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AstraZeneca US COVID-19 vaccine trial may resume as soon as this week

AstraZeneca's COVID-19 vaccine trial in the United States is expected to resume as early as this week after the US Food and Drug Administration completed its review of a serious illness, four sources told Reuters.

AstraZeneca's large, late-stage US trial has been on hold since September 6, after a participant in the company's British trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis.

The vaccine candidate, which is being developed with the University Oxford, is one of the two projects that Australia has inked formal supply agreements for at this stage. Under an agreement between the federal government, AstraZeneca and CSL, the Australian biotech plans to make more than 30 million doses of the product in Melbourne from next year. 

AstraZeneca had been seen as a frontrunner in the race for a vaccine until its trials were put on hold.Credit:AP

The Australian government has said it remains in conversations with a range of vaccine makers but the AstraZeneca project and the University of Queensland's vaccine remain a focus, with CSL preparing to make doses of both.

In a research and development briefing held for CSL investors on Tuesday, the company's chief scientific officer Dr Andrew Nash said preparations to produce both vaccines were moving along well and production of the AstraZeneca product could start early next year.

He said the AstraZeneca/Oxford and University of Queensland projects used different approaches, with UQ's being a more "classical" vaccine model while AstraZeneca's was a newer approach, and it was a positive that both projects could be made in Melbourne.

"We feel that in terms of technology platforms, the development of a classical platform and a next-generation platform provides CSL and the Australian population with important options moving forward," he said.

'Insufficient evidence'

Sources who were briefed on AstraZeneca US trial but asked to remain anonymous, said they have been told the US trial could resume later this week. It was unclear how the FDA would characterise the participant's illness that had prompted the halting of the trial, they said.

An FDA spokeswoman declined to comment.

The agency is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources.

British regulatory officials previously reviewed the illness and determined there was “insufficient evidence to say for certain” that it was or was not related to the vaccine. It permitted the trial to resume in the UK, according to a draft of the updated consent form shared with Reuters.

“In this case, after considering the information, the independent reviewers and MHRA (Medicines and Healthcare products Regulatory Agency) recommended that vaccinations should continue,” the draft consent form stated. “Close monitoring of the affected individual and other participants will be continued.”

Regulators in Brazil, India and South Africa also previously allowed AstraZeneca to resume its vaccine trials there.

AstraZeneca, which is developing the vaccine with Oxford University researchers, had been seen as a frontrunner in the race to produce a vaccine for COVID-19 until its trials were put on hold to investigate the illness. Early data from large-scale trials in the United States of vaccines from Pfizer and Moderna are expected some time next month.

Johnson & Johnson last week paused its Phase III COVID-19 vaccine trial to investigate an unexplained illness in one of the study participants. At the time of the announcement, the company did not know whether the volunteer had been given its vaccine or a placebo.

A J&J spokesman on Tuesday said the study remains on pause as the company continues its review of medical information before deciding to restart the trial. J&J noted that its "study pause" was voluntary, in contrast to AstraZeneca's "regulatory hold," which is imposed by health authorities.

Vaccines are seen as essential to helping end the pandemic that has battered economies around the world and claimed more than 1 million lives – over 220,000 of them in the United States.

Responding to a request about the AstraZeneca trial, British regulators shared with Reuters a draft of a form letter to UK vaccine trial participants, dated October 14 and signed by the Oxford COVID-19 Vaccine Team. It says the US FDA had “completed their analysis” and said vaccination in the United States would resume shortly.

FDA "has come to the same conclusion as the other drug regulators including the MHRA," the letter states.

Walking the line

The Health Research Authority, which helps regulate UK medical research, did not say if the letter had been sent or respond to questions about it.

An AstraZeneca spokeswoman said the communication is not from the company and it "cannot verify the content," referring to the draft letter to study participants. "We also cannot comment on a pending FDA decision," she said.

In another of the documents directed at trial participants, the Oxford vaccine study team noted that there was not enough evidence to link the neurological problem seen in the UK trial to the vaccine.

Dr Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia who reviewed the document, said it can be difficult to link a rare side effect specifically to a vaccine to the exclusion of other potential causes.

