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Embargoed: Annual Report to the Nation part 2: New cancer diagnoses fell abruptly early in the COVID-19 pandemic

New diagnoses of six major cancer types in the United States fell abruptly in early 2020, coinciding with the start of the COVID-19 pandemic, according…

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New diagnoses of six major cancer types in the United States fell abruptly in early 2020, coinciding with the start of the COVID-19 pandemic, according to findings from part 2 of the latest Annual Report to the Nation on the Status of Cancer. The volume of pathology reports also declined sharply in early 2020, suggesting that fewer cancer screenings and other cancer-related procedures were performed during that time. Taken together, the findings suggest that many cancers were not being diagnosed in a timely manner during the early part of the COVID-19 pandemic, likely due to interruptions in medical care.

Credit: National Cancer Institute

New diagnoses of six major cancer types in the United States fell abruptly in early 2020, coinciding with the start of the COVID-19 pandemic, according to findings from part 2 of the latest Annual Report to the Nation on the Status of Cancer. The volume of pathology reports also declined sharply in early 2020, suggesting that fewer cancer screenings and other cancer-related procedures were performed during that time. Taken together, the findings suggest that many cancers were not being diagnosed in a timely manner during the early part of the COVID-19 pandemic, likely due to interruptions in medical care.

“These missed opportunities for early cancer detection are alarming, particularly for those vulnerable populations that continue to face significant barriers in accessing cancer care,” said Monica M. Bertagnolli, M.D., director of the National Cancer Institute (NCI). “This report highlights the urgency in helping all Americans get back on track with their cancer care so that we can avoid unnecessary deaths and complications from cancer. That’s exactly why expanding cancer screening access and awareness is a key priority of the Biden-Harris administration’s Cancer Moonshot.”

This study is the largest to date using population-based data from central cancer registries to assess the impact of the COVID-19 pandemic on cancer incidence (new diagnoses of cancer) in the United States. The report appeared September 27, 2023, in Cancer. 

The Annual Report to the Nation on the Status of Cancer is a collaborative effort among NCI, part of the National Institutes of Health; the Centers for Disease Control and Prevention (CDC); the American Cancer Society; and the North American Association of Central Cancer Registries to provide information about cancer occurrence and trends in the United States. Part 1 of the latest report, which focused on national cancer statistics, was released in October 2022. 

Part 2 of the latest report focuses on changes in cancer diagnoses in the United States during the first year of the COVID-19 pandemic. The authors suggest that these changes were due in part to interruptions in medical care. In particular, early 2020 saw a decline in cancer screenings. In addition, diagnoses made as a result of early symptoms or in the course of routine medical visits may have been delayed when people held off on seeing their doctors.  

The authors analyzed cancer incidence data for 2015 to 2020 using data from select population-based cancer registries that participate in CDC’s National Program of Cancer Registries or NCI’s Surveillance, Epidemiology, and End Results (SEER) Program. 

The authors compared the number of newly diagnosed cases of cancer in 2020 with what was expected based on previous years. They looked at female breast, lung, and colorectal cancers, which are often diagnosed through screening tests or other forms of early detection that may have been disrupted by the pandemic; thyroid and prostate cancers, which are often diagnosed incidentally; and pancreatic cancer, which is usually diagnosed when the patient presents with symptoms. The authors also compared the volume of electronic pathology reports sent to central cancer registries in 2020 with the volume sent in 2019. 

From March to May 2020, new cases of all six cancer types fell sharply. By July 2020, however, diagnoses of all cancer types except prostate cancer had returned to pre-pandemic levels, with little difference between observed and expected numbers during the second half of the year. 

Over the same period in early 2020, the volume of electronic pathology reports also declined steeply before returning to pre-pandemic levels. Because these reports are transmitted automatically to cancer registries, the findings suggest that the decline in new cancer diagnoses was not due to delays in reporting caused by pandemic disruptions but rather to missed screenings and delays in other cancer-related procedures.

The authors also looked at declines in new cancer cases by cancer stage at diagnosis, sex, age, and population group. For each cancer type in the study, new cases of early-stage cancers fell more sharply than new cases of advanced cancers. The declines were greatest for the cancers typically diagnosed through screening (female breast, lung, and colorectal cancer). For example, 7,147 cases of early-stage colorectal cancer were expected to be diagnosed in 2020, but only 5,983 cases were diagnosed—meaning that potentially more than 16% of early-stage colorectal cancer cases weren’t caught.

“We are deeply concerned about the implications of delayed diagnosis, which is typically associated with more aggressive disease and worse outcomes,” said Karen E. Knudsen, M.B.A., Ph.D., chief executive officer of the American Cancer Society. “It is imperative to ensure that we make up for lost ground on finding cancers early, and thereby maximize opportunities for effective treatment and survival.”

However, missed screenings only partly explain the observed declines in new cancer cases. Fewer in-person medical visits likely also contributed to the underdiagnoses, particularly for diseases such as thyroid cancer, which is often caught incidentally during other medical procedures. 

