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Health

FDA requires federal investigation into approval

Biogen shares fell on Friday after the head of the Food and Drug Administration called for an investigation into the recent approval of the company’s Alzheimer’s drug, Aduhelm.

Acting FDA Commissioner Dr. Janet Woodcock asked the Office of the Inspector General to investigate interactions between the US agency and Biogen representatives prior to the drug’s approval on June 7.

“I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” Woodcock wrote in a letter sent Friday.

Shares of Biogen fell by more than 3% after the announcement.

Biogen’s stock surged last month after the FDA approved the biotech company’s drug, the first medication cleared by US regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

That decision marked a departure from the advice of the agency’s independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At least three members of the panel have resigned in protest following the agency’s approval.

Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab. STAT News and other media outlets reported FDA officials used a regulatory shortcut to gain approval in order to get the drug on the market sooner.

Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.

It’s rare for an FDA chief to call for an investigation into the agency’s own decisions. It’s the latest setback for the company and the drug, which has been controversial since it showed promise in 2016.

In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the medication after all.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.

Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.

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Entertainment

Ballet Tech Names a New Inventive Director

Ballet Tech, the nonprofit group that brought ballet training to thousands of promising New York school children, has a new leader. The organization announced on Friday that the dancer Dionne D. Figgins will succeed its founder Eliot Feld as artistic director in August.

“We are delighted to have found in Dionne the ideal person to work with the staff, board of directors and the community of Ballet Tech to advance the fundamental ideas,” said Patricia Crown, chairwoman of the board of the Ballet Tech Foundation.

When the pandemic broke out, Figgins was preparing to appear in Miami in the musical “A Wonderful World” about Louis Armstrong. But when performances were canceled, she began teaching dance online at the Jones-Haywood School of Ballet in Washington. It was this experience that convinced her to move from the stage towards the studio and classroom.

“I was really inspired by the determination of my students,” she said. “I was inspired by how much they put into the room and it really made me realize that this is a room that I should be in all the time.”

Figgins began her career at the Dance Theater of Harlem, where she played leading roles in George Balanchine’s “Four Temperaments” and “Agon”, among others. She is also a Broadway actress and has appeared in several productions including “Motown: The Musical” and “Memphis”.

In 2012 she co-founded Broadway Serves with Dana Marie Ingraham and Kimberly Marable, a nonprofit dedicated to creating charitable opportunities for theater professionals.

Field, 78, shared his plans to retire last year, citing his desire to “pass the baton on to a new generation of leaders.” “I wish to wish my good hopes and goodwill to Dionne in completing the work that I have half done,” he said in a statement.

Part of this work is Feld’s goal of recruiting students from all of the city’s public elementary schools. Figgins said in an interview that “part of my mission is to get these other schools involved in what is happening at Ballet Tech so they at least know that this is an option.”

The educational initiative that resulted in Ballet Tech began in the late 1970s as an offshoot of Feld Ballet, the founder’s professional company. Public schoolchildren in grades 3 to 5 were invited to try it out and students who were gifted for dancing were able to continue their education in Feld’s studio near Union Square in Manhattan.

Ballet Tech, which founded its own public school for grades four through eight in 1996, estimates that in more than 40 years it has auditioned around 900,000 students and enrolled more than 20,000 in non-teaching classes.

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Health

15 States Attain a Deal With Purdue Pharma Over Opioids

At a press conference Thursday to announce the settlement, the Massachusetts, New York and Minnesota attorneys general pointedly noted that they had asked the Sacklers for years to admit guilt and apologize, but family members refused.

Government lawyers said that instead of spending years looking for more money to meet urgent needs created by the opioid epidemic, they agreed to step back in order to free funds faster.

New York Democrat Rep. Carolyn B. Maloney and California Democrat Mark DeSaulnier introduced a law they call the Sackler Act that would allow states to prosecute company owners in bankruptcy proceedings that the attorneys general are tracking down strongly support own statements. But even if Congress passed such a law, the attorneys general added, the Sacklers and Purdue would almost certainly have closed the case long ago and would have escaped the scope of the bill.