Transverse myelitis, which the study volunteer is believed to have developed, typically occurs at a rate of 1-in-200,000 people, Offit said, so it would be unusual to see it in a trial of 9000 individuals.

Other viruses including those that cause West Nile and polio can trigger the condition, as can physical trauma.

The regulators have to weigh whether a rare side effect is vaccine-related and could occur again against the sickness and deaths linked with COVID-19, Offit said.

"That's always the line that you walk," he said.

Reuters

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‘Integrity’ of financial system at stake as $1.3b Westpac fine upheld: Federal Court

Federal Court judge Jonathan Beach has said the integrity of Australia's financial system depends on upholding anti-money laundering laws as he approved Westpac's $1.3 billion record penalty for systemic failures in its approach to financial crime.

Justice Beach said the penalty, which is the biggest in Australian corporate history, was appropriate for Westpac’s widespread breaches of the Anti-Money Laundering (AML) and Counter-Terrorism Financing Act, including its failure to report suspicious payments and conduct due diligence on its correspondent bank partners.

"Clearly the integrity of Australia's financial system depends upon Westpac and other major banks having first class, compliant, risk-based systems to address anti-money laundering and terrorism financing risks," he said on Wednesday.

Justice Jonathan Beach approved the largest fine in Australian corporate history in the Federal Court. Credit:The Age

"Financial institutions are an important line of defence in protecting the community and financial system … even minor or inconsequential breaches of the act have very serious consequences."

Justice Beach said Westpac accounts for a very significant portion of the payments made through Australia’s financial system and therefore a substantial fine was necessary.

Banks needed to ensure transparency of international payments to prevent financial crime, he said. "It’s obvious that money laundering is all about obscuring the origin and destination of funds."

The financial crimes watchdog AUSTRAC launched legal action against Westpac in November after the bank was found to have breached AML laws 23 million times, including a failure to report 262 customers linked to child exploitation.

Westpac has since made significant investments in bolstering its AML compliance by improving its digital systems and retraining staff. AUSTRAC's barrister Wendy Harris, QC, said Westpac had demonstrated it took AML compliance "very seriously" but only time would tell if this would be effective.

"Now of course the proof is always in the pudding," Ms Harris said. "You can have a system but there’s also the implementation of the system, obviously we don’t have a direct line of sight in that regard.”

Wendy Harris QC has blasted Westpac’s failures in the final hearing in the case against AUSTRAC. Credit:Alina Gozin’a

The Federal Court heard Westpac's failure jeopardised law enforcement's ability to fight crime.

"Westpac’s failures resulted in significantly less transparency in the flow of funds in and out of Australia," Ms Harris said. "They compromised the ability of law enforcement agencies to deal with and prevent unlawful activity, and they undermined the taxation system by denying important information to the ATO [Australian Taxation Office]."

Ms Harris cleared the bank's board of any wrongdoing but said management oversight of AML compliance had been inadequate.

"There wasn’t any deliberate intention to contravene the [anti-money laundering] Act. They did take steps to ensure Westpac complied," Ms Harris said. "But despite those steps, that oversight by [the] board and senior management was deficient in a number of respects."

The final hearing in the landmark case against Westpac comes after The Age and The Sydney Morning Herald revealed the lender maintained a correspondent banking relationship until 2018 with an offshore bank, Euro Pacific, that is now the subject of a major global tax evasion and money laundering probe. The investigation prompted senior academics from the University of Sydney and University of Melbourne to call for reform, including criminal prosecution for non-compliance and greater information-sharing between institutions.

Justice Beach said $300 million of the $1.3 billion fine was attributed to Westpac's failure to conduct proper screening of its international bank partners and he would have insisted a higher penalty if this breach was taken in isolation. "Contamination from the suspect practices of foreign correspondent banks and their customers must be avoided."

Westpac's lawyer John Sheahan, QC, reiterated the bank's "profound expression of regret" before pointing to the ongoing collaboration between Westpac and AUSTRAC.

"The bank also appreciates its failures were serious and they call for a serious penalty," Mr Sheahan said.