Asian or Pacific Islander populations had greater declines in new cases of all cancer types, except for pancreatic cancer, compared with White, Black, and American Indian or Alaska Native populations. Another notable population group difference was a greater decline in prostate cancer diagnoses among White people than Black people. 

The authors acknowledged that the data comprise information reported to a subset of cancer registries, which may not be representative of the entire U.S. population. Nor does it include in-depth analyses on cancer diagnoses in Hispanic populations, which will be incorporated at a later point.

Nevertheless, the findings suggest that there were missed opportunities for early cancer detection during the pandemic. Other studies have suggested that delays in cancer detection may lead to long-term consequences, such as shorter survival and greater number of deaths. The authors noted that efforts to get people back on track with screening should focus on removing barriers to preventive care visits and reducing disparities in early detection.

As part of the reignited Cancer Moonshot, the President and First Lady announced a call to action on cancer screening to jump-start progress on the nearly 10 million screenings in the United States that were missed as a result of the pandemic. To date, the Cancer Moonshot has accelerated innovations in cancer prevention, detection, and treatment and has expanded access to cancer screening across all 50 states, territories, and Tribal organizations, including through $200 million invested from CDC. The Biden-Harris administration continues to prioritize closing the screening gap so Americans can catch cancer early, when outcomes are best, and encourage Americans to get recommended screenings.

“We recommend everyone get back into routine health care, including cancer screening,” said Lisa C. Richardson, M.D., M.P.H., director of CDC’s Division of Cancer Prevention and Control. “It’s also important to make sure children, adolescents, and adults are up to date on vaccines to prevent infections with viruses—like hepatitis B virus and human papillomavirus—that can lead to cancer.” 

Meanwhile, research is ongoing to gain additional insights into the impacts of the pandemic on cancer trends. 

“This study is a reminder that a decline in cancer incidence may not always reflect progress in the fight against cancer,” said Betsy A. Kohler, M.P.H., North American Association of Central Cancer Registries executive director. “We are currently conducting more in-depth analysis of the full 2020 data to further understand the implications of the pandemic on cancer outcomes.”

For more about the report, see: https://seer.cancer.gov/report_to_nation/. 

# # # 

About the National Cancer Institute (NCI): NCI leads the National Cancer Program and NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at cancer.gov or call NCI’s contact center, the Cancer Information Service, at 1-800-4-CANCER (1-800-422-6237). 

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih.gov. 

About the American Cancer Society (ACS): The American Cancer Society is a leading cancer-fighting organization with a vision to end cancer as we know it, for everyone. For more than 100 years, we have been improving the lives of people with cancer and their families as the only organization combating cancer through advocacy, research, and patient support. We are committed to ensuring everyone has an opportunity to prevent, detect, treat, and survive cancer. To learn more, visit cancer.org or call our 24/7 helpline at 1-800-227-2345. Connect with us on Facebook, Twitter, and Instagram.

About the Centers for Disease Control and Prevention (CDC): CDC works 24/7 protecting America’s health, safety, and security. Whether diseases start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world. 

About the North American Association of Central Cancer Registries (NAACCR): The North American Association of Central Cancer Registries, Inc., is a professional organization that develops and promotes uniform data standards for cancer registration; provides education and training; certifies population-based registries; aggregates and publishes data from central cancer registries; and promotes the use of cancer surveillance data and systems for cancer control and epidemiologic research, public health programs, and patient care to reduce the burden of cancer in North America. For more, see naaccr.org.

 


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Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide…

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Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide Black Lives Matter riots in the summer of 2020, some elite colleges and universities shredded testing requirements for admission. Several years later, the test-optional admission has yet to produce the promising results for racial and class-based equity that many woke academic institutions wished.

The failure of test-optional admission policies has forced Dartmouth College to reinstate standardized test scores for admission starting next year. This should never have been eliminated, as merit will always prevail. 

"Nearly four years later, having studied the role of testing in our admissions process as well as its value as a predictor of student success at Dartmouth, we are removing the extended pause and reactivating the standardized testing requirement for undergraduate admission, effective with the Class of 2029," Dartmouth wrote in a press release Monday morning. 

"For Dartmouth, the evidence supporting our reactivation of a required testing policy is clear. Our bottom line is simple: we believe a standardized testing requirement will improve—not detract from—our ability to bring the most promising and diverse students to our campus," the elite college said. 

Who would've thought eliminating standardized tests for admission because a fringe minority said they were instruments of racism and a biased system was ever a good idea? 

Also, it doesn't take a rocket scientist to figure this out. More from Dartmouth, who commissioned the research: 

They also found that test scores represent an especially valuable tool to identify high-achieving applicants from low and middle-income backgrounds; who are first-generation college-bound; as well as students from urban and rural backgrounds.

All the colleges and universities that quickly adopted test-optional admissions in 2020 experienced a surge in applications. Perhaps the push for test-optional was under the guise of woke equality but was nothing more than protecting the bottom line for these institutions. 

A glimpse of sanity returns to woke schools: Admit qualified kids. Next up is corporate America and all tiers of the US government. 

Tyler Durden Mon, 02/05/2024 - 17:20

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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