Thermo Fisher Raises 2021 Sales, Earnings Guidance

 Thermo Fisher Scientific Inc. Wednesday raised its full-year earnings guidance after the company surpassed analysts' expectations for sales and profits in the latest quarter.

Thermo Fisher now expects sales of $37.1 billion this year, a $1.2 billion increase over the company's previous guidance. That would be 15% revenue growth over last year.

The company also raised its adjusted earnings guidance to $23.37, a $1.30 a share increase.

Analysts had been forecasting earnings of $22.21 a share and sales of $36.1 billion.

https://www.marketscreener.com/quote/stock/THERMO-FISHER-SCIENTIFIC-14623/news/Thermo-Fisher-Raises-2021-Sales-Earnings-Guidance-36795640/

CDC panel to discuss COVID-19 shots for younger kids on Nov. 2

 An advisory panel of the U.S. Centers for Disease Control and Prevention will meet on Nov. 2 to discuss the use of COVID-19 vaccines in children aged between 5 and 11 years.

Advisors to the U.S. Food and Drug Administration had on Tuesday voted overwhelmingly to recommend that the regulator authorize Pfizer and BioNTech's vaccine for younger children.

The shot has been authorized for ages 12-15 since May and it was cleared for those aged 16 and above in December last year.

https://www.marketscreener.com/news/latest/U-S-CDC-panel-to-discuss-COVID-19-shots-for-younger-kids-on-Nov-2--36803732/

In Major Shift, NIH Admits Funding Risky Virus Research in Wuhan

 “I totally resent the lie you are now propagating.”

Dr. Anthony Fauci appeared to be channeling the frustration of millions of Americans when he spoke those words during an invective-laden, made-for-Twitter Senate hearing on July 20. You didn’t have to be a Democrat to be fed up with all the xenophobic finger-pointing and outright disinformation, coming mainly from the right, up to and including the claim that COVID-19 was a bioweapon cooked up in a lab.

The immediate target of Dr. Fauci’s wrath was Senator Rand Paul, who was pressing the nation’s top doctor to say whether the National Institutes of Health had ever funded risky coronavirus research at the Wuhan Institute of Virology. Based on new information disclosed by the National Institutes of Health, however, Paul might have been onto something.

On Wednesday, the NIH sent a letter to members of the House Committee on Energy and Commerce that acknowledged two facts. One was that EcoHealth Alliance, a New York City–based nonprofit that partners with far-flung laboratories to research and prevent the outbreak of emerging diseases, did indeed enhance a bat coronavirus to become potentially more infectious to humans, which the NIH letter described as an “unexpected result” of the research it funded that was carried out in partnership with the Wuhan Institute of Virology. The second was that EcoHealth Alliance violated the terms of its grant conditions stipulating that it had to report if its research increased the viral growth of a pathogen by tenfold.

The NIH based these disclosures on a research progress report that EcoHealth Alliance sent to the agency in August, roughly two years after it was supposed to. An NIH spokesperson told Vanity Fair that Dr. Fauci was “entirely truthful in his statements to Congress,” and that he did not have the progress report that detailed the controversial research at the time he testified in July. But EcoHealth Alliance appeared to contradict that claim, and said in a statement: “These data were reported as soon as we were made aware, in our year four report in April 2018.”

The letter from the NIH, and an accompanying analysis, stipulated that the virus EcoHealth Alliance was researching could not have sparked the SARS-CoV-2 pandemic, given the sizable genetic differences between the two. In a statement issued Wednesday, NIH director Dr. Francis Collins said that his agency “wants to set the record straight” on EcoHealth Alliance’s research, but added that any claims that it could have caused the SARS-CoV-2 pandemic are “demonstrably false.”

EcoHealth Alliance said in a statement that the science clearly proved that its research could not have led to the pandemic, and that it was “working with the NIH to promptly address what we believe to be a misconception about the grant’s reporting requirements and what the data from our research showed.”

But the NIH letter—coming after months of congressional demands for more information—seemed to underscore that America’s premier science institute has been less than forthcoming about risky research it has funded and failed to properly monitor. Instead of helping to lead a search for COVID-19’s origins, with the pandemic now firmly in its 19th month, the NIH has circled the wagons, defending its grant system and scientific judgment against a rising tide of questions. “It’s just another chapter in a sad tale of inadequate oversight, disregard for risk, and insensitivity to the importance of transparency,” said Stanford microbiologist Dr. David Relman. “Given all of the sensitivity about this work, it’s difficult to understand why NIH and EcoHealth have still not explained a number of irregularities with the reporting on this grant.”

