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Moderna Announces the Start of Final Phase III Testing of Covid-19 Vaccine in July

Moderna to start final testing stage of coronavirus vaccine in July

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This article was originally published by PharmaLive.

CHICAGO (Reuters) – Moderna Inc (MRNA.O) on Thursday confirmed it plans to start a trial of 30,000 volunteers of its much-anticipated coronavirus vaccine in July as the company enters the final stage of testing. The Cambridge, Massachusetts-based biotech said the primary goal of the study would be to prevent symptomatic COVID-19, the disease caused by the novel coronavirus. The key secondary goal would be prevention of severe disease, as defined by keeping people out of the hospital. The company’s shares jumped 6 percent in premarket trading. Moderna said it has selected the 100-microgram dose of the vaccine for the late-stage study. At that dose level, the company is on track to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021 from the company’s internal U.S. manufacturing site and strategic collaboration with Swiss drugmaker Lonza (LONN.S). The company said it chose the 100-microgram dose to maximize the immune response and minimize adverse reactions. Moderna said is has completed manufacturing of enough vaccine to start the phase 3 trial.
In the midstage study, the company said it has enrolled 300 healthy adults, who have each been dosed with at least one shot, as well as the first 50 older adults, aged 18 to 54. Testing the vaccine in older adults with be critical because this group is at higher risk for the most severe effects of the virus, and older adults typically have less efficient immune function. The midstage study is testing the safety and preliminary effectiveness of two doses of the vaccine given 28 days apart.

FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyder/File Photo

Study participants will be followed for a year.

Reporting by Julie Steenhuysen; Editing by Bernadette Baum and Nick Zieminski

Reuters source:

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Spread & Containment

Rent Control Is A Disaster – Don’t Let It Spread Across The Nation

Rent Control Is A Disaster – Don’t Let It Spread Across The Nation

Authored by Betsy McCaughey via The Epoch Times,

America’s renters -…

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Rent Control Is A Disaster - Don't Let It Spread Across The Nation

Authored by Betsy McCaughey via The Epoch Times,

America’s renters - more than one-third of the nation’s households - are in for trouble.

Left-wing politicians are demanding rent regulation from coast to coast. Wherever it is adopted, the result will be a disastrous reduction in the rental housing supply, leaving renters desperate for places to live.

New York is the poster child for the failures of rent regulation. The U.S. Supreme Court is currently mulling a challenge to the constitutionality of the city’s rent regime.

Whatever the justices decide, the public needs to consider less destructive, more targeted ways to help low-income people pay for housing. The court of public opinion needs to consider these facts.

Fact No. 1: Rent regulation isn’t targeted to the poor.

In New York, there’s no means test. What you need is luck or connections. The mean income of a rent-stabilized apartment dweller is $47,000, but census data show that tens of thousands of them earn more than $150,000 per year. Some occupants use what they’re saving on rent to pay for a weekend place in the Hamptons or New England.

The pols don’t object—a sure sign they’re calling for rent regulation to help themselves politically, not the poor.

In New York, 44 percent of rental apartments are regulated by the Rent Guidelines Board (RGB), established in 1969, which sets the maximum amount by which landlords are allowed to raise the rent. Those limits apply to all buildings of six or more units built before 1974.

In 2022, the RGB set the maximum rent hike at 3.25 percent on one-year leases and this year at 3 percent. Never mind that last year, fuel costs to heat the buildings soared by 19 percent and overall inflation hit 8.3 percent.

The decisions are political, not economic. Many Democratic politicians vilify building owners as “greedy landlords” and depict themselves as the champions of the downtrodden. It’s a scam.

Fact No. 2: Winners and losers.

The winners are the lucky few with rent-regulated apartments and the pols who count on an army of tenant activists to turn out at the polls. The losers are the 56 percent of renters who don’t score a regulated apartment and have to scour neighborhoods for an unregulated place that they can afford. They’re paying more.

Why? Because regulation causes some landlords to walk away, reducing the overall supply of apartments. The laws of supply and demand mean rents go up. New Yorkers in unregulated apartments are paying the highest rents in the United States for a one-bedroom apartment. They're the real victims, and they should be furious.

Yet the left-wing press pretends that rent control offers only benefits. The New Republic warns that the Supreme Court challenge threatens “laws that have benefitted the city’s tenants for generations.” Sorry, untrue—only some tenants, and not always the neediest.

It’s economic madness. The saner way to help those who need assistance paying rent is with a voucher. We offer the needy SNAP debit cards to help them pay for groceries. No one slaps price controls on grocery stores or designates certain stores as “regulated,” forcing them to sell at below cost.

Yet New York forces certain landlords to pay what should be a public cost shared by all, an argument made to the court.

Fact No. 3: The Marxist fantasy that rent regulation will help the poor is spreading across the United States and Europe as well.

Maine and Minnesota have enacted laws allowing municipalities to impose rent regulations. In November 2024, California voters will be asked to approve a proposition allowing local governments to add additional restrictions to the state’s existing rent caps.

The laws of supply and demand are international. Berlin froze rents in 2019, and the rental supply plummeted, according to the Ifo Institute, a think tank.

Yet London Mayor Sadiq Khan is calling for freezing rents for two years. London provides housing vouchers to the poor—a smarter approach—but when the city froze the voucher amounts during the COVID-19 pandemic, fewer apartments were available in the price range. The answer is to raise the voucher amount. Freezing rents will only make the shortage worse.

Ignore the demagogues. The evidence is in: Rent regulation is a political scam. There are better ways to help Americans afford a place to live.

Tyler Durden Sat, 10/14/2023 - 16:20

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Government

China’s Birth Rate Plummets 10% To Lowest On Record

China’s Birth Rate Plummets 10% To Lowest On Record

China’s birthrate fell 10% last year to its lowest level on record, a significant drop…

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China's Birth Rate Plummets 10% To Lowest On Record

China's birthrate fell 10% last year to its lowest level on record, a significant drop in spite of extensive efforts by the CCP to encourage people to get busy.

Children play outside a cafe in Beijing, China. (AFP)

The country had just 9.56 million births in 2022, the lowest figure since they began keeping records in 1949, according to a report by the National Health Commission.

The high costs of child care and education, growing unemployment and job insecurity as well as gender discrimination have all helped to deter many young couples from having more than one child or even having children at all. -NBC News

China's population also fell for the first time in six decades, dropping to 1.41 billion people - a demographic shift that's caused officials to worry that the country will 'get old before it gets rich' - with a slowing economy and declining tax receipts amid increases in government debt due to soaring health and welfare costs.

According to the report, the demographic downturn is largely thanks to China's one-child policy imposed between 1980 and 2015. Nearly 40% of Chinese babies last year were the second child of a married couple, while 15% were from families with three or more children.

The sharp decline in births comes despite Beijing's efforts to increase child care and provide other financial incentives. In May, President Xi Jinping presided over a panel to study the topic.

Not just China

As we noted in June, Japan's birth rate has also plummeted to a record low for the seventh straight year, with the number of babies born falling below 800,000 this year, health ministry data showed on June 2.

The number of newborns in Japan fell to 770,747 this year, down 40,875 from the previous year and the lowest since the country began record-keeping in 1899, Kyodo News reported, citing health ministry data.

Japan’s fertility rate—the average number of children born to a woman in her lifetime—fell from 1.30 in 2021 to 1.26 last year, equivalent to the previous low recorded in 2005. The number is far below the 2.07 rate necessary to sustain a stable population.

The decline in Japan’s birth rate is attributed to people delaying parenthood due to the economic impact brought on by the COVID-19 pandemic, as well as the prevailing trend among couples to delay marriage, according to the report.

The US birthrate has also been in decline, falling slightly in 2022 compared to 2021, with roughly 3.7 million babies born nationwide. It still hasn't recovered to pre-pandemic levels according to the CDC.

And as Mike Shedlock noted two years ago.

More via Mish Talk, worth a review:

The Pandemic Caused a Baby Bust, Not a Boom

Scientific American reports The Pandemic Caused a Baby Bust, Not a Boom

When the COVID pandemic led to widespread economic shutdowns and stay-at-home orders in the spring of 2020, many media outlets and pundits speculated this might lead to a baby boom. But it appears the opposite has happened: birth rates declined in many high-income countries amid the crisis, a new study shows.

Arnstein Aassve, a professor of social and political sciences at Bocconi University in Italy, and his colleagues looked at birth rates in 22 high-income countries, including the U.S., from 2016 through the beginning of 2021. They found that seven of these countries had statistically significant declines in birth rates in the final months of 2020 and first months of 2021, compared with the same period in previous years. Hungary, Italy, Spain and Portugal had some of the largest drops: reductions of 8.5, 9.1, 8.4 and 6.6 percent, respectively. The U.S. saw a decline of 3.8 percent, but this was not statistically significant—perhaps because the pandemic’s effects were more spread out in the country and because the study only had U.S. data through December 2020, Aassve says. The findings were published on Monday in the Proceedings of the National Academy of Sciences USA.

Birth rates fluctuate seasonally within a year, and many of the countries in the study had experienced falling rates for years before the pandemic. But the declines that began nine months after the World Health Organization declared a public health emergency on January 30, 2020, were even more stark. “We are very confident that the effect for those countries is real,” Aassve says. “Even though they might have had a bit of a mild downward trend [before], we’re pretty sure about the fact that there was an impact of the pandemic.”

Covid Accelerated the Existing Trend

Covid accelerated the already declining birth rates. 

Given the 16-year lag between births and the civilian noninstitutional population coupled with the aging of the workforce there will be fewer and fewer workers supporting retired workers on Social Security. 

Notice the relatively steep decline in the birth rate starting in 2008 and continuing through today. 

That impact will start showing up in 2024 and last a minimum of 12 years.

How long depends on whether the birth rate picks up after Covid. I highly doubt the birth rate will pick up.

Deflationary and Inflationary Impacts

  1. Inflationary: Shortage of workers increases wage pressures
  2. Deflationary: Fewer workers support an increasing number of retirees
  3. Deflationary: Older workers need more assistance, buy fewer things, travel less. 
  4. Deflationary: More government debt and deficits. Government spending has a negative impact on real GDP.

*  *  *

Time for another sexual revolution?

Tyler Durden Fri, 10/13/2023 - 22:40

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Government

TDR’s Top 7 Cannabis Developments For The Week Of October 9

Welcome to TDR’s review of the Top 7 Cannabis Developments for the week of October 9. Aside from presenting a synopsis of news events, interviews and…

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Welcome to TDR’s review of the Top 7 Cannabis Developments for the week of October 9. Aside from presenting a synopsis of news events, interviews and closing market prices for publicly-listed companies.

7. Trulieve Announces Filing of Amended Federal Tax Returns Claiming $143 Million Refund

Trulieve Cannabis announced the filing of amended federal tax returns with refund claims for several of the company’s business entities for the years 2019, 2020, and 2021. In total, the company is claiming a refund of $143 million from taxes paid which the company believes it does not owe, although there is no guarantee of receipt.

Trulieve believes its determination is supported by legal interpretations that challenge the company’s tax liability under Section 280E of the Internal Revenue Code.

6. The Cannabist Company Pays Down $25 Million of Debt

The Cannabist Company Holdings has delivered a notice of partial redemption to the holders of the company’s outstanding 13% senior secured notes due May 14, 2024. The Notice provides that the company will, on October 23, 2023, redeem US$25 million of the total US$38.2 million principal amount of the Notes currently outstanding.

On the Redemption Date, Holders of Notes will have a portion of their 13% Notes, in denominations of $1,000, redeemed effective as of the Redemption Date on a pro rata basis in accordance with the terms of the trust indenture between the company and Odyssey Trust Company dated May 14, 2020, as amended and supplemented.

5. Marijuana Consumers Who Caught COVID Had ‘Better Outcomes And Mortality’ Than Nonusers, Study Finds

Cannabis consumers who caught COVID-19 had significantly lower rates of intubation, respiratory failure and death than people who do not use marijuana, according a new study based on hospital data that was presented this week at the annual conference of The American College of Chest Physicians (CHEST) in Honolulu.

Authors analyzed records from 322,214 patients from the National Inpatient Sample, a government database that tracks hospital utilization and outcomes. Of those patients, 2,603—less than 1 percent—said they consumed cannabis.

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Chart Of The Week—Select MSOs Net Cash Flows After Interest Expense, CAPEX, Taxes And Debt Maturities

Interview Of The Week: Jason Wild Speaks On The Eve Of TerrAscend’s Investor Day

TerrAscend (TSX: TSND) Chairman Jason Wild is here to share the latest developments in the industry, the recent news surrounding the house speaker in Washington, the upcoming ballot news in Florida and more.

Georgia To Become First State Selling Medical Marijuana In Pharmacies

Widely Held MSOs & LP Weekly Performance

CompanySymbolPrevious Week CloseEnd Of Week Close% Change On Week
AdvisorShares Pure Cannabis ETFMSOS7.087.04-0.56
Aurora CannabisACB0.56720.5039-11.16
Ayr WellnessAYRWF1.821.70-6.59
Canopy GrowthCGC0.70480.70-0.68
Cresco LabsCRLBF1.661.670.60
Curaleaf HoldingsCURLF4.224.06-3.79
Green Thumb IndustriesGTBIF10.129.75-3.65
High Tide Inc.HITI1.651.54-6.66
Marimed Inc.MRMD0.39040.382-2.15
TerrAscend Corp.TSNDF1.841.903.26
Tilray BrandsTLRY2.062.01-2.42
Trulieve CannabisTCNNF5.155.04-2.13
Verano HoldingsVRNOF4.084.315.63

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4. States Made More Than $5.7 Billion In Marijuana Tax Revenue Over 18-Month Period, New Federal Census Bureau Report Shows

The U.S. Census Bureau has released its first report on state-level marijuana tax revenue data following what the agency calls “a complete canvass of all state agencies” going back to July 2021. In the 18-month period between then and the end of 2022, the data show, states collected more than $5.7 billion from licensed cannabis sales.

