(Reuters) – A federal judge ordered the U.S. government to pay slightly more than $230 million to survivors and family members of victims of a 2017 mass shooting at a Texas church that killed 26 people.
“The losses and pain these families have experienced is immeasurable,” wrote Rodriguez, who works in San Antonio, Texas.
Kelley, whom the judge found 40% responsible, used firearms he should not have been allowed to buy after admitting in a 2012 court martial to domestic assault.
By Timothy Annett February 8, 2022, 6:23 AM CST with my remarks in (…)
Merck & Co. said that it had provided about 3.1 million courses of its Covid-19 pill to the U.S. government, fulfilling the terms of a federal pact that the drugmaker and partner Ridgeback Biotherapeutics LP agreed to last year.
The companies said in a statement on Tuesday that they have completed manufacturing of 10 million courses of the therapy and are on track to make at least 20 million courses this year.
(Can’t you see them jumping for joy as you read this? )
The surge in coronavirus infections in the U.S. spurred by the omicron variant has caused demand for treatments to soar. However, some monoclonal antibodies are ineffective against the new strain. While Merck’s pill and another oral Covid treatment calledPaxlovidmade by Pfizer Inc. work against omicron, supplies of the authorized therapies have been tight in some places. (WRONG– they have been denied)
Though the omicron wave has begun to ebb in the U.S., deaths from the virus remain high, recently averaging about 2,500 a day, according to Johns Hopkins University data. Merck Chief Executive Robert Davis said in the statement that the companies believe molnupiravir “will be a critical addition in helping curb the impact of Covid-19.”
Shares of Merck were down 0.2% in premarket trading in New York.
Merck said in its statement that it has entered into purchasing and supply agreements for molnupiravir in more than 30 markets worldwide, and has so far shipped the drug to more than 25 countries.
Investors (REMEMBER THAT WORD… “INVESTORS”) have begun to brace for the possibility that a sustained decline in Covid infections could undercut expected demand for vaccines, drugs and other virus products like masks and diagnostic tests. (THINK ABOUT THIS) Pfizer said on Tuesday that it had $22 billion in ordersfor Paxlovid, lower than the $25 billion in sales analysts had been expecting, on average.
Merck and Ridgeback Announce That 3.1 Million Courses of Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Merck and Ridgeback Announce That 3.1 Million Courses of Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Have Been Supplied to the U.S. Government for Use in the United States Merck Has Completed Manufacturing of 10 Million Courses of Therapy and Remains on Track to Produce at Least 20 Million Courses in 2022 to Provide Widespread Access to Molnupiravir Globally
KENILWORTH, N.J. & MIAMI — February 8, 2022
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that a total of approximately 3.1 million courses of molnupiravir, an investigational oral antiviral COVID-19 medicine, have been provided to the U.S. government for allocation across the country. The U.S. Department of Health and Human Services (HHS) has created a public website to help providers identify locations that have received shipments of government procured COVID-19 therapeutics available under Emergency Use Authorization. In 2021, Merck entered a procurement agreement with the U.S. government under which the company agreed to supply approximately 3.1 million courses of molnupiravir to the U.S. government upon Emergency Use Authorization or approval from the U.S. Food and Drug Administration.
This press release features multimedia. View the full release here:
In addition to the U.S. agreement, Merck has entered into advance purchase and
supply agreements for molnupiravir in more than 30 markets worldwide,
including Australia, Canada, Korea, Japan, Thailand, Ukraine and United
Kingdom, pending regulatory authorizations, and is currently in discussions
with additional governments. To date, Merck has shipped molnupiravir to more
than 25 countries; in countries where it is approved or authorized, patients
have begun to receive the medicine.
About Merck’s Global Efforts to Accelerate Access to Molnupiravir Following Regulatory Authorizations or Approvals
Global access has been a priority for Merck and Ridgeback since the inception
of their molnupiravir collaboration. The companies are committed to providing
timely access to molnupiravir globally through our comprehensive supply and
access approach, which includes investing at risk to produce millions of
courses of therapy; tiered pricing based on the ability of governments to
finance health care; entering into supply agreements with governments;
allocating up to 3 million courses of therapy for distribution through UNICEF
and the ACT Accelerator Therapeutics Partnership; and granting voluntary
licenses to generic manufacturers and to the Medicines Patent Pool to make
generic molnupiravir available in more than 100 low- and middle-income
countries following local regulatory authorizations or approvals.