As such, Purdue will cease to exist as such and re-emerge as a new company that would manufacture limited quantities of OxyContin and overdose reversal drugs, according to the overall bankruptcy filing. It would be overseen by an appointed board of directors. The profits would feed payments to funds for distant plaintiffs that would primarily support drug treatment and prevention programs.

Lawyers involved in the negotiations underlined the importance of the public document archive, which can hardly be surpassed in its breadth and depth. Although Purdue has already produced 13 million documents during the litigation, it has now added 20 million more. The size of this one company’s documents rivals that uncovered by the entire tobacco industry, a coveted consequence of the Big Tobacco litigation some 20 years ago.

The Purdue documents will contain statements, emails, and letters that go back two decades. They are expected to reveal detailed details of Purdue’s behind-the-scenes contacts with federal investigators and Food and Drug Administration officials as the company fended off tougher penalties for promoting turbo sales that touted OxyContin as effective and non-addictive. Experts assume that the considerations and mandates of Dr. Richard Sackler, a former President and CEO of Purdue.

In Thursday’s briefing, Maura Healey, the Massachusetts attorney general who was the first to suing Sacklers, said the document pool served as a promise to the families of opioid victims. “It will tell the whole story, all of the conversations, all of the discussions, all of the planning, all of the ways they make money and evade accountability and regulation,” she said.

Categories
Politics

Biden presses Putin to disrupt cybercriminals in Russia

United States President Joe Biden speaks before signing an executive order in the State Dining Room of the White House in Washington, DC, the United States, on Friday, July 9, 2021.

Alex Edelmann | Bloomberg | Getty Images

WASHINGTON – President Joe Biden in a phone call Friday morning urged Russian President Vladimir Putin to take action to contain recent ransomware attacks by groups based in Russia.

“I made it very clear [Putin] that when a ransomware operation comes off its soil despite not being state sponsored, the United States expects that if we give them enough information to act who it is, we expect them to act said Biden at the White House on Friday afternoon.

When asked by a reporter whether there would be “consequences” for such attacks, Biden replied, “Yes”.

The US and Russia, according to the President, have “now regularly set up a means of communication in order to be able to communicate with each other when each of us thinks that something is happening in another country that affects our home country”.

Overall, the call “went well, I’m optimistic,” said Biden.

The conversation came just days after a massive new cyber attack by the REvil group believed to be based in Russia.

The hacking gang is demanding $ 70 million in cryptocurrency to unlock data from the attack that spread to hundreds of small and medium-sized businesses in a dozen countries.

A senior government official said Friday that the United States will take “action” to respond to the attack.

“We will not telegraph what exactly these actions will be. Some will be obvious and visible, others may not, but we expect these to take place in the coming days and weeks,” said the official, who asked for anonymity discuss sensitive negotiations.

The official spoke just moments after Biden, who boarded Air Force One en route to Delaware, was asked if it made sense for the United States to attack the actual servers that are hosting ransomware attacks. Biden replied, “Yes.”

The latest REvil attack is part of a series of serious ransomware attacks carried out by groups originating in Russia this spring and summer.

In May, REvil targeted JBS, the world’s largest meat supplier. The company eventually paid a $ 11 million ransom, but not before it temporarily ceased all of its U.S. operations.

Earlier that month, another cybercriminal targeted the operator of the country’s largest gas pipeline, the Colonial Pipeline. The attack forced the company to shut down a pipeline roughly 5,500 miles long, cutting fuel supplies to the east coast of almost half.

As of early Friday afternoon, the Kremlin had not yet published its own reading of the Biden Putin appeal, so it is unclear how the Russian president reacted to Biden’s pressure.

White House press secretary Jen Psaki told reporters Friday the United States had no new information suggesting the Russian government was directly responsible for the attacks.

Putin has always denied any involvement or direct knowledge of ransomware attacks from Russia.

However, US officials say the idea that Putin does not know who these attackers are is not credible as he has a tight grip on Russia’s intelligence services and its more opaque network of contractors.

In June, Biden met personally with Putin in Geneva, where he warned the Russian President to crack down on cyberattacks from Russia.

US President Joe Biden gestures at a press conference after the US-Russia Summit with Russia’s President Vladimir Putin on June 16, 2021 in Geneva, Switzerland.

Kevin Lamarque | Reuters

There, Biden said he presented Putin with a list of critical infrastructures in the United States that, if attacked by Russia-based cybercriminals, would pose a serious national security threat to the United States

“Certain critical infrastructures should be closed to attacks, cyber or other means,” said Biden after the meeting. “I gave them a list, 16 specific entities that are defined as critical infrastructure under US policy, from the energy sector to water systems.”

“So we agreed to hire experts in our two countries to work on specific agreements on what is forbidden and investigate specific cases that come from other countries or from one of our countries,” he said.

By identifying critical infrastructure as locked down, Biden also circled targets that, if attacked by state or non-state actors, would likely deserve a government response.

The White House has so far declined to detail the retaliatory measures taken by the United States in several recent attacks against the cybercriminals themselves on the grounds that such information must remain confidential.

During the phone call on Friday, Putin and Biden also praised their teams’ joint work after the meeting in Geneva, the White House said.

This work led to an important vote in the UN Security Council on Friday to resume the delivery of humanitarian aid to Syria.

4:00 p.m. – This story has been updated to include President Joe Biden’s comments on the call, as well as remarks from a senior administrator.

– CNBC’s Kevin Breuninger contributed to this report.

Categories
World News

‘Mom, When Will You Come?’: The Covid Orphans of India

When Shawez, who had given up his studies to work with his father, returned home without his parents, the landlord had locked them out, saying he would give them the key only after the rent was paid. His uncle borrowed money to cover some of the debt so that Shawez and his siblings could collect their belongings.

Shawez’s younger sister, Kahkashan, 9, has been hit the hardest. Nearly every day, she picks up the phone and dials her mother, talking to her as if she were on the other end.

“Mother, when will you come? I miss you,” she says.

“My only dream is to educate my siblings,” Shawez said. “My mother would call me when I would be out for work and ask, ‘Son, it is getting late. When will you come home?’ Now no one will call me anymore,” he said.

In Pattapur, Sonali, too, feels as if she has lost her most powerful protector.

In a thick diary, on the page next to the one on which she has noted the dates of her parents’ deaths, Sonali jotted a poem dedicated to her mother.

On a recent day, she read it aloud to her siblings.

Undergoing the ups and downs of life, our mother brings us up.

Our mother is the tallest in this world, she is the one who can keep us well.

This world is barren without mother, this world is not the same place without her.

Mother bears the pain on our behalf, but we fail to bear the pain on mother’s behalf.

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Health

No proof a booster shot is required, says Dr. Ashish Jha

Covid booster doses are currently not required, said the dean of the School of Public Health at Brown University on Friday, as highly transmissible new variants test the protection of available vaccines.

“Let me tell you where we are: the data is very clear, if you got your two shots from Moderna or Pfizer or a single shot from J&J you have a very high level of protection against all variants, including Delta” said Dr. Ashish Jha. “I haven’t seen any evidence yet that anyone needs a third shot.”

Jha’s comments come after Pfizer and BioNTech announced Thursday that they are developing a Covid-19 booster shot that will target the Delta variant. Company officials say another vaccination may be needed as immunity to the vaccine appears to decline over time.

In CNBC’s The News with Shepard Smith, Jha emphasized the importance of waiting for the dates when it comes to a booster shot.

“When this evidence comes along, and of course we will want to take that into account, I think I think it is unlikely that we will need third shots for most people,” Jha said.

The Centers for Disease Control and Prevention and the Food and Drug Administration issued a joint statement stating that Americans who are fully vaccinated do not need a booster vaccination.

