FDA Approves Genentech’s Lucentis (Ranibizumab Injection) For Diabetic Retinopathy
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The Leading Cause Of Blindness Among Working Age Adults In The United States

  • First and only medicine FDA-approved to treat all forms of diabetic retinopathy
  • Granted Priority Review Designation by the FDA based on analysis of results from a National Institutes of Health (NIH)-funded collaborative group study

South San Francisco, Calif. – April, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. The most common cause of vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among adults aged 20 to 741 and affects nearly 7.7 million people in the U.S.2

With this approval, Lucentis becomes the first and only FDA-approved medicine to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye. In February 2015, Lucentis received FDA approval for the treatment of diabetic retinopathy in people with DME based on data from the pivotal RIDE and RISE Phase III clinical trials.

The FDA granted Lucentis Priority Review for the treatment of diabetic retinopathy without DME based on an analysis of the Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Protocol S study. This NIH-funded study compared Lucentis treatment to panretinal laser treatment in diabetic retinopathy patients both with and without DME. In the analysis that supported this approval, patients with and without DME in the Lucentis group experienced improvements in the severity of their retinopathy. Adverse events were consistent with those seen in previous studies.

“Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the U.S. between the ages of 20 and 74. We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic retinopathy.”

Priority Review Designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. The FDA previously granted Lucentis Breakthrough Therapy Designation for diabetic retinopathy in 2014 based on the pivotal RIDE and RISE Phase III clinical trials. Breakthrough designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible.

Diabetes affects more than 29 million people in the U.S.3 The longer a person has diabetes, especially if it is poorly controlled, the higher the risk of developing diabetic retinopathy and vision loss. Diabetic retinopathy occurs when blood vessels in the retina become damaged. This can cause vision loss or distortion when the abnormal vessels leak blood or fluid into the eye.1

About Protocol S

The Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Protocol S study was a randomized, active-controlled study comparing Lucentis to a type of laser therapy called panretinal or scatter photocoagulation (PRP) in 305 patients with proliferative diabetic retinopathy, including those with and without diabetic macular edema (DME). In the Lucentis group, patients received a baseline 0.5 mg intravitreal injection followed by three monthly intravitreal injections, after which treatment was guided by pre-specified re-treatment criteria.

In the analysis that supported the approval, 37.8 percent (n=56/148) of patients in the Lucentis group without baseline DME had a two-step or better improvement in their diabetic retinopathy and 28.4 percent (n=42/148) had a three-step or better improvement at two years, according to the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS). In Lucentis-treated patients with baseline DME, 58.5 percent (n=24/41) had a two-step or better improvement in their diabetic retinopathy and 31.7 percent (n=13/41) had a three-step or better improvement at two years. Adverse events were similar to those seen in other Lucentis trials.

The DRCR.net is funded by the National Eye Institute, part of the National Institutes of Health. The DRCR.net is a collaborative network dedicated to facilitating multicenter clinical research of diabetic retinopathy, DME and associated conditions, and supports the identification, design and implementation of multicenter clinical research initiatives focused on diabetes-induced retinal disorders. The DRCR.net was formed in September 2002 and currently includes over 115 participating sites with over 400 physicians throughout the U.S. The Protocol S study was supported, in part, by Genentech as part of the company’s ongoing commitment to supporting independent research and collaboration to advance science.

About Lucentis

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.

Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy and myopic choroidal neovascularization (mCNV).

Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.

Outside the U.S., Lucentis is approved in more than 110 countries to treat patients with wet AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO) and visual impairment due to choroidal neovascularization (CNV).

Lucentis Important Safety Information

Patients should not use Lucentis if they have an infection in or around the eye or are allergic to Lucentis or any of its ingredients. Lucentis is a prescription medication given by injection into the eye and it has side effects. Some Lucentis patients have had detached retinas and serious infections inside the eye. If the eye becomes red, sensitive to light, or painful, or if there is a change in vision, patients should call or visit an eye doctor right away.

Some patients have had increased eye pressure before and within one hour of an injection.

Uncommonly, Lucentis patients have had serious, sometimes fatal problems related to blood clots, such as heart attacks or strokes. Fatal events were seen more often in patients with diabetic macular edema and diabetic retinopathy with Lucentis compared with patients who did not receive Lucentis.

Serious side effects include inflammation inside the eye and, rarely, problems related to the injection procedure such as cataracts. These side effects can make vision worse.

The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision and increased eye pressure. The most common non-eye-related side effects are nose and throat infections, headache, lung/airway infections, and nausea.

Patients may report side effects to the FDA at (800) FDA-1088 or

http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.

For additional safety information, please see Lucentis full Prescribing Information, available here: http://www.gene.com/download/pdf/lucentis_prescribing.pdf

About Genentech in Ophthalmology

Genentech’s vision for ophthalmology is to bring innovative therapeutics to people with eye diseases. Currently, the company is conducting Phase III clinical trials for people with geographic atrophy (GA), an advanced form of AMD, as well as investigating platforms for sustained ocular drug delivery and a treatment for giant cell arteritis, a form of vasculitis that can lead to blindness. Additional focus includes using bispecific antibodies to simultaneously address multiple targets for patients with AMD and diabetic eye disease.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.4 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.

About Genentech
Founded 41 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Demi Lovato reveals in new YouTube doc that she had 3 strokes and a heart attack
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By Nardine Saad

Never one to shy away from the intimate details of her personal life, singer Demi Lovato is laying it on the table in a new documentary, “Demi Lovato: Dancing With the Devil.”

And like hotel heiress Paris Hilton and singer Justin Bieber before her, Lovato’s YouTube Originals release sees the “Barney & Friends” alum readily sharing what really happened when she was treated for a drug overdose in July 2018 and how it left her with brain damage.

“I’ve had so much to say over the past two years, wanting to set the record straight about what it was that happened,” she says in the trailer for the four-part documentary, which debuts March 23. The trailer dropped Wednesday during the virtual Television Critics Assn. press tour.

“FYI, I’m just going to say it all, and if we don’t want to use any of it, we can take it out,” the “Confident” singer adds. “Any time that you suppress a part of yourself, it’s gonna overflow.”

Lovato, 28, who has publicly struggled with her sobriety and physical and mental health, revealed in the trailer that she’d had three strokes and a heart attack. She said her doctors told her she had “five to 10 more minutes” to live when she was hospitalized for two weeks before entering an in-patient rehab facility.

She survived, of course, and told interviewers that, like her cat, she’d had a lot of lives and now she was on her “ninth life.”

In a video call Wednesday, Lovato told the Associated Press that she still was dealing with the effects: “I don’t drive a car because I have blind spots in my vision. For a long time, I had a really hard time reading. It was a big deal when I was able to read a book, which was, like, two months later, because my vision was so blurry.”

But her endurance is surprising to those around her.

Continue on to the LA Times to read the complete article.

Bill Gates Says it Will Take Latin America 6 to 12 months Longer Than The U.S. to Control COVID-19
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In an interview about his latest book and several other pressing issues, Bill Gates sounded especially concerned when I asked him about the slow pace of COVID-19 vaccination in Latin America and other parts of the developing world.

The Microsoft founder and mega-philanthropist, whose Bill and Melinda Gates Foundation has donated more than $1 billion to help combat the coronavirus pandemic especially in developing countries, told me that in the best case scenario the vaccines will control the virus in Latin America six months after the United States. But he cautioned that the delay could be much longer, perhaps of up to 12 months.

If things go well with the AstraZeneca, Johnson & Johnson and Novavax vaccines, “the inequity will be about a six-month” delay. “If things don’t go well with those vaccines, it could be nine to twelve months,” he said.

Gates lamented that, under the Trump administration, the United States failed to support the World Health Organization’s COVAX global vaccination program to help developing countries get 2 billion COVID-19 vaccines by the end of this year.

While president, Donald Trump withdrew from the WHO, and did not contribute funds for the COVAX program. His measures were strongly criticized by the scientific community, because you can’t defeat a pandemic if the rest of the world gets infected.

In addition, “the previous administration said that every American should have a vaccine before a single vaccine gets out of the country, which, you know, I don’t agree with,” Gates told me.

Fortunately, the Biden administration’s $900 billion COVID relief package includes $4 billion for the COVAX initiative, and “we encourage the Congress to finally show up to help the global effort,” Gates said. He added that “the Biden administration is very engaged in saying no, it’s not just America.”

Read the full article at Miami Herald.

Latin American Fintech Startups for the 2021 Acceleration Program
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Techstars together with Western Union are looking for Latin American startups that want to create the financial products that the world needs, and have announced the start of the call for their acceleration program that will be carried out remotely during 2021.

This program for fintech startups is led by mentors and takes place in 13 weeks, in which it is possible to connect entrepreneurs with up to 100 of the best Fintech mentors within the Western Union ecosystem and other recognized experts worldwide.

In addition, it offers consulting on fundraising issues, including a week with investors where projects with around 50 Venture Capital are introduced within the Techstars network. On average, each startup that has been part of this program has raised more than a million dollars of investment, representing a total market capitalization of more than 63 million dollars in its category.

In 2021, the third cohort of this program will be developed, which will select 10 startups at an early stage, preferably with an MVP ready to go to market. The program will kick off on July 19 remotely, with the possibility of spending the last weeks at Western Union headquarters in Denver, Colorado.

“We are specifically interested in Latin America because it is the region where entrepreneurs with incredible ideas are emerging; In addition, Western Union has a strong presence there, so we seek to continue to gain more traction by supporting initiatives that seek to revolutionize the way money is moved in the United States and emerging markets, ”says Elle Bruno, Managing Director of Techstars & Western Union Accelerator.

Applications will be open until April 7, 2021. For more information, you can visit the official site of Techstars & Western Union Accelerator.

Read the original article at Entrepreneur.

Some Latino Groups More Wary of Covid Vaccine, so Messaging Needs to be Tailored
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close up shot of Latina nurse administering COVID vaccine to a patient

Experts are urging Biden administration officials to better understand the source behind Covid-19 vaccine skepticism across different Latino communities to improve vaccine rollout strategies nationwide.

Surveys have found an “element of fear and mistrust” about the vaccine, but such fears manifest differently across different Latino subgroups, according to researchers Gabriel Sanchez and Juan Peña in a Brookings Institution analysis published Monday.

At least 28 percent of all Latinos surveyed by the Latino advocacy nonprofit UnidosUS in October reported that they were unlikely to get vaccinated for Covid-19. Latinos of Puerto Rican and Mexican origins were the most likely to report they would not get vaccinated, overwhelmingly citing concerns over potential negative long-term health effects and side effects from the vaccine, according to disaggregated data from the UnidosUS survey.

“Given that Mexican Americans and Puerto Ricans are the two largest national origin groups among Latinos, with roughly 41 million Latinos from these groups living in the United States, this is a significant concern for the ability the reach the goal of herd immunity through high rates of vaccine uptake across the population,” Sanchez and Peña said.

Over a third of all Latinas surveyed by UnidosUS stated they will likely not get vaccinated, compared to 22 percent of Latino men.

“This gender gap in the likelihood of vaccination identifies how important it will be to conduct more in-depth research with the Latino population and to better understand what is driving fear and concerns about the vaccine to help devise solutions,” Sanchez and Peña said.

While President Joe Biden “has taken an important first step” by establishing a Covid-19 Health Equity Task Force within the Department of Health and Human Services, Sanchez and Peña said more needs to be done in order to improve trust in the vaccine among Latinos.

Read the full article at NBC News.

Monica Lozano Joins Apple’s Board of Directors
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By Apple Newsroom

On January fifth Apple announced that Monica Lozano, president, and CEO of College Futures Foundation, has been elected to Apple’s board of directors. Lozano brings with her a broad range of leadership experience in the public and private sectors, as well as a long and storied track record as a champion for equity, opportunity, and representation.

Prior to joining College Futures Foundation, Lozano spent 30 years in media as editor and publisher of La Opinión, the

Image Credit – (Monica Lozano is the newest member of Apple’s board. Photo: Getty Images)

largest Spanish-language newspaper in the US, helping shine a light on issues from infant mortality to the AIDS epidemic. She went on to become chairman and CEO of La Opinión’s parent company, ImpreMedia. Lozano continues to serve on the boards of Target Corporation and Bank of America Corporation.

“Monica has been a true leader and trailblazer in business, media, and an ever-widening circle of philanthropic efforts to realize a more equitable future — in our schools and in the lives of all people,” said Tim Cook, Apple’s CEO. “Her values and breadth of experience will help Apple continue to grow, to innovate, and to be a force for good in the lives of our teams, customers, and communities.”

“Monica has been a pioneer in every organization fortunate enough to benefit from her vision and expertise,” said Arthur Levinson, Apple’s chairman. “After a thorough and fruitful search, I couldn’t be more confident in the positive impact Monica will have on our board and Apple as a whole.”

“I’ve always admired Apple’s commitment to the notion that technology, at its best, should empower all people to improve their lives and build a better world,” said Lozano. “I look forward to working with Tim, Art, and the other board members to help Apple carry those values forward and build on a rich and productive history.”