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While doing business between 2013 and 2015 Trump paid $188,561 in taxes to China. He paid $750 in taxes to the US in 2016 and then 2017.

  • President Donald Trump paid more in taxes to China through his business ventures between 2013 and 2015 than he did in the US in the years 2016 and 2017, according to tax records obtained by The New York Times.
  • The tax records reviewed by The Times showed an account controlled by Trump International Hotels Management LLC in China "paid $188,561 in taxes in China while pursuing licensing deals there from 2013 to 2015," according to The Times report.
  • Trump also operated an office in China and held a partnership with a government-controlled company in the country, The Times reported.
  • "The tax records do not include details on how much money may have passed through the overseas accounts," The Times reported, "though the Internal Revenue Service does require filers to report the portion of their income derived from other countries."
  • In an earlier report published by The Times analyzing Trump's tax records, the president paid $750 in federal income taxes in both 2016 and 2017 respectively.
  • Alan Garten, a lawyer for the Trump Organization, told The Times that the company "opened an account with a Chinese bank having offices in the United States in order to pay the local taxes" in association with the company's business efforts.
  • "No deals, transactions or other business activities ever materialized and, since 2015, the office has remained inactive," Garten told The Times. "Though the bank account remains open, it has never been used for any other purpose."
  • Trump has accused Democratic presidential nominee Joe Biden of being lenient on the Chinese government, citing his son Hunter Biden's business dealings in the country.
  • Read the full story at The Times »
  • Visit Business Insider's homepage for more stories.

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DIGITAL WEALTH MANAGEMENT: Leading robo-advisors have held onto consumer appetite amid the pandemic — here's what incumbents can learn from them to maintain their grasp on a $43 trillion market

  • Insider Intelligence publishes thousands of research reports, charts, and forecasts on the Fintech industry. You can learn more about becoming a client here.
  • The following is a preview of one Fintech report, Digital Wealth Management. You can purchase this report here.

Although they only hold a fraction of the more than $43 trillion in investable assets under management (AUM) in North America, digital wealth management adoption is set to grow in the future — presenting an opportunity for fintechs and incumbents alike.

Digital wealth managers, also called robo-advisors, came into existence after the financial crisis in 2008, when fintechs aimed to simplify and democratize wealth management services. They use technology such as AI algorithms and machine learning to manage users' assets, while often relying on a hybrid model including human advice to enhance the customer relationship.

Insider Intelligence estimates that just around $330 billion was invested in robo-advisors in North America in 2019. However, we expect that number to increase significantly over the next few years to reach $830 billion by 2024 — presenting an opportunity to fintechs and incumbents already in the space, as well as financial institutions (FIs) that want to get involved with digital wealth management. 

Offering digital wealth management services allows players to make their operations more efficient and offer users a broader suite of services, as customers are increasingly expecting digital and automated services from their wealth managers. Additionally, it can help FIs lure in younger demographics that can't yet afford conventional wealth management, and later graduate them to more premium offerings, as they build their wealth. At the same time, digital wealth managers are facing their first economic downturn amid the coronavirus pandemic, which could impact the sustainability of their businesses moving forward if they don't adjust their services.

In The Digital Wealth Mangement Report, Insider Intelligence explains what the current digital wealth management market looks like, what makes the segment worthwhile for incumbents, and how they can find success in the space. We profile the four biggest digital wealth managers in North America in detail to provide insight into their onboarding process, portfolio management, and pricing, as well as how they've been affected by the pandemic and what they're doing to accommodate changing customer needs.

Our outreach process involved exclusive interviews across three providers in May 2020, while Personal Capital's profile is based on desk research and email conversations with the company due to interviewee unavailability. Additionally, we discuss why more incumbents should offer robo-advisory services, and define a digital maturity model for robo-advisors to showcase important features and capabilities that incumbents should take note of to find success.

