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Thursday, January 13, 2022

BridgeBio Announces Clinical Collaboration with Amgen on Cancer Combo

First clinical combination study of BBP-398 and LUMAKRAS set to evaluate safety and preliminary efficacy in solid tumors with the KRAS G12C mutation

 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced a non-exclusive clinical collaboration with Amgen Inc. (Amgen) to evaluate the combination of BBP-398, a potentially best-in-class SHP2 inhibitor, with LUMAKRAS® (sotorasib), a KRASG12C inhibitor, in patients with advanced solid tumors with the KRAS G12C mutation.

The Phase 1/2 study will include a dose escalation period followed by dose expansion and optimization, and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of BBP-398 in combination with LUMAKRAS. Under the terms of the non-exclusive collaboration, BridgeBio will sponsor the study and Amgen will provide a global supply of LUMAKRAS.

BBP-398 is a potent small-molecular inhibitor of SHP2 developed in collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division. SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/ERK MAPK pathway to regulate cellular proliferation and survival. By combining SHP2 inhibition with KRASG12C inhibition in patients with the KRAS G12C mutation, there is potential that the investigational combination could prevent oncogenesis and overactive cellular proliferation.

https://finance.yahoo.com/news/bridgebio-announces-clinical-collaboration-amgen-123000365.html

Amgen-Astrazeneca Tezpire available in U.S. for severe asthma

 Amgen (NASDAQ:AMGN) and AstraZeneca today announced TEZSPIRE™ (tezepelumab-ekko) is now available for shipment to wholesalers in the U.S. TEZSPIRE was approved by the U.S. Food and Drug Administration (FDA) on Dec. 17, 2021 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.1



https://finance.yahoo.com/news/tezspire-tezepelumab-ekko-now-available-120000189.html

Denali: FDA Clinical Hold on DNL919 Investigational Alzheimer's Drug

 Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that after the close of business (Eastern Time) on Wednesday, January 12, 2022, the company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) that the DNL919 (ATV:TREM2) Investigational New Drug (IND) application has been placed on clinical hold. The FDA indicated they will provide an official clinical hold letter to Denali in approximately 30 days. Denali plans to provide additional updates pending discussion with the FDA.

https://finance.yahoo.com/news/denali-therapeutics-announces-fda-clinical-130000130.html

Wednesday, January 12, 2022

COVID-19 case trajectories may be predicted by surveying communities

 The public’s willingness to comply with Centers for Disease Control and Prevention (CDC) recommendations correlates with COVID-19 case projections in zip codes where those surveyed about their intended behaviors live, according to Penn State College of Medicine researchers. The researchers said that surveys may be useful for predicting outbreaks of COVID-19 and other infectious diseases and identifying “hot spots” where interventions like promoting prevention behaviors and vaccination may prevent surges.

Dr. Robert Lennon, associate professor of family and community medicine, led a research team that surveyed more than 10,600 people between April 9 and July 12, 2020. Participants answered questions about whether they would comply with certain public health measures for mitigating the spread of the novel coronavirus. In collaboration with researchers from Mathematica, they found that in areas where participants were less likely to follow certain recommendations, there were more likely to be higher COVID-19 case counts in the following days.

“As we continue to respond to the COVID-19 pandemic and see variants like omicron and delta emerge, it’s important to have tools that help predict where cases may surge,” Lennon said. “Surveying is a simple tool and could help identify where increased education and messaging may be needed.”

The study participants provided information about where they lived and were asked about how likely they were to comply with public health measures (no, probably no, maybe, probably yes and yes). The survey was updated in June 2020 in response to updated CDC guidance and listed recommendations including:

  • Wash your hands often (for 20 seconds or more).
  • Maintain social distancing/social isolation even if you have no symptoms.
  • Avoid touching your eyes, nose and mouth.
  • Cough or sneeze into your elbow.
  • Stay home if you feel unwell. If you have fever, cough and difficulty breathing, seek medical attention and call in advance.
  • Wear a cloth face cover (face mask) when out in public.
  • Stay out of crowded places and avoid mass gatherings.

The researchers used participants’ zip codes to determine COVID-19 case trajectories in the areas where they lived for 30, 14 and 7 days before and after they completed the survey. While overall intent to comply was high, the team noticed a correlation between willingness to follow public health recommendations and COVID-19 case trajectories. Areas where residents expressed less willingness to follow guidance had higher amounts of COVID-19 cases compared to areas where residents expressed greater intent to comply. The results were published in the Southern Medical Journal.

Lennon’s team estimates that for every 3% increase in composite intent to comply score, 9% of COVID-19 cases in a participant’s area could be prevented during the following 30 days. He said this could be achieved by increasing the average compliance rating a single point on the scale for any one recommendation. For example, if a community sample increased their average intention to avoid touching their face from “maybe” to “probably yes,” their number of COVID-19 infections over the next 30 days would be expected to decrease 9%.

“Our study demonstrates that personal mitigation behaviors do make a difference,” Lennon said. “While there are fewer restrictions and mandates at this stage of the pandemic, public health guidance is still being issued and should be followed.”

The researchers said their findings demonstrate that surveying communities about their intent to comply with public health recommendations may be a useful tool for predicting case trajectories not only for COVID-19 but other respiratory or emerging infectious diseases.

Aleksandra Zgierska, Erin Miller, Bethany Snyder and Lauren Jodi Van Scoy of Penn State College of Medicine, and Aparna Keshaviah, Xindi Hu and Hanzhi Zhou of Mathematica, also contributed to this research. The researchers declare no conflicts of interest.

This research was supported in part by the Huck Institutes of the Life Sciences and the Social Science Research Institute at Penn State and the Department of Family and Community Medicine at Penn State College of Medicine.

Read the full manuscript in Southern Medical Journal.

Study calls into question early claims of COVID-19 ‘infodemic’ of health misinformation

 In a first-of-its-kind study comparing hundreds of millions of social media posts about online health topics, a team of researchers found that posts about COVID-19 were less likely to contain misinformation than posts about other health topics. The researchers found that health misinformation was already widespread before the COVID-19 pandemic. Although all types of information about COVID-19 — including misinformation — were popular between March and May 2020, posts about COVID-19 were more likely to come from governments and academic institutions. In many cases, these posts were more likely to go viral than posts from sources that routinely spread misinformation. 

At the start of the pandemic, governments and organizations around the world started paying attention to the problem of health misinformation online,” David Broniatowski, an associate professor of engineering management and systems engineering at the George Washington University and associate director of GW’s Institute for Data, Democracy and Politics, said. “But when you compare it to what was going on before the pandemic, you start to see that health misinformation was already widespread. What changed is that, when  COVID-19 hit, governments and social media platforms started paying attention and taking action.”

The team collected public posts on Twitter and Facebook at the very start of the pandemic –  between March 2020 and May 2020 – when content about COVID-19 was growing rapidly. They compared those posts to posts about other health topics from the same time period in 2019, looking at the credibility of the websites that each post shared. More credible sources included government and academic sources as well as the traditional news media. Sources deemed “not credible” comprised conspiracy-oriented sites and state-sponsored sites known for spreading  propaganda, which were 3.67 times more likely to spread misinformation than credible sites. 

“Misinformation has always been present, even at higher proportions before COVID-19 started. Many people knew this, which makes the ensuing misinformation spread during COVID-19 entirely predictable,” Mark Dredze, an associate professor of computer science at Johns Hopkins University, and co-author of the study, said. “Had we been more proactive in fighting misinformation, we may not have been in an anti-vaccination crisis today.”

“These findings suggest that the ‘infodemic’ of misinformation is a general feature of health information online, not one restricted to COVID-19,” Broniatowski said. “Clearly there is a lot of misinformation about COVID-19, but attempts to combat it might be better informed by comparison to the broader health misformation ecosystem.”  

Sandra Crouse Quinn, a professor at the University of Maryland’s School of Public Health and a co-author on the paper, emphasized the research’s focus on the pandemic’s beginning. 

“At this point in the pandemic, it is critical for new research to further explore COVID-19 misinformation within the health misinformation ecosystem, but most importantly, how we can combat this challenge,” Quinn said.

The paper, “Twitter and Facebook posts about COVID-19 are less likely to spread misinformation compared to other health topics” was published in the journal PLOS ONE on Jan. 12. The research team also included researchers at the University of Maryland, Johns Hopkins University, University of Pittsburgh, University of Memphis and San Diego State University.

Broniatowski is affiliated with the GW Institute for Data, Democracy & Politics, which launched in 2019 with the support of the John S. and James L. Knight Foundation. The institute’s mission is to help the public, journalists and policy makers understand digital media’s influence on public dialogue and opinion, and to develop sound solutions to disinformation and other ills that arise in these spaces.

-GW-

Canada drops COVID-19 vaccine mandate for its truckers after pressure from industry

 Canada will allow unvaccinated Canadian truckers to cross in from the United States, reversing a decision requiring all truckers to be inoculated against the coronavirus, Canada's border agency said on Wednesday (Jan 12).

Canadian Prime Minister Justin Trudeau had faced pressure from the main opposition party and trucking lobby to drop the vaccine mandate for truckers, due to come into force on Saturday, saying it could result in driver shortages, disrupt trade and drive up inflation.

The Canada Border Services Agency (CBSA) said that unvaccinated or partially vaccinated Canadian truck drivers arriving at the US-Canada border will remain exempt from pre-arrival, arrival and post-arrival testing and quarantine requirements.

However, truckers from the United States will still need to be vaccinated or they will be turned back at the border from Jan 15, a CBSA spokesperson said.

A Canadian government source said the decision was taken to ensure smooth supply chains.

Trudeau's Liberal government had set the Saturday deadline requiring all truckers entering from the United States to show proof of vaccination as part of its fight against COVID-19.

With more than two-thirds of the CUS$650 billion (US$511 billion) in goods traded annually between Canada and the United States travelling on roads, the trucking industry is key.

The Canadian Trucking Alliance had estimated the government mandate could force some 16,000 cross-border drivers - 10 per cent of them - off the roads.

The mandate was the first policy measure taken since the pandemic began that could limit cross-border trucking traffic. Trucks crossed the border freely when the border was closed for 20 months because they were considered essential to keep supply chains open.

Supply chain disruptions drove Canada's headline inflation to an 18-year high in November, and the Bank of Canada has signalled that it could raise interest rates as soon as April.

The cost of bringing a truckload of fruit and vegetables from California and Arizona to Canada doubled during the pandemic due to a driver shortage, Steve Bamford, chief executive of Bamford Produce, an importer and exporter of fresh fruit and vegetables based in Ontario told Reuters last week.

Fresh foods are sensitive to freight problems because they expire rapidly.

The Biden administration wants truck drivers at companies with 100 or more employees to be vaccinated or submit to weekly testing, a policy that has been challenged to the Supreme Court.

https://www.channelnewsasia.com/world/canada-drops-covid-19-vaccine-mandate-its-truckers-after-pressure-industry-2432406

U.S. Business Fears Never Ending Liability From 'Take-Home' COVID-19 Lawsuits

 As COVID-19 cases surge in the United States, businesses say they fear a California court ruling has increased the likelihood that companies will be sued for infections, even by people who are not employees or customers.

The Dec. 21 ruling allowed a wrongful death lawsuit to proceed against See's Candies Inc, owned by Berkshire Hathaway, by the family of Arturo Ek of Los Angeles who died in April 2020 at 72 from COVID-19.

See's employed his wife, Matilde Ek, who said she was infected by the coronavirus while working inches apart from sick coworkers, and then her husband caught it from her at home.

The ruling is the first by an appeals court to allow a novel "take-home" COVID-19 lawsuit, which seek damages from a business over allegations of violating safety protocols and setting off a chain of infections beyond the company's premises.

See's, which did not respond to a request for comment, could appeal to California's supreme court.

The See's ruling is only binding in California, but it may offer guidance to judges in other states, legal experts said.

Business groups warned in court papers filed before the See's decision that such a ruling could prompt lawsuits by an infected employee’s family and friends, and anyone infected by that circle of people.

The groups called it a "never-ending chain" of liability.

To counter COVID-19 lawsuits, including take-home cases, business interests have persuaded at least 30 states to adopt laws that make it difficult to bring them, often by requiring plaintiffs to show gross negligence.

California wasn't one of those states.

"The appellate court’s ruling could open up California employers to frivolous COVID-related lawsuits that will further dampen the ability of small businesses in particular to recover," said Kyla Christoffersen Powell, the president of Civil Justice Association of California, a business group.

Hours after the decision, a California construction worker and his wife cited the ruling to a U.S. appeals court in San Francisco. The couple is seeking to revive a similar lawsuit against Victory Woodworks Inc.

There have been at least 23 take-home COVID-19 lawsuits across the United States, which are all in the early stages. Defendants include Amazon.com Inc, Walmart Inc, Royal Caribbean Cruises Ltd, Conagra Brands Inc and Pilgrim's Pride, an affiliate of meat producer JBS SA.

The lawsuits generally allege negligence toward COVID-19 protocols: employees were packed into work vans, symptomatic workers were kept in company dorms or infected people weren't screened before entering a worksite. They seek damages on behalf of employees' children and spouses who wound up on ventilators or even died of the disease.

At least six of the lawsuits have been dismissed including against Southwest Airlines Co and six, including two against McDonald's Corp, appear to have resulted in a private settlement, said Stephen Jones, general counsel of Praedicat Inc, a firm that evaluates risks for insurers.

The cases are not limited to employees. Royal Caribbean's Celebrity Cruise line was sued in federal court in Miami for a COVID-19 outbreak on a ship, infecting two passengers who brought the disease home to their children. The two sides are scheduled to begin mediation later this month.

"Until you get a jury verdict, we won't know one way or other if there will be an explosion of cases," said Jones.

The See's ruling helped to resolve an initial question that has hung over take-home COVID-19 cases by finding that employers aren't shielded from lawsuits by workers' compensation. The system provides quick payments without the need to prove fault for workplace injuries and in return it blocks lawsuits.

The California Court of Appeal, Second Appellate District, said Arturo Ek's death was dependent on his wife as a conduit for the virus. His death was not, as See's had argued, dependent on her disease.

The Ek family must still convince a judge that See's owed a duty to family and acquaintances of employees. Plaintiffs have failed to establish that in cases that were dismissed against Southwest Airlines, an Illinois meat processing company and a Maryland hospital.

To ultimately prevail, plaintiffs must also show that there is a link between the workplace and the case of take-home COVID-19.

"You would have to have a situation where an employee came to and from work and neither the employee nor anyone else in the family/household went anywhere else," said Amberly Morgan, an attorney with Fisher Phillips, which defends employers.