Throughout her accomplished career as a business leader, public servant, and philanthropist, Lozano has made an indelible impact on companies and communities in the US and around the world, earning awards from organizations like The Leadership Conference on Civil and Human Rights and the United States Hispanic Chamber of Commerce.

In her role as CEO of College Futures Foundation, Lozano has been a tireless advocate for expanding access to higher education, partnering with philanthropic organizations, state and local governments, and local communities to improve opportunity for low-income students and students of color.

Lozano is a co-founder of the Aspen Institute Latinos and Society Program, and a former chair of both the University of California Board of Regents and the board of directors of the Weingart Foundation, a private philanthropic organization. Lozano is also a former board member of The Walt Disney Company.

Read the original article at Apple Newsroom.

In Minority Communities, Doctors Are Changing Minds About Vaccination
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two black women waiting in line outside buiding waiting for vaccination

Many Black and Hispanic Americans mistrust government officials, and instead have turned to physicians they have long known.

Like many Black and rural Americans, Denese Rankin, a 55-year-old retired bookkeeper and receptionist in Castleberry, Ala., did not want the Covid-19 vaccine.

Ms. Rankin worried about side effects — she had seen stories on social media about people developing Bell’s palsy, for example, after they were vaccinated. She thought the vaccines had come about too quickly to be safe. And she worried that the vaccinations might turn out to be  (Image Credit – The New York Times)                                      another example in the government’s long history of medical experimentation on Black people.

Then, one recent weekend, her niece, an infectious disease specialist at Emory University in Atlanta, came to town. Dr. Zanthia Wiley said one of her goals in making the trip was to talk to friends and family back home in Alabama, letting them hear the truth about the vaccines from someone they knew, someone who is Black.

Across the country, Black and Hispanic physicians like Dr. Wiley are reaching out to Americans in minority communities who are suspicious of Covid-19 vaccines and often mistrustful of the officials they see on television telling them to get vaccinated. Many are dismissive of public service announcements, the doctors say, and of the federal government.

Continue to the original article at The New York Times. 

Farmworker turned astronaut Jose Hernandez urges kids not to give up
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Astronaut Jose Hernandez in spacesuit smiling holding his space suit helmet

Former NASA astronaut Jose Hernandez spent most of his youth working the fields.

So many kids have struggled with remote learning, but Hernandez wants them all to know when it comes to their future, the sky’s the limit.

As a young boy, Hernandez picked fruits and vegetables alongside his family.

“We spent nine months in California, three months in Mexico, but those nine months I went to three different school districts,” he explained.

The family settled in Stockton. Jose couldn’t speak English until he was 12 years old, but STEM subjects spoke to him.

“I gravitated towards math because 1 + 3 is 4 in any language,” Hernandez said.

When he was ten, Jose told his dad he wanted to be an astronaut, so his father laid out a five-part recipe for success.

First, set a goal. Then recognize how far away you are from that goal.

“The third thing is you have to draw yourself a road map to know where you’re at to where you want to go,” Hernandez added. “And then I asked what’s the fourth? He said you’ve got to get an education.”

The University of the Pacific grad called hard work the fifth ingredient.

But his path was a difficult one.

“NASA rejected me not once, not twice, not three times but 11 times. It wasn’t until the 12th time that I got selected,” he said.

Hernandez would blast off with the crew of the Space Shuttle Discovery in 2009.

“It’s a ride that even Disneyland would be envious of because you go from zero to 17,500 miles an hour in eight and a half minutes,” he recalled.

Jose worked on the International Space Station during the 14-day trip, which covered 5.4 million miles.

“I wish we had a frequent flyer program,” Hernandez laughed.

He circled the globe 217 times but remains a down to Earth guy who tells kids how to realize their own dreams.

“Hard work and perseverance and not being afraid to dream big,” he said.

Continue on to the NBC 7 to read the complete article.

Hispanic and Latino health and the Affordable Care Act
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The ACA has narrowed racial gaps in access to health care, but Latinos are still nearly three times more likely to be uninsured.

As a little girl, I would accompany my immigrant mother to her numerous doctor’s appointments; I didn’t know it, but at the time, she was fighting a brain tumor. By the tender age of 7, I had translated most medical terminology from English to Spanish; see, my mother did not speak any English and when she went to the doctor’s office, I was her tiny translator, not that I knew much, but I tried my best.

