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Pfizer and BioNTech Coronavirus Vaccine Accepted for Rolling Review in Canada – Motley Fool

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The coronavirus vaccine candidate being developed by Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) is now undergoing its first regulatory review in North America. The two companies announced that their BNT162b2 has been accepted for a rolling review by Health Canada, that country’s healthcare regulatory authority.

A rolling review is one undertaken while a candidate is still in development; this is done in cases of urgent need, as with the current global pandemic.

Image source: Getty Images.

No estimate was provided as to when Health Canada might complete its review; the two companies wrote that the regulator “will not make a decision on whether to authorize any vaccine being considered under rolling review until it has received the necessary evidence to support its safety, efficacy and quality.”

BNT162b2 is currently in phase 3 clinical trials, having reached that stage relatively quickly. As such, it is considered by many observers and pundits to be the leading COVID-19 vaccine candidate for approval.

According to Pfizer and BioNTech, around 37,000 participants have been enrolled in more than 120 testing sites around the world in the trials. Twenty-eight thousand of those patients have received the second dose of the two-dose vaccination.

Meanwhile, Pfizer and BioNTech continue to get their ducks in a row regarding the manufacture and distribution of BNT162b2 should it be approved for use. On Monday, the pair said they’ve signed an agreement to supply 1.5 million doses to New Zealand. The financial terms of the deal were not specified.

In mid-afternoon trading Monday, Pfizer’s shares were up by 0.3%, lagging the gains of the S&P 500 index. BioNTech’s stock was down marginally.

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Goldman Sachs agrees to largest penalty ever in 1MDB scandal – Times of India

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NEW YORK: Global financial titan Goldman Sachs agreed to pay $2.9 billion in penalties to settle criminal charges in the 1MDB Malaysian bribery scandal, the largest US fine ever in a corruption case, the Justice Department announced Thursday.
Acting US Assistant Attorney General Brian C. Rabbitt said Goldman “accepted responsibility” in the case that involved $1.6 billion in bribes, the largest ever recorded, and massive gains laundered through the US financial system.
Goldman Sachs helped raise $6.5 billion for the Malaysian government’s sovereign wealth fund. The US Justice Department has said more than $4.5 billion was stolen from 1MDB by high-level officials at the fund and their associates between 2009 and 2015.
The investment fund “was looted by corrupt officials and their co-conspirators, including senior Goldman bankers” turning it “into a piggy bank for corrupt public officials and their cronies,” Rabbitt said at a press briefing.
In a first for Goldman Sachs, the company’s Malaysian unit pleaded guilty in a US court Thursday for violations of American bribery law as part of a deal to end the criminal probe in the sweeping case that involved authorities in nine countries.
The guilty plea could curtail activities of Goldman Sachs Malaysia but allows the parent company to avoid admitting wrongdoing in court — which would have damaged its ability to do business.
The parent company pleaded not guilty in US court and agreed to “deferred prosecution” for three-and-a-half years, during which time the firm will face increased monitoring by regulators.
But Rabbitt stressed that despite the deal, the company has been charged in the bribery scandal, “so there has been a significant amount of criminal liability” for Goldman and “imposes meaningful consequences” in the cases.
The Justice Department has charged three individuals in the case including two former Goldman executives. Tim Leissner, the former Southeast Asia Chairman, has pleaded guilty, while Ng Chong Hwa, also known as “Roger Ng,” former head of investment banking for GS Malaysia, is awaiting trial, and Low Taek Jho remains a fugitive.
“Goldman admitted today that, in order to effectuate the scheme, Leissner, Ng, Employee 1, and others conspired with Low Taek Jho” to pay the bribes and ignored red flags, the statement said.
In another stunning turn, the company said it will demand repayment of $174 million in salary and bonuses paid to current and former executives including Chief Executive David Solomon and his predecessor Lloyd Blankfein.
These so-called clawbacks are almost unheard of in corporate cases.
Solomon said in a statement “it is abundantly clear that certain former employees broke the law, lied to our colleagues and circumvented firm controls,” adding, “we recognize that we did not adequately address red flags.”
Included in the total penalty amount, Goldman will pay a $400 fine to the SEC and repay $600 million in earnings, and pay a $154 million fine to the Federal Reserve, which also will require the company to improve its risk management and internal oversight.
The Malaysian government dropped the charges against Goldman in July after reaching a $3.9 billion settlement with the financial giant.
The firm, which posted profits of $3.5 billion in the latest quarter, had set aside more than $3.1 billion as of September 30 “for litigation and regulatory proceedings.”
Goldman shares closed US trading 1.2 percent higher after settling the uncertainty.

