Cystic fibrosis group partners with Moderna founder for potentially curative treatment

 A prominent patient advocacy group has teamed up with Flagship Pioneering, the biotechnology incubator that founded Moderna and more than two dozen other health companies, in an effort to create potentially curative treatments for cystic fibrosis.

Unveiled Wednesday, the partnership will use funding from the Cystic Fibrosis Foundation and technologies from various Flagship-backed entities to establish single-asset companies, each focused on developing one treatment. Overall, the foundation expects to invest as much as $110 million in the collaboration, with an upfront commitment of $20 million.

Cystic fibrosis is a rare, genetic disease affecting roughly 35,000 people in the U.S. It causes a thick mucus to build up in the lungs, damaging the organ and leading to trouble breathing as well as increased risk of infection.

Though the disease remains serious and life-threatening, patients can now live longer thanks to improvements in care over the past few decades, including the availability of new drugs. Since 2012, the Food and Drug Administration has approved four medicines that, according to their developer, Vertex Pharmaceuticals, can treat approximately 90% of the cystic fibrosis population.

Still, Vertex and the Cystic Fibrosis Foundation, themselves longstanding partners, want treatments for the last 10% of patients, whose different mutations make them ineligible to the drugs on the market. Flagship, through its "Pioneering Medicines" initiative, is now trying to help the foundation find and develop such treatments.

"Their motivation was that we need to do something for this 10%," Paul Biondi, an executive director at Flagship, said in an interview.

"You can imagine how devastating that is," he added, "that there's a fantastic standard of care if you have to have one mutation, [but if you've got others] you're left out. So they feel a huge sense of urgency to come up with other therapies."

Already, Flagship has gotten buy-in from one portfolio company, Tessera Therapeutics, which touts a so-called "gene writing" technology that it claims can modify DNA in a variety of ways — from changing single units of genetic material, to inserting or deleting small segments, to writing in entire genes.

When applied to cystic fibrosis, the hope is this technology could correct defects in CFTR, the gene that's mutated in patients with the disease.

"If you could go in and just simply replace all the faulty aspects of the CFTR genes in an individual, that's exciting because essentially you cure those patients," Biondi said. "It could be that we could solve this for everybody."

While the partnership is prioritizing patients for whom there aren't drugs available, they aren't the only focus. For example, Flagship also plans to explore how targeted methods of drug delivery, as well as RNA technologies, could aid the search for more effective cystic fibrosis drugs.

The firm is perhaps best known for its work in RNA research, having built and supported Moderna, which rapidly developed a powerfully effective coronavirus vaccine.

"Similar in that RNA can create the spike protein in the COVID vaccine, the idea is you can have RNA therapies for aiding CFTR proteins in the right tissues," Biondi said. "That would be a way to at least treat it, maybe more effectively than some of the current modifiers that are out there."

Flagship is in talks with two more of its portfolio companies for the cystic fibrosis partnership, Biondi said, though it's not disclosing which ones. If the partnership generates any profits, he said they'll be shared with the companies that lent their resources.

Initially, the goal is to form one to two new companies, according to Biondi. They'll be responsible for early research and development, but once a potential treatment passes the human "proof-of-concept" stage, Flagship would probably look for another company to take on late-stage testing and commercialization.

"These companies that we create are single-asset companies, so they're not operating companies," Biondi said. "But, by having that legal, financial piece around the actual molecule, we can transact on it."

Even so, Biondi noted that Flagship could make these new companies operational, and either spin them out or outfit them with management teams and other capabilities that allow them to conduct late-stage drug development and commercial activities.

https://www.biopharmadive.com/news/flagship-cystic-fibrosis-foundation-partnership/609413/

Gates: "Germ Games" Needed To Prepare For Bioterrorist Attacks

 by Jack Phillips via The Epoch Times,

Microsoft co-founder Bill Gates on Tuesday warned that international authorities, including the World Health Organization, need to take action against the threat posed by bioterrorism and said “germ games” is the best way to prevent it.

“It’ll take probably about a billion a year for a pandemic Task Force at the WHO level, which is doing the surveillance and actually doing what I call ‘germ games’ where you practice,” Gates during an interview with the chair of the Health Select Committee, Jeremy Hunt, for the think tank Policy Exchange, according to Sky News.

Gates then asked: “You say, OK, what if a bioterrorist brought smallpox to 10 airports? You know, how would the world respond to that?”

