Iowans fired for refusing COVID-19 vaccine will be granted jobless benefits

 Republican Iowa Gov. Kim Reynolds on Friday signed a bill that allows state residents to obtain unemployment benefits if they are fired for refusing the COVID-19 vaccine.

Reynolds, who has previously opposed other government vaccine mandates, said in a statement that "no Iowan should be forced to lose their job or livelihood over the COVID-19 vaccine," according to The Associated Press. 

The Iowa Legislature passed the bill in a one-day special session Thursday with a 68-27 vote.

The governor also announced Friday that she will join nine other states in suing the Biden administration over its vaccine requirement for workers, the Des Moines Register reported.

Reynolds is vaccinated and has encouraged Iowans to get the vaccine, but has stated she believes getting the shot should be a personal choice. 

Nearly 7,000 Iowans have died as a result of the coronavirus, and Iowa is currently 23rd in the country for percentage of its residents fully vaccinated at 55.4 percent, the AP noted. 

https://thehill.com/homenews/state-watch/579239-iowans-who-are-fired-for-refusing-covid-19-vaccine-will-be-granted

AGs in 10 GOP states join fight against Biden vaccine mandate

 Ten attorneys general in states with GOP governors shave joined the fight to push back against a Biden administration vaccine mandate for federal contractors, arguing that it is “unconstitutional, unlawful, and unwise.”

The lawsuit filed by the Attorneys Generals from the states of Missouri, Nebraska Alaska, Arkansas, Iowa, Montana, New Hampshire, North Dakota, South Dakota and Wyoming called a vaccine mandate issued by the Biden administration to require federal contractors to get the COVID-19 shot by Dec. 8 a “power grab.”

The lawsuit alleged that the requirement was an unlawful usurpation of the states’ police powers, violated the Tenth Amendment and was “non consistent” with procurement law, among other concerns. 

“If the federal government attempts to unconstitutionally exert its will and force federal contractors to mandate vaccinations, the workforce and businesses could be decimated, further exacerbating the supply chain and workforce crises,” Missouri Attorney General Eric Schmitt said in a statement.

“The federal government should not be mandating vaccinations, and that’s why we filed suit today – to halt this illegal, unconstitutional action.”

“The ramifications of the federal contractor vaccine mandate are significant,” Nebraska Attorney General Douglas Peterson said in a statement. “It will impact countless employees, exacerbate existing workforce shortages, and create economic instability. Most importantly, it puts individual employees who happened to work for federal contractors out of a job if they simply make the personal choice not to be vaccinated.”

A White House official told McClatchy, responding to legal challenges waged by Missouri and Florida, that President Biden “has authority to protect the federal workforce and promote efficiency in federal contracting in this way,” arguing that federal procurement law is not violated by the vaccine mandate.

The Hill has reached out to the White House for comment.

The lawsuit follows legal challenges to the federal contractor vaccine mandate that have been waged by several other states including Georgia, Alabama, Idaho, Kansas, South Carolina, Utah, West Virginia, Texas and Florida.

https://thehill.com/homenews/state-watch/579240-attorneys-general-in-10-gop-states-join-fight-against-biden

AbbVie: FDA Approves VUITY 1.25%, First and Only Eye Drop to Treat Presbyopia

 Allergan, an AbbVie (NYSE: ABBV) company, today announced the U.S. Food and Drug Administration (FDA) approval of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population.

https://www.streetinsider.com/Corporate+News/AbbVie+%28ABBV%29+Announces+FDA+Approval+of+VUITY+1.25%25%2C+the+First+and+Only+Eye+Drop+to+Treat+Presbyopia/19131846.html

Dex Com Q3 Results

 DexCom, Inc. (Nasdaq: DXCM) Thursday reported its financial results as of and for the quarter ended September 30, 2021.

Third Quarter 2021 Financial Highlights:

• Revenue grew 30% versus the same quarter of the prior year to $650.2 million on a reported basis and 28% on an organic1 basis.

• U.S. revenue growth of 23% and international revenue growth of 57% on a reported basis. International growth was 46% on an organic1 basis.

• GAAP operating income of $118.3 million or 18.2% of revenue, a decrease of 60 basis points compared to the third quarter of 2020. Non-GAAP operating income* of $123.8 million or 19.0% of revenue, in line with the same quarter of the prior year.

Strategic Highlights:

• Received FDA clearance for two key software solutions that enhance Dexcom’s connected ecosystem:

  • The Dexcom real-time API makes it possible for third-party developers to integrate real-time CGM data into their digital health apps and devices, ultimately offering Dexcom users a greater variety of options in where and how they engage with their glucose data.2

  • The Dexcom app-in-app module directly integrates with third party healthcare apps, making managing diabetes easier for Type 2 Non-intensive insulin therapy (NIIT) users by enabling a convenient, single-app experience.

• Completed the acquisition of our distributor in Australia and New Zealand, advancing Dexcom’s strategy to transition certain international markets from distributors to direct sales.

• Introduced a new product with the launch of Dexcom ONE, a key addition to our portfolio as we seek to broaden access to healthcare for people with diabetes globally.

https://finance.yahoo.com/news/dexcom-reports-third-quarter-2021-200200293.html

FDA approves Novartis Scemblix for chronic myeloid leukemia

 

• Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukemia (CML) who suffer with intolerance or inadequate response after at least two previous tyrosine kinase inhibitor (TKI) treatments1
  
  
• In the pivotal Phase III ASCEMBL trial, Scemblix demonstrated significant and clinically meaningful superiority in major molecular response (MMR) rate vs. Bosulif®* (bosutinib) (25% vs. 13%) at 24 weeks, and more -than -three times lower discontinuation rates due to side effects (7% vs. 25%)2,3
  
  
• Additional Phase I data in patients with CML with the T315I mutation supported the FDA approval for a second indication in this patient population4
  
  
• With a new mechanism of action known in scientific literature as a STAMP inhibitor and clinical trials across treatment lines – including in the first-line setting –, Scemblix reinforces Novartis’ two-decade commitment to bring transformative therapies to people living with CML2-18

https://www.globenewswire.com/news-release/2021/10/29/2323914/0/en/FDA-approves-Novartis-Scemblix-asciminib-with-novel-mechanism-of-action-for-the-treatment-of-chronic-myeloid-leukemia.html

Glaxo sidelines COVID drug otilimab to focus on Xevudy

 GlaxoSmithKline said today it would halt further development of its antibody for severe COVID-19 pneumonia – otilimab – in order to focus its resources on Xevudy for mild-to-moderate disease.

The drugmaker said in its third-quarter results update this morning that it had decided to invest more in generating data on Vir BioTech-partnered anti-SARS-CoV-2 antibody Xevudy (sotrovimab) “given the continued evolution of  the pandemic.”

Otilimab – which targets the cytokine GM-CSF – had been in clinical testing to see if it could treat severe pulmonary COVID-19 related disease in patients 70 years and older, and had shown signs of improving survival in a phase 2 trial reported earlier this year.

It’s not the end of the line for the drug however, as otilimab is also in phase 3 trials for rheumatoid arthritis patients who have had an inadequate response to disease modifying drugs or targeted therapies, with results due in the second half of next year.

GSK also revealed that Xevudy had generated £130 million (around $179 million) in sales in the first nine months of the year, with £114 million of that total coming in the third quarter, while its adjuvant products used to boost the efficacy of COVID-19 vaccines generated £352 million.

It already has binding agreements in place for the sale of more than 420,000 doses of Xevudy, with an additional 220,000 doses reserved through other agreements.

The news came as GSK reported a 5% increase in prescription drug sales to £4.4 billion in the third quarter, with overall revenues up by the same margin to £9.1 billion.

The star performers were shingles vaccine Shingrix, which grew 34% to £502 million and helped GSK’s vaccines division post sales up 7% to £2.2 billion.

HIV sales managed only a modest 3% gain to £1.3 billion, while GSK’s new respiratory drugs grew 27% to £741 million, driven by triple therapy Trelegy (fluticasone furoate/umeclidinium/vilanterol) which grew 68% to £326 million. That helped offset a 12% decline for Seretide/Advair (salmeterol/fluticasone propionate) to £324 million due to generic competition.

“GSK has delivered another quarter of strong business performance, with double-digit sales growth in pharmaceuticals and vaccines,” said chief executive Emma Walmsley (pictured), who has been forced to face down rebel investors trying to push for a change in management at the drugmaker.

“This has allowed us to improve our full-year guidance and…reinforces our confidence in the outlook for a step-change in growth and performance in 2022 and beyond,” she added.

Walmsley also gave an update on the planned demerger of GSK’s consumer health division, noting that its new headquarters will be in Weybridge in the UK and a chair for the business will be announced before the end of the year.

https://pharmaphorum.com/news/gsk-side-lines-covid-drug-otilimab-to-focus-on-xevudy/

Lancet Study Exposes Limits Of Vaccines At Preventing COVID Infection

 The Lancet has just released another study comparing the efficacy of COVID vaccines to the efficacy of protection provided by previous COVID infections. Their conclusion: while vaccines lower the risk of infections with the delta variant within households, those who are fully vaccinated are still vulnerable to a 'breakthrough' infection if somebody they live with gets infected.

What's more, people who have been vaccinated against COVID can be equally as infectious as the unvaccinated, the study showed.

The new study, which was published Thursday in the Lancet, the British medical journal that published some of the earliest research on COVID, is one of few to use detailed infection data from actual examples of household transmission, and it showed that - as we noted above - the viral loads of both vaccinated and unvaccinated patients infected with COVID are "broadly similar".

The study involved 621 people in the UK with mild COVID infections, identified via the UK's contact-tracing system.

The data showed that vaccination status doesn't make a whole lot of difference in the ability to pass COVID on to others.

Roughly 25% of vaccinated household members subsequently tested positive for the virus after close contact with a fellow household member with a confirmed case of COVID. That's compared with 38% of infection for people who haven't been vaccinated.

These data show that the delta variant has a "greater capability for breaching the vaccine's defenses when compared with predecessors.

"Our findings show that vaccination alone is not enough to prevent people from being infected with the Delta variant and spreading it in household settings," said Professor Ajit Lalvani of Imperial College London, the co-leader of the study.

The study's author said the lower transmission rates between vaccinated patients is just another reason to get the jab - although not a particularly compelling one.

"The ongoing transmission we are seeing between vaccinated people makes it essential for unvaccinated people to get vaccinated to protect themselves from acquiring infection and severe Covid-19, especially as more people will be spending time inside in close proximity during the winter months," he said.

The study also underlines the importance of the vulnerable to get booster shots, since it also shows that vaccine immunity wanes with time.

"We found that susceptibility to infection increased already within a few months after the second vaccine dose – so those eligible for Covid-19 booster shots should get them promptly," the professor said.

Following a summary of its findings, the Lancet wrote the "interpretation" of the study: "Vaccination reduces the risk of delta variant infection and accelerates viral clearance. Nonetheless, fully vaccinated individuals with breakthrough infections have peak viral load similar to unvaccinated cases and can efficiently transmit infection in household settings, including to fully vaccinated contacts. Host–virus interactions early in infection may shape the entire viral trajectory."

Readers can find the full study below:

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https://www.zerohedge.com/covid-19/latest-lancet-study-shows-limits-vaccines-preventing-infection-household-members