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HEALTH CARE BRIEFING: Two-Dose Crunch Complicates Full Immunity

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HEALTH CARE BRIEFING: Two-Dose Crunch Complicates Full Immunity

 

Nearly a month after U.S. vaccination campaigns ramped up to give Covid-19 shots to more than a million people a day, their second doses are coming due, straining state rollouts and leaving some without complete immunizations.

In Texas alone, almost 6,000 people were overdue for their second shots in early February. In Washington state, health officials said last week that some mass vaccination clinics would be delivering follow-up doses only. A Michigan hospital system canceled last-dose appointments for the past week after its supply was reduced.

“All I have on hand is enough to get me through today and tomorrow,” Carolyn Wilson, chief operating officer of Beaumont Health system in Michigan, said in an interview.

U.S. public health officials warned last year that two-shot regimens would raise the degree of difficulty for Covid-19 immunizations, and originally held back second shots to make sure they would be available as recommended three to four weeks after the first. As President Joe Biden accelerates purchases and distribution in a push to get protection for almost all Americans by the end of the summer, critical weaknesses in the system are starting to show.

Timing of the doses is seen as a key factor in effective Covid-19 immunization. Moderna says shots must be given four weeks apart to ensure efficacy, while the partnership of Pfizer and BioNTech recommends a three-week pause. A working group of Centers for Disease Control and Prevention advisers is considering recommendations for extending that interval, though it still isn’t clear what effect that might have on protection. Read more from John Tozzi.

Biden Slams Trump’s Vaccine Record: President Biden on Friday blasted Donald Trump for failing to secure enough shots as he toured a Michigan facility where Pfizer is manufacturing its vaccine. “My predecessor, as my mother would say, God love him, failed to order enough vaccines,” Biden said Friday, repeating criticism he’s made of Trump. “Failed to mobilize the effort to administer the shots. Failed to set up vaccine centers.” Read more from Jennifer Epstein and Riley Griffin.

  • Pfizer CEO Albert Bourla said on Friday that the company will use more of its manufacturing capacity and work with new suppliers to ramp up production of its Covid-19 vaccine. Bourla said the company will employ additional capacity at its Kalamazoo facility to produce the shot’s formulation as well as a component of the vaccine—lipids—which help deliver the genetic material into the body. Riley Griffin have more.

Pfizer Prods FDA to Approve Easier Storage: Pfizer and BioNTech asked the FDA to allow their coronavirus vaccine to be stored for two weeks at temperatures found in normal pharmaceutical freezers, a change that could simplify the distribution of the shot. The partners submitted new data showing stability when the vaccine is stored at minus-25 to minus-15 degrees Celsius (-13°F to 5°F), they said in a statement. Read more from Jason Gale and Naomi Kresge.

Pfizer-BioNTech Prevents Virus Transmission: The Pfizer and BioNTech coronavirus vaccine appeared to stop the vast majority of recipients in Israel becoming infected, providing the first real-world indication that the immunization will halt transmission of Covid-19. The shot was 89.4% effective at preventing laboratory-confirmed infections, a copy of a draft publication posted online and confirmed by a person familiar showed. Naomi Kresge and Jason Gale have more.

  • Separately, another Israeli study found that a single dose of the Pfizer-BioNTech vaccine reduced Covid-19 infections by 85%. Among the health workers who got the vaccine, symptomatic infections were cut down by that percentage in the 15 to 28 days after just the first dose. Ivan Levingston, Robert Langreth and John Lauerman have more.

Opioid Epidemic Worsens Amid Coronavirus

The opioid epidemic has been eclipsed in the public consciousness by Covid-19, but it hasn’t abated. The coronavirus has only exacerbated the crisis, piling stress and grief on top of substance-abuse problems and jeopardizing hopes of recovering. People are “living in tents because they lost their spot in sober homes because they lost their job,” said Charlotte Bismuth, a former New York assistant district attorney. “It’s so much worse than it was when Covid began.”

Drug overdoses of all kinds killed 84,000 people in the U.S. from August 2019 to July 2020. That is 23% more than in the previous 12-month span, and the highest number of overdose deaths ever seen in a single year. Opioids accounted for over 61,000, or 73%, of those deaths. Valerie Bauman and Ian Lopez have more.

More on the Pandemic

Push to Find Covid Variants Remains Piecemeal: U.S. efforts to detect dangerous, fast-moving Covid-19 mutations that are already bedeviling states remain slim and disconnected as the Biden administration seeks to speed up the process. While as many as 7,000 to 8,000 samples are being analyzed weekly, that’s just 1.7% of the 463,843 new cases in the U.S. last week, making it little more than a random effort. Meanwhile, three highly-contagious variants have gained significant footholds in the country, with two showing an ability to evade — though not yet overcome — existing vaccines.

State health departments directly send just 770 of the samples analyzed by U.S. health officials, with the rest coming from academic, commercial and state labs. That can lead to over-sampling in areas where labs are located. And the academic labs often have little direct contact with local health departments that need to swiftly start contact tracing to control spread, said David Haussler, scientific director at the University of California-Santa Cruz Genomics Institute. Read more from Jill R. Shah.

Fauci ‘Stunning’ Toll of 500,000 U.S. Covid-19 Deaths: The top U.S. infectious diseases specialist says the U.S. isn’t out of the “stunning” coronavirus pandemic, even as cases fall sharply and vaccinations expand, though “normality” may be at hand by year-end. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, spoke as the U.S. was on GFN of a milestone few imagined when the first coronavirus cases were diagnosed just a year ago: 500,000 deaths. Read more from Ros Krasny.

Agencies Pitch Testing Hubs to Reopen K-8 Schools: The Biden administration envisions a nationwide network of coronavirus testing hubs to boost capacity and enable K-8 schools to reopen, a notice published on Friday shows. The effort by the Army and Health and Human Services Department would open four centers to organize laboratory networks and prioritize schoolchildren. Each hub location could report as many as 25 million test results each month. Read more from Travis J. Tritten.

More Headlines:

Global Headlines:

Happening on the Hill

Stimulus Plan Enters 3-Week Congress Dash: Democrats begin the final push on their $1.9 trillion stimulus bill this week, dropping any pretense of bipartisanship to quickly pass the package before an earlier round of benefits runs out. This will be the first real test for Democrats’ full control of government since Trump’s impeachment trial, with implications for the rest of Biden’s agenda and the pandemic-battered economy. The House plans to vote as soon as Friday on Democrats’ stimulus package, setting up a Senate vote as soon as next week. Erik Wasson and Laura Davison have the latest.

Senators Urged to Press Becerra on Disability Issues: Advocacy nonprofit Patients Rising is urging senators to make sure “American patients are on the agenda of the future Secretary of Health and Human Services,” according to a statement on Friday ahead of this week’s Health, Education, Labor and Pensions Committee confirmation hearing for Xavier Becerra. The group called on the senators to press Becerra on strengthening Essential Health Benefits and expediting FDA approvals, among other issues. Read the group’s letter here.

  • Becerra’s nomination is also a lightning rod for the religious right. Faith-based advocacy groups are bracing for Biden’s HHS to reverse course on controversial steps the Trump administration took to protect, and expand, religious liberties. Under Becerra, the office is expected to walk back rules barring federally funded providers from referring women for abortions. Read more from Lydia Wheeler.
  • In addition to the Becerra hearing at the Senate Health, Education, Labor, and Pensions Committee tomorrow, the Senate Finance Committee will hear from him on Wednesday.

Lawmakers Call for Cuomo Pandemic Probe: Rep. Alexandria Ocasio-Cortez (D-N.Y.) on Friday called for a federal investigation of New York Gov. Andrew Cuomo’s handling of nursing homes through the early days of the Covid-19 pandemic, joining other lawmakers like Sen. Chuck Grassley (R-Iowa) who have called for a probe. Cuomo stepped up his defense of his administration, stating he should have been more aggressive in calling out what he said were critics’ lies about the nursing-home residents who died of Covid-19. Read more from Stacie Sherman.

Veterans Affairs Gives Shots to 1 Million Veterans: The Department of Veterans Affairs has given at least one dose of a Covid-19 vaccine to about 1 million veterans, Richard Stone, acting undersecretary of health for the Veterans Health Administration, told lawmakers on Friday. VA has received about 2 million doses and is reserving hundreds of thousands of doses to ensure everyone who receives a first dose through VA can receive a second one, Stone told members of the House Appropriations panel responsible for funding the VA.

There’s about 18.5 million veterans in the U.S., Stone said. VA has about 9.5 million enrolled in their care and roughly 6 million “active users” of the VA health system. Members of Congress said they were frustrated the VA hadn’t vaccinated more veterans. “If we have 2 million doses and 1 million or so have been administrated, there’s 1 million outstanding that aren’t getting the care they need now,” Rep. Charlie Crist (D-Fla.) said, Alex Ruoff reports.

Other Hearings This Week:

  • The Senate Health, Education, Labor, and Pensions Committee scheduled a hearing Thursday to consider the nominations of Vivek Murthy, former U.S. Surgeon General under former President Barack Obama, to reprise the job under Biden and Rachel Levine, former Pennsylvania Secretary of Health, to serve as assistant HHS secretary.
  • The House Appropriations Labor-HHS-Education Subcommittee will hold a virtual roundtable on the pandemic with CDC Director Rochelle Walensky and key agency leaders tomorrow.
  • The House Appropriations Labor-HHS-Education Subcommittee plans a hearing on Wednesday on public health infrastructure.
  • The House Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing tomorrow on how to expand the availability of Covid-19 vaccines.

What Else to Know Today

ACA Veteran Named to Lead Medicare Office: Biden has chosen Chiquita Brooks-LaSure to run his Centers for Medicare and Medicaid Services, tasking the experienced health-care aide with expanding the Affordable Care Act and rolling back Trump-era changes to the Medicare and Medicaid programs. The former official at HHS who helped carry out Obamacare, will be entrusted with one of Biden’s top health policy priorities: strengthening the signature health law. Read more from Shira Stein.

Appeal of LGBTQ-Friendly ACA Decision Halted: A federal appeals court in Washington has halted proceedings in a case challenging the Trump administration’s rewrite of an Affordable Care Act regulation clarifying that health providers cannot discriminate against LGBTQ people, pending the rule’s review by Biden’s White House. HHS’s appeal from an order that blocked it from enforcing its modification of a rule implementing Obamacare’s discrimination provision, Section 1557, will be held in abeyance, the court said. Read more from Mary Anne Pazanowski.