The world’s fourth-richest noted that to prepare for a doomsday scenario, the United States and United Kingdom would have to spend “tens of billions” on research and development.

“There’s naturally-caused epidemics and bioterrorism-caused epidemics that could even be way worse than what we experienced today and yet, the advances in medical science should give us tools that, you know, we could do dramatically better,” Gates also remarked.

During his interview with Hunt, Gates also said there should be a “new way” to manufacture vaccines that can stop the transmission of a virus better. That also would require global research and development, he said.

“You know, we didn’t have vaccines that block transmission. We got vaccines that help you with your health, but they only slightly reduced transmission,” he explained.

“We need a new way of doing the vaccines.”

“The nice thing is a lot of the [research and development] we need to do to be ready for the next pandemic are things like making vaccines cheap, having big factories, eradicating the flu, getting rid of the common cold, making vaccines just a little patch you put on your arm, things that will be incredibly beneficial even in the years when we don’t have pandemics,” Gates said, without elaborating how it could be accomplished.

Watch the full interview below:

The billionaire’s comments come as it was revealed last month that the World Economic Forum, Bill & Melinda Gates Foundation, and Johns Hopkins Center for Health Security hosted a “high-level pandemic exercise” known as “Event 201” in October 2019 to simulate a pandemic.

The participants in the scenario were presented with a simulated outbreak of “novel zoonotic coronavirus” that was transmitted from bats to pigs to people, causing a pandemic.

“The disease starts in pig farms in Brazil, quietly and slowly at first, but then it starts to spread more rapidly in healthcare settings,” according to the Event 201 scenario. 

https://www.zerohedge.com/geopolitical/bill-gates-germ-games-needed-prepare-bioterrorist-attacks

UK to roll out COVID-19 antiviral drug trial this month

Britain will start to roll out Merck's molnupiravir COVID-19 antiviral pill through a drug trial later this month, Susan Hopkins, Chief Medical Adviser at the UK Health Security Agency said on Sunday.

Last week Britain became the first country in the world to approve the potentially game-changing COVID-19 antiviral pill, jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics.

The government said in October it had secured 480,000 courses of the Merck drug, as well as 250,000 courses of an antiviral pill developed by Pfizer Inc.

Asked about the molnupiravir approval, Hopkins told BBC television: "That is great news and it will start to be rolled out through a drug trial in the end of this month/the beginning of December."

Hopkins said all the trials so far had been done with the unvaccinated, so this would help understand how it will work in the wider vaccinated population.

"The new Pfizer drug is probably not going to be licensed until the new year some time," she added. "It is still likely to be a couple of months away."

https://denvergazette.com/news/uk-to-roll-out-covid-19-antiviral-drug-trial-this-month--health-security-agency/article_7cc33f8c-be45-55be-9c8b-1cf35e9892c1.html

AC Immune: Families affected by Alzheimer’s could almost triple by 2050

  AC Immune, developer of drugs against Alzheimer’s disease (ACIU.O) expects the number of families affected by the degenerative disease to nearly triple by 2050 to 150 million, its CEO said in an interview with a German magazine.

The company recently secured a multi-million dollar investment from major backers of German COVID-19 vaccine developer BioNTech (22UAy.DE) while acquiring a possible vaccine against Parkinson’s disease.

AC Immune CEO Andrea Pfeifer, in an interview with German business magazine Wirtschaftswoche published in its online edition on Sunday, described Alzheimer’s disease, an uncurable disease whose origin is unknown, as “a slow pandemic which is advancing towards the world”. It currently affects 55 million families, she said.

Athos, the holding company of Andreas and Thomas Struengmann – pillar investors of BioNTech (22UAy.DE) – With the finance companies, MIG and First Capital Partner jointly own 12% of AC Immune following an agreement reached a few weeks ago, Pfeifer said. The planned investment was announced in July.

Athos and MIG participated in the creation of BioNTech which, with its partner Pfizer (PFE.N) developed the most widely used COVID-19 vaccine in the Western world, and they remain the major shareholders.

Pfeifer said having the Struengmann twins on board was a “blessing” for AC Immune.

“If anyone knows how vaccines can be marketed, then these are the main investors in BioNTech,” she said.

AC Immune is working on several compounds for Alzheimer’s and Parkinson’s disease, including vaccines.

The company has yet to launch a drug.