The launch of the report, which the agency plans to update on a quarterly basis going forward, signals that at least some parts of the federal government are now beginning to treat the cannabis industry as a legitimate sector of the economy. The Census Bureau first announced in January 2021 that it would begin collecting marijuana tax figures for its quarterly summary of state and local government tax revenue. It also said it wants states to submit cannabis revenue data as part of annual reports as well.

In the news…

4Front Ventures has agreed to issue 1,283,425 subordinate voting share purchase warrants pursuant to an amendment to a previously entered promissory note purchase agreement. Pursuant to the Agreement, the lender has agreed to extend the maturity date of its loan, which has a principal amount of US$2,000,000, with a payment of an extension fee of C$65,000, which is payable in Warrants.

Aleafia Health announced that Red White & Bloom Brands Inc. has been selected as the successful bidder pursuant to the court-approved sale and investment solicitation process in connection with the previously announced proceedings of Aleafia and certain of its subsidiaries under the companies’ Creditors Arrangement Act.

BioHarvest Sciences announced that VINIA, its flagship nutraceutical product derived from red grape cells, has received its Canadian product license from Health Canada’s Natural and Non-Prescription Health Products Directorate.

California Governor vetoes cannabis cafe and marijuana labeling bills…

Canopy Growth has received EU GMP certification from RP Tuebingen, Regional Health Inspectorate of Baden-Wuerttemberg for the company’s cannabis cultivation facility in Kincardine, Ontario.

Cardiol Therapeutics announced positive study results from one of its international collaborating research centers demonstrating that subcutaneously administered cannabidiol, the active pharmaceutical ingredient in Cardiol’s novel CRD-38 subcutaneous formulation prevented increases in key cardiac inflammatory and remodelling markers in a model of heart failure.

Charlotte’s Web Holdings announced the appointment of Angela McElwee to its Board of Directors.

CLS Holdings USA announced its financial results for the fiscal quarter ended August 31, 2023.

Colorado cannabis sales surpassed the $15 billion mark in August – a milestone since legal adult-use sales launched in the state in 2014.

Connecticut cannabis sales hit $25.2M in September 2023…

Cresco Labs announced the launch of its Good News brand in the Commonwealth of Pennsylvania.

Curaleaf Holdings will report its financial and operating results for the third quarter ended September 30, 2023 after market close on November 9, 2023.

Curaleaf Holdings has filed its application to list the Company’s subordinate voting shares on the Toronto Stock Exchange.

Eurofins CDMO Alphora Inc. announced that it has received its Health Canada Cannabis Drug License issued within the Cannabis Act and Cannabis Regulations for its Oakville, Ontario operations in September 2023. 

Goodness Growth Holdings and Grown Rogue International, Inc. have completed the issuance of warrants to purchase listed shares as previously announced on May 25, 2023.

Heritage Cannabis Holdings announced the procurement of an EU GMP certified extraction machine to be added to the existing fleet of extractors which will double the company’s hydrocarbon processing capacity.

iAnthus Capital Holdings announces that Robert Galvin will transition out of his role as Interim Chief Operating Officer of the Company, effective immediately. 

IM Cannabis, a medical cannabis company with operations in Israel and Germany, releases message from the CEO about the Israel-Hamas War and announces the company, through its wholly-owned subsidiaries, IMC Holdings Ltd. and Rosen High Way Ltd., has secured C$1,390,000 in short-term debt.

IM Cannabis announced that Uri Birenberg will join the company’s leadership team as Chief Financial Officer effective October 10, 2023. 

Lead GOP Senate cosponsor of a bipartisan marijuana banking bill says a planned floor vote is on pause until he can ensure the legislation will later pass the Republican-controlled House, according to a cannabis financing executive who spoke with the senator this week.

Legislative Review of the Cannabis Act: What We Heard Report

Letter to Attorney General Garland and DEA Administrator Milgram urging halt to rescheduling process.

MariMed, Inc announced “Small Batch Exclusives,” a unique, limited-time program that gives customers the opportunity to purchase legendary flower strains.

