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Pink hospitalized after fracturing her ankle: ‘2020 is the gift that keeps on giving’

Pink shared a picture of herself from the hospital after fracturing her ankle.

 

— FOX News

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International & World

Nations move to isolate U.K. over virus variant

Several countries are barring travelers from Britain. Meanwhile, Moderna’s vaccine rolls out in the U.S. And, the Bidens are set to be inoculated today.

— NYT: Top Stories

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Healthcare

Legend Biotech announces initiation of rolling submission of Biologics License Application to U.S. FDA seeking approval of BCMA CAR-T therapy cilta-cel for the treatment of relapsed and/or refractory multiple myeloma

Legend Biotech also achieves fifth milestone payment under its collaboration agreement with Janssen in clinical development of cilta-cel

SOMERSET, N.J.–(BUSINESS WIRE)–#LegendBiotech–Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today the initiation of a rolling submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma.

The submission is based on results from the pivotal Phase 1b/2 CARTITUDE-1 study which evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapsed and/or refractory multiple myeloma.1 The latest data from the study were recently presented (Abstract #177) at the 62nd American Society of Hematology Annual Meeting.

“Initiation of the BLA submission is an important milestone in advancing this therapy for patients with multiple myeloma who are heavily pretreated and in need of treatment options,” said Ying Huang, PhD, CEO and CFO of Legend Biotech. “Together with our collaborator Janssen, we look forward to working with the FDA to fulfill this unmet medical need with the goal of making this breakthrough treatment available to patients and healthcare providers in the future.”

Based on this submission, Legend Biotech also announced, according to the terms and conditions of an agreement with Janssen Biotech, Inc. (Janssen), achievement of a $75M milestone payment relating to the clinical development of cilta-cel. Janssen, Legend Biotech’s collaboration partner, initiated the submission of the BLA for cilta-cel. The FDA previously granted Breakthrough Therapy Designation (BTD) for cilta-cel and has agreed to a rolling review of the BLA in which completed portions of the application will be submitted and reviewed on an ongoing basis.

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory (to at least 1 immunomodulatory drug [IMiD], 1 proteasome inhibitor [PI] and 1 anti-CD38 antibody).1

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.1

About Ciltacabtagene autoleucel (cilta-cel)

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.2 Although treatment may result in remission, unfortunately, patients will most likely relapse. 3 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.4 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.5,6 While some patients with multiple myeloma have no symptoms until later stages of the disease, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.7 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options.8

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.

We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or at www.legendbiotech.com.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s clinical efforts, its partnership with Janssen, and the regulatory submission and review of the BLA for cilta-cel. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the “Risk Factors” section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

_____________________________

1 CARTITUDE-1 (NCT03548207). Available: https://clinicaltrials.gov/ct2/show/NCT03548207. Accessed December 2020.

2 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Accessed December 2020.

3 Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–2207.

4 National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. Accessed December 2020.

5 National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. Accessed December 2020.

6 Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.

7 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed December 2020.

8 Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

Contacts

For Media and Investor Relations inquiries, please contact:
Jessie Yeung, Head of Corporate Finance and Investor Relations, Legend Biotech

jessie.yeung@legendbiotech.com or investor@legendbiotech.com

Surabhi Verma, Manager of Investor Relations and

Corporate Communications, Legend Biotech USA Inc.

Surabhi.Verma@legendbiotech.com or media@legendbiotech.com

For Medical Affairs inquiries, please contact:
Tonia Nesheiwat, Executive Director, Medical Affairs, Legend Biotech

tonia.nesheiwat@legendbiotech.com or medicalinformation@legendbiotech.com

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‘Saturday Night Live’ mocks Donald Trump, Scarlett Johansson in last ‘Weekend Update’ segment of the year

“Saturday Night Live” closed out its last “Weekend Update” segment under a Donald Trump presidency with a final round of jabs at the president as well as some self-deprecating humor about its hosts. 

 

— FOX News

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Congress racing to close stimulus deal

Votes on final legislation surrounding a $900 billion relief bill are expected to unfold as early as Sunday afternoon.

— NYT: Top Stories

 

 

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A conservative Justice in Wisconsin says he followed the law, not the politics

Like officials in Arizona and Georgia, Justice Brian Hagedorn is a longtime Republican who is now under fire for ruling against President Trump’s challenges to the election.

— NYT: Top Stories

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Some European countries begin barring U.K. travelers

Widespread vaccinations at ravaged U.S. nursing homes are expected to begin this week. Apple is shuttering its California stores as the virus surges in the state.

— NYT: Top Stories

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President in the pews: DC churches offer Biden options

 

FILE – In this Dec. 18, 2020, file photo President-elect Joe Biden and his wife Jill Biden walk from St. Joseph on the Brandywine Roman Catholic Church in Wilmington, Del. Biden says Americans should be allowed to attend church during the pandemic “safely,” and his transition team has underscored the importance of heeding local restrictions. Still, if he does become a regular Washington churchgoer, Biden will have plenty of choices. (AP Photo/Carolyn Kaster, File)

 

WILMINGTON, Del. (AP) — His motorcade thunders around Delaware, snarling traffic. Everywhere he goes, a security team envelops him and a pack of journalists trails behind.

Yet President-elect Joe Biden enters his church, St. Joseph on the Brandywine, with startlingly little interruption.

Wearing a dark suit and medical mask, Biden slipped into a polished wooden pew near the back of the sanctuary for a recent Saturday evening Catholic Mass. He was one of only about 40 worshippers with attendance limited by the coronavirus pandemic. His row was empty except for a Secret Service agent sitting on the aisle and others stationed around the sanctuary. They had flak jackets under their dress clothes.

This is one of the last places where Biden can at least try to blend in, a luxury that probably will fade away completely when he takes office next month. Once he arrives in Washington, the trappings of the presidency — and the eagerness of the city’s residents to be near power — could make a casual church visit nearly impossible.

A Biden transition team official refused to say which church Biden might attend in the nation’s capital or whether he might return to Delaware for services, at least to start. Washington’s COVID-19 measures restrict large indoor services, and many churches have moved services online.

Biden says Americans should be allowed to attend church during the pandemic “safely,” and his transition team has underscored the importance of heeding local restrictions. Still, if he does become a regular Washington churchgoer, Biden will have plenty of choices.

Four Catholic churches sit within 2 miles (3.2 kilometers) of the White House. As vice president, Biden attended Holy Trinity Catholic Church in Washington’s tony Georgetown neighborhood, where the nation’s only other Catholic president, John F. Kennedy, frequently went to Mass before his inauguration.

Also nearby is New York Avenue Presbyterian, which maintains the pew where Abraham Lincoln once worshipped. Even closer is St. John’s Episcopal Church, walkable across Lafayette Square from the White House for the presidents who have made a historic practice of worshipping there at least once.

St. John’s was thrust into the headlines this summer when police forcibly dispersed protesters so President Donald Trump could pose with a Bible outside its butter-yellow front doors. But its status as the “Church of Presidents” dates to James Madison, and it’s accustomed to the special scrutiny that comes with hosting commanders in chief.

The Rev. Luis Leon, rector at St. John’s from 1994 to 2018, said congregants were very good about high-powered visits: “They treated the president’s experience of worship as they would treat their own experience of worship.”

The VIP presence nonetheless had its own specific effects on churchgoers’ behavior. Leon joked that, on days when the reserved “President’s pew” was occupied, the church “would get tilted” because so many congregants wanted to sit on the same side of the sanctuary as the chief executive, hoping to shake his hand during the Episcopalian exchange of the peace.

While Trump often consulted with spiritual leaders in the Oval Office, he never adopted a home church in Washington. He preferred private prayer, including with the Rev. Jentezen Franklin, a Georgia-based megachurch pastor who recalled at least 10 visits with Trump on faith matters.

Franklin said the outgoing president “always was so receptive” of spiritual encounters.

“When we first started meeting with him, we asked him, could we pray with him? And he was very open to that, very thankful,” Franklin said.

