Em nota, a Anvisa destacou que o medicamento foi desenvolvido para reconhecer e se ligar seletivamente à proteína c-Met presente na superfície das células tumorais, permitindo a internalização do complexo e a liberação intracelular da monometilauristatina E, resultando em morte celular direcionada.

Notícias relacionadas:

• Anvisa proíbe lotes de medicamento para tratar câncer.
• Anvisa determina apreensão de lote falsificado de toxina botulínica.
• Ashwagandha: Anvisa alerta que suplemento do TikTok não tem registro.

Ainda segundo a Anvisa, o câncer de pulmão figura como uma das principais causas de mortalidade pela doença no mundo. O CPCNP representa aproximadamente 85% dos casos, sendo que cerca de 70% correspondem ao subtipo não escamoso, alvo da medicação aprovada.

“Pacientes com doença localmente avançada ou metastática (quando as células do tumor se propagam para outras partes do corpo) apresentam prognóstico desfavorável. Após a quimioterapia e imunoterapia, há uma limitada disponibilidade de terapias”, reforçou a agência.

Câncer de mama

A Anvisa também aprovou o registro do medicamento Poherdy (pertuzumabe), indicado para o tratamento de câncer de mama metastático e para câncer de mama em estágio inicial.

No caso da doença metastática, o uso é indicado em combinação com trastuzumabe e docetaxel, voltado para pacientes com câncer de mama HER2-positivo metastático ou localmente recorrente não operável, que não tenham recebido tratamento prévio com medicamentos anti-HER2 ou quimioterapia.

Já para pacientes com câncer de mama inicial, a indicação é o uso combinado com trastuzumabe e quimioterapia, para os seguintes casos:

tratamento neoadjuvante (antes da cirurgia) de pacientes com câncer de mama HER2-positivo localmente avançado, inflamatório ou em estágio inicial, com elevado risco de recorrência como parte de um esquema terapêutico completo para o câncer de mama inicial.

tratamento adjuvante (após a cirurgia) de pacientes com câncer de mama HER2-positivo em estágio inicial, com elevado risco de recorrência.

Em nota, a Anvisa citou o caso de uma mulher britânica que teve falência do fígado, paradas cardíacas e sérios danos cerebrais após o uso do produto e reforçou que o suplemento não tem registro no Brasil.

Notícias relacionadas:

• Anvisa proíbe lotes de medicamento para tratar câncer.
• Anvisa determina apreensão de lote falsificado de toxina botulínica.
• Anvisa proíbe canetas emagrecedoras sem registro vendidas na internet.

“Sua fabricação, comercialização, distribuição e uso são proibidos no país. A substância não integra a lista de ingredientes autorizados para uso nesse tipo de produto.”

A agência destacou que suplementos alimentares figuram como alternativa para complementar a alimentação e podem ser úteis para pessoas que precisam melhorar o consumo de algum nutriente ou praticar atividades físicas intensas.

“É terminantemente proibido vincular o uso desses produtos a alegações de cura, tratamento e prevenção de doenças.”

Entenda

A Resolução da Diretoria Colegiada nº 243/2018 define que suplementos alimentares devem ser feitos com substâncias autorizadas e podem conter aditivos e ingredientes de uso tradicional em alimentos, adicionados ao produto para dar sabor, cor e aroma, entre outras funções. 

São produtos para consumo via oral em formas de comprimido, cápsula, pastilha, pó e barra, destinados a suplementar a alimentação de pessoas saudáveis com nutrientes, substâncias bioativas, enzimas ou probióticos. “Nem todas as pessoas precisam utilizar esