Novartis Reports Encouraging Results From Study of Cancer Treatment Lutathera

 Novartis AG said the final analysis of a study of its Lutathera radioligand therapy for the treatment of cancer showed clinically relevant improvement in median overall survival data.

A secondary objective of the Phase 3 study of treatment using Lutathera in patients with midgut neuroendocrine tumors showed prolongation in median overall survival of 11.7 months, the Swiss drugmaker said late Thursday.

This analysis, however, didn't reach statistical significance, Novartis said. The analyses of overall survival may have been affected by multiple factors, the company said. No new safety concerns emerged in the study analysis, it said.

The study's previously reported primary analysis showed statistically significant improvement in progression-free survival, the company said.

Radioligand therapy combines a targeting compound that binds to receptors expressed by tumors and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication and may lead to cell death, the company said.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-Reports-Encouraging-Results-From-Study-of-Cancer-Treatment-Lutathera-35516356/

Fauci calls on China to release medical records of Wuhan lab workers

 Top U.S. infectious disease expert Dr. Anthony Fauci has called on China to release the medical records of nine people whose ailments might provide vital clues into whether COVID-19 first emerged as the result of a lab leak, the Financial Times reported on Thursday.

"I would like to see the medical records of the three people who are reported to have got sick in 2019. Did they really get sick, and if so, what did they get sick with?" the report https://on.ft.com/3igFTgU quoted Fauci as saying.

The origin of the virus is hotly contested, with U.S. intelligence agencies still examining reports that researchers at a Chinese virology laboratory in Wuhan were seriously ill in 2019 a month before the first COVID-19 cases were reported.

However, Chinese scientists and officials have consistently rejected the lab leak hypothesis, saying the virus could have been circulating in other regions before it hit Wuhan and might have even entered China through imported frozen food shipments or wildlife trading.

Financial Times reported that Fauci continues to believe the virus was first transmitted to humans through animals, pointing out that even if the lab researchers did have COVID-19, they could have contracted the disease from the wider population.

https://www.marketscreener.com/news/latest/Fauci-calls-on-China-to-release-medical-records-of-Wuhan-lab-workers-FT--35516264/

Johnson & Johnson talking to Taiwan about providing COVID-19 vaccine

 

Johnson & Johnson said on Friday that it has been in talks with Taiwan about providing its COVID-19 vaccine to the island since last year.

"Johnson & Johnson has been in confidential discussions with the Taiwan Government regarding supply of the Johnson & Johnson COVID-19 vaccine since last year," it said in an emailed statement to Reuters, without giving details.

https://www.marketscreener.com/quote/index/MSCI-TAIWAN-STRD-107361484/news/Johnson-Johnson-talking-to-Taiwan-about-providing-COVID-19-vaccine-35516287/

Goldman May Payrolls Preview

 A few brief excerpts from a note by Goldman Sachs economist Spencer Hill:

We estimate nonfarm payrolls rose 750k in May (mom sa) ... Following the surprisingly weak April report, we believe the further easing of business restrictions more than offset a moderate drag from labor supply factors and seasonality. ... We estimate a three-tenths drop in the unemployment rate to 5.8% (consensus 5.9%), reflecting a strong household employment gain but a further rise in the participation rate.
emphasis added

CR Note: The consensus is for 650 thousand jobs added, and for the unemployment rate to decrease to 5.9%.

https://www.calculatedriskblog.com/2021/06/goldman-may-payrolls-preview.html

Vaccine Lotteries Credited With Enticing Millions To Accept Jabs

 In the US, the first winners of the "vaccination lotteries" being adopted by a growing number of states - including West Virginia (which is offering guns, trucks & "piles of cash), California and a handful of others - are taking home life-changing money, all because they decided to get vaccinated.

And according to WSJ, the incentives that these programs create are already having a positive impact on the vaccination rate, which has finally eclipsed 50% of American adults. The program is also having some success in Hong Kong.

But while it's impossible to determine exactly how many people are getting vaccinated because of the potential monetary rewards created by the vaccination lotteries, the anecdotal evidence is clear, as the Toledo Blade showed in a recent story about one of Ohio's "Vax-a-Million" winners who happened to be a Toledo resident.

"I kept hemming and hawing about it, and I work all the time, and when the Vax-a-Million thing started I immediately went down there and got it. It pushed me over the edge," he said.

Mr. Carlyle said after he hung up with the governor, he then called his girlfriend to let his family know he had won.

"It’s overwhelming. I don't know what to do. I'm still dreaming,” he said.

In Ohio alone, 3.2MM people entered the drawing - all of whom hadn't been previously vaccinated despite being eligible for weeks or months. And Ohio's Gov. ike DeWine credited the lottery enticements for a recent spike in vaccinations in the Buckeye State.

More than 3.2 million Ohioans entered the drawing to win the $1 million prize, and nearly 133,000 Ohioans ages 12 to 17 entered the college scholarship drawing, according to the Ohio Department of Health and the Ohio Lottery. The entry period for the next Ohio Vax-a-Million drawing ends June 6, 2021 at 11:59:59 p.m.

Governor DeWine credited the lottery enticement for a spike in new vaccinations after his initial announcement, but the numbers show the rate has again leveled off.

WSJ's Mike Bird added that the efficacy shown so far is evidence that vaccination lotteries create benefits that far outweigh their costs.

It’s difficult to overstate just how small the lottery payouts are relative to the economies they cover. In Hong Kong’s case, a real-estate developer is offering an apartment valued at roughly $1.39 million. That prize, though highly valuable to the winner, is equivalent to 0.0004% of the city’s already-reduced 2020 GDP.

Faster vaccinations enable more rapid economic normalization, especially in places that still have significant international travel restrictions in place. That normalization is worth far more than any plausible prizes. One percentage point of GDP growth for Hong Kong would be equivalent to around 2,500 such apartments. The same is true for Ohio’s million-dollar payouts, in an economy with output in the hundreds of billions of dollars a year.

What's more, there's evidence from a study in Singapore showing financial incentives are effective at boosting vaccination rates.

But there is evidence that financial incentives work. Vouchers worth just 10-30 Singapore dollars ($7.56 to $22.69) could boost take-up of influenza vaccines by 4.5% to 9.2% in one study, with the strongest effect among elderly recipients. A review of the literature by the U.S. Community Preventive Services Task Force showed vaccination rates rising by a median of 8 percentage points in the studies assessed.

At the very least, using financial incentives is certainly more humane than coercing people by allowing employers to effectively require all new hires to be vaccinated, which risks excluding people who object to vaccination for religious or other reasons from the workforce.

https://www.zerohedge.com/covid-19/it-pushed-me-over-edge-vaccine-lotteries-credited-enticing-millions-accept-jabs

Protagonist, Janssen Win Breakthrough Therapy Designation for Oncology Candidates

 Shares of Protagonist Therapeutics climbed nearly 4% in premarket trading after the company announced its lead drug candidate rusfertide snagged Breakthrough Therapy Designation from the U.S. Food and Drug Administration.

California-based Protagonist is developing rusfertide as a potential treatment of patients with polycythemia vera (PV) for the reduction of erythrocytosis. Specifically, the drug candidate is being developed for those patients who no longer require additional treatment for thrombocytosis and/or leukocytosis.

Suneel Gupta, chief development officer at Protagonist, expressed excitement over winning the designation for rusfertide. Gupta said PV is a severe disease with unmet medical needs. Better treatment options are needed for those patients, Gupta said. PV is a rare type of blood cancer that causes the marrow to make too many red blood cells. The increase of red blood cells causes a thickening of the blood and can cause serious and life-threatening blood clots. 

“Rusfertide is a natural hormone mimetic and may stand out as the first non-cytoreductive therapeutic drug for PV. We look forward to working closely with FDA regulators to advance and complete all relevant clinical studies, both ongoing and planned, as quickly as possible,” Gupta said in a statement.

The FDA based its designation on data from an ongoing Phase II study of rusfertide in PV patients. The ongoing data was presented in December at the American Society of Hematology meeting. 

The data showed that most patients treated with rusfertide were able to eliminate therapeutic phlebotomies and maintain a target hematocrit level of less than 45%, Protagonist said. Additionally, data showed these patients were able to reverse their iron deficiency and also saw improvements in their PV symptoms. The company will present updated data from the ongoing Phase II study at the European Hematology Association next week. 

Breakthrough Therapy Designation is granted to experimental drugs that may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Drugs that receive this designation can also benefit from expedited development and regulatory reviews. 

Previously, the FDA granted orphan drug status and Fast Track Designation to rusfertide in this indication.

Protagonist isn’t the only company this week to be awarded Breakthrough Therapy Designation. Janssen’s multiple myeloma asset teclistamab was also given the designation. 

Teclistamab is an off-the-shelf, T-cell redirecting, bispecific antibody that targets both B-cell maturation antigen (BCMA) and CD3 receptors. The Breakthrough Therapy Designation followed PRIME (PRIority MEdicines) designation granted by the European Medicines Agency for teclistamab.

Peter Lebowitz, Global Therapeutic Area Head in Oncology at Janssen Research & Development, was pleased with both the FDA and EMA designations. He said the teclistamab program “exemplifies our commitment to advancing science for patients living with multiple myeloma.” 

Lebowitz also said the designations strengthen the company’s robust portfolio in oncology. The FDA designation for teclistamab marked the 11th such designation received by Janssen's Oncology Therapeutic Area.

The FDA awarded Breakthrough Therapy Designation for teclistamab based on data from the Phase I MajesTEC-1 study, which evaluated the oncology asset in adults with measurable multiple myeloma that is relapsed or refractory to established therapies or be intolerant of those established multiple myeloma therapies. 

Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients. Updated results from the MajesTEC-1 study will be presented at the 2021 American Society of Clinical Oncology Annual Meeting next week. 

Teclistamab is currently being evaluated in a Phase II clinical study for the treatment of relapsed or refractory multiple myeloma and is also being explored in combination studies. 

https://www.biospace.com/article/protagonist-janssen-win-breakthrough-therapy-designation-for-oncology-drugs/

States Are Passing Laws That Threaten Public Health: Report

 In the wake of the COVID-19 pandemic, states are passing laws that could endanger the public health, according to a report from the National Association of County and City Health Officials (NACCHO).

"In recent months, at least 15 state legislatures have passed or are considering measures to limit severely the legal authority of public health agencies, and other states may consider such legislation in the future, hindering the ability of health departments to do their jobs and putting wide swaths of the public at risk," the organization said in a statement last week when it released the report.

Examples of laws cited in the report include:

• Prohibiting requiring masks in any situation, including cases of active tuberculosis. In North Dakota, a new law would remove the authority of the state health office to require face masks or covering.

• Blocking the closure of businesses necessary to prevent the spread of disease, allowing for super-spreader venues. In Kansas, a new law removes the governor's ability to close businesses during a public health emergency.

• Banning the use of quarantine. In Montana, a new law prohibits local board of health emergency orders from separating those individuals who are not yet ill but are reasonably believed to be infected or exposed. Prohibition of quarantine orders undermines the basis of infection control and would make it impossible to stop outbreaks of deadly diseases that are spread by individuals who are not yet symptomatic.

• Blocking state hospitals and universities from requiring vaccinations for employees and students in dormitories to protect state residents. In Arizona, a new law prohibits requirements that a person receive a vaccination -- except in K-12 school settings -- and creates criminal penalties for violating the ban.

• Giving unilateral power to legislatures to stop public health actions. In Ohio, a new law will allow the legislature alone to rescind any order or action by the state health department or director of health to control or [stop] the spread of contagious or infectious disease. The governor, who vetoed the law, issued a statement saying that the law "strikes at the heart of local health departments' ability to move quickly to protect the public from the most serious emergencies Ohio could face." The governor's veto was overridden by the legislature, and the law will take effect on June 23.

NACCHO noted in its report that the introduction of these types of bills "appears to be coordinated, in part, [by] the American Legislative Exchange Council (ALEC)," a conservative-leaning organization that develops model bills for state legislatures, and whose membership includes one-quarter of state legislators.

"ALEC is advocating a slate of policy initiatives and model bills crafted to limit the authority of public health agencies and weaken their ability to protect the public's health ... Many of the bills that have been, or will be considered, in a majority of states are based on ALEC's model acts," the report said, adding that "in some cases, the legislation uses language that is almost verbatim to ALEC's model bill."

Asked to comment on the report, an ALEC spokesman said in an email: "The NACCHO report is incorrect in its assertion. ALEC does not have model bills or any public policy initiatives crafted to limit the authority of public health agencies." He added that "In fact, ALEC has no public health model policy of any sort on COVID-19. As a 501(c)(3), we don't advocate policy. We have, however, empowered legislators with fact-based CDC information, discussions on vaccine safety and touchless travel innovations."

The spokesman also gave a link to ALEC's model policy database.

Georges Benjamin, MD, executive director of the American Public Health Association, said he found the trend in the laws disturbing. "We've been looking at what one needs to do about this because this is a big issue," Benjamin said in a phone interview. "Governmental public health is the only entity in the community that has legal authority to protect your health ... The fact that this legal authority is being attacked, which we believe are for reasons that are unacceptable, concerns us."

As to why these laws are being passed, "we think they don't understand what they're doing in their zeal to rein in things," Benjamin said of the state legislators. "It's like telling a bunch of doctors, 'We don't like the fact that you take out appendixes, so we're going to take away your authority to do surgeries.' It's like going to a fire chief and saying, 'Hey, we don't want you to have authority to do inspections or close down a venue because it's a fire hazard.'

"They're taking away core authorities that public health needs to do its work ... and undermining the work of government employees who are just doing their job," Benjamin said.

This is especially concerning when it comes to any public health emergency, he added. "You don't run an emergency by committee; it doesn't work that way. That's why the fire department and the police department have a chain of command. If you undermine those efforts, you're going to find that people won't have the authority they need, and bad things will happen."

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/92915