The disclosures of the last four months—since Vanity Fair was first to detail how conflicts of interest resulting from U.S. government funding of controversial virology research hampered America’s investigation into COVID-19’s origins—present an increasingly disturbing picture.

Early last month, The Intercept published more than 900 pages of documents it obtained through a Freedom of Information Act lawsuit against the NIH, relating to EcoHealth Alliance’s grant research. But there was one document missing, a fifth and final progress report that EcoHealth Alliance had been required to submit at the end of its grant period in 2019.

In its letter Wednesday, NIH included that missing progress report, which was dated August 2021. That report described a “limited experiment,” as the NIH letter phrased it, in which laboratory mice infected with an altered virus became “sicker than those infected with” a naturally occurring one.

The letter did not mention the phrase “gain-of-function research” that has become so central to the bitter clashes over COVID-19’s origins. That type of controversial research—the manipulation of pathogens with the aim of making them more infectious in order to gauge their risk to humans—has divided the virology community. A review system established in 2017 requires federal agencies to particularly scrutinize any research proposals that involve enhancing a pathogen’s infectiousness to humans.

Dr. Fauci’s spokesperson told Vanity Fair that EcoHealth Alliance’s research did not fall under that framework, since the experiments being funded “were not reasonably expected to increase transmissibility or virulence in humans.”

However, Alina Chan, a Boston-based scientist and coauthor of the book Viral: The Search for the Origin of COVID-19, said the NIH was in a “very challenging position. They funded research internationally to help study novel pathogens and prevent against them. But they had no way to know what viruses had been collected, what experiments had been conducted, and what accidents might have occurred.”

As scientists remain in a stalemate over the pandemic’s origins, another disclosure last month made clear that EcoHealth Alliance, in partnership with the Wuhan Institute of Virology, was aiming to do the kind of research that could accidentally have led to the pandemic. On September 20, a group of internet sleuths calling themselves DRASTIC (short for Decentralized Radical Autonomous Search Team Investigating COVID-19) released a leaked $14 million grant proposal that EcoHealth Alliance had submitted in 2018 to the Defense Advanced Research Projects Agency (DARPA).

It proposed partnering with the Wuhan Institute of Virology and constructing SARS-related bat coronaviruses into which they would insert “human-specific cleavage sites” as a way to “evaluate growth potential” of the pathogens. Perhaps not surprisingly, DARPA rejected the proposal, assessing that it failed to fully address the risks of gain-of-function research.

The leaked grant proposal struck a number of scientists and researchers as significant for one reason. One distinctive segment of SARS-CoV-2’s genetic code is a furin cleavage site that makes the virus more infectious by allowing it to efficiently enter human cells. That is just the feature that EcoHealth Alliance and the Wuhan Institute of Virology had proposed to engineer in the 2018 grant proposal. “If I applied for funding to paint Central Park purple and was denied, but then a year later we woke up to find Central Park painted purple, I’d be a prime suspect,” said Jamie Metzl, a former executive vice president of the Asia Society, who sits on the World Health Organization’s advisory committee on human genome editing and has been calling for a transparent investigation into COVID-19’s origins.

The claims of a lab origin, made without evidence in April 2020 by President Donald Trump, have turned into a legitimate, long-haul hunt for the truth that even U.S. intelligence agencies cannot seem to determine. This summer an intelligence review ordered by President Joe Biden drew no definitive conclusions but left open the possibility that the virus leaked from a laboratory in Wuhan, China.

The NIH’s letter to Congress stated that the agency is giving EcoHealth five days to submit any unpublished data from the experiments it funded. Republican leaders of the House Committee on Energy and Commerce, who in June asked the NIH to demand such data, said in a statement Wednesday that “it’s unacceptable that the NIH delayed asking EcoHealth Alliance to submit unpublished data about risky research that they were required to under the terms of their grant.”

Meanwhile, members of the DRASTIC coalition have continued their research. As one member, Gilles Demaneuf, a data scientist in New Zealand, told Vanity Fair, “I cannot be sure that [COVID-19 originated from] a research-related accident or infection from a sampling trip. But I am 100% sure there was a massive cover-up.”

https://www.vanityfair.com/news/2021/10/nih-admits-funding-risky-virus-research-in-wuhan

Lilly kick-starts speedy FDA review for Alzheimer's hopeful donanemab, cans 2nd candidate

 The great Alzheimer's R&D resurgence continues as Eli Lilly nabs an accelerated FDA review for its mixed bag drug donanemab, while also plotting direct head-to-head tests against Biogen’s new and controversial therapy Aduhelm.