The other investors in AC Immune are Dietmar Hopp through his biotech holding company Dievini with just over 20%, as well as institutional and private investors, Pfeifer said.

https://tittlepress.com/health/1263811/

Delta dragged down hospital margins in September: Kaufman Hall

 

• The median change in operating margins for hospitals fell 18.2% in September compared to August, according to the latest monthly report from Kaufman Hall, a hospital consultant group.
• Patient volumes declined in almost every key category, including emergency room visits and operating room minutes, potentially signaling that the rise in the delta variant caused some to once again defer care out of concern over contracting the coronavirus. Outpatient revenues declined, too, further underscoring this potential trend.
• Although fewer patients were admitted, patients were sicker and stayed longer. The average length of stay is also trending above pre-pandemic levels. 

The latest report signals continued turbulence in the pandemic recovery for hospitals. 

One key area that continues to weigh on hospitals' performance is labor supply issues. It has been well documented how labor supply is tight for many hospitals throughout the country, causing them to hike rates for contracted labor. 

That also was reflected in the latest report from Kaufman Hall. Labor expenses per adjusted discharge increased 9.5% from August to September, and nearly 16% compared to pre-pandemic levels. 

Overall, total expenses were up about 10% compared to pre-pandemic figures. 

In addition to increased labor costs, drug expenses have also increased considerably along with supply costs, which "point to worldwide supply chain issues," Kaufman Hall said. 

A separate report released in mid-October also found that hospitals are still spending more on personal protective equipment and labor, according to group purchasing organization Premier.

Contract labor is also contributing to rising expenses as hospitals try to fill gaps with traveling nurses, who often command a higher rate, according to a recent survey from Aya Healthcare, a staffing firm. 

On the other hand, a separate report from Kaufman Hall noted that physician productivity and revenue is on a strong rebound, surpassing pre-pandemic levels in the third quarter, according too an analysis of data from nearly 100,000 employed physicians. 

This marks the "second consecutive quarter of significant physician revenue increases" after holding steady.

https://www.healthcaredive.com/news/delta-drags-down-hospital-margins-september-kaufman-hall/609280/

Healthcare workers must be fully vaccinated by Jan. 4 with no testing exception: CMS

 

• Hospitals and other healthcare facilities must mandate COVID-19 vaccination among employees or risk losing Medicare and Medicaid funding, CMS said Thursday. Employees must be fully vaccinated by Jan. 4.
• The rule came coupled with an order from the Occupational Safety and Health Administration requiring businesses with 100 or more employees to ensure workers are fully vaccinated, and those who aren't must be tested on a weekly basis by Jan. 4. Employers must also provide paid-time off for employees who need to get vaccinated.
• The CMS rule will affect about 17 million healthcare workers at 76,000 facilities, the agency said. Unlike the OSHA requirement, healthcare employees will not be able to forego the vaccine and be tested regularly.

The rules that dropped Thursday follow others rolled out in July requiring vaccinations for federal employees and contractors. As it stands today, 70% of American adults have received two doses of a coronavirus vaccine, according to a White House press release.

Hospitals, ambulatory surgery centers, dialysis facilities, home health agencies and long-term care facilities that receive federal funding from Medicare or Medicaid will have to ensure staff have received at least one dose before they can provide any care, treatment or services to patients by Dec. 5.

The rule applies to both clinical and non-clinical employees, including students, trainees, volunteers and people providing treatment or other services under contract or other arrangements.

"The prevalence of COVID-19, in particular the Delta variant, within health care settings increases the risk of unvaccinated staff contracting the virus and transmitting the virus to patients," CMS said in a release. "When health care staff cannot work because of illness or exposure to COVID-19, the strain on the health care system becomes more severe and further limits patient access to safe and essential care."

Both states and health systems have historically used vaccination requirements for other diseases, such as influenza and hepatitis B, according to a White House report.

And roughly 40% of all U.S. hospitals currently have COVID-19 vaccination requirements for their workforce.

Despite concerns around widespread resignations due to vaccine mandates, systems that implemented their own have fared positively, according to the report.

After UNC Health and Novant Health in North Carolina required the shots, staff vaccination rates rose to 97% and 99%, respectively, according to the report.

Among Novant Health's 35,000 employees, about 375 were suspended for not complying, and about 200 of those suspended employees did end up getting vaccinated so they could return to work, according to the report.

