Mr. Navalny, Russia’s most prominent opposition leader, was arrested at a Moscow airport after five months in Germany. The hearing took place inside the police station where he was being detained.
— NYT: Top Stories
Author: Michelle Dryden
Two-Day Special Event Will Showcase The Latest Innovations in Eye Care
OAKLAND, N.J.–(BUSINESS WIRE)–#RDx–Topcon Healthcare, a leading provider of medical devices and software solutions for the global eye care community, announced today that it will host a two-day virtual symposia and expo entitled eyeRISE on February 9-10, 2021.
eyeRISE, or Eye Research Innovation Symposia & Expo, is a new, multi-disciplinary virtual congress showcasing the latest innovations in eye care. It will feature three solutions-focused tracks, delivering clinical and practical education through symposia, roundtable discussions and interactive workshops.
The two-day special event will feature more than three dozen globally-renowned speakers representing 17 countries and a range of specialties. Educational tracks are Building Clinical Confidence which includes topics focused on retina, glaucoma and imaging; Entering New Markets which addresses the barriers to entering myopia and dry eye management; and Too Many Patients, Not Enough Time highlighting topics such as ocular telehealth and remote diagnostics.
“We are very excited to announce eyeRISE, a one-of-a-kind, ground-breaking event that will bring together some of the most recognized names in the eye care industry to discuss the latest research and trends in patient care and practice management. In the absence of live meetings, eyeRISE provides an engaging, interactive virtual platform and offers education for a wide range of disciplines. It features solution-focused tracks for real world clinical and business management applications. eyeRISE is the culmination of Topcon’s unwavering commitment to support continued innovation in eye care,” stated Carolyn Evangelista, Global Director of Medical Affairs for Topcon Healthcare.
“eyeRISE will build on the success of our previous ISSOCT conferences and expand to include all facets of eye care, delivering clinical education for the retina, glaucoma and anterior segment subspecialties. The esteemed lecture panel will present their clinical findings on the latest research topics and innovation in eye care. It should prove to be a highly informative and enlightening meeting for all attendees,” stated ISSOCT Chairman Richard F. Spaide, MD, of Vitreous Retina Macula Consultants of New York, United States.
“Having the opportunity to network with colleagues and learn about the latest trends and technologies in eye care is critical for today’s practitioners, particularly in light of the global pandemic. eyeRISE provides practitioners with a unique opportunity to interact with the faculty and each other and gain practical tips and clinical insights. Given the challenges facing today’s eye care practitioners, eyeRISE represents a wonderful learning opportunity for all clinicians,” summarized faculty member Mingguang He, MD, PhD, Professor at the University of Melbourne, Australia.
For more information on eyeRISE or to register for the event, please visit Eyerise2021.com.
About Topcon Healthcare
Topcon Healthcare sees eye health differently. Our vision is to empower providers with smart and efficient technologies for enhanced patient care. Keeping pace with the ever-changing landscape of the healthcare industry, we offer the latest integrated solutions including advanced multi-modal imaging, vendor-neutral data management, safe distancing and ground-breaking remote diagnostic technology.
A globally oriented business, Topcon is focused on developing solutions towards solving societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, access to healthcare and physician shortages. By investing in value-driven innovations, Topcon works to enable people to enjoy good health and a high quality of life.
Contacts
Christina Kirby
Director, Product Marketing Americas
Topcon Healthcare
E-mail: ckirby@topcon.com
FILE – In this Tuesday, Nov. 24, 2020 file photo, Vice President-elect Kamala Harris speaks as she and President-elect Joe Biden introduce their nominees and appointees to key national security and foreign policy posts at The Queen theater, in Wilmington, Del. Vice President-elect Kamala Harris will be sworn in by Justice Sonia Sotomayor on Wednesday, Jan. 20, 2021, a history-making event in which the first Black, South Asian and female vice president will take her oath of office from the first Latina justice. (AP Photo/Carolyn Kaster, File)
WILMINGTON, Del. (AP) — Vice President-elect Kamala Harris will resign her Senate seat on Monday, two days before she and President-elect Joe Biden are inaugurated.
Aides to the California Democrat confirmed the timing and said Gov. Gavin Newsom was aware of her decision, clearing the way for him to appoint fellow Democrat Alex Padilla, now California’s secretary of state, to serve the final two years of Harris’ term.
Padilla will be the first Latino senator from California, where about 40% of residents are Hispanic. Newsom announced his choice in December, following intense lobbying for the rare Senate vacancy from the nation’s most populous state.
Harris will give no farewell Senate floor speech. The Senate is not scheduled to reconvene until Tuesday, the eve of Inauguration Day.