Supply: In anticipation of the results from MOVe-OUT and the potential for
regulatory authorization or approval, Merck produced molnupiravir at risk,
manufacturing 10 million courses of treatment by the end of 2021, with at
least 20 million courses expected to be produced in 2022. To date, Merck has
shipped molnupiravir to over 25 markets, including approximately 3.1 million
patient courses supplied to the U.S. government; in countries where it is
approved or authorized, patients have begun to receive the medicine. To supplement the supply from licensed generic manufacturers, Merck has entered an agreement with UNICEF to allocate up to 3 million courses of therapy to low- and middle-income countries through the first half of 2022.
Supply agreements: Merck entered into a procurement agreement with the U.S. government under which the company has supplied approximately 3.1 million courses of molnupiravir to the U.S. government, upon Emergency Use Authorization or approval from the U.S. Food and Drug Administration. The procurement of molnupiravir was supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, in collaboration with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number W911QY21C0031.
The U.S. Department of Health and Human Services (HHS) has created a public
website to help providers locate dispensing sites that have received shipments
of government-procured COVID-19 therapeutics available under Emergency Use
Authorization. Merck has also entered into advance purchase and supply
agreements for molnupiravir with governments for over 30 markets worldwide,
including Australia, Canada, Korea, Japan, Thailand, Ukraine and United
Kingdom, pending regulatory authorizations, and is currently in discussions
with additional governments. Merck is implementing a tiered pricing approach
based on World Bank country income criteria to reflect countries’ relative
ability to finance their health response to the pandemic.
Voluntary licenses:As part of its commitment to widespread global access, Merck previously announced that it has entered into a licensing agreement with the Medicines Patent Pool to increase broad access for molnupiravir in low- and middle-income countries. Additionally, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.
Merck continues to discuss additional measures and collaborations to accelerate broad, global access to molnupiravir.
Authorized Use of Molnupiravir in the U.S.
The U.S. Food and Drug Administration (FDA) has issued an EUA for the emergency use of the unapproved molnupiravir, a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis, for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate. Molnupiravir is not FDA-approved for any use including for use for the treatment of COVID-19. Prior to initiating treatment with molnupiravir, carefully consider the known and potential risks and benefits.
Molnupiravir is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of molnupiravir under section 564(b)(1) of the Federal, Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Molnupiravir is not authorized for use in patients less than 18 years of age or who are hospitalized due to COVID-19. Benefit of treatment with molnupiravir has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19. Molnupiravir is not authorized for use for longer than five consecutive days. Molnupiravir is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.Molnupiravir may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which molnupiravir belongs (i.e., anti-infectives).
Selected Safety Information for Molnupiravir
No contraindications have been identified based on the limited available data on the emergency use of molnupiravir authorized under this EUA.
Warnings and Precautions
There are limited clinical data available for molnupiravir. Serious and unexpected adverse events may occur that have not been previously reported with molnupiravir use.
Molnupiravir is not recommended for use during pregnancy. Based on findingsfrom animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. There are no available human data on the use of molnupiravir in pregnant individuals to evaluate the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Molnupiravir is authorized to be prescribed to a pregnant individual only after the healthcare provider has determined that the benefits would outweigh the risks for that individual patient. If the decision is made to use molnupiravir during pregnancy, the prescribing healthcare provider must document that the known and potential benefits and the potential risks of using molnupiravir during pregnancy were communicated to the pregnant individual.
There is a pregnancy surveillance program that monitors pregnancy outcomes in individuals exposed to molnupiravir during pregnancy. The prescribing healthcare provider must document that a pregnant individual was made aware of
Merck’s pregnancy surveillance program at 1-877-888-4231 or
in the pregnancy surveillance program and allows the prescribing healthcare provider to disclose patient specific information to Merck, the prescribing healthcare provider must provide the patient’s name and contact information to Merck. Pregnant individuals exposed to molnupiravir can also report the exposure by contacting Merck at 1-877-888-4231 or pregnancyreporting.msd.com.
