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Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug

A sign for the Food and Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.

Sarah Silbiger | Getty Images

A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has learned.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.

“At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.

He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”

Shares of Biogen surged 38% Monday after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

The agency’s decision was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At the time, the panel also criticized agency staff for what it called an overly positive review of the data.

This is a developing story. Please check back for updates.

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World News

China sanctions U.S. spiritual freedom officers, Canadian member of parliament

China sanctions U.S. religious freedom officials, Canadian member of parliament

A masked protester holds a US flag during a protest against China’s human rights violations against Uyghur Muslims in Xinjiang Province and calls on the US government to crack down on Beijing on April 6, 2019 in Washington, USA.

Yasin Ozturk | Anadolu Agency | Getty Images

China has imposed sanctions on two US religious rights officials, a Canadian MP and a subcommittee on human rights, in Canada’s lower house, according to a statement released by the Chinese State Department on Saturday.

The sanctions are the latest escalation in a growing dispute between Western nations and Beijing over the treatment of ethnic and religious minorities in China, particularly in Xinjiang Province.

The Chinese sanctions target the chairman and vice chairman of the US Commission on International Religious Freedom, Gayle Manchin and Tony Perkins. USCIRF has condemned China’s treatment of the Uyghur Muslim population in Xinjiang and approved recent US sanctions against Chinese officials.

Beijing also targeted Canadian MP Michael Chong, who is vice chairman of the House of Common’s Foreign Affairs Committee. The Foreign Affairs Subcommittee on International Human Rights was also sanctioned.

The House of Common Foreign Affairs Committee released a report earlier this month based on meetings of the subcommittee that concluded that human rights violations against Uighur Muslims in China constitute crimes against humanity and genocide.

Chinese sanctions prohibit officials from entering mainland China, Hong Kong, and Macau, and prohibit Chinese citizens and institutions from doing business with the officials and interacting with the Human Rights Subcommittee.

The sanctions are in response to penalties imposed by the US on two Chinese officials earlier this week. The government of Biden said it imposed these sanctions in response to human rights violations against Uighur Muslims.

The US sanctions were directed against China’s Wang Junzheng, secretary of the Xinjiang Production and Construction Corps Party Committee, and Chen Mingguo, director of the Xinjiang Public Security Bureau.

The two officials were targeted for their links to “arbitrary detention and aggravated physical abuse, among other serious human rights violations against Uyghurs,” the Treasury Department said in a statement Monday.

Canada also imposed sanctions on Chinese officials for treating Uyghurs.

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Business

J&J board member says 20 million Covid vaccine doses might be delivered by the tip of March

These are the most common side effects from J&J's

According to Dr. Johnson & Johnson board member Mark McClellan expects the company to have 20 million doses by the end of March as the US is just one step away from adding a third safe and effective vaccine to its arsenal.

“There will be a ramp-up, so 4 million doses are expected next week, rising in March, with 20 million doses dispensed by the end of March,” the former FDA commissioner said in an interview Friday night on The News with Shepard Smith. ” “So that’s 20 million people who are fully vaccinated because it’s just one dose of the vaccine.”

A panel of advisors to the Food and Drug Administration unanimously voted late Friday to recommend Johnson & Johnson’s single-dose shot for approval for emergency use. The FDA will decide on Saturday whether the vaccine will be approved. A recommendation from advisors to the Centers for Disease Control and Prevention would enable three to four million doses to be delivered next week.

McClellan told The News with Shepard Smith that the addition of the J&J vaccine will take the US a big step forward in fighting the coronavirus pandemic and protecting millions of people from the virus.

“That comes on top of some additions to the Pfizer and Moderna vaccine offering. They expect almost 90 million, 100 million doses … it’s a two-dose vaccine, but it all adds up to that we can get this far. ” At least 100 million people here in the US had been vaccinated by the end of March, “said McClellan, a health policy expert at Duke University.

Nationwide, average daily cases, hospitalizations and deaths have been going down for weeks, but Rochelle Walensky, director of the Centers for Disease Control and Prevention, said recent declines could flatten out.

“We may be through with the virus, but the virus clearly isn’t through with us,” Walensky said. “We cannot take it easy or give in to a false sense of security that the worst pandemic is behind us. Not now, not when mass vaccination is so close.”

The CDC director added that we may begin to see the effects of the new, contagious variants of Covid that are spreading across the country. McClellan agreed with Walensky, warning that “we should be concerned” when it comes to the new variants, but doubled the importance of vaccinations.

“The good news is that the vaccines offer really strong protection against the variants. The best way to contain the variants is to get as many people as possible vaccinated as soon as possible,” said McClellan.

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Politics

Republican Rep. Ron Wright of Texas is first sitting member of Congress to die of Covid

Republican Rep. Ron Wright of Texas is first sitting member of Congress to die of Covid

Elected Ron Wright, R-Texas Rep. Participates in a welcome meeting for new members at the Capitol Visitor Center on November 15, 2018.