Padilla’s arrival, along with Harris becoming the Senate’s presiding officer when she’s sworn-in as vice president, is part of Democrats’ upcoming Senate majority. But the party still needs Sens.-elect Jon Ossoff and Raphael Warnock of Georgia to be certified as victors in their Jan. 5 elections and then be sworn in.
Harris will be the first Black woman and first woman of South Asian descent to serve as vice president, but her Senate departure leaves the chamber’s roster without a Black woman. Harris was just the second Black woman senator, winning her California election 17 years after Democrat Carol Moseley Braun finished a single term representing Illinois.
Among many potential successors to Harris, Newsom passed over at least two prominent Black women, U.S. Reps. Karen Bass and Barbara Lee. Bass also was among Biden’s finalists for running mate.
Democrats were in the minority during Harris’ four years on Capitol Hill. Perhaps her biggest mark came as a fierce questioner of judicial nominees and other witnesses as a member of the Senate Judiciary Committee.
Harris was viewed as a future presidential candidate almost immediately upon joining the Senate in 2017. She announced her White House bid in January 2019 but dropped out the subsequent December after a lackluster campaign and before the ballots were cast in Iowa’s first-in-the-nation caucuses. Biden, himself a former senator, invited her to join the national ticket in August.
The wins by Ossoff and Warnock in Georgia ensured a 50-50 Senate, positioning Harris as the tie-breaking vote for Democratic control. But Ossoff and Warnock cannot join the chamber until Georgia Secretary of State Brad Raffensperger certifies the final vote tally. Raffensperger, a Republican, has said he could act as soon as Tuesday, conceivably allowing Padilla, Ossoff and Warnock to join the Senate together as early as that afternoon’s session.
But Republicans will maintain a narrow majority until all three take office and Harris sits in the presiding officer’s chair.
Harris’ early departure from the Senate has multiple precedents.
Biden was the last sitting senator to be elected vice president. He resigned his Delaware post on Jan. 15, 2009, five days before he and Barack Obama were inaugurated. Obama, a senator at the time of his election, had resigned his Illinois seat two months before Biden.
— Associated Press
Dwayne “The Rock” Johnson is returning to the small screen with the help of NBC.
— FOX News
FILE – In this March 4, 2020, file photo Chairman of the Joint Chiefs of Staff Gen. Mark Milley testifies to Senate Armed Services Committee about the budget on Capitol Hill in Washington. President-elect Joe Biden will inherit Milley as his senior military adviser, and although Biden could replace him, he likely won’t. (AP Photo/Jacquelyn Martin, File)
WASHINGTON (AP) — In taking charge of a Pentagon battered by leadership churn, the Biden administration will look to one holdover as a source of military continuity: Gen. Mark Milley, chairman of the Joint Chiefs of Staff.
President-elect Joe Biden will inherit Milley as his senior military adviser, and although Biden could replace Milley, he likely won’t.
A Princeton-educated history buff with the gift of gab, Milley has been a staunch defender of the military’s apolitical tradition even as President Donald Trump packed the Pentagon with political loyalists. Milley reassured Congress that the military would stay out of the elections and, in no uncertain terms, told troops that the Capitol riot was an act of sedition. Last summer, he put his own job on the line by apologizing for being part of the entourage that accompanied Trump to a photo-op outside a church near the White House after peaceful protesters were forcibly removed from the area.
Military leaders always have critical roles in ensuring stability from one administration to the next. But Milley will be especially important for continuity after a delayed, rocky postelection transition and uncertainty about when the Senate will confirm top Pentagon nominees.
Milley, 62, is early in the second year of a four-year term as the military’s top officer. His predecessor, Marine Gen. Joseph Dunford, now retired, was a similarly transitional figure, appointed by President Barack Obama and continuing for nearly three years with Trump.
The chairman of the Joint Chiefs does not command troops but advises a president and a secretary of defense on approaches to major military problems.
Biden will have many problems on his plate from the get-go, including Iran and North Korea. In addition to dealing with potential military crises, Biden would look to Milley, along with his prospective secretary of defense, Lloyd Austin, for advice on broader strategic goals, including pursuing arms control with Russia, countering terrorism in the Mideast and competing with China.
Milley already is being singled out as a go-to official at a beleaguered Pentagon.
House Speaker Nancy Pelosi, D-Calif., called him two days after the Jan. 6 insurrection at the Capitol to ask what might be done to check Trump’s authority to order a nuclear attack in his final days in office. The Joint Chiefs chairman is not in the nuclear chain of command, but Pelosi’s call reflected a view that, with no Senate-confirmed secretary of defense in place, stability starts with Milley.
Milley is not shy about taking charge.
He loves to talk, often relying on his deep knowledge of military history, occasionally personalizing his point, never reluctant to assert his view. Milley speaks reverently of his late father, a veteran of combat in the Pacific theater of World War II, and worriedly of America’s vulnerability to space-based warfare, which he says could bring on the next Pearl Harbor.
A Massachusetts native, Milley was commissioned as an armor officer in 1980 and rose to become Army chief of staff 35 years later. When Trump announced him as his choice to be Joint Chiefs chairman nearly a year before Dunford’s term expired, he called Milley a “great gentleman” and outstanding soldier.
By June 2020, however, Milley seemed at risk of being fired; he privately opposed Trump’s talk of invoking the Insurrection Act to put active-duty troops in the streets of the nation’s capital to counter protests sparked by the killing by Minneapolis police of a Black man, George Floyd.
Milley also expressed public regret at being part of a Trump entourage that strolled across Lafayette Square on June 1 to be positioned near a church where Trump held up a Bible for photographers. Critics hit Milley for appearing to be a political pawn. Days later, Milley said he had made a big mistake. Through the months that followed, he seemed at risk of being sacked by Trump.
Michael O’Hanlon, a defense analyst at the Brookings Institution, said Biden should not see Milley as tainted by Trump.
“If Biden wants to send some messages about reconciliation and bipartisan cooperation, working closely with Milley … wouldn’t be a bad place to start,” O’Hanlon said.
It appears unlikely that Austin, Biden’s defense secretary nominee, will win Senate confirmation by Inauguration Day, Wednesday. Anticipating that bump, Biden has persuaded a Trump administration official, Deputy Defense Secretary David Norquist, to stay on temporarily as acting secretary. That makes Milley’s presence even more significant.
Once confirmed, Austin would enter a Pentagon reeling from an extraordinary period of leadership instability. Trump went through the most defense secretaries of any one-term president in history — two who had been confirmed by the Senate and three others who served only in an acting, placeholder capacity.
The Austin nomination adds a further twist in Milley’s path, given Austin’s background as a recently retired Army general. Questions are being raised in Congress and elsewhere about how having a former career military officer lead the Pentagon will affect relations between civilian and military officials.
Roger Zakheim, Washington director of the Ronald Reagan Presidential Foundation and Institute, says the extra effort required to win a congressional waiver of the prohibition against recently retired military officers serving as defense secretary would appear to give Biden less reason to remove Milley.
“You don’t want to create more turbulence here beyond what they’re already going to have to deal with getting Gen. Austin through the nomination process,” Zakheim said.
Biden would look to Milley not just for advice on current problems but also for guidance on future adjustments to military structure and strategy, including changes to the U.S. military footprint abroad. Milley seems amenable to the prospect of Biden seeking to find savings in defense budgets.
“We in the Pentagon, civilian and military alike, have got to do a quick reality check on the national budget and what is likely to happen in the not-too-distant future,” Milley said recently. “I suspect that at best the Pentagon’s budgets will start flattening out. There is a reasonable prospect that they could actually decline.”
— Associated Press
This satellite photo combo provided Sunday Jan. 17, 2021 by Planet Labs, Inc. shows the destruction of U.N. World Food Program warehouses at the Shimelba refugee camp in Ethiopia’s Tigray region on Jan. 5, 2021, bottom center left, and before it was destroyed on Dec. 10, 2020, top. Starvation threatens the survivors of fighting in Tigray, and authorities say more than 4.5 million people need emergency food. Food supplies have been a target in the conflict, experts say. (2021 Planet Labs, Inc via AP)
NAIROBI, Kenya (AP) — New satellite images of a refugee camp in Ethiopia’s embattled Tigray region show more than 400 structures have been badly damaged in what a research group believes is the latest “intentional attack” by fighters.
The report by the U.K.-based DX Open Network nonprofit, shared with The Associated Press, says “it is likely that the fire events of 16 January are yet another episode in a series of military incursions on the camp as reported by (the United Nations refugee agency).”
The Shimelba camp is one of four that hosted 96,000 refugees from nearby Eritrea when fighting erupted in early November between Ethiopian forces and those of the defiant Tigray region. The fighting has swept through the camps and two of them, including Shimelba, remain inaccessible to aid workers. Many refugees have fled.
On Thursday, U.N. refugee chief Filippo Grandi cited recent satellite imagery of fires and other destruction at the two inaccessible camps as “concrete indications of major violations of international law.”
On Sunday the U.N. refugee agency urged that it be given access to the camps.
“Until November, 8,700 refugees were registered in Shimelba. We have no information on how many refugees were still in the camp last week,” U.N. refugee agency spokesman Chris Melzer said in an email. “We still have no access to the two northern camps, Shimelba and Hitsats (25,248 refugees registered in November). We demand access since the refugees are without supplies for two and a half months now and we are extremely concerned. We also saw satellite pictures and heard frightening reports. But since we don’t have access we cannot confirm them.”