Former President Barack Obama and his family attended the historically Black Nineteenth Street Baptist Church in the early days of his administration. But a competition emerged among the city’s houses of worship to attract the first family, and the Obamas ultimately never settled on a full-time church home in the capital.

Joshua DuBois, who was Obama’s faith adviser during his first term, recalled the search for a church as “a beautiful challenge.”

“On the one hand, President Obama wanted to worship as often as he could with local congregations, and to worship God and be in community with others in his new home,” DuBois said. But “we were acutely aware of the disruption of a presidential visit and wanted to be mindful, to limit that disruption as much as possible.”

President George W. Bush often opted to worship at Camp David during his years in Washington.

The Clintons were the last first family to regularly attend church in the city. They became members of Foundry United Methodist Church, just north of the White House on 16th Street, where then-teenage Chelsea was active in the youth group.

The Rev. J. Philip Wogaman, then-Foundry’s pastor, said he would help minimize crowding by asking the congregation to remain seated at the end of the service for the Clintons to exit.

“Anytime he seemed to be a little sleepy I thought to myself, ’Well, at least today I can serve the people of the United States by giving their president a bit of a rest with my sermon,’” Wogaman said.

For now, Biden’s churchgoing remains low-key.

He attends Mass nearly every week at St. Joseph’s — a yellow church built in 1841 on land donated by manufacturing magnate Charles I. DuPont — less than five minutes by motorcade from his lakeside home in Wilmington. Biden sometimes goes on Saturday evening but most often on Sunday mornings, attending with his wife, Jill, or his adult grandchildren, though more frequently coming solo.

Biden attended Mass on Friday to mark the anniversary of the deaths of his first wife and daughter, who were killed in a 1972 car crash and are buried at the church cemetery. His son Beau, a former Delaware attorney general who died of brain cancer in 2015, is also buried there. Biden occasionally attends Mass at other churches, such as St. Joseph’s in downtown Wilmington, or St. Edmund near his vacation house in Rehoboth Beach, Delaware.

On this Saturday evening at St. Joseph’s, the Rev. Glenn Evers didn’t acknowledge the incoming president in the congregation’s midst, instead cautioning anyone worried about “an opportunity to catch” the virus to stay away from the traditionally crowded Christmas Eve afternoon Mass. Most pews were roped off to ensure social distancing, but parishioners nearby could hear Biden softly reciting the Lord’s Prayer.

When Evers asked them to turn and greet their neighbors, they tried not to gawk at the president-elect, who offered warm but quick smiles in return.

Biden’s traveling press pool waited just outside the church grounds, and bomb-sniffing dogs checked the area long before anyone arrived. Biden entered the church a few minutes late and was the first to exit at the end of the service, keeping disruption to a minimum.

He did that so effectively that the only sign he had ever even been there was a Secret Service agent, who lingered to hold the door open for others who filed out a few minutes behind the president-elect.

“We’ve inconvenienced you enough,” the agent said. “It’s the least I can do.”

___

Schor reported from Washington.

___

Associated Press religion coverage receives support from the Lilly Endowment through the Religion News Foundation. The AP is solely responsible for this content.

— Associated Press

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‘Hurting for hope,’ South Dakota rural churches mark Advent

White crosses on the lawn of Good Samaritan Society nursing home Dec. 8, 2020, in Canton, S.D., commemorate residents who have died in recent weeks of the coronavirus. (AP Photo/Stephen Groves)

 

CANTON, S.D. (AP) — The Nativity stable at Canton Lutheran Church will be silent this year, breaking from a community tradition of gathering for a live Christmas performance. Instead, churches in this rural corner of South Dakota are grappling with how to approach an Advent filled with quiet mourning after the coronavirus tore through the region.

Church announcements are marked not with parties and performances, but with deaths. South Dakota and North Dakota, states largely spared from the worst of the pandemic during the spring and summer, have seen a frightening pace of death since October. The states’ per capita death over the fall was almost double that of even the next worst-off state.

Even as congregations mourn, they are finding new significance in Advent, when Christians mark the long, dark nights leading up to Christmas as they prepare to celebrate the birth of Jesus Christ.