“Americans who have been fully vaccinated currently do not need a booster vaccination. FDA, CDC, and [the National Institutes of Health] are involved in a science-based, rigorous process to check if or when a refresher might be needed, “said a joint statement released Thursday evening.

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Health

The C.D.C. Points New College Steerage, With Emphasis on Full Reopening

In another shift, the C.D.C. made clear that masks could be optional for vaccinated people, in line with its recommendations for the general public.

Still, the agency said that schools may opt to require universal masking if local cases were rising, for example, or if a school could not determine how many of its students and staff members were vaccinated. And it urged schools to “be supportive of people who are fully vaccinated, but choose to continue to wear a mask.” In general, students and staff members did not need to be masked when outdoors, the agency said.

The C.D.C. also strongly urged schools to promote vaccination, which the guidance called “one of the most critical strategies to help schools safely resume full operations.” Studies suggest that vaccines remain effective against the Delta variant.

The country’s two major teachers’ unions, which have close relationships with the Biden administration, praised the guidance. Randi Weingarten, the president of the American Federation of Teachers, whose members in some cases fought the reopening of schools this past school year, said the recommendations are “grounded in both science and common sense.”

Still, both school and public health officials predicted challenges ahead.

Ms. Weingarten said the mask guidance posed a particular test, since classes with students 12 and older would most likely include a mix of vaccinated and unvaccinated students. Many officials in areas with low vaccination rates have already said they will not require masks in schools — and at least eight states have already banned such requirements.

Updated 

July 9, 2021, 6:08 p.m. ET

Some parents who have advocated school reopening greeted the new guidelines with relief. Meredith Dodson, whose son is entering kindergarten this fall in San Francisco, organized a group of parents who spent the last school year fighting for the city to open its schools. The city finally allowed elementary school students to return in mid-April, but most middle and high school students were not able to do so at all.

“This is a huge step in the right direction,” Ms. Dodson said.

Many schools have already largely or entirely returned to in-person learning. By mid-spring, the vast majority of districts had allowed at least younger students to return to classrooms, although many, especially on the West Coast, only allowed them to attend part-time. Many families — especially Asian American, Black and Hispanic families — chose to keep their children learning remotely.

Categories
Politics

Chief Guantánamo Prosecutor Retiring Earlier than Sept. 11 Trial Begins

WASHINGTON – The army general who led a decade of war crimes charges in Guantánamo Bay, Cuba, is retiring and turning the trial of the five men charged with conspiracy in the September 11, 2001 attacks on a not yet elected successor.

Brig. General Mark S. Martins of the Army served as chief prosecutor for military commissions across the Obama and Trump administrations.

His decision to step down came as a surprise as he had received an extension until January 1, 2023. Instead, he will retire on September 30th, according to a statement from a public prosecutor’s office, Karen V. Loftus, to the families of the nearly 3,000 people killed in the 9/11 attacks.

General Martins, a graduate of Harvard Law School at West Point, had served as the public face of the military commissions for many years. During his early years in office, he ran a public speaking campaign to promote the hybrid form of justice established by the Bush administration after the invasion of Afghanistan.

The Obama administration made some changes to the system and decided to pursue the 9/11 case against Khalid Shaikh Mohammed and four accused accomplices in Guantánamo rather than in federal court. A death penalty case that has sunk in pre-trial proceedings since the indictment in May 2011 as the sites deal, among other things, with issues relating to the torture of the defendants in CIA prisons prior to their 2006 transfer to Guantánamo Bay.

Although no military judge is currently assigned to the case, Pentagon officials are preparing for its first hearings since February 2020, due to take place in the first two weeks of September, coinciding with the 20th anniversary of the attack.

General Martins filed his annuity papers Wednesday after repeatedly arguing with lawyers from the Biden administration in Guantánamo court over positions of his office on applicable international law and the Convention against Torture, according to senior government officials who knew about the disputes. General Martins did not respond to a request for comment.