The new report says the satellite images show “smoldering ruins, blackening of structures and collapsed roofs.” The structures, it said, “match the profile of mud-brick dwellings constructed by the refugees themselves. The attackers likely split into multiple groups going door to door to set fires inside buildings,” consistent with previous attacks on the Hitsats camp, which also is inaccessible.
Neither the U.N. nor DX Open Network has blamed anyone for the attacks, but the presence of troops from Eritrea, a bitter enemy of the Tigray region’s now-fugitive leaders, has caused alarm. Grandi noted “many reliable reports and firsthand accounts” of abuses including the forced return of refugees to Eritrea.
The day after Grandi’s statement, Eritrean Information Minister Yemane Gebremeskel tweeted that “UNHCR seems to indulge, yet again, in another bout of gratuitous & irresponsible smear campaigns against Eritrea.” He said Eritrea rejects the “forced repatriation of ‘refugees.'”
Eritrea has been described by human rights groups as one of the world’s most repressive countries. Thousands of people have fled the country over the years to avoid a system of military conscription.
Fighting continues in parts of the Tigray region. Thousands of people have been killed and more than 2 million displaced.
— Associated Press
Supporters of leading opposition challenger Bobi Wine cheer as election officials count the ballots after polls closed in Kampala, Uganda, Thursday, Jan. 14, 2021. Ugandans voted in a presidential election tainted by widespread violence that some fear could escalate as security forces try to stop supporters of Wine from monitoring polling stations.(AP Photo/Jerome Delay)
KAMPALA, Uganda (AP) — Uganda’s electoral commission says longtime President Yoweri Museveni has won a sixth term while top opposition challenger Bobi Wine alleges rigging and officials struggle to explain how polling results were compiled amid an internet blackout.
In a generational clash widely watched across the African continent, with a booming young population and a host of aging leaders, the 38-year-old singer-turned-lawmaker Wine posed arguably the greatest challenge yet to Museveni. He had strong support in urban centers where frustration with unemployment and corruption is high.
The electoral commission said Museveni received 58% of ballots and Wine 34%, and voter turnout was 52%.
The top United States diplomat to Africa has called the electoral process “fundamentally flawed.”
Thursday’s vote followed the East African country’s worst pre-election violence since the 76-year-old Museveni took office in 1986. Wine and other opposition candidates were often harassed, and more than 50 people were killed when security forces put down riots in November over Wine’s arrest. Wine petitioned the International Criminal Court this month over alleged torture and other abuses by security forces.
While the president holds on to power, at least 15 of his Cabinet ministers, including the vice president, were voted out, with many losing to candidates from Wine’s party, local media reported.
Wine claimed victory Friday, asserting that he had video evidence of vote-rigging and saying “every legal option is on the table” to challenge the official election results, including peaceful protests. Candidates can challenge election results at the Supreme Court.
Hours later, he tweeted that the military had entered his home compound and “we are in serious trouble,” which a military spokeswoman denied. Wine, whose real name is Kyagulanyi Ssentamu, was roughed up and arrested several times while campaigning but was never convicted, and eventually he campaigned wearing a flak jacket and said he feared for his life.
A heavy presence of security forces remained around his home, where he has said he was alone with his wife and a single security guard.
Uganda’s electoral commission has said Wine should prove his allegations of rigging, and it has deflected questions about how countrywide voting results were transmitted during the internet blackout by saying “we designed our own system.” It could not explain how it worked.
Monitoring of the vote was further complicated by the arrests of independent monitors and the denial of accreditation to so many members of the U.S. observer mission that the U.S. called it off. Another major observer, the European Union, said its offer to deploy electoral experts “was not taken up.”
“Uganda’s electoral process has been fundamentally flawed,” the top U.S. diplomat for Africa, Tibor Nagy, tweeted Saturday, calling for the immediate and full restoration of internet access and warning that “the U.S. response hinges on what the Ugandan government does now.”
Museveni, once praised as part of a new generation of African leaders, still has support among some in Uganda for bringing stability. A longtime U.S. security ally, he once criticized African leaders who refused to step aside but has since overseen the removal of term limits and an age limit on the presidency.
The head of the African Union observer team, Samuel Azuu Fonkam, told reporters he could not say whether the election had been free and fair, noting the “limited” AU mission which largely focused on the capital, Kampala. Asked about Wine’s allegations of rigging, he said he could not “speak about things we did not see or observe.”
The East African Community observer team in its preliminary statement noted issues including “disproportionate use of force in some instances” by security forces, the internet shutdown, some late-opening polling stations and isolated cases of failure in biometric kits to verify voters. But it called the vote largely peaceful and said it “demonstrated the level of maturity expected of a democracy.”
Uganda’s elections are often marred by allegations of fraud and abuses by security forces. The previous election saw sporadic post-election riots.