Health Deals See Torrid Pace: Health-care and life sciences deal volume started the year at a sizzling pace in January with the most transactions per month—258—in more than a year. The Biden administration has begun moving aggressively on legislation to provide more stimulus and financial support for pandemic aid, “while actively promoting spending on the expansion of health-care coverage,” Larry Kocot of KPMG said. Read more from Sara Hansard.

More Headlines:

With assistance from Alex Ruoff

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

Fashion

60+ AAPI-Owned Fashion and Beauty Brands to Support and Shop Now

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60+ AAPI-Owned Fashion and Beauty Brands to Support and Shop Now
aapiowned fashion and beauty brands

May is Asian American and Pacific Islander Heritage Month, and as such, it is an especially important opportunity to support brands that are crafted, designed, and founded by people of AAPI descent. Here we’ve rounded up of some of the most stylish and fabulous AAPI beauty, fashion, jewelry, and accessory brands to shop and support now and forever.

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Sandy Liang

A native of Bayside, Queens, Sandy Liang’s collections touch on her Chinese heritage while also fusing playful tomboyish separates.

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Prabal Gurung

Beloved by the red carpet set, this Nepalese fashion designer is known for his innovative designs which are produced primarily local to NYC.

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Jason wu

The Taiwanese-born designs are known for their sophistication and intricate crafting.

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To it

The ultra-wearable and fashion forward designs from Adeam are the work of Tokyo-born designer Hanako.

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Altuzarra

Former winner of the 2014 CFDA Womenswear Designer of the Year Award, Altuzarra’s collections are best known for their fresh feminine spin on classic tailoring.

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Anna Sui

The ’90s babydoll dress was practically invented by the perennially relevant Anna Sui.

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Nells Nelson

Ultra-wearable knits and suiting are the name of the Nells Nelson game, for those who lean toward comfortable separates and sets.

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Peter Do

Youthful and fresh, Peter Do made a name for himself working for the likes of both Derek Lam and Phoebe Philo.

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Commission

Design trio Huy Luong, Dylan Cao, and Jin Kay sought to re-envision their Asian heritage through western dressing sculptures, modifying cuts from the 80s that their mothers used to wear.

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Opening Ceremony

Opening Ceremony emerged on the scene in 2002, with their own fresh contemporary designs and also retail for other designers.

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Derek Lam |

Born into a family that specialized in design, Lam launched his own brand known for sophisticated feminine silhouettes fused with a relaxed sensibility.

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Thakoon

Thai-American designed Thakoon specializes in modern capsule wardrobe staples with a touch of elevated luxury.

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Delaroq

NYC-based designer Jennifer Lyu’s collection of accessories are grounded in sustainability by using only excess materials.

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Deveaux

Originally a menswear collection, Deveaux’s streetwear (designed by Matthew Breen and Andrea Tsao) seeks to recontextualize classic items through fit, fabrication, and silhouette.

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Issey Miyake

If there is anything Tokyo-born designer Issey Miyaki is known for, it’s her technologically forward designs and signature pleating.

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Superegg

Vegan and plant-based formulations are how Superegg made their name—they’re even made to match an egg’s nutritional value. Egg has played a role in many Asian beauty practices throughout history, which founder Erica Choi sought to reflect.

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JINsoon

JinSoon Choi’s eponymous nail collection (and salons in NYC) take high-tech polish fused with fashion-forward colors, to render her one of the most successful nail artists in the game.

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Bibhu Mohapatra

Mohapatra grew up on the east Indian coast, and his designs reflect those sumptuous and colorful textures—particularly in evening wear and cocktail dresses.

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Seree

Founded by a women-led team in NYC, the jade, agate, quartzite, and unique jewels made by Seree are ethically sourced across Asia and given a modern twist.

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Naeem Khan

Indian American fashion designer Naeem Khan is known for his intricate evening wear and gowns.

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Memorial Day

Crochet clothes and accessories worn by the likes of Ella Emhoff is made by FIT student Delsy Gouw.

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Snow Xue Gao

Parsons graduate Snow Xue Gao focuses on East-meets-West and mixed media with her up-and-coming collection.

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Paper Project

Paper Project’s speciality is clothing that is both comfortable and functional—and made from Japanese paper yarn, a practice that has been used in Japan for centuries.

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Air Pop

Air Pop’s masks were designed to protect from not only airborne pathogens but also anthropogenic and ecological airborn threats too.

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Chunks

Chunks’ quirky and colorful accessories are responsibly made through a partnership with a Chinese manufacturer started by Seattle-based brand founder Tiffany Ju.

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Pattaraphan

Pattaraphan’s brand mission is to work with Thai artisans and ethically sourced materials to create unpretentious jewelry that is reflective of Thai craftmanship.

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Nana Jacqueline

LA-based contemporary collection, founded by two Chinese women, Nana and Jacqueline, aims to create a dual sense of lightness and bold sexiness with women’s clothing.

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V Coterie

Leena Van Merkey founded V Coterie as a means of creating thoughtfully designed jewels that are made to be easily worn by healthcare professionals—artfully made jewels for those who care.

