation of the two businesses to speed up.

David Cumming, investment chief at shareholder Aviva, noted in an interview with Radio 4 that Elliott Management had been able to build its stake because of GSK’s slumping share price, which is 15% down since Walmsley took charge in 2017.

“It has left a gap they can exploit. Often the easiest catalyst to enforce change is to change the CEO, so the jury is still out on her future.

“She’ll have to demonstrate a more positive view to shareholders in terms of her leadership if Elliott is to be kept at bay.”

For now, investors including Blackrock, Dodge & Co and Royal London are reportedly backing Walmsley and her plans to split the firm in two.

Emma Walmsley

But Aviva is the first to go on record to criticise Walmsley and the strategy of splitting GSK into two companies, with one specialising in pharma and another dealing with consumer healthcare products.

The split was announced in 2018 after GSK struck a deal with Pfizer to create a £10 billion joint venture.

Scheduled to complete in mid-2022 the new GSK will be focused on pharmaceuticals and vaccines.

There have been question marks about the company’s R&D strategy, which Walmsley has left in the hands of Hal Barron, who made his name at Roche’s Genentech unit and oversaw the development of some of its most successful drugs.

But there have been some high-profile failures, including the cancer drug bintrafusp alfa, developed in a partnership with Germany’s Merck KGaA.

GSK has also lagged behind rivals with its response to COVID-19, teaming up with vaccines giant Sanofi only to see the project hit a speed bump while rivals Pfizer/BioNTech, Moderna and AstraZeneca hurried their shots to market.

https://pharmaphorum.com/news/elliott-management-could-force-out-gsk-ceo-walmsley-investor-warns/