— Associated Press
The campaign is unfolding in India, a country that has reported more than 10 million coronavirus infections.
— NYT: Top Stories
FILE – In this Dec. 23, 2020 file photo, a woman participates in a protest against Brazilian President Jair Bolsonaro’s handling of the new coronavirus pandemic in Brazilia, Brazil. The country hasn’t approved a single vaccine yet, and independent health experts who participated in its immunization program say the plan is still incomplete, at best. (AP Photo/Eraldo Peres, File)
RIO DE JANEIRO (AP) — Like many Brazilian public health experts, Dr. Regina Flauzino spent most of 2020 watching with horror as COVID-19 devastated Brazil. When the opportunity to join the government’s vaccination effort came, she was thrilled: She would be able to share her decades of on-the-ground experience.
But her excitement quickly faded. Flauzino, an epidemiologist who worked on Brazilian vaccine campaigns for 20 years, became frustrated with what she described as a rushed, chaotic process.
The government has yet to approve a single vaccine, and Health Ministry officials have ignored outside experts’ advice. Shortly after the government presented its vaccination plan, more than a quarter of the roughly 140 experts involved demanded their names be excised.
“We weren’t listened to,” Flauzino told The Associated Press. The plan’s creation “was postponed for too long and now it’s being done in a rush.”
Brazil has suffered more than 200,000 COVID-19 deaths, the second-highest total in the world after the United States, with infections and deaths surging again. Despite a half-century of successful vaccination programs, the federal government is trailing regional and global peers in both approving vaccines and cobbling together an immunization strategy.
The AP interviewed four expert committee members and four former Health Ministry officials. They criticized the government’s unjustifiable delay in formulating a vaccination plan, as well as months spent focused on a single vaccine manufacturer.
They also complained of President Jair Bolsonaro undermining the ministry’s effectiveness, pointing to the removal of highly trained professionals from leadership positions, who were replaced with military appointees with little or no public health experience. Experts also blamed the president, a far-right former army captain, for fueling anti-vaccine sentiment in Brazil, compromising the mass immunization effort.
‘STILL WAITING’
The government’s COVID-19 immunization plan, finally released on Dec. 16, lacked essential details: How many doses would be sent to each state and how would they be refrigerated and delivered? How many professionals would need to be hired and trained — and, above all, how much funding would governors receive to implement the campaign? The plan did not include a start date.
“How is each state going to organize its campaign if it doesn’t know how many doses it is going to receive, and the timeline for delivery?” said Dr. Carla Domingues, an epidemiologist who oversaw the logistics of Brazil’s 2009 H1N1 vaccine campaign, and worked on more than a dozen other vaccination efforts.
Bolsonaro’s press office and the Health Ministry did not respond to AP requests for comment about Brazil’s vaccination campaign or why more contracts with vaccine manufacturers were not signed in 2020.
The Health Ministry’s National Immunization Program has a long history of success. Created over 40 years ago, it has enabled Brazil to eradicate polio and significantly reduce measles, rubella, tetanus and diphtheria. The effort won recognition from UNICEF for reaching the vast country’s most remote corners and has contributed to extending Brazilians’ life expectancy from 60 to over 75 years.
The program “is the central axis of all vaccination campaigns in the country,” Flauzino said.
That is no small task in a nation of 210 million people, the world’s sixth-largest population. The program provides a complex blueprint for vaccination campaigns across more than 5,500 municipalities in 26 states and the federal district.
In a Dec. 1 Zoom meeting, Health Ministry officials presented the experts with a general overview of the COVID-19 vaccination plan. The consultants the AP interviewed said it became abundantly clear the ministry was incapable of providing many crucial details.
Epidemiologist Dr. Ethel Maciel, who was among those who later demanded her name be removed from the plan, said many of the experts’ recommendations weren’t implemented, including obtaining vaccines from more than one manufacturer. But neither she nor other consultants could voice their concerns.
“They didn’t let us talk during this meeting, our microphones remained on mute,” Maciel said, adding that officials instructed them to send their comments in writing, and that they would receive a response within a week.
“To this day, we’re still waiting,” she said.
SYRINGE SHORTAGE
Maciel was also shocked to hear that five months after the ministry signed its first contract to obtain vaccine doses in June – up to 210 million of the AstraZeneca and University of Oxford shot — it still hadn’t secured syringes to administer them.
The Health Ministry published its tender for 331 million syringes in mid-December, but received bids for only 8 million by its Dec. 29 deadline. Brazilian syringe manufacturers complained the government’s price limit was below market value.
State health secretaries had for months warned the federal government about the need to buy syringes as soon as possible to avoid excessive pricing, but to no avail, said Carlos Lula, chair of the National Council of Health Secretaries.