The companies mentioned in the report include: Acorns, Betterment, BlackRock, Blooom, Charles Schwab, Ellevest, FutureAdvisor, Invessence, InvestCloud, M1 Finance, Personal Capital, RobustWealth, TD Ameritrade, Vanguard, Wealthfront, Wealthsimple

 

Here are some key takeaways from the report:

  • Although digital wealth managers only hold a fraction of investable AUM in North America, robo-advisor adoption is set to grow in the future — presenting an opportunity for fintechs and incumbents alike.
  • While some incumbent FIs already offer digital wealth management services, not all have gotten in on the trend, despite its many benefits — and of those that have, not all have found success.
  • The pandemic represents a potential threat to digital wealth managers, but there are ways to navigate the crisis and support their customers. For that reason, digital wealth management still represents an attractive opportunity for incumbents looking to enter the space.
  • Betterment, Wealthfront, Wealthsimple, and Personal Capital all rely heavily on technology like algorithms to build portfolios for customers and support their wealth management experience, which helps them to offer their services at a lower cost when compared with conventional offerings.

In full, the report:

  • Outlines the benefits of launching a digital wealth management offering
  • Details the Digital Wealth Management Maturity Model used to assess the progress that players are making in the space.
  • Spotlights the four biggest fintech digital wealth managers in North America and what they offer.
  • Highlights how technology is being used across the services, and how this impacts pricing.
  • Discusses how these players have been impacted by the coronavirus crisis

Interested in getting the full report? Here's how you can gain access:

  1. Join other Insider Intelligence clients who receive this report, along with thousands of other Fintech forecasts, briefings, charts, and research reports to their inboxes. >> Become a Client
  2. Purchase the individual report from our store. >> Buy The Report Here

Are you a current Insider Intelligence client? Log in and read the report here.

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Ingraham: Biden alliance with teachers' unions should alarm women wary of Trump

Ingraham: Keeping schools closed is psychologically damaging kids

‘The Ingraham Angle’ host examines the potential dangers virtual learning poses for children

President Trump could make gains among women by pointing out Joe Biden's support of teachers' unions who have pushed to keep schools closed to in-person instruction amid the coronavirus pandemic, Laura Ingraham suggested Tuesday.

"The Ingraham Angle" host cited a recent New York Times poll that showed Trump leading Biden among likely male voters by six percentage points, but trailing by 23 percentage points among women.

"If that poll is anywhere near accurate, the president would have a hard time closing that gap with women but he could narrow it," said Ingraham, who added that many media members and public health authorities have "frightened and misled" women across the country about the nature of COVID-19.

"They are afraid the kids will go to school and they will get sick or they will bring sickness back to their own communities and back to their own homes," she said, "when any honest adult knows virtual learning is a train wreck for almost every kid out there, especially for those who are poor.

"But Biden and his handlers don’t care about the kids," she continued. "They keep concerning themselves with what their political allies think: The teachers' union. They need to keep them happy."

Ingraham pointed out that in Fairfax County, Va., one of the richest school districts in America, the local union has pushed to keep classrooms closed until August of 2021.

"This is child abuse," she alleged. "My hope is school officials see how damaging it will be to children but my expectations are low."

"The left," Ingraham went on, "doesn’t care about the science it invokes if it conflicts with their goals … Teachers' unions are ignoring the science to make absurd demands."

The host later warned that "with Biden in the White House, what we are seeing in Fairfax County will be happening nationwide. You won’t be able to just move across county or state lines to escape. Your child won’t see the inside of a classroom for a very long time.

"What he or she learns online about America will be left-wing propaganda courtesy of the 1619 Project," Ingraham continued. "Under President Biden this scenario might be great for Black Lives Matter and the NEA but horrendous in every other way. How can any parent, especially any mom, support this?

"I think women are naturally protective of our children. That’s just the way we are," she concluded. "For this reason alone, female voters should drop their old hang-ups about Trump. He is not the heartless or mean force in this race. He is the opposite. He wants your sons and daughters in school and learning. He wants you to be free to work for your family."

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‘Integrity’ of financial system at stake as $1.3b Westpac fine upheld: Federal Court

Federal Court judge Jonathan Beach has said the integrity of Australia's financial system depends on upholding anti-money laundering laws as he approved Westpac's $1.3 billion record penalty for systemic failures in its approach to financial crime.