Advise individuals of childbearing potential of the potential risk to a fetus and to use an effective method of contraception correctly and consistently during treatment with molnupiravir and for 4 days after the final dose.
Prior to initiating treatment with molnupiravir, assess whether an individual of childbearing potential is pregnant or not, if clinically indicated.
Molnupiravir is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. The safety and efficacy of molnupiravir have not been established in pediatric patients.
The most common adverse reactions occurring in ≥1% of subjects in the
molnupiravir treatment group in the Phase 3 double-blind MOVe-OUT study were:
diarrhea (2% versus placebo at 2%), nausea (1% versus placebo at 1%), and
dizziness (1% versus placebo at 1%) all of which were Grade 1 (mild) or Grade
Serious adverse events occurred in 7% of subjects receiving molnupiravir and
10% receiving placebo; most serious adverse events were COVID-19 related.
Adverse events leading to death occurred in 2 (<1%) of the subjects receiving
molnupiravir and 12 (2%) of subjects receiving placebo.
No drug interactions have been identified based on the limited available data on the emergency use of molnupiravir. No clinical drug-drug interaction trials of molnupiravir with concomitant medications, including other treatments for mild to moderate COVID-19, have been conducted.
There are no data on the presence of molnupiravir or its metabolites in human
milk. It is unknown whether molnupiravir has an effect on the breastfed infant
or effects on milk production. Based on the potential for adverse reactions in
the infant from molnupiravir, breastfeeding is not recommended during
treatment with molnupiravir and for 4 days after the final dose. A lactating
individual may consider interrupting breastfeeding and may consider pumping
and discarding breast milk during treatment and for 4 days after the last dose
Males of Reproductive Potential
Nonclinical studies to fully assess the potential for molnupiravir to affect
offspring of treated maleshave not been completed. Advise sexually active
individuals with partners of childbearing potential to use a reliable method
of contraception correctly and consistently during treatment and for at least
3 months after last dose of molnupiravir. The risk beyond three months after
the last dose of molnupiravir is unknown.
Required Reporting for Serious Adverse Events and Medication Errors
The prescribing healthcare provider and/or the provider’s designee are/is
responsible for mandatory reporting of all serious adverse events and
medication errors potentially related to molnupiravir within 7 calendar days
from the healthcare provider’s awareness of the event.
Submit adverse event and medication error reports, using FDA Form 3500, to FDA
January 19, 2022: Eighty percent (80%) of voters favor requiring voters to show a photo ID before casting a ballot. A Scott Rasmussen national survey found that 85% also favor a requirement for states to clean voter rolls by removing people who have died or moved from the voter registration lists.
Additionally, 76% favor requiring all ballots to be received by Election Day. 
All three reforms are favored by a solid majority of every measured demographic group.
Support for photo ID requirements comes from 91% of Republicans, 77% of Democrats, and 75% of Independent voters. Eighty-six percent (86%) of White voters favor photo ID requirements along with 71% of Hispanic voters and 65% of Black voters.
Data released earlier found that 50% believe the top priority for election reform should be making it harder to cheat. Thirty-eight percent (38%) think the focus should be on making it easier to vote.
Scott Rasmussen is founder and president of the Rasmussen Media Group. He is a political analyst, author, public speaker, independent public opinion pollster and columnist for Creators Syndicate. Read Scott Rasmussen’s Reports — More Here.
“We put together I think the most extensive and inclusive voter fraud organization in the history American politics“ – Joe Biden
Former President Donald Trump on Thursday said President Joe Biden questioned the 2020 election results “in his own very different way.”
During a rare press conference on Wednesday, Biden said the upcoming midterm election results could be “illegitimate.”
“President Biden admitted yesterday, in his own very different way, that the 2020 election may very well have been a fraud, which I know it was,” Trump said in a statement released by his joint fundraising committee Save America.
“I’m sure his representatives, who work so hard to make it look legit, are not happy,” he added.
Biden on Wednesday was asked whether he believed the 2022 election will be conducted fairly and its results legitimate.