“It took too long,” Lula said. Dozens of other countries are already vaccinating, “and we’re falling behind.”
Hamstrung, the government told Brazilian syringe makers in December it would requisition 30 million units, to be delivered by the end of January. A call for an additional 30 million followed.
However, in an injunction issued last week, the Supreme Court prohibited the federal government from requisitioning syringes from state governments like Sao Paulo that had already purchased them.
“The federal government’s negligence cannot penalize the diligence of the state of Sao Paulo, which has been preparing for a long time, with due zeal, to face the current health crisis,” Justice Ricardo Lewandowski wrote in the ruling.
The syringe shortfall has left state governors scouring markets for their own supplies. The Health Ministry said this week that state stocks amounted to just 52 million syringes, plus an additional 71 million acquired by Sao Paulo.
For Domingues the confusion is emblematic of the government’s poor pandemic planning.
“You’d need at least six months to go through all the bureaucratic procedures and make that purchase,” she said.
A FAILURE OF LOGISTICS
The Health Ministry’s planning difficulties are all the more glaring considering the background of Health Minister Eduardo Pazuello, an active-duty army general tapped for his expertise in logistics.
The rise of a military man with no experience in public health to the top of the institution in the midst of a pandemic worried experts. “We don’t have a minister who understands the health sector,” Flauzino said.
Since Pazuello took over in May, more than 30 military personnel have been appointed to key ministry positions, including the head of Anvisa, the agency that approves use of vaccines.
Bolsonaro’s contentious relationship with Sao Paulo state Gov. João Doria, a likely rival in next year’s presidential race, also played a role in Brazil’s vaccination debacle.
While Sao Paulo had zeroed in on Chinese pharmaceutical Sinovac Biotech’s CoronaVac vaccine with a contract in September for 46 million doses, the Bolsonaro administration delayed signing a contract for months, focusing only on the AstraZeneca shot, ignoring experts and state officials who urged including Sinovac in the national vaccination strategy.
“Neither laboratory has the capacity to supply the entire national territory,” said Luiz Henrique Mandetta, health minister during the first months of the COVID-19 health crisis until he was removed by Bolsonaro. “We will need a lot of vaccines.”
Then last week, even as Bolsonaro continued scoffing at CoronaVac, the Health Ministry announced it was buying up to 100 million doses of the Chinese-made vaccine.
But with the need to provide two doses of vaccine to some 210 million people, Brazil is still far short.
Pazuello this week visited the Amazon city of Manaus that’s suffering a brutal second wave of the virus, with hospitals again pushed beyond capacity. He offered assurance that vaccines would be dispatched to all states within four days of approval by health regulators, which could come as early as Sunday — followed by a 16-month vaccination campaign.
However, Pazuello was was still unable to provide a rollout date.
“The vaccine in Brazil will arrive on D Day and H Hour,” he said cryptically.
___ Álvares reported from Brasilia.
— Associated Press
- First HER2 directed medicine approved for patients with gastric cancer in a decade
TOKYO & MUNICH & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
In the U.S., gastric cancer is more frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving five years.1,2 Approximately one in five gastric cancers are HER2 positive.3
“Patients with metastatic HER2 positive gastric cancer with progression following first-line treatment have historically faced poor outcomes, including low response to treatment and rapid disease progression,” said Ronan Kelly, MD, MBA, Director of the Charles A. Sammons Cancer Center and the W.W. Caruth, Jr. Chair of Immunology at Baylor University Medical Center, Dallas, Texas. “This approval represents the first time a HER2 directed medicine has demonstrated a significant improvement in survival compared to chemotherapy for patients following initial treatment in the metastatic setting and it has the potential to become the new standard of care for this patient population.”
Regular approval by the U.S. Food and Drug Administration (FDA) was based on the positive results from the randomized pivotal DESTINY-Gastric01 phase 2 trial, in which ENHERTU demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) and objective response rate (ORR) versus chemotherapy (irinotecan or paclitaxel) in patients with advanced gastric or GEJ adenocarcinoma who had progressed on at least two prior regimens including trastuzumab, a fluoropyrimidine and a platinum-containing chemotherapy. ENHERTU is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicity.
In the DESTINY-Gastric01 trial, patients (n=126) in the ENHERTU treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; p=0.0097) at a pre-specified interim analysis with a median OS of 12.5 months [95% CI 9.6-14.3] versus 8.4 months [95% CI 6.9-10.7] with chemotherapy.