But wait, there's more. Lilly is also terminating a phase 2 Alzheimer's asset called zagotenemab after the drug failed a phase 2 clinical trial. Executives touted the therapy to Fierce Biotech as recently as September, when Mark Mintun, M.D., Sr. VP of Neuroscience R&D for Lilly, said that results for a phase 2 study of the large molecule anti-tau antibody were eagerly awaited. Lilly now says the drug "failed to meet the primary endpoint in a Phase 2 study."

Let's start with the FDA news where, in third-quarter earnings posted early Tuesday morning, Lilly said a rolling submission had been started with the agency, where data can be added as it comes in for the memory-wasting disease therapy donanemab.

This is also being done under an accelerated approval and specifically in early Alzheimer's disease, as the U.S. Big Pharma hopes to ride the Alzheimer's train which pulled out of the station with Biogen's recent approval for Aduhelm.

That approval has, however, proven highly controversial, given that the data for the green light were mixed and partly mined from a sub group of patients. The decision relied largerly on the biomarker of clearing amyloid, something that has in the past not seen significant improvements in helping Alzheimer's patients.

This, alongside a price tag of around $50,000 per patient, has seen doctors in the U.S. balk, with Biogen at last count only making $300,000 from the med, despite being on the market for a good few months now.

Lilly acknowledged the tough road ahead for donanemab, with SVP and Chief Scientific and Medical Officer Daniel Skovronsky, M.D., Ph.D., taking a shot at Biogen's early sales numbers during the Tuesday morning earnings call. 

"Given the current environment, we think it's reasonable to have modest expectations for the scale of patient impact for anti-amyloid therapies available under accelerated approval prior to the readout of their definitive phase 3 data," Skovronsky said. 

Should Lilly's therapy be approved under the accelerated pathway in the second half of the year, Skovronsky expects to have clinical trial results to confirm the effect by mid-2023. This throws down the gauntlet to Biogen, which was granted nine years to complete a confirmatory study for Aduhelm. 

"The window of accelerated approval without definitive phase 3 data is likely to be brief," Skovronsky said. 

Not discouraged by the issues of Biogen, Lilly is in fact hoping to capitalize on the drama. Alongside the rolling submission news, the Indianapolis Big Pharma also laid down plans for a key phase 3 trial, to be known as TRAILBLAZER-ALZ 4, as a head-to-head comparing donanemab to Aduhelm (aducanumab) “to assess superiority of brain amyloid plaque clearance in early symptomatic Alzheimer's disease.”

Initial primary endpoint results from the study should be available in the second half of 2022, according to Skovronsky. Enrollment is expected to begin this year, and will be keenly watched by the market and the FDA. If donanemab can out-do Aduhelm—and Lilly can be savvy on pricing—the company could have a more marketable drug on its hands; though it will likely need to show some impact on the disease too, or fall into the same issues Aduhelm has faced.

The head to head trial may not get at the key question facing all of the companies working on Alzheimer's therapies: Do they work? Skovronsky said the trial will be small and short, with an endpoint focused on removing plaque rather than clinical efficacy. 

"If we believe that plaque lowering is the appropriate surrogate, that question will certainly be answered in the next year to 18 months," he said.

There’s no slam dunk here though: while Aduhelm appeared to open the gates for new Alzheimer's approvals after such a long dearth of hope, the agency was burned by the green light as AdComm members left in droves arguing that the therapy should have been rejected. Now the agency is under investigation, with calls for scrutiny over how and why Aduhelm passed the finish line.

This backdrop means Lilly cannot expect an easy ride for donanemab, which like Aduhelm also has seen some murky past results. Earlier in the year the pharma talked up data from a phase 2 clinical trial that was hailed as showing a “significant slowing of decline” in Alzheimer’s disease patients.

But in March when the full results were shared, the donanemab data turned out to be a mixed bag, with a slight win on one disease scale undermined by a failure on a more widely used measure of Alzheimer’s.

It appeared as if the drug may have been better off on the back burner—but Aduhelm spurred Lilly back into action and the rolling submission we see today.

Moving on to zagotenemab, this therapy was listed as the next-in-line behind donanemab with the phase 2 results coming soon. Now, that trial has failed and Lilly is cutting its loses. Skovronsky said the therapy "was unable to modulate tau spread in the brain."

Lilly sent some mixed signals on whether tau therapies will continue to be a part of Lilly's pipeline. On one hand, Skovronsky said the pharma plans to continue to study it as a potential target for slowing cognitive decline in Alzheimer's. 