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Bonbon Whims

Founded by Clare Ngai, Bonbon Whims helps underserved communities that are supported by organizations such as GirlTrek, Send Chinatown Love, and Stop AAPI Hate, with whimsical and and nostalgic jewels.

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The Wobbles

The Wobbles crochet kits for beginners give users everything they need to make handmade gifts for loved ones.

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CJW

Hand illustrated accessories and loungewear are founder Christina’s playful manifesto, at a friendly price point.

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JW Pei

JW Pei specializes in ethical and sustainable vegan accessories with a modern and minimal aesthetic.

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Night

Founder Jessica Tse designs jewelry that is a quirky blend of New York taste and dolce vita wanderlust.

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Ookioh

Made out of regenerated materials, Ookioh’s swimwear is inspired by the pleasure-seeking lifestyle of Edo-era Japan.

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Rastah

Rastah was founded to support underserved artisans, designers, and technical workers in the subcontinent.

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SVNR

Ethics meets aesthetics with Christina Tung’s SVNR, whose brand focuses on re-used, upcycled, and natural materials.

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Pineapple

Abacaxi specializes in mindfully-made and boldly colored clothing that is inspired by travel, designed by South Asian American Sheena Sood.

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Pink Moon

Founded by Lin Chen, Pink Moon is a sustainable beauty and wellcare brand that specializes in providing products for women at all phases of life.

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R0AM

ROAM has carved out a space in the footwear with their cool and sporty designs that are casual and elevated.

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Kim Shui

A truly global transplant, with parents from Beijing and Sichuan and having grown up between the US and Rome, Kim Shui’s design is a reflection of the ability to assimilate diverse techniques into a clothing collage.

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Private Policy

Genderless silhouettes and high quality fabrics combined with classic shapes for clothes that are both tactile and visually fun are the Private Policy signature.

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KÚR

Designer Kasuni Rathnasuriya embraces the heritage and style of old Ceylon to incorporate artisanal handmade lace to contemporary design with two main collections each year.

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Senreve

Designed in NYC and crafted in Italy, Senreve is known for accessories made for a modern and professional woman.

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Wishbone

Wishbone’s relaxed contemporary line was created to help aid the drug epidemic by supporting drug prevention non-profits and organizations.

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Sundae School

Based in NYC, Sundae School is a brand of boutique smokewear.

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3.1 Phillip Lim

Street elegance is the name of the game for Philip Lim’s eponymous line, which first hit the scene in 2005.

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Prim Botanicals

Prim Botanicals (founded by a Filipino-born New York native) makes delicious smelling skincare that is just as yummy as it is good for your complexion. And they’re members of 1% for the Planet, too.

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Vera Wang

New York based designer Vera Wang is a fashion institution, known for exquisite red carpet gowns and bridal dresses.

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Social-Work

NY-based Social-Work was founded around creating functional and androgynous designs, subverting classical styles, and workwear basics.

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Chop Suey Club

Chop Suey is a downtown New York boutique which focuses on contemporary Chinese designs, arts, and culture, with the aim of making Chinese culture available to more audiences.

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Grace Lee

Grace Lee designs everyday fine jewelry with ethical and conflict free diamonds made to be stacked and layered.

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Neha Dani

Naja Dani is known for her jewels’ spectacular and sculptural movement in design.

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Sanjay Kasliwal

A storied heritage of jewelry design is reflected in the spectacular gemstones in this designer’s repertoire.

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Kamal

Kamal’s keepsake pieces are minimal and simply adorned—and meant to pass on.

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Aaryah

Consciously crafted meaningful jewelry that is as reflective of the craftsman as it is the wearer.

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Mizuki

Mizuki’s delicate pearl designs stand in a fresh and modern class of their own.

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Anita Ko

Anita Ko’s design ethos is feminine sophistication with a fresh twist—and an aim to be worn from day to day.

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Nam Cho

Nam Cho favors bright and fresh jewels and gemstones, for a presentation and design signature that is unlike anything on the market.

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Kavant & Sharart

Designed and founded by a couple, Kavant & Sharart makes baubles that are made to not only reflect exquisite craftsmanship, but also the personality of the wearer, meant to be passed down through generations.

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KATKIM

Katherine Kim is known for her simple design, clean designs, and unexpected silhouettes.

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Better

Mejuri fine jewelry is famously without a markup, and made with selective materials that everyone can feel good about.

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This content is created and maintained by a third party, and imported onto this page to help users provide their email addresses. You may be able to find more information about this and similar content at piano.io

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Business

Nuvation Bio Reports First Quarter 2021 Financial Results and Provides Business Update

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Nuvation Bio Reports First Quarter 2021 Financial Results and Provides Business Update

NEW YORK, May 17, 2021 /PRNewswire/ — Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the first quarter ended March 31, 2021, and provided a business update.