A major point of contention was General Martins’ recent decision to give a testimony to the CIA while tortured by a man accused of orchestrating the bombing of the USS Cole in 2000 while he was being tortured to speak to the military judge, who presided over this case to take a stand is also a death sentence. Defense lawyers for prisoner Abd al-Rahim al-Nashiri from Saudi Arabia are appealing the admissibility of this evidence.

On the same day that General Martins opted to retire, he filed a brief asking the U.S. Court of Justice to review the Military Commission for additional time to respond to the appeal.

“Has he been asked to resign or has he resigned in protest?” Said Navy Capt. Brian L. Mizer, Mr. Nashiri’s senior military defender. “I dont know.”

Ms. Loftus said General Martins had chosen to retire “in the best interests of the ongoing cases”. Military commission hearings are slated to resume next week for the first time since the pandemic began, in a case involving an Iraqi man accused of commanding armed forces that committed war crimes in Afghanistan in 2003 and 2004.

Ms. Loftus called the point in time “an ideal window for identifying a successor”, since proceedings “after the pandemic-related break are finally in sight for all of our cases”.

General Martins made an impressive figure in court with a height of six feet and a chest full of medals on his blue army uniform. As a former Rhodes Fellow, he had made it an important part of his job to meet and brief the families of the victims and to connect with some of them through social opportunities in Guantánamo Bay. In an effort to bring the 9/11 case to court, he had repeatedly received extensions of his term.

“My first thought is that only the defendants and family members will be left,” said Joel Shapiro, whose wife Sareve Dukat was killed in the World Trade Center and has since worked as a guide at the 9/11 Memorial & Museum in New York. “Almost everyone else involved in this case took the opportunity to get on with their lives.”

“I was shocked that Mark was stepping down,” said Adele Welty, whose firefighter son Timothy was killed on September 11th. “I thought he was very committed to pulling it off. But who can blame him? The whole Guantánamo enterprise is almost comical in its ridiculous turns – judge after judge step down, and now General Martins. “

Chief Defense Counsel, Brig. General John G. Baker of the Marines, will leave his post on November 1st. The process of replacing him with a new one-star military attorney – to put him on a par with General Martins – was already underway as a potential candidate.

Defense officials said a panel would likely be put together to select a new chief prosecutor who could match the rank of Army Colonel rather than a one-star general. In the meantime, Ms. Loftus said, General Martins’ civilian deputy, Michael J. O’Sullivan, will serve as assistant chief defender.

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Entertainment

The Ending of Worry Avenue Half 2: 1978, Defined

Fear Street Part 2: 1978 officially picks up where Fear Road Part 1: 1994 ends – or rather, it brings us back 16 years. The second installation of the Scared street The trilogy begins with Deena and Josh dragging a possessed Sam to C. Berman’s house to demand answers to the 300-year-old curse that is ravaging the town of Shadyside. Although C. Berman did not want to help the children at first, she finally tells the story of how she survived the bloody massacre at Camp Nightwing in 1978 Fear Street Part 2: 1978 end and pave the way for Fear Street Part 3: 1666? Let’s break down the main events in the second movie.

What happened at Camp Nightwing?

Most of the film takes place in 1978, when Ziggy Berman and her sister Cindy visit Camp Nightwing. (At first it might seem safe that the “C” in C. Berman stands for Cindy, but we’ll talk more about that later.) We find out early on who the camp killer is – it’s Tommy Slater, Cindy’s friend. While Cindy, Tommy, Alice and Alice’s friend Arnie sneak around the campsite at night, they end up in the house of Sarah Fier, the witch at the center of the Shadyside curse. Obsessed by Sarah, Tommy embarks on a series of murders with an ax and claims Arnie as his first victim. Then he goes to the main camp where Ziggy and the other campers are.

Cindy eventually escapes the witch’s house through the Mess Hall, where she finds Ziggy hiding from Tommy. Cindy kills Tommy just in time – at least she thinks. Soon after, Alice also makes her way back to camp with the hand of the witch who, if she is reunited with her body, is supposed to end the Shadyside curse. However, Ziggy accidentally bleeds his hand. This effectively causes Tommy and the other witch-possessed Shadyside killers to come back to life and hunt them down.