But then, he added during the Q&A: "At present, I don't see a path forward for this antibody and I would be reluctant to invest in really any anti-tau antibody."

https://www.fiercebiotech.com/biotech/eli-lilly-kickstarts-speedy-fda-review-for-alzheimer-s-hopeful-donanemab-plots-aduhelm-head

Judge rules Southwest can order pilots to be vaccinated against COVID

 A judge ruled Southwest Airlines can order its pilots to be vaccinated against COVID-19 after the union tried to get a restraining order on the policy.

The Southwest Airlines Pilots Association took the company to court saying it needs to negotiate the coronavirus vaccine requirement in the collective bargaining agreement, The Dallas Morning News reported. 

U.S. District Judge Barbara Lynn ruled against the temporary restraining order saying Southwest Airlines is fulfilling its obligation under the collective bargaining agreement to provide a safe work environment.

The vaccine requirement will “likewise improve the safety of air transportation, the efficiency of Southwest’s operations, and further the [collective bargaining agreement] goal of safe and reasonable working conditions for pilots,” the judge wrote in her ruling, according to the local outlet. 

The company required its employees to get the vaccine after the Biden administration said companies with more than 100 employees had to mandate the vaccine or face repercussions.

Employees at Southwest Airlines need to get an exemption or provide proof of vaccination by Nov. 24.

The push against the mandate comes as the company lost $75 million in October due to air control issues, staffing shortages and weather delays. 

The company said it will cut flights back in December to avoid the mass cancellations they endured in October. 

"We have reined in our capacity plans to adjust to the current staffing environment, and our ontime performance has improved, accordingly,” CEO Gary Kelly said. “We are aggressively hiring to a goal of approximately 5,000 new employees by the end of this year, and we are currently more than halfway toward that goal.”

https://thehill.com/policy/healthcare/578672-judge-rules-southwest-can-order-pilots-to-be-vaccinated-against-covid-19

CDC: Some immunocompromised people can get 4th vaccine dose

 The Centers of Disease Control and Prevention (CDC) issued updated guidance Monday saying some immunocompromised people can get a fourth COVID-19 vaccine dose for additional protection.

The federal agency permits moderately and severely immunocompromised adults to get a fourth booster shot if they completed an initial series of an mRNA vaccine and received a third additional dose. The fourth shot can be administered six months after the most recent dose.

The adjusted recommendations come days after the CDC approved mix-and-match booster shots, where a person receives a different brand dose from their initial vaccination. 

Under this guidance, moderately and severely immunocompromised people who got the Pfizer-BioNTech or Moderna vaccines for their first three shots can get a different booster shot if desired.

The CDC distinguished the definitions for additional dose and booster shot, saying an additional dose referred to a subsequent shot for people thought not to have an adequate immune response to the initial vaccine series.

Booster shots, on the other hand, refer to a subsequent dose given to those whose protection from the initial vaccine series is expected to have decreased over time. 

The CDC officially advised immunocompromised people to get a third additional dose of an mRNA vaccine in August, so the earliest third dose recipients would not be eligible for a fourth shot until February. The additional third shot was recommended at least 28 days after the second dose. 

Immunocompromised Johnson & Johnson recipients received different instructions to get a single COVID-19 booster shot at least two months after their initial dose, just like all adults who got the single-dose shot. 

The federal agency granted the option for specific Moderna and Johnson & Johnson recipients to get booster shots last week following a unanimous advisory panel vote.

While all Johnson & Johnson-vaccinated adults are advised to get a booster, the CDC recommended the extra shot to certain vulnerable Moderna and Pfizer-BioNTech populations, including those aged 65 and older, those in long-term care facilities and those aged 50 to 64 with underlying medical conditions.

The CDC also granted the option of a booster dose following an mRNA vaccine to other adults with underlying medical conditions and adults at risk of contracting COVID-19 due to their occupational or institutional setting. 

Pfizer-BioNTech was authorized to be given to these populations last month, ahead of the Moderna and Johnson & Johnson booster approvals.

https://thehill.com/policy/healthcare/578676-cdc-some-immunocompromised-people-can-get-fourth-vaccine-dose

Ocugen Files with U.S. FDA for Phase 3 Clinical Trial of COVID-19 Vaccine Candidate COVAXIN

 The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population

Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that it has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN™ outside the United States.

COVAXIN™ is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.

The Phase 3 trial proposed in the IND is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the U.S. who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier.

https://finance.yahoo.com/news/ocugen-inc-announces-submission-investigational-103500850.html