Confirmed ORR, assessed by independent central review, was a major efficacy outcome. Results showed a confirmed ORR of 40.5% [95% CI 31.8-49.6] with ENHERTU compared to 11.3% [95% CI 4.7-21.9] with chemotherapy. Patients treated with ENHERTU had a 7.9% complete response rate (n=10) and a 32.5% partial response rate (n=41) compared to a complete response rate of 0% (n=0) and a partial response rate of 11.3% (n=7) for patients treated with chemotherapy. Additionally, ENHERTU showed a median duration of response (DoR) of 11.3 months [95% CI 5.6-NR] versus 3.9 months [95% CI 3.0-4.9] with chemotherapy.
ENHERTU also demonstrated a median progression-free survival (PFS) of 5.6 months [95% CI 4.3-6.9] compared to 3.5 months [95% CI 2.0-4.3] (HR=0.47; 95% CI 0.31-0.71) with chemotherapy.
Results from the DESTINY-Gastric01 trial were presented at the 2020 American Society of Clinical Oncology (ASCO) meeting and published in The New England Journal of Medicine.4
ENHERTU is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicity. The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01. The most common adverse reactions (≥20%), including laboratory abnormalities, were hemoglobin decreased, white blood cell count decreased, neutrophil count decreased, lymphocyte count decreased, platelet count decreased, nausea, decreased appetite, anemia, aspartate aminotransferase increased, fatigue, blood alkaline phosphatase increased, alanine aminotransferase increased, diarrhea, hypokalemia, vomiting, constipation, blood bilirubin increased, pyrexia, and alopecia. In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, interstitial lung disease occurred in 10% of patients. Median time to first onset of ILD was 2.8 months (range: 1.2 to 21.0).
“ENHERTU is the first antibody drug conjugate to receive approval in the U.S. for the treatment of patients with metastatic gastric cancer, and represents a major advance in managing this difficult-to-treat disease,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “This second indication in the U.S. represents an important step forward in our ambitious plan to accelerate the development of ENHERTU across a broad range of HER2 targetable cancers.”
“Today’s approval of ENHERTU represents the first HER2 directed medicine approved in a decade for patients with HER2 positive metastatic gastric cancer,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca. “The results from the DESTINY-Gastric01 trial highlight the potential to change clinical practice, showing a forty-one percent improvement in survival and a response rate more than three times higher with ENHERTU compared to chemotherapy. We are thrilled to bring this important medicine to more patients and physicians in the U.S.”
This is the second regulatory approval for ENHERTU in the U.S. ENHERTU is also approved in the U.S. under accelerated approval, and in Japan, under the conditional early approval system, for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial. ENHERTU is also approved in Japan for HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy based on the DESTINY-Gastric01 trial.
ENHERTU previously received Priority Review and Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of patients with previously treated HER2 positive metastatic gastric cancer, as well as Orphan Drug Designation (ODD) for patients with gastric cancer, including gastroesophageal junction cancer. Two additional phase 2 trials, DESTINY-Gastric02 and DESTINY-Gastric03, are underway, further evaluating the use of ENHERTU in patients with HER2 positive metastatic gastric cancer.
Daiichi Sankyo and AstraZeneca are committed to ensuring that patients in the U.S. who are prescribed ENHERTU can access the medication and receive necessary financial support. Provider and patient support, reimbursement and distribution for ENHERTU in the U.S. will be accessible by visiting www.ENHERTU4U.com or calling 1-833-ENHERTU (1-833-364-3788).
Please visit www.ENHERTU.com for full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
About Gastric Cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the third leading cause of cancer mortality with a five-year survival rate of 5% for metastatic disease; there were approximately one million new cases reported in 2020 and more than 768,000 deaths.2,5 In the U.S., it is estimated that 27,600 new cases of gastric cancer were diagnosed in 2020 and more than 11,000 people died from the disease.6
Approximately one in five gastric cancers are HER2 positive.3 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancer. Gastric cancer is usually diagnosed in the advanced stage, but even when diagnosed in earlier stages of the disease, the survival rate remains modest.1 Recommended first-line treatment for HER2 positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab, an anti-HER2 medicine, which has been shown to improve survival outcomes when added to chemotherapy. For patients with metastatic gastric cancer that progresses following initial treatment with a trastuzumab-based regimen, there were previously no other approved HER2 targeted medicines prior to the approval of ENHERTU.3
About DESTINY-Gastric01
DESTINY-Gastric01 is an open-label, multi-center, randomized, pivotal phase 2 trial evaluating the safety and efficacy of ENHERTU (6.4 mg/kg) versus investigator’s choice of chemotherapy in a primary cohort of 188 patients from Japan and South Korea with HER2 positive (defined as IHC3+ or IHC2+/ISH+), advanced gastric or GEJ adenocarcinoma who had progressed on two or more prior treatment regimens including trastuzumab, a fluoropyrimidine and platinum-containing chemotherapy. Patients were randomized 2:1 to receive ENHERTU or investigator’s choice of chemotherapy (paclitaxel or irinotecan monotherapy). Patients were treated with ENHERTU 6.4mg/kg once every three weeks or chemotherapy.