Does Ziggy die at Camp Nightwig?

Tommy kills Alice before she can take revenge on Arnie. After her death, the Bermans try to dig up Sarah Fier’s body from the Hanging Tree, but instead find a rock that says “The Witch Lives Forever”. Not long after, the resurrected Shadyside Killers seemingly murder the sisters. However, Ziggy miraculously makes it out alive after a young Nick Goode – who is the 1994 Sheriff of Shadyside – performs CPR on her.

At this point we learn that Cindy is not the only survivor of the massacre. Nick tells a paramedic that Ziggy’s real name is Christine or C. Berman. (I told you we would come back to this.) After the events of that night, Ziggy holds back, living in constant fear of the witch.

How does Fear Street: 1978 connect with Fear Street: 1666?

After hearing Ziggy’s story, Deena realizes that she and her friends found the witch’s body in the woods between Sunnyvale and Shadyside. Deena and Josh go to the mall (formerly warehouse) to dig up the hand under the hanging tree. Deena’s nose begins to bleed as she puts her hand next to the bones in the forest. In 1666 she immediately experienced a vision in which she was in Sarah Fier’s body. It seems like the curse hasn’t broken yet, so we need to adjust to it Fear Street Part 3: 1666 to see how everything plays out in this slasher trilogy!

Categories
Health

Mississippi well being officers plead with aged to keep away from mass indoor gatherings as delta Covid variant rips by state

Medical workers with Delta Health Center wait to vaccinate people at a pop-up Covid-19 vaccination clinic in this rural Delta community on April 27, 2021 in Hollandale, Mississippi.

Spencer Platt | Getty Images

Mississippi state health officials issued new guidance on Friday that calls for state residents over the age of 65 and immunocompromised residents, vaccinated or unvaccinated, to avoid any indoor mass gatherings for the next two weeks amid “significant transmission” of the delta variant over the coming weeks.

The new guidance is in place until July 26 and is not mandatory. The guidance should instead be considered a recommendation.

“We’re not recommending any mandates. What we’re doing is we’re providing personal recommendations for individuals who are at high risk for severe outcomes,” Mississippi State Health Officer Dr. Thomas Dobbs said during a press briefing Friday. “We don’t want anybody to die needlessly.”

Dobbs said he currently “does not anticipate” the guidance being expanded to other age groups in the future.

Officials said they are starting to see significant transmission of the delta variant that is very reminiscent of what was seen in the early days of the pandemic. Mississippi state health epidemiologist Dr. Paul Byers specifically highlighted church groups, school and summer programs, funeral gatherings and workplaces as well as long-term care facilities as areas where officials are already seeing spikes in infections.

“We have directly identified that they are the result of the delta variant, and the transmission … has been pretty significant,” Byers said at the press briefing Friday.

The state is second to last to Alabama out of all states when it comes to the percentage of the population that is fully vaccinated with two doses. About 25% of Mississippians over age 65 are still unvaccinated, and make up the majority of Covid deaths in the state. State health officials also said they are seeing deaths in vaccinated residents as well, “because we are exposing them over and over again,” Dobbs said, though it is a miniscule percentage.

Zoom In IconArrows pointing outwards

Graph shows cases, hospitalizations and deaths among vaccinated vs unvaccinated in Mississippi from June 3 to July 1, 2021.

Mississippi State Health Department

Mississippi is ranked last in the country in its share of adults with at least one Covid shot and the state is also ranked last in the country in the percentage of residents age 12 and older with at least one shot.

“I don’t think that we’re going to have some miraculous increase in our vaccination rate over the next few weeks, so people are going to die needlessly,” Dobbs warned.

State health officials asked vaccinated residents to speak with others about their experience with the vaccine in an effort to raise awareness about the safety and efficacy of the shots.

“Let people, let your family know, let your neighbors know, let your friends know,” Dobbs said. “There’s no more powerful message than trust and faith for people to know how widely utilized the vaccine has been, and understand that people are safe and excited to be protected.”