“Advent is the season when we look forward, and long and wait for that new life to come upon us,” the Rev. Tim Thies said. “We’re a people hurting for hope.”

The church’s annual Nativity performance often draws a crowd of thousands to Canton, a city of about 3,500 people nestled against the Big Sioux River dividing South Dakota from Iowa. People come to see the camels, the angels who ascend on a hydraulic lift — and of course, the infant Jesus, played by one of the church’s newest arrivals.

Not this year.

The church canceled the live show, fearing that a large gathering would add to the virus’ toll.

“There’s just a void and you can’t fill it,” Thies said.

Community grieving also has been halted, even as the impact of the deaths from the virus has rippled, said Cheryl Johnson, a member of Canton Lutheran. Memorial services for some people were postponed; others had small graveside gatherings.

“These were pillars of the community,” said Johnson. “There should have been hundreds of people at those services.”

One man who died operated a construction company that built many of the homes people live in; another operated a manufacturing business that was a big employer. Many from the older generation were faithful donors to the churches that run charities in town.

Canton Lutheran’s congregation has lost 12 members over the last few months, from COVID-19 and other causes, Thies said.

The virus has been a crucible on the neighborly harmony that is the pride of many towns. Impassioned debates over politics and mask requirements, the unrelenting discomfort of isolation, the pain of losing loved ones and the pressures on medical workers have all compounded into discord.

Churches saw needs arising, even as they waded through divisions.

The Grand Valley Lutheran Church, a 126-year-old congregation of mostly farming families a few miles south of Canton, shut down services during the early days of the pandemic. But the Rev. Lance Lindgren — who later died of the virus — was adamant that the church continue to provide some form of worship, so hymns from the church organ streamed over Facebook.

The church did everything it could to meet spiritual needs, while still attempting to keep people safe. It purchased an FM transmitter so worshippers could listen from their cars, and Lindgren held drive-through communion. As the weather grew colder, Eric Scott, the congregational president, measured off the church’s fellowship hall to separate chairs by 6 feet (1.8 meters).

“At those times, people were really looking for something, and going back to their faith, going back to God,” Scott said.

Then Canton was hit by a wave of cases. The 77-year-old pastor died on Nov. 3.

“With the passing of pastor Lance, the first question was: What do we do now?” Scott said.

Grand Valley was not the only area church reeling from loss. The pages of the local newspaper, The Sioux Valley News filled with obituaries. The nursing home began marking deaths with small, white crosses on its front lawn.

Churches asked members to gather outside the nursing home, laying hands on its brick walls to offer prayers for residents and staff.

“It was a powerful moment where we were coming together in faith,” said Clay Lundberg, the pastor of the United Methodist Church in Canton.

Still, pastors struggled with how to comfort their congregations.

“We’re called to be the hands and feet of Christ, but how do you do that when you can’t touch somebody? How do you do that when you can’t give them a hug?” said Thies, the pastor at Canton Lutheran.

He and other pastors said they’ve been going back to the basics of ministering to their congregations: making phone calls, writing letters, and trying to make their presence felt.

“We don’t want people to slip through the cracks and be lost in these terrible pandemic days,” he said.

Church members who usually organize the live Nativity performance thought the congregation needed a message of hope, so they recruited the shop class from the high school to assemble a stable, even if it remained empty of people.

”(It’s) a reminder to the people — that this is the true meaning of Christmas,” said Dorothy Trumm, a 76-year-old church member.

At Grand Valley, the congregation decided to forego some of its midweek Advent services, but felt that continuing Sunday services and delving into the grief was what Lindgren would have wanted.

“I look at this pandemic as an opportunity,” Scott said. “We’re in waiting, and it’s waiting for something good.”

___

Associated Press religion coverage receives support from the Lilly Endowment through the Religion News Foundation. The AP is solely responsible for this content.

— Associated Press

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A second vaccine comes at a stark moment in the U.S.

Over 251,000 new virus cases were reported in the country, a once-unthinkable daily record.

— NYT: Top Stories