The main efficacy outcome measures were ORR assessed by independent central review according to RECIST v1.1 and OS in the intent-to-treat population. Additional efficacy outcome measures were PFS and DoR.
About ENHERTU
ENHERTU® (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S.) is a HER2 directed antibody drug conjugate (ADC). Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.
ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. ENHERTU is comprised of a humanized anti-HER2 IgG1 monoclonal antibody with the same amino acid sequence as trastuzumab attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker.
ENHERTU (5.4 mg/kg) is approved in the U.S. under accelerated approval, and in Japan, under the conditional early approval system, for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial, and received a CHMP positive opinion in December 2020 as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. ENHERTU (6.4 mg/kg) is also approved in the U.S. and Japan for the treatment of previously treated patients with HER2 positive metastatic gastric cancer based on the DESTINY-Gastric01 trial.
About the ENHERTU Clinical Development Program
A comprehensive development program is underway globally with nine pivotal trials evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.
In May 2020, ENHERTU received BTD in the U.S. for the treatment of patients with metastatic non-small cell lung cancer whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy.
In March 2020, the European Medicines Agency’s CHMP granted ENHERTU accelerated assessment for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.
About the Collaboration between Daiichi Sankyo and AstraZeneca
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU (a HER2 directed ADC) in March 2019, and datopotamab deruxtecan (Dato-DXd; DS-1062; a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of ENHERTU and datopotamab deruxtecan.
U.S. Important Safety Information for ENHERTU
Indications
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:
- Unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
|
WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY
|
Contraindications
None.
Warnings and Precautions
Interstitial Lung Disease / Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.
Metastatic Breast Cancer
In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients treated with ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to 8.3).
Locally Advanced or Metastatic Gastric Cancer
In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21.0).
Neutropenia
Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.
Metastatic Breast Cancer
In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4mg/kg, a decrease in neutrophil count was reported in 62% of patients. Sixteen percent had Grade 3 or 4 decrease in neutrophil count. Median time to first onset of decreased neutrophil count was 23 days (range: 6 to 547). Febrile neutropenia was reported in 1.7% of patients.
Locally Advanced or Metastatic Gastric Cancer
In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.
Left Ventricular Dysfunction
Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported. In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.
Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure.
Embryo-Fetal Toxicity
ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.
Additional Dose Modifications
Thrombocytopenia
For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less. Reduce dose by one level.
Adverse Reactions
Metastatic Breast Cancer
The safety of ENHERTU was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 7 months (range: 0.7 to 31).
Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were interstitial lung disease, pneumonia, vomiting, nausea, cellulitis, hypokalemia, and intestinal obstruction. Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock.
ENHERTU was permanently discontinued in 9% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 33% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, thrombocytopenia, leukopenia, upper respiratory tract infection, fatigue, nausea, and ILD. Dose reductions occurred in 18% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, and neutropenia.
The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (79%), white blood cell count decreased (70%), hemoglobin decreased (70%), neutrophil count decreased (62%), fatigue (59%), vomiting (47%), alopecia (46%), aspartate aminotransferase increased (41%), alanine aminotransferase increased (38%), platelet count decreased (37%), constipation (35%), decreased appetite (32%), anemia (31%), diarrhea (29%), hypokalemia (26%), and cough (20%).
Locally Advanced or Metastatic Gastric Cancer
The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01. Patients intravenously received at least one dose of either ENHERTU (N=125) 6.4 mg/kg once every three weeks or either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) in the ENHERTU group and 2.8 months (range: 0.5 to 13.1) in the irinotecan/paclitaxel group.
Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in one patient each (0.8%).
ENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and hypokalemia. Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia.
The most common (≥20%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (75%), white blood cell count decreased (74%), neutrophil count decreased (72%), lymphocyte count decreased (70%), platelet count decreased (68%), nausea (63%), decreased appetite (60%), anemia (58%), aspartate aminotransferase increased (58%), fatigue (55%), blood alkaline phosphatase increased (54%), alanine aminotransferase increased (47%), diarrhea (32%), hypokalemia (30%), vomiting (26%), constipation (24%), blood bilirubin increased (24%), pyrexia (24%), and alopecia (22%).
Contacts
Media:
Global/US:
Victoria Amari
Daiichi Sankyo, Inc.
vamari@dsi.com
+1 908 900 3010 (mobile)
EU:
Lydia Worms
Daiichi Sankyo Europe GmbH
lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)
+49 176 11780861 (mobile)
Japan:
Masashi Kawase
Daiichi Sankyo Co., Ltd.
kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)
Investor Relations:
DaiichiSankyoIR@daiichisankyo.co.jp