The new rules from both CMS and OSHA preempt any inconsistent state or local laws, including those banning or limiting an employer's authority to require vaccination, masks or testing, according to the White House release.

They also allow for exemptions for medical conditions or religious beliefs, though facilities must develop a plan for permitting exemptions in line with federal law.

Provider groups including the American Hospital Association, American Medical Association and American Nurses Association said in a Thursday statement that "the only way to truly end this pandemic is to ensure widespread vaccination and continue taking the preventive public health measures that we know work in curbing the spread of this virus." The statement did not directly address the mandate.

The rule did receive pushback. In a hearing Thursday morning on the country's COVID-19 response, Sen. Richard Burr, R-N.C., said the CMS mandate "will only suggest to doctors not to accept Medicare or Medicaid patients," although he did not offer evidence for the statement.

https://www.healthcaredive.com/news/CMS-healthcare-worker-COVID-vaccine-mandate-Medicare-Medicaid/609491/

Kaiser healthcare workers to go on strike

 Kaiser Permanente healthcare workers in southern California sent a strike notice to executives on Thursday, notifying them of their intent to begin an open-ended strike beginning Nov. 15 over disputes for a new contract. 

As many as 28,400 healthcare workers, including a large contingent of nurses, could walk off the job in southern California. Another 3,400 are set to strike in Oregon. The strike notices were sent from three separate unions who are a part of a larger umbrella union that bargains as one.

The work stoppage could pose a significant challenge to operations in Kaiser's southern California market, where the union members represent about 37% of the workforce in the region where Kaiser operates 14 hospitals and more than 200 clinics.   

"We did not want to get to the point where we're striking," Peter Sidhu, a union representative at the bargaining table, said. Sidhu is also a former Kaiser ICU nurse. "The reason that we're going to strike is all about patient care, because [we] want to attract the best quality nurses."

In a statement Friday, Kaiser said labor unions are an important part of its history and said the challenge it faces is the "increasingly unaffordable" cost of healthcare. The system said that wages and benefits account for half of its operation costs.

"We are asking our labor partners to work with us to address this very real problem through an interest-based process, just as we have done with other challenges over the course of our partnership," according to the statement.

Kaiser said that if a strike occurs it will bring in contingency staff as needed and patient care will continue.

During negotiation, the two sides could not come to terms on wages and staffing issues.  

Workers are opposed to Kaiser's proposal to institute a two-tier wage structure in which new hires would be paid on a lower wage scale in an effort to cut costs. Workers fear it will hinder the system's ability to attract and retain top talent, and breed resentment. 

The union is calling for 4% raises across the board each year for the next three years and greater collaboration and transparency into staffing levels and needs across the region. 

It's poised to be the largest work stoppage this year, according to data through September from the Bureau of Labor Statistics.

If a deal is not reached before Nov. 15, Kaiser employees will join thousands of workers across the country who have taken to the picket line to extract better pay and benefits from their employers, including workers at John Deere and Kellogg's.

Open-ended healthcare strikes can last for quite a long time. Two examples come from this year alone. Nurses at a Tenet hospital in Worchester, Massachusetts, have been on the picket line for more than eight months. Similarly, employees at Catholic Health's Mercy Hospital in Buffalo, New York, have been on a strike that's currently at 34 days.

Workers with the United Nurses Associations of California/Union of Health Care Professionals voted to authorize a strike in mid-October. About 96% of those who voted, 18,000 members of 21,000 eligible, opted to authorize a strike. The results signaled a strong rebuke from healthcare workers who are burned out from the pandemic and seeking to improve wages and staffing. Union members from United Steelworkers Local 7600 in southern California also voted to authorize a strike. USW represents another 7,400 Kaiser employees in the region.

The two sides have been bargaining since the spring, Sidhu said, and the contract expired in September.

The last major work stoppage by this union occurred nearly four decades ago, in 1980, according to union officials. In 1995, a strike was averted after a contract was agreed to after members voted to authorize a strike. 

Officials with the United Nurses Associations of California/Union of Health Care Professionals said they represent the vast majority of Kaiser's registered nurses in southern California and all of Kaiser's physician assistants, pharmacists, midwives, physical and occupational therapists and optometrists.

UNAC/UHCP is part of 21 partner unions under the larger umbrella of the Alliance of Health Care Unions, which leads bargaining.

https://www.healthcaredive.com/news/kaiser-healthcare-california-strike/609440/