Tom Williams | CQ Appeal, Inc. | Getty Images

Texas Republican MP Ron Wright died weeks after contracting Covid-19, his office said Monday. He was 67 years old.

Wright, who took office in 2019, died on Sunday. He had undergone treatment for lung cancer after it was diagnosed in 2018.

He and his wife Susan were hospitalized in Dallas for two weeks before the Congressman died fighting the disease. The congressman, whose Arlington district was a part, announced that he tested positive for Covid-19 on Jan. 21.

“As friends, family and many of his constituents will know, Ron kept his quick wit and optimism to the end,” said Wright’s office. “Despite years of painful, sometimes debilitating cancer treatment, Ron never lacked the desire to get up and go to work, motivate those around him, or give fatherly advice.”

Wright is the first seated member of Congress to die after contracting Covid. Luke Letlow, a Louisiana Republican who was elected to the House of Representatives in November, died of complications from Covid-19 a month later before taking office.

According to GovTrack, at least 71 officials and senators have been diagnosed with Covid. Nationwide, more than 27 million people have contracted the disease and killed more than 463,000 Americans.

Texas will eventually hold a special election to elect Wright’s successor in the Texas 6th Ward, which is in Tarrant County outside of Dallas.

Wright’s death means Democrats now have an 11-seat advantage in the house. There are four vacancies in the 435-person home, including Letlow’s 5th Ward in Louisiana.

Wright’s final vote was against the charges against former President Donald Trump for provoking the January 6 uprising in the U.S. Capitol, the House employee said. He also voted to object to the election count in Pennsylvania and Arizona last month.

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Health

J&J plans to have 100 million vaccines for Individuals by spring, board member says

J&J plans to have 100 million vaccines for Americans by spring, board member says

Dr. Johnson & Johnson board member Mark McClellan told CNBC that “if the clinical trial works,” the company could significantly increase the availability of Covid vaccines in the coming weeks.

“I know J&J has a very large supply with its production both here in the US and elsewhere in the world, with the goal of maybe having enough vaccines for 100 million Americans by spring or April So,” said the former FDA commissioner in a Thursday evening interview on “The News with Shepard Smith”.

During a speech at the White House Thursday, government lead infectious disease doctor Anthony Fauci said Johnson & Johnson would have enough data on its vaccine to start analysis within a week or two. McClellan told host Shepard Smith that the most important thing about the company’s vaccine is the large-scale clinical trial that is ongoing.

“Based on these results, the independent scientists overseeing this study should take a closer look in the near future and we’ll see how quickly the vaccine could advance,” McClellan said.

According to the Centers for Disease Control and Prevention, an average of 883,000 syringes of the Covid vaccine are given per day in the US for the past six days. Even so, less than 50% of the 37,960,000 cans distributed have found their way into people’s arms.

At least 12 states have reported vaccine shortages. Officials from San Francisco and New York warned they could be completely out of dose this week. At least 15 vaccination sites in New York City are temporarily closed. New York Mayor Bill DeBlasio told NBC’s Gabe Gutierrez that at least 23,000 vaccine appointments must be postponed.

McClellan noted that “the supply will go up, but probably not enough to keep up with the large number of Americans who are now really looking to get vaccinated.” However, he told Smith that he believes the Biden administration can help speed up the vaccine adoption rate.

“It’s going to be a challenge, but I think more than 100 million Americans can be vaccinated in the next few months,” said McClellan, a health policy expert at Duke University.

President Joe Biden promised a “full war effort” to fight the coronavirus pandemic and accelerate vaccine production using the Defense Production Act during a briefing Thursday.

“We have already identified suppliers and are working with them to move the plan forward,” said Biden.

He added that the DPA would help fix supply chain issues, including a shortage of syringes.

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Business

U.S. to stay a WHO member and be part of Covid vaccine plan

U.S. to remain a WHO member and join Covid vaccine plan

Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases.

Patrick Semansky | Bloomberg | Getty Images

The US will remain a member of the World Health Organization under President Joe Biden, said Dr. Anthony Fauci on Thursday and intends to join a global alliance that aims to deliver coronavirus vaccines to low-income countries.

One day after Biden took office, US Chief Medical Officer Fauci spoke to the WHO Executive Board via videoconference from Washington: “President Biden will later today issue a directive stating the United States’ intention to join COVAX and support ACT. ” – Accelerators to advance multilateral efforts for Covid-19 vaccine distribution, therapeutic and diagnostic distribution, equitable access, and research and development. “

The US will remain a member of WHO, the United Nations health agency, and “meet its financial commitments,” said Fauci. He added that Biden’s government plans to work with the other 193 member states to help reform the group.

“This is a good day for WHO and a good day for global health,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus.

“We’re all happy that the United States is staying with the family,” Tedros said on Twitter.

WHO delegates “warmly” welcomed the decision, and many underlined their appreciation that the new government would now attempt to reunite with the international aid group in the face of the ongoing coronavirus pandemic.

Fauci, America’s foremost infectious disease expert, accepted Biden’s offer to join his administration and serve as chief medical officer last month. He will lead a US delegation to WHO’s annual meetings during the week.