“Well, it all depends on whether or not we’re able to make the case to the American people that some of this is being set up to try to alter the outcome of the election,” said Biden, taking a stance for which Trump has been vilified by the left and the mainstream media.
The former president and his allies have said that Biden prevailed in 2020 due to voter fraud in several key battleground states.
Later, during the press conference Biden was asked whether the 2022 election would be “free and fair” if some state legislatures reformed their voting protocols.
“Oh, yeah, I think it easily could be — be illegitimate,” the president said.
Biden said the legitimacy of the midterms could depend on whether Democrats passed their voting legislation — which was blocked by Republicans on Wednesday evening.
The bill would have implemented election reform demanding federal “pre-clearance” from the Justice Department before states and localities could change voting regulations — a power the Constitution left to the states.
Biden and fellow progressives have insisted that states — largely GOP-led ones — are making it harder to vote, particularly for minorities.
Republicans say states simply are tightening requirements to improve the voting process and its accuracy so there are fewer problems going forward.
By Jeffrey Rodack | Friday, 04 February 2022 12:01 PM
Former President Donald Trump is blasting President Joe Biden, saying he is destroying the country.
Trump’s comments came during an interview on the “NRSC Red Zone” podcast. The podcast is hosted by Sen. Rick Scott, R-Fla., chairman of the National Republican Senatorial Committee.
Trump ripped into Biden policies on border security, Afghanistan, the economy and gas prices. He also took the opportunity to go after those Democrats who favor defunding the police.
“Our country is being destroyed in one year,” Trump said. “The borders are horrible. So many things are horrible. The way [Biden] has handled COVID has been horrible. So many things are bad, but this is a thing that’s really hit people: This all took place in one year.
“I think the withdrawal from Afghanistan was so bad on so many fronts. Number one: The way it was done. I was the one who was going to get out. But we were going to get out with strength and dignity. To this day many Americans are left behind.
“Nobody even knows what happened., But you had 13 killed and many, many wounded of our military and other people. We took our military out first. It was absolutely ridiculous. Then, of course, you had $85 billion worth of equipment — 70,000 trucks, 700,000 machine guns and rifles [left behind]. … One of the most incredible, stupid deals, that I’ve ever heard of.”
Trump noted that during his administration the U.S. had “the greatest economy in history.”
“I don’t think there’s anything that’s ever been like it,” he said. “Then we had COVID and then we built it up again from that point.”
But he added: “Bad things are happening for our country.”
And he said the price of fuel has to be brought back down.
“They [Biden Administration officials] have no idea what they’re doing,” he said. “It’s a very sad situation because we were energy independent. We had very low gasoline prices, very low heating prices, etc. etc. Natural gas was coming out stronger and stronger. It’s clean. And we were doing great both in terms of the environment and in terms of the costs.
“I think a very important thing to do right now is getting the energy costs down. It’s a big factor in respect to inflation.
“We were at $1.87 for gasoline and now we’re hitting $5, $6 and $7. Pretty incredible. I think it’s had a huge, negative impact on the Biden administration.”
Trump agreed with Scott that Biden doesn’t seem to “care” about border security and the amount of migrants entering the U.S.
“We had the lowest numbers in history, and today you have the highest number,” he said. “We had the lowest amounts of drugs coming in in decades and now you have the most. Drugs are pouring through the border right now. I had it down to a number nobody had seen in decades.
“It actually looks like [Biden] doesn’t care about the drugs coming in and they’re killing people by the tens of thousands.”
And he criticized Democrats for the move to defund police.
“In New York we just lost as number of great policemen — shot, killed,” he said.
He condemned those responsible for the fatal attacks on police.
“These are murderers — horrible murderers,” he said. “And nothing happens. If you’re a murderer they let you out. No cash bail. It’s just killing our country.
“All Democrat-run cities. We don’t have Republican cities like this. The only way you’re going to fix it is the opposite of what they’re doing. Not defund the police, but to defend the police. Police can do their jobs so well. They had for years and now this philosophy to defund the police. It’s not going away. It’s so ridiculous.
“The American people are on our side. These are just politicians who have gone crazy.”