By the time I was 13, I understood what was happening to my mother and knew how to discuss her symptoms with all her physicians, including neurologists and radiologists. I had my mom buy me a Spanish-to-English medical dictionary and became well-versed in the processes that happen at every one of my mother’s appointments: blood pressure check, weight check, neurological tests. When I moved out of my parent’s home at the age of 24, she stopped going to her doctor’s appointments regularly and chose which doctors she “felt” like going to at the time. I have heard all of the excuses in the book: “I don’t know if they will have an interpreter,” “I feel fine, why do I need to go?” and the most recent one, “I don’t have the money to go to the doctor.”

Read the full article at Benefits Pro.

Why Many Latinos Are Wary Of Getting The COVID-19 Vaccine
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NPR’s Rachel Martin talks to Dr. Eva Galvez about the issue of vaccination hesitancy among the Latino community she serves in Oregon. Polling shows Latinos are less likely to trust a vaccine.

New data from the CDC this month continues to show the disproportionate impact the pandemic is having on certain communities. Those numbers show that Latinos are being hospitalized at almost four times the rate of whites. Polling has also shown that Latinos are less likely to trust a vaccine.

 (Photo Credit – BBC News)

So why is that? I spoke with Dr. Eva Galvez. She’s a family physician at Virginia Memorial Health Center in Hillsboro, Ore. Most of her patients are first and second-generation Latinos.

EVA GALVEZ: There continues to be just a lack of accurate information available to the community about the vaccine. So in other words, information that we are reading in different media platforms is often not in a language or at a literacy level that my patients can understand. So definitely this leads to many questions and also leads to much misinformation. What often happens is when people don’t have access to accurate information, they rely on other platforms, word of mouth, social media, and those are often not accurate. And we have seen anti-immigrant rhetoric. We’ve seen anti-immigrant policies. And there’s just mistrust, I think, of the federal government. And so when you have what they perceive as a federal government trying to bring a vaccine to the community, naturally there is some mistrust, and there is fear.

MARTIN: Do you see that fear and distrust across the board, or is it more acute among undocumented immigrants?

GALVEZ: We have a lot of mixed-status families, so even families who maybe have the documents to be in this country, they’re worried about grandma or aunt or uncle or Mom and Dad who don’t have documents. So, really, this fear is being seen whether or not people have legal status.

MARTIN: Is there a particular anecdote you can share, a conversation you’ve had with someone who was honest about those fears or concerns?

GALVEZ: Yeah, absolutely. It was a family who came in to get care for their children. And so the visit really was not a visit for Mom and Dad. But Mom asked me if the vaccine was safe, and she had heard some information on a social media platform that the vaccine had long-term side effects and that the vaccine was actually risky. And then she asked me, how can you ensure that this vaccine is safe? And then what I told her was that we had done very many studies, and it had gone through a rigorous process and that, based on my reading, that it was safe. And what I conveyed to her was that all vaccines have side effects, but that the risks of the side effects generally are less than the benefits of getting the vaccine. And that was how we ended up leaving the conversation. So she didn’t tell me that she was going to get the vaccine, but she certainly seemed open to the vaccine. And so it’s really fighting two battles here. One is trying to convince people that the vaccine is safe and that it is important, but at the same time is also trying to rectify all of those messages that they have been getting from other sources. So these conversations really do take time.

Continue to the full article at NPR.

Free Zoom alternative: Microsoft Teams lets 300 users video chat for 24 hours
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This year has been a huge year for Zoom, as families and friends around the world have turned to the video chat service to stay in touch during the COVID-19 pandemic.

Microsoft Teams just barreled into the room to make Zoom look a little silly by comparison.

According to The Verge, Microsoft’s primarily business-focused video call app is getting a free tier with a 24-hour time limit on calls just in time for the holidays.

As many as 300 people can jam into one room, with a gallery view that can display up to 49 of them on one screen. (Zoom has a max of 100 participants for Basic and Pro users.) There’s also a feature called Together Mode that will arrange everyone’s video feeds so it looks like they’re sitting together in a theater or coffee shop. If your family is that big, feel free to go nuts with Microsoft Teams — and good luck following the conversation.

Calls can be started and joined from a web browser so you don’t need to download an app. Whoever starts the call will need a Microsoft account, which you should have on hand if you’ve ever used Office or an Xbox but is pretty easy to set up if you haven’t. Crucially, folks who don’t have Microsoft accounts can join calls.

Continue on to Mashable to read the complete article.

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