Justice Beach said the penalty, which is the biggest in Australian corporate history, was appropriate for Westpac’s widespread breaches of the Anti-Money Laundering (AML) and Counter-Terrorism Financing Act, including its failure to report suspicious payments and conduct due diligence on its correspondent bank partners.

"Clearly the integrity of Australia's financial system depends upon Westpac and other major banks having first class, compliant, risk-based systems to address anti-money laundering and terrorism financing risks," he said on Wednesday.

Justice Jonathan Beach approved the largest fine in Australian corporate history in the Federal Court. Credit:The Age

"Financial institutions are an important line of defence in protecting the community and financial system … even minor or inconsequential breaches of the act have very serious consequences."

Justice Beach said Westpac accounts for a very significant portion of the payments made through Australia’s financial system and therefore a substantial fine was necessary.

Banks needed to ensure transparency of international payments to prevent financial crime, he said. "It’s obvious that money laundering is all about obscuring the origin and destination of funds."

The financial crimes watchdog AUSTRAC launched legal action against Westpac in November after the bank was found to have breached AML laws 23 million times, including a failure to report 262 customers linked to child exploitation.

Westpac has since made significant investments in bolstering its AML compliance by improving its digital systems and retraining staff. AUSTRAC's barrister Wendy Harris, QC, said Westpac had demonstrated it took AML compliance "very seriously" but only time would tell if this would be effective.

"Now of course the proof is always in the pudding," Ms Harris said. "You can have a system but there’s also the implementation of the system, obviously we don’t have a direct line of sight in that regard.”

Wendy Harris QC has blasted Westpac’s failures in the final hearing in the case against AUSTRAC. Credit:Alina Gozin’a

The Federal Court heard Westpac's failure jeopardised law enforcement's ability to fight crime.

"Westpac’s failures resulted in significantly less transparency in the flow of funds in and out of Australia," Ms Harris said. "They compromised the ability of law enforcement agencies to deal with and prevent unlawful activity, and they undermined the taxation system by denying important information to the ATO [Australian Taxation Office]."

Ms Harris cleared the bank's board of any wrongdoing but said management oversight of AML compliance had been inadequate.

"There wasn’t any deliberate intention to contravene the [anti-money laundering] Act. They did take steps to ensure Westpac complied," Ms Harris said. "But despite those steps, that oversight by [the] board and senior management was deficient in a number of respects."

The final hearing in the landmark case against Westpac comes after The Age and The Sydney Morning Herald revealed the lender maintained a correspondent banking relationship until 2018 with an offshore bank, Euro Pacific, that is now the subject of a major global tax evasion and money laundering probe. The investigation prompted senior academics from the University of Sydney and University of Melbourne to call for reform, including criminal prosecution for non-compliance and greater information-sharing between institutions.

Justice Beach said $300 million of the $1.3 billion fine was attributed to Westpac's failure to conduct proper screening of its international bank partners and he would have insisted a higher penalty if this breach was taken in isolation. "Contamination from the suspect practices of foreign correspondent banks and their customers must be avoided."

Westpac's lawyer John Sheahan, QC, reiterated the bank's "profound expression of regret" before pointing to the ongoing collaboration between Westpac and AUSTRAC.

"The bank also appreciates its failures were serious and they call for a serious penalty," Mr Sheahan said.

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Apollo Board to Examine Leon Black’s Ties to Jeffrey Epstein

Apollo Global Management Inc. board members are investigating co-founder Leon Black’s ties to disgraced financier Jeffrey Epstein after more information emerged this month about their longtime business dealings.

Black asked the board’s conflict committee to hire counsel and undertake a thorough review to independently confirm his past descriptions of a professional relationship with Epstein, a company spokesman said in an emailed statement late Tuesday. The panel tapped law firm Dechert LLP to conduct interviews and examine records.

Black told the board such a review “is the best way to assure all of our stakeholders that they have all of the relevant facts, and I look forward to cooperating fully,” according to the statement. He made the request during a regularly scheduled meeting.

The moves follow a report in the New York Times last week describing the extent to which Black had turned to Epstein for help with financial matters, allegedly wiring him at least $50 million in the years after Epstein’s 2008 conviction for soliciting prostitution from a teenage girl. The article didn’t accuse Black of breaking the law.

“With the benefit of hindsight — and knowing everything that has come to light about Mr. Epstein’s despicable conduct more than 15 years ago — I deeply regret having had any involvement with him,” Black said in a letter to Apollo’s limited partners dated last week. Black reiterated that he had turned to Epstein for matters such as taxes, estate planning and philanthropy, and said that nothing in the Times’ report was inconsistent with his earlier description of their ties.

Still, the private-equity firm’s stock has tumbled 14% since the newspaper’s report on Oct. 12. The Wall Street Journal reported the board’s review of Black earlier Tuesday.

Black, 69, and Apollo representatives have said Epstein never invested in the firm’s funds. The two men had been acquaintances since at least the early 1990s. From time to time, Epstein met with Black at Apollo’s New York offices, and he pitched personal tax strategies to the firm’s executives, Bloomberg has reported.

Apollo conducted an internal review into its involvement with Epstein to ensure that any ties went no further than the firm’s co-founder, people with knowledge of the matter said last year. That included examining emails and records to determine there was no connection between the company and Epstein, one of the people said.

Epstein was found dead in his Manhattan jail last year, where he was awaiting trial on sex-trafficking charges involving underage girls. Authorities later ruled it a suicide.

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Emotional flight attendants say farewell after being furloughed

Hong Kong (CNN Business)Cathay Pacific (CPCAY) is eliminating thousands of jobs and shuttering its regional airline Cathay Dragon as the Covid-19 pandemic roils the global travel industry.

The cuts will affect 5,300 employees in Hong Kong, where the company is based. Some 600 workers outside of the Asian financial hub will also be affected, Cathay said in a statement.
The company also plans to eliminate additional jobs that remained unfilled, either through a recruitment freeze or natural attrition. All told, Cathay is reducing about 8,500 jobs across the company, accounting for about 24% of its headcount.

    “We have taken every possible action to avoid job losses up to this point,” said Cathay Pacific Group CEO Augustus Tang in a statement. He said the airline has scaled back capacity, deferred new aircraft deliveries, frozen recruitment and cut executive pay, among other measures.
    Even so, Tang said the company continues to burn as much as 2 billion Hong Kong dollars ($258 million) per month. Wednesday’s changes will reduce the company’s cash burn by about 500 million Hong Kong dollars ($65 million) per month, he added.

    Cathay Pacific stock jumped 4% Wednesday in Hong Kong after the news.
    Like other major airlines, Cathay Pacific has taken drastic steps to shore up its business this year. Earlier this summer, the Hong Kong government agreed to lead a $5 billion bailout of the airline, taking a minority stake.
    Cathay said this week it expects to operate approximately 10% of pre-pandemic passenger flight capacity for the rest of 2020, and under 50% for 2021.
    A lack of consumer confidence, the drop in business travel, and fresh coronavirus spikes in the United States, Europe and elsewhere continue to weigh heavily on global air travel.

      The International Air Transport Association, which represents some 290 airlines, said last week that it estimates airline revenues this year will be down at least 50% ($419 billion compared to $838 billion in 2019). The trade group urged governments to use Covid-19 testing to safely re-open borders and called for more financial support “to prevent the systemic collapse of the aviation industry,” IATA said in a statement last week.
      — Sherisse Pham contributed to this report.
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      A 'blue wave' in U.S. elections could bring forward Fed rate hikes, says Morgan Stanley

      • A Democratic sweep in the coming U.S. elections will likely unleash more fiscal stimulus, said Jim Caron, a fixed income portfolio manager at Morgan Stanley Investment Management.
      • That could boost U.S. growth prospects beyond 2021, but could also cause the Federal Reserve to hike interest rates earlier than expected, said Caron.
      • Caron warned that a "blue wave" might not be all good for the U.S. economy.

      A Democratic sweep in the coming U.S. elections will likely unleash more fiscal stimulus, but it could also cause the Federal Reserve to hike interest rates earlier than expected, said a Morgan Stanley portfolio manager.