“Nuvation Bio continues to make meaningful progress on advancing our deep pipeline of therapies for difficult-to-treat cancers and remains on track to submit five additional Investigational New Drug (IND) applications by 2026,” said David Hung, M.D., founder and chief executive officer of Nuvation Bio. “We also continue to enroll and dose patients in our Phase 1/2 study of NUV-422, our lead cyclin-dependent kinase (CDK) 2/4/6 inhibitor, in high-grade gliomas and expect top-line data from the Phase 1 portion of this study in 2022. Our strong cash, cash equivalents and marketable securities of $824.7 million at the end of the first quarter provides us sufficient resources to continue to execute on our robust clinical development plan and grow our pipeline of novel and mechanistically distinct cancer treatments.”

Recent Business Highlights

  • Enrollment ongoing in Phase 1/2 study of NUV-422. Nuvation Bio continues to enroll and dose patients in the Phase 1/2 study of its lead investigational compound, NUV-422, a CDK 2/4/6 inhibitor, in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM). The Phase 1 dose escalation portion of the study is designed to evaluate safety and tolerability, as well as to determine a recommended Phase 2 dose based on the tolerability profile and pharmacokinetic properties of NUV-422. The Phase 2 dose expansion portion of the study is expected to initially focus on patients with high-grade gliomas and is designed to evaluate overall response rate, duration of response and survival. Data from the Phase 1 portion of this study is expected in 2022.

First Quarter 2021 Financial Results

As of March 31, 2021, Nuvation Bio had cash, cash equivalents, and marketable securities of $824.7 million.

For the three months ended March 31, 2021, research and development expenses were $15.9 million, compared to $7.3 million for the three months ended March 31, 2020. The increase of $8.6 million was due to an increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial. Also, the current period includes approximately $3.7 million related to the issuance of common stock as consideration for the purchase of in-process research and development.

For the three months ended March 31, 2021, general and administrative expenses were $4.6 million, compared to $1.9 million for the three months ended March 31, 2020. The increase of $2.7 million was due to increased personnel-related costs driven by an increase in headcount, as well as increases in professional fees, insurance costs and tax expense.

For the three months ended March 31, 2021, Nuvation Bio reported a net loss of $20.4 million, or $(0.12) per share. This compares to a net loss of $8.7 million, or $(0.10) per share, for the comparable period in 2020.

Restatement of Panacea Financial Statements

Nuvation Bio also announced that, as reported in a Current Report on Form 8-K filed with the SEC on May 14, 2021, as a result of guidance provided by the SEC on April 12, 2021 regarding the accounting for warrants issued by special purpose acquisition companies (SPACs), it is restating the previously issued 2020 consolidated financial statements of Panacea Acquisition Corp. (Panacea). Panacea combined with Nuvation Bio Inc. (Legacy Nuvation Bio) and changed its name to Nuvation Bio Inc. on February 10, 2021 (the Merger).

The restatement pertains to the accounting treatment for Panacea’s public and private placement warrants that were outstanding on December 31, 2020, as well as the forward purchase agreement (the “FPA”) with certain anchor investors, which provided for the potential future issuance of securities, including additional warrants. Consistent with market practice among SPACs, Panacea had been accounting for the warrants and the FPA as equity under a fixed accounting model. However, in light of the recent SEC guidance, we are restating Panacea’s historical financial statements for the year ended December 31, 2020 such that the warrants and the FPA are accounted for as liabilities and marked-to-market each reporting period. In general, under the mark-to-market accounting model, we measure the fair value of the liability-classified warrants and the FPA at the end of each reporting period and recognize any changes in their fair value in our operating results. As of December 31, 2020, Panacea had 4,954,167 warrants outstanding and subject to reclassification. Upon completion of the Merger, an additional 833,333 warrants were issued pursuant to the FPA.

The change in accounting treatment does not impact the historical financial statements of Legacy Nuvation Bio, which became the historical financial statements of the combined company upon completion of the Merger. In addition, Nuvation Bio currently expects that the reclassification of the warrants will have no impact on the liquidity or cash or cash equivalents in the historical financial statements of Panacea.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes six novel and mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com.

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential therapeutic benefit of Nuvation Bio’s product candidates, expected future IND filings, the expected timing of clinical trial data and the expected impact of the restatement of Panacea’s 2020 financial statements. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Nuvation Bio. Forward-looking statements are subject to a number of risks and uncertainties, including those factors discussed in the Quarterly Report on Form 10-Q filed with the SEC on or about May 17, 2021, in the section titled “Item 1A. Risk Factors,” and other documents that Nuvation Bio has filed or will file with the SEC. If any of these risks materialize or Nuvation Bio’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Nuvation Bio does not presently know, or that Nuvation Bio currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Nuvation Bio’s expectations, plans or forecasts of future events and views as of the date of this press release. Nuvation Bio anticipates that subsequent events and developments will cause Nuvation Bio’s assessments to change. However, while Nuvation Bio may elect to update these forward-looking statements at some point in the future, Nuvation Bio specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nuvation Bio’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Nuvation Bio Investor Contact:
[email protected]

Nuvation Bio Media Contact:
Argot Partners
Leo Vartorella
[email protected]

NUVATION BIO INC. and Subsidiaries








Condensed Balance Sheets




‘(In thousands, except share and per share data)

March 31,


December 31,


2021


2020





Assets








Current assets:




Cash and cash equivalents

$    638,904


$             29,755

Prepaid expenses

5,138


914

Marketable securities available-for-sale, at fair value

185,809


185,997

Interest receivable on marketable securities

1,015


1,092

Deferred financing costs


2,925

Total current assets

830,866


220,683





Property and equipment, net

772


688





Other assets:




Lease security deposit

421


421





Total assets

$    832,059


$           221,792





Liabilities and stockholders’ equity







Current liabilities:




Accounts payable

$        6,003


$               2,171

Accrued expenses

3,984


4,380

Total current liabilities

9,987


6,551

Warrant liability

15,561


Deferred rent – non current

167


157

Total liabilities

25,715


6,708





Commitments and contingencies (Note 11)








Stockholders’ equity




Class A and Class B common stock and additional paid in capital, $0.0001 par value per share;




1,060,000,000 shares authorized as of March 31, 2021 (Class A 1,000,000,000, Class B 60,000,000)




and 1,174,094,678 shares authorized as of December 31, 2020 (Class A 880,000,000, Class B 294,094,678);




217,650,055 (Class A 216,650,055, Class B 1,000,000) and 149,042,155 (Class A 91,397,142,




Class B 57,645,013) issued and outstanding as of March 31, 2021 and December 31, 2020, respectively

901,720


289,482

Accumulated deficit

(96,357)


(75,955)

Accumulated other comprehensive income

981


1,557

Total stockholders’ equity

806,344


215,084





Total liabilities and stockholders’ equity

$    832,059


$           221,792

NUVATION BIO INC. and Subsidiaries








Condensed Statements of Operations and Comprehensive Loss




(In thousands, except share and per share data)








For The Three Months Ended March 31,

2021


2020









Operating expenses:




Research and development

$       15,879


$       7,295

General and administrative

4,605


1,925

Total operating expenses

20,484


9,220





Loss from operations

(20,484)


(9,220)





Other income (expense):




Interest income

438


519

Investment advisory fees

(108)


(60)

Change in fair value of warrant liability

(293)


Realized gain on marketable securities

45


15

Total other income (expense)

82


474





Loss before income taxes

(20,402)


(8,746)





Provision for income taxes






Net loss

$     (20,402)


$     (8,746)

Net loss attributable to common stockholders




Net loss per share attributable to common stockholders, basic and diluted

$        (0.12)


$       (0.10)

Weighted average common shares outstanding, basic and diluted

169,659,037


85,714,375





Comprehensive loss:




Net loss

$     (20,402)


$     (8,746)

Other comprehensive income, net of taxes:




Change in unrealized (loss) gain on available-for-sale securities

(576)


819





Comprehensive loss

$     (20,978)


$     (7,927)

SOURCE Nuvation Bio, Inc.

Related Links

www.nuvationbio.com

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Get to Know the 12- Player Beach Soccer National Team

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Get to Know the 12- Player Beach Soccer National Team


USA ROSTER FOR 2021 CONCACAF BEACH SOCCER CHAMPIONSHIP

GOALKEEPERS (2): 1-Chris Toth (San Marcos, Calif., 12-Esteban Sapetnitzky (Miami, Fla.)


DEFENDERS (4):
2-Jason Santos (Cardiff-By-Sea, Calif.), 3-David Mondragon (Santa Cruz, Calif.), 5-Nicolas Perea (Hollywood, Fla.), 10-Gabe Silveira (San Francisco, Calif.)


FORWARDS (6):
4-Fredo Dilbert (Miami, Fla.), 6-Chris Albiston (Virginia Beach, Va.),7-Nick Perera (Carlsbad, Calif.), 8-Alessandro Canale (Venice, Calif.) 9-Antonio Chavez (Oceanside, Cali.), 11-Conner Rezende (Davie, Fla.)

Head Coach: Francis Farberoff (Miami, Fla.)

Assistant Coach: Ben Astorga (Miami, Fla.)

Performance Coach: Daniel Wartner (Atlanta, Ga.)

USA ROSTER NUMERICAL

Jersey #, Name, Position, Age, Height, Weight, Hometown


#1 CHRIS TOTH | GOALKEEPER | 31 | 6-1 | 178 | SAN MARCOS, CALIF.

Born August 4, 1989 in San Diego, Calif…is a third generation goalkeeper: grandfather György was well-known pro outdoor player in Hungary…father, Zoltan, also a former Hungarian international, defected to the USA and became a legend in the pro indoor game with the San Diego Sockers…Born with a rare heart condition that required surgery at birth, Chris attended Fallbrook HS and was a field player until doctors discover that he would need another heart procedure…following surgery was advised to consider less running – and so he turned to goalkeeping…played one year at Mira Costa College before turning pro and has been one of the top goalkeepers in both pro indoor and international beach soccer for several years…has played in the MASL with San Diego, Ontario and Tacoma, winning three Goalkeeper of the Year awards…has played Beach with clubs in Spain and Hungary, and has been named Top 50 Beach Soccer Players in the world three times…member of the U.S. Beach NT at the 2013 and 2019 (1 goal) FIFA Beach Soccer World Cups… has six career WCQ goals in four Concacaf Championships: 1 in 2013, 2 in 2015, 3 in 2017, 0 in 2019…WATCH: 12 STORIES PROFILE…IG: @christoth31


#2 JASON SANTOS | DEFENDER | 32 | 6-0 | 185 | CARDIFF BY THE SEA, CALIF.

Born June 29, 1988 in Southern California…has Spanish and Mexican ancestry…played at La Costa Canyon High School (league All-American) and club with Surf Soccer in Del Mar, Calif…played at UC Davis, graduating with a degree in Civil and Environmental Engineering…had tryouts in Mexico and Spain, and pro indoor stint with San Diego Sockers…while always into his studies and soccer, enjoys the surf and the snow with the occasional attempts to learn how to fly through skydiving…made his Beach NT debut against Japan in the 2014 Portugal Mundialito…next month scored hat trick against Brazil in Florida…member of USA teams at the 2015, 2017 (2 goals) and 2019 Concacaf Championships and 2019 FIFA Beach Soccer World Cup (1 goal)…is a Civil Engineer in San Diego…volunteers his time helping teach land development to high school and college students…WATCH: 12 STORIES PROFILE…IG: @sandtoesesq


#3 DAVID MONDRAGON | DEFENDER | 29 | 5-6 | 156 | SANTA CRUZ, CALIF.

Born Oct. 18, 1991 in Santa Cruz, Calif… Nicknamed ‘GuI was,’…parents are from Mexico…Played club with Santa Cruz County Breakers and De Anza Force, and briefly at Cabrillo College…was introduced to beach soccer at age 13 and influenced by former U.S. Beach MNT players Jevan Albuquerque and Yuri Morales…paid his way to tryout with U.S. Beach MNT but was not selected…later was on a club team that scrimmaged the USA and caught coach’s eye after scoring twice…debut with Beach MNT in 2017 Puerto Vallarta Cup against France…first goal was against Colombia, and also scored against Mexico – celebrating by doing the CauhtemIt’smoc Blanco pose (his idol)…scored 3 goals at the 2019 Concacaf Beach Soccer Championship and was member of the USA team at the 2019 FIFA Beach Soccer World Cup…WATCH: 12 STORIES PROFILE… IG: @wedventures


#4 FREDO DILBERT | FORWARD | 23 | 5-9 | 140 | MIAMI, FLA.

Born Nov. 25, 1997 in Miami…full name is Wilfredo Antonio Ramos Dilbert…mom Alicia Hodgson is from Honduras…dad Erich Kuhnke is born in Miami but raised in Germany and played for Frankfurt’s reserve team and in the beach soccer circuit for over 20 years…was always home-schooled, and played for Sports Leadership & Management High School in Miami…played club with Miami Shores, and began playing beach soccer at age 14…was recruited to play at Florida Gulf Coast Univ but did not attend…briefly attended and played at Palm Beach Atlantic Univ…had 1.5 month trial at Fortuna Dusseldorf and continues to pursue a career in beach soccer….earned first Beach NT cap against Iran at the 2018 Intercontinental Cup in Dubai…was among the final 15 player pool for the 2019 FIFA Beach Soccer World Cup but did not make the final 12-player roster…IG: @fredoad


#5 NICOLAS PEREA | DEFENDER | 28 | 6-0 | 168 | HALLANDALE BEACH, FLA.

Born August 6, 1992 in in Bucaramanga, Colombia…friends refer to him as Nico (“Neeko”)…moved to USA when he was seven…bilingual ENG/ESP… played club at Weston FC…played four years at Syracuse University, first Orangemen men’s soccer team to qualify for NCAA College Cup tournament…made Sweet 16 as sophomore year…graduated with Psychology degree…played with Jacksonville Armada and Rio Grande Valley…was identify by Beach MNT coach Farberoff during 2018 camp in Ft. Lauderdale…first Beach NT camp was January 2019…joined Indy Eleven for 2019 season…assists IG influencer and girlfriend Taylor Dante with handle @taystytravels with creative content and logistic…IG: @nicolasperea


#6 CHRIS ALBISTON | FORWARD | 28 | 6-0 | 165 | VIRGINIA BEACH, VA

Born Sept. 26, 1992 in Virginia Beach… played club soccer with Beach FC…played at Frank W. Cox High School, helping team to 25-0 record and a No.1 national ranking per ESPN.com in 2010…back-to-back state champs (2009 and 2010)…played four years at William & Mary University, graduating in 2015…then attended four years at Univ. of Richmond Law School…played for HRSC Elite in the North American Sand Soccer Championships U.S. Open and caught the eyes of Beach NT coaches…made Beach MNT debut at the 2018 Balaton Cup in Hungary against Japan, scoring the tying goal in 5-3 win…was among the final 15 player pool for the 2019 FIFA Beach Soccer World Cup but did not make the final 12-player roster…passed bar exam in fall of 2019 and is an attorney in Virginia…IG: @chris_albiston


#7 NICK PERERA | FORWARD | 34 | 6-3 | 200 | ENCINITAS, CALIF.

Born June 5, 1986…in Madrid, Spain to American mom, Spanish dad…family moved to Brussels Belgium when he was one year old…speaks English, Spanish, French, Dutch, Italian and Portuguese…family moved to San Diego, Calif. when he was 18…played at UC Santa Barbara as a walk-on, later leading the school to the 2006 NCAA College Cup final, scoring in the 2-1 win over UCLA…graduated with English degree…joined two Spanish lower division clubs but chose to return to San Diego and tried out for indoor giants, San Diego Sockers…simultaneously introduced to beach, and committed to the five-aside disciplines…made Beach MNT debut in 2011 at Miami Cup against Mexico, Spain and Brazil…is the USA’s all-time leading scorer with 99 goals entering 2021, and 37 goals in WCQ…has scored 7 goals at two FIFA Beach Soccer World Cups (5 in 2013, 2 in 2019) …current player/coach of Tacoma Stars (MASL)…has earned numerous accolades on turf and sand, including MASL MVP (2019) and three Top 50 Beach Soccer Player Worldwide twice…WATCH: 12 STORIES PROFILE…IG: @nickperera_soccer


#8 ALESSANDRO CANALE | FORWARD | 31 | 5-9 | 180 | VENICE BEACH, CALIF.

Born Dec. 29, 1989 in Santa Monica, Calif and grew up in Venice Beach…dad is Italian, mom is from Costa Rica…played club soccer for Santa Monica United Scorpions; played at Santa Monica High School, also one year at Santa Monica College before transferring to UC-San Diego for final two years, where he earned degree in Urban Studies and Planning…has appeared in Oreos, KFC, Dr. Pepper commercials and episode of Malcolm in the Middle…dad is an actor…made Beach MNT debut in 2013 versus El Salvador…youngest member of the 2013 FIFA Beach Soccer World Cup team (2 goals), and veteran of 2019 World Cup (3 goals)…fourth all-time leading scorer in World Cup Qualifying with 14 goals…played for the Tacoma Stars (MASL) during the 2020-21 season…owns a boutique creative design business called “Pattern Pending”…WATCH: 12 STORIES PROFILE… IG: @ssvndro


#9 ANTONIO CHAVEZ | FORWARD | 20 | 6-1 | 167 | OCEANSIDE, CALIF.

Born Jan. 30, 2001 in Oceanside…Mexican heritage through grandparents…older sister Graciela introduced him to soccer as kid…played club at Oceanside Breakers…played at El Camino High School…currently attending and playing at University of Saint Katherine…majoring in Kinesiology…Dad introduced hair philosophy “It ain’t hip until it’s to the hip” so Antonio has had long hair since first grade…has been playing beach soccer since 10 when youth club entered Oceanside Beach Soccer Championship…has been playing with SoCal Legacy beach soccer club, including tournaments in Portugal, Virginia Beach and Florida…saw IG post about NBSL in Ft. Lauderdale and teammates entered the tournament in December, where he caught the eye of Beach MNT coach Farberoff…is making his first U.S. Beach NT camp and potential debut…IG: @@antonio_chavez9


#10 GABRIEL SILVEIRA | DEFENDER| 29 | 5-9 | 165 | SAN FRANCISCO, CALIF.

Born April 28, 1992 in Greenbrae, Calif…both parents are from Brasilia, Brazil…moved back to live in Natal, Brazil from ages 2-7 before returning to Northern Calif…fluent in both Portuguese and English…played all forms of soccer growing up from futsal to beach and traditional 11v11…played club soccer with Marin FC and futsal with Bay Area club DiBufala…played at Redwood HS and four years at Sacramento State before graduating with an International Business degree…earned first Beach MNT cap against Japan at the 2018 Balaton Beach Soccer Cup in Hungary…injured during the 2019 pre- WCQ camp but returned and made the 2019 FIFA Beach Soccer World Cup roster…joined the US Futsal National team in Croatia for a preparatory camp early 2020…WATCH: 12 STORIES PROFILE… IG: gcamelosilveira


#11 CONNER REZENDE | FORWARD | 28 | 5-8 | 160 | DAVIE, FLA

Born Jan, 21, 1993 in Greenwich, Connecticut…grew up Davie, Fla…Dad is from Brazil…identical twin brother Calvin, currently playing at Moratalaz in Spain…played club at Weston SC…played and attended U (University) High School…played for Univ. of Virginia as freshman in 2011…left for Europe, trained with Italian club Cortone FC and Spanish side Cadiz…returned to US and attended / played at Saint Francis University in PA, graduated with Business degree…played for Miami FC under Alessandro Nesta…America Ninja Warrior contestant in 2016…first taste of beach was in 2011 when he played with FBS at Virginia beach tourney…first call up to Beach NT was in Jan.. 2017, in a combined camp with Japan’s Beach NT in Ft. Lauderdale…provides personal fitness plans and challenges on self-named influencer YouTube channel…IG: @_kiingcon


#12 ESTEBAN SAPETNITZKY | GOALKEEPER | 24 | 5-10 | 160 | MIAMI, FLA.

Born Sept. 15, 1996 in Miami, FLA…parents from Argentina…bilingual in Spanish and English…attended and played at Gulliver Prep HS, two-time Florida state champs…played club at Coral Gables Toros…competed against a number of Argentina youth club in Buenos Aires with Florida teammates in 2011-12…played one year at Clark University before transferring and graduating from Babson College with Business degree…Played at FBS FC at the Virginia Beach Tourney in 2013…picked beach soccer back up during Covid-19 in summer 2020 and worked his way into the team…first official MNT camp and looking to make debut…works as an associated at Crystal Lagoon U.S. Corp…IG: @estebansapet

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