MariMed Inc. retail footprint has once again expanded, as the company officially unveiled an adult-use Thrive dispensary in Casey, Illinois. This marks the fifth dispensary in operation within the state of Illinois and the 12th dispensary in MariMed’s expanding portfolio across five states.

Organigram Holdings has obtained a receipt for a final short form base shelf prospectus filed with the securities commissions in each of the provinces and territories of Canada. A corresponding shelf registration statement on Form F-10 has been filed with the United States Securities and Exchange Commission (SEC File No. 333-274686) but is not yet effective.

RISE Dispensaries owned by Green Thumb Industries Inc. announced that RISE Dispensary Brandon, the Company’s 9th retail location in Florida, will open on October 14th.

SAFE Banking now with 84 co-sponsors…

SunStream Bancorp announced a receivership court order granting the sale of certain assets of Greenpeak Industries Inc. and certain affiliated entities d.b.a. Skymint to Skymint Acquisition Co., a newly formed designee entity of Tropics LP.  Tropics is a limited partnership fully owned by an affiliate of Sunstream, a joint venture sponsored by SNDL Inc.

Texas activists say they have secured enough signatures to put a local marijuana decriminalization initiative on the ballot in the city of Lubbock if lawmakers there do not enact the reform legislatively.

The Cannabist Company Holdings will report its financial results for the third quarter ended September 30, 2023 before U.S. financial markets open on Tuesday, November 14, 2023. 

The Cannabist Company to report third quarter 2023 results on November 14, 2023 before U.S. financial markets open.

Trulieve Cannabis announced the relocation of a medical cannabis dispensary in Melbourne, Florida.

Trulieve Cannabis has added $500,000 to a ballot initiative aimed at legalizing the recreational use of marijuana, bringing its total contributions to $39.55 million, according to a newly filed finance report.

Verano Holdings announced the opening of Zen Leaf Newington, the company’s second social equity joint venture location in Connecticut and fourth cannabis dispensary statewide, on October 13, following a ceremonial ribbon cutting at 9 a.m. local time.

Vext Science has completed the previously announced non-brokered private placement of $11.5 million through the issuance of 67,647,058 common shares at a price of $0.17 per Common Share, including the full exercise of a $1.5 million over-allotment option.

3. TerrAscend Corp. Raises Full Year 2023 Guidance Prior To Investor Day Presentations At The TSX

Tier-1 cannabis multistate operator TerrAscend Corp. has made a notable splash in advance of Investor Day presentations at the Toronto Stock Exchange. The company has elevated forward-looking forecasts for net revenue and Adjusted EBITDA from ongoing operations for the entirety of 2023, signaling that business operations are exceeding previously-stated expectations.

For its full fiscal 2023, TerrAscend now expects net revenue and Adjusted EBITDA to register a minimum of $317 million and $63 million, respectively, versus previous a previous forecast of $305 million and $58 million. This represents year-over-year growth of 28% in net revenue and 62% in Adjusted EBITDA from continuing operations—both well above Tier-1 industry averages.

Furthermore, TerrAscend anticipates that its gross margin will surpass the 50% mark, and generate positive free cash flow from ongoing operations during the latter half of the year.

2. Cannabis Adversary Steve Scalise Drops Out Of Speaker Race

The House GOP’s pick for speaker, Steve Scalise, announced Thursday he will no longer seek the gavel as he confronted a likely insurmountable vote shortage. While Scalise had won a majority of votes in an internal GOP ballot a day earlier, he faced an ever-growing list of Republicans who vowed to support only his opponent, Rep. Jim Jordan, on the floor. The Ohio Republican is now expected to make another run for the position.

Scalise announced his decision on Thursday evening, following a conference meeting in which it became clear that he had no path to winning the 217 votes needed to ascend to the speakership.

1. Jim Jordan Wins Nomination In GOP’s Chaotic House Speaker Battle

House Republicans voted Friday to nominate conservative firebrand Jim Jordan for speaker of the House — the latest twist in a chaotic battle for speakership. Jordan, the chairman of the Judiciary Committee, received 124 votes — still more than 90 votes shy of the 217 he will need to grab the gavel in a vote on the House floor, according to members and aides who were the room. That floor vote has not yet been scheduled.

Jordan had an opponent in the conference vote for speaker: Rep. Austin Scott, who filed to run for the top spot shortly before the vote went down. Scott received 81 votes in the candidate forum.

Jordan had earlier backed out of the speaker race, saying he would cast a vote for Rep. Steve Scalise after the majority leader earned the nomination is a similar closed-door session Wednesday. Scalise backed out Thursday night after he failed to secure the votes needed to become speaker.

The post TDR’s Top 7 Cannabis Developments For The Week Of October 9 appeared first on The Dales Report.

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