      The first rate hike by the Fed could be brought forward from around 2024-2025 to 2023-2024 — depending on how other policies, such as taxation, turn out in the event of a "blue wave," said Jim Caron, a senior member of Morgan Stanley Investment Management's global fixed income team.

      A "blue wave" refers to an election outcome where Joe Biden defeats Donald Trump in the presidential race, and Democrats win a majority in both chambers of Congress.   

      Caron told CNBC's "Squawk Box Asia" on Wednesday that the U.S. economy, under pressure from the coronavirus pandemic this year, was already expected to rebound in 2021. Additional stimulus that's likely to come with a "blue wave" would boost that growth potential further, he added.

      "That means the growth impact could go into not just 2021, but also 2022," he said.

      "The effect that this has though — that we need to be wary of — is that this could bring the first rate hike, nobody wants to talk about rate hikes right now, but this could bring the first rate hike by the Fed in from 2024 to 2025 to maybe 2023 to 2024," he explained.

      The Fed has maintained its policy rate near zero since March and indicated that rates could stay at that level through 2023. That has kept Treasury yields low, even though they rose on Tuesday on a potential stimulus package ahead of the November elections.

      But Caron warned that a Democratic win in the November elections might not be all good for the U.S. economy. He said there could be "more questions than answers" on issues such as the Democrats' tax policy and their approach toward regulation, which could create uncertainties.

      Many investors fear that a Biden win could result in higher taxes and tighter regulations — which could lead to lower corporate profits and less economic growth.

      "I think the markets are being a little bit complacent about, just thinking that: 'Well on Nov. 3, the day of the election, we're going to get all the answers and everything's going to be great going forward'," said Caron.

      "I actually think there's going to be more questions than answers after the election than there is right now."

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      LLY Pauses COVID-19 Antibody Trial, JNJ Boosts Annual Outlook, Double Whammy For GOSS

      Today’s Daily Dose brings you news about Lilly temporarily halting phase III trial of COVID-19 antibody, Gossamer Bio’s oral GB001 flunking in both asthma and chronic rhinosinusitis trials, encouraging data from Regeneron/Sanofi’s Dupixent trial, and Johnson & Johnson’s rosy outlook.

      Read on…

      1. Lilly Pauses Phase III trial of COVID-19 Antibody

      A phase III trial evaluating Eli Lilly and Co.’s (LLY) investigational monoclonal antibody LY-CoV555 in combination with standard of care Gilead SciencesInc.’s (GILD) Remdesivir in hospitalized COVID-19 patients has been paused due to a potential safety concern, according to reports.

      Launched in August, the phase III study, dubbed ACTIV-3, was initially designed to enroll about 300 volunteers who have been hospitalized with mild to moderate COVID-19 and is led by the National Institutes of Health.

      Another NIH-led phase III study of LY-CoV555, dubbed ACTIV-2, is ongoing in patients with mild to moderate symptoms of COVID-19 who have not been hospitalized.

      Last week, Lilly had submitted an initial request for emergency use authorization for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19 based on data from an interim analysis of another trial, dubbed BLAZE-1, which is a phase II study.

      It is not known whether the pausing of the ACTIV-3 study will impact the other ongoing LY-CoV555 trials.

      On Monday, Johnson & Johnson (JNJ) announced that it is temporarily suspending a phase III study of its COVID-19 vaccine candidate, JNJ-78436735, due to an unexplained illness in a study participant.

      In September, AstraZeneca plc’s (AZN) phase III trial of COVID-19 vaccine candidate, AZD1222, which was underway in the U.S., UK, Brazil, South Africa, and other countries, was put on hold over a safety issue. While the phase III trial has resumed in other countries now, it continues to remain on hold in the U.S.

      LLY closed Tuesday’s trading at $150.08, down 2.85%.

      2. Double Whammy for Gossamer as GB001 Fails In Two Trials

      Shares of Gossamer Bio Inc. (GOSS) plunged more than 25% on Tuesday, following disappointing data from its phase II trials of oral GB001 in asthma and chronic rhinosinusitis.