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Goldman Sachs Agrees To Largest Penalty Ever Of $2.9 Billion In 1MDB Scandal – NDTV

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Goldman Sachs helped raise $6.5 billion for the Malaysian government’s sovereign wealth fund

New York:

Global financial titan Goldman Sachs agreed to pay $2.9 billion in penalties to settle criminal charges in the 1MDB Malaysian bribery scandal, the largest US fine ever in a corruption case, the Justice Department announced Thursday.

Acting US Assistant Attorney General Brian C. Rabbitt said Goldman “accepted responsibility” in the case that involved $1.6 billion in bribes, the largest ever recorded, and massive gains laundered through the US financial system.

Goldman Sachs helped raise $6.5 billion for the Malaysian government’s sovereign wealth fund. The US Justice Department has said more than $4.5 billion was stolen from 1MDB by high-level officials at the fund and their associates between 2009 and 2015.

The investment fund “was looted by corrupt officials and their co-conspirators, including senior Goldman bankers” turning it “into a piggy bank for corrupt public officials and their cronies,” Rabbitt said at a press briefing.

In a first for Goldman Sachs, the company’s Malaysian unit pleaded guilty in a US court Thursday for violations of American bribery law as part of a deal to end the criminal probe in the sweeping case that involved authorities in nine countries.

The guilty plea could curtail activities of Goldman Sachs Malaysia but allows the parent company to avoid admitting wrongdoing in court — which would have damaged its ability to do business.

“Meaningful consequences”

The parent company pleaded not guilty in US court and agreed to “deferred prosecution” for three-and-a-half years, during which time the firm will face increased monitoring by regulators.

But Rabbitt stressed that despite the deal, the company has been charged in the bribery scandal, “so there has been a significant amount of criminal liability” for Goldman and “imposes meaningful consequences” in the cases.

The Justice Department has charged three individuals in the case including two former Goldman executives. Tim Leissner, the former Southeast Asia Chairman, has pleaded guilty, while Ng Chong Hwa, also known as “Roger Ng,” former head of investment banking for GS Malaysia, is awaiting trial, and Low Taek Jho remains a fugitive.

“Goldman admitted today that, in order to effectuate the scheme, Leissner, Ng, Employee 1, and others conspired with Low Taek Jho” to pay the bribes and ignored red flags, the statement said.

In another stunning turn, the company said it will demand repayment of $174 million in salary and bonuses paid to current and former executives including Chief Executive David Solomon and his predecessor Lloyd Blankfein.

These so-called clawbacks are almost unheard of in corporate cases.

Solomon said in a statement “it is abundantly clear that certain former employees broke the law, lied to our colleagues and circumvented firm controls,” adding, “we recognize that we did not adequately address red flags.”

Included in the total penalty amount, Goldman will pay a $400 fine to the SEC and repay $600 million in earnings, and pay a $154 million fine to the Federal Reserve, which also will require the company to improve its risk management and internal oversight.

The Malaysian government dropped the charges against Goldman in July after reaching a $3.9 billion settlement with the financial giant.

The firm, which posted profits of $3.5 billion in the latest quarter, had set aside more than $3.1 billion as of September 30 “for litigation and regulatory proceedings.”

Goldman shares closed US trading 1.2 percent higher after settling the uncertainty.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

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Moderna gets 30000 patients for final stage of vaccine trial – BNN

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Moderna Inc. has completed enrollment of its 30,000 participants in its final-stage COVID-19 trial, while more than 25,000 volunteers have received their second shot.

The announcement on Thursday is another indication that vaccine trials are moving into their home stretch. Moderna has said it could get an initial readout on whether the vaccine works by late November. The drugmaker is only slightly behind Pfizer Inc., which is working with German biotech BioNTech SE and expects results from its 44,000-person trial as soon as the end of this month.

Moderna shares rose as much as 4.4 per cent on Thursday morning in New York. This year, the stock has more than tripled in value.

Moderna had slowed trial enrollment in September in order to recruit more minorities, a key goal of U.S. health officials. Overall, 37 per cent of volunteers in the trial come from communities of color, the company said. Also, 42 per cent of are at high risk of developing severe cases of Covid-19, either because they are 65 or older or have pre-existing conditions.

Both Moderna and Pfizer say they won’t submit for an emergency-use authorization until they have collected two months of safety data on the participants. That means that even if Pfizer gets positive initial results this month, it won’t submit for an emergency authorization until after it gets the safety results in the third week of November.

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