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Politics

Senate confirms Avril Haines, first Biden Cupboard member

Senate confirms Avril Haines, first Biden Cabinet member

Avril Haines speaks during her confirmation hearing before the Senate Intelligence Committee that she will be President-elect Joe Biden’s National Intelligence Directorate on January 19, 2021 in Washington, DC.

Joe Raedle | Pool | Reuters

WASHINGTON – The Senate confirmed Avril Haines as director of national intelligence on Wednesday evening, making her the first official member of President Joe Biden’s cabinet.

Before the evening was adjourned, the Senate voted 84-10 on Haines’ confirmation.

Haines, Biden’s election to head the nation’s 18 intelligence agencies, is the first woman to hold the position.

“Our opponents will not stand by and wait for the new government to fill critical positions, and I am pleased that my Senate colleagues, together with me, have quickly confirmed Director Haines for this important post,” said Senator Marco Rubio, R-Fla., Vice chairman of the Senate Select Committee on Intelligence, wrote in a statement.

“Avril Haines was the right choice for the director of the National Intelligence Service,” wrote Senate Majority Leader Chuck Schumer, DN.Y., in a statement Wednesday evening. “We appreciate the bipartisan collaboration to be confirmed tonight and we hope there will be much more of it as the nation is in crisis and we need to deploy President Biden’s team as soon as possible,” he added.

White House press secretary Jen Psaki said in her first briefing Wednesday night that the gathering was of paramount importance to Biden’s cabinet and his national security team.

On Tuesday, Haines told the Senate Intelligence Committee, which had voted on her nomination, that one of her main initiatives would be to build trust in the country’s intelligence services.

“The DNI must never shrink from telling the truth to power – even if it can be impractical or difficult,” said Haines. “The DNI must insist that when it comes to intelligence, there is simply no place for politics – never.”

Susan Rice (left), Avril Haines and Lisa Monaco with President Barack Obama in December 2015.

Pete Souza | The White House | Wikipedia

Prior to joining the Biden administration, Haines was deputy national security adviser to former President Barack Obama.

Previously, she was also the CIA deputy director. She is the first woman to hold both positions.

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World News

RBI financial coverage committee member on inflation, development

RBI monetary policy committee member on inflation, growth

SINGAPORE – Inflationary pressures and the state of economic recovery will guide future policy moves by the Reserve Bank of India, a member of the bank’s monetary policy committee told CNBC.

In her personal capacity, Ashima Goyal, who is also an economics professor at India’s Indira Gandhi Development Institute, said the RBI’s monetary policy committee “is concerned about inflation”.

According to local media reports, Goyal was appointed to the central bank’s monetary policy committee in October.

“Inflation has been above our target for the past few months, but it has been falling over the past month,” she said on CNBC’s Street Signs Asia on Wednesday.

“I think the reason for this is that the ongoing effects of the lockdown are generally less than expected,” Goyal said. She referred to India’s national lockdown between late March and May to slow the spread of the coronavirus, causing a collapse in private consumption and investment demand and forcing the economy into two consecutive quarters of contraction.

We believe that inflation will return to the target range.

Ashima Goyal

Member of the Monetary Policy Committee of the Reserve Bank of India

Economists were unimpressed by the government’s fiscal measures announced last year to revive growth. Some suggest it was up to the RBI to do the heavy lifting on short notice. The central bank has kept the key interest rate at which it grants commercial banks loans unchanged since May.

Inflation has remained well above the RBI’s target range of 2% to 6% in recent months. However, retail inflation fell to 6.93% in November as food prices fell, Reuters reported. Some economists expected inflation to continue easing in both December and early 2021.

“Due to inflationary pressures, the RBI has been on hold and has not cut rates after the initial cuts. They have been stable over the past few months,” said Goyal, adding: “We believe inflation will return to the target range. “” It did not provide a precise timetable for when inflation could fall below 6%.

When asked about future central bank interest rate movements, Goyal said the monetary policy committee would make “data-driven” decisions. “We are seeing what happens to inflation and how the recovery takes shape,” she added.

The World Bank recently forecast a recovery in Indian economic growth to 5.4% in 2021 but said “The recovery from a low base will be offset by subdued private investment growth amid weaknesses in the financial sector.”

A naval officer walks past the Reserve Bank of India (RBI) building in Mumbai, India on Tuesday, March 3, 2020.

Kanishka Sonthalia | Bloomberg | Getty Images

Citi economists said in a statement Monday that data suggests the government’s position is “less precarious” ahead of the 2022 budget submission on Feb.1. They said that while government spending on incentives subsided in areas such as agriculture and rural areas, spending by infrastructure-related ministries such as railways, road transport, water and housing has picked up.

While a compression in government spending weighed on the second quarter of India’s fiscal year 2021, which ends March 31, Citi economists said, “Spending trends in the (third quarter) support the recovery in growth.”

The government has also generated better-than-expected gross tax revenues in recent months, suggesting “a less challenging fiscal position,” the economists said.