      In a phase IIb trial of oral GB001 in patients with moderate-to-severe eosinophilic asthma, dubbed LEDA, the primary endpoint of asthma worsening was not met. However, statistically significant improvements in the secondary endpoint of time to first asthma worsening compared to placebo were observed.

      The company noted that it will discuss its findings related to oral GB001 in asthma with global regulatory authorities and continue discussions with potential strategic partners.

      In a phase IIa trial of oral GB001 in patients with chronic rhinosinusitis with and without nasal polyps, dubbed TITAN, the primary endpoint of change from baseline in *SNOT-22 score at Week 16, and the secondary endpoint of change from baseline to Week 16 in nasal polyp score were not met. (*SNOT-22 or Sino-Nasal Outcome Test is a validated questionnaire that assesses patients with chronic rhinosinusitis).

      The company has decided not to pursue the development of GB001 in chronic rhinosinusitis.

      GOSS closed Tuesday’s trading at $10.09, down 25.75%.

      3. JNJ Boosts Annual Outlook

      Johnson & Johnson (JNJ), which reported better-than-expected third-quarter financial results on Tuesday, has boosted its outlook for full-year 2020.

      On an adjusted basis, net earnings for the third quarter of 2020 rose to $5.87 billion or $2.20 per share from $5.67 billion or $2.12 per share in the year-ago quarter. On average, Wall Street analysts expected earnings of $1.98 per share.

      Sales for the recent third quarter were $21.08 billion compared to $20.73 billion in the same quarter last year and well above analysts’ consensus estimate of $20.20 billion.

      Looking ahead, the company now expects operational sales to range between $82.0 billion and $82.8 billion, up from its prior forecast range of $81.0 billion and $82.5 billion. The consensus estimate for sales predicted by Wall Street analysts for the year is $81.03 billion.

      JNJ closed Tuesday’s trading at $148.36, down 2.29%.

      4. Regeneron/Sanofi’s Cash Cow Dupixent Does It Again!

      Regeneron Pharmaceuticals Inc. (REGN) and Sanofi’s (SNY) pivotal phase III trial of Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma has met its primary and all key secondary endpoints.

      Despite standard-of-care therapy such as inhaled corticosteroids, children with uncontrolled moderate-to-severe asthma are said to be at risk of severe asthma attacks and this often leads to frequent hospitalizations and emergency room visits.

      In the phase III trial, dubbed LIBERTY ASTHMA VOYAGE, Dupixent significantly reduced severe asthma attacks by up to 65% over one year compared to placebo. In addition, the drug was associated with a significant and rapid improvement in lung function within two weeks and it was sustained for up to 52 weeks.

      Commenting on the trial results, John Reed, Global Head of Research and Development at Sanofi, said, “Dupixent is the only biologic shown in a controlled Phase 3 trial to improve lung function in children, which is generally consistent with results seen in the adolescent and adult trials”.

      The companies are planning to make U.S. and EU regulatory submissions, seeking approval for Dupixent for children aged 6-11 years with uncontrolled moderate-to-severe asthma, by the first quarter of 2021.

      Dupixent is already approved for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis, as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older and as an add-on maintenance treatment in adult patients with chronic rhinosinusitis with nasal polyposis.

      The drug recorded annual sales of $2.32 billion in 2019. SVB Leerink analyst Geoffrey Porges expects Dupixent to bring in sales of $3.86 billion in 2020.

      REGN closed Tuesday’s trading at $607.98, up 1.07%.

      5. Stocks That Moved On No News

      Aethlon Medical Inc. (AEMD) closed Tuesday’s trading at $1.97, up 33.11%.

      SOS Limited (SOS) closed Tuesday’s trading at $2.69, up 27.49%.

      BiondVax Pharmaceuticals Ltd. (BVXV) closed Tuesday’s trading at $40.79, up 19.90%.

      Liquidia Technologies, Inc. (LQDA) closed Tuesday’s trading at $4.08, down 29.53%.

      Avenue Therapeutics Inc. (ATXI) closed Tuesday’s trading at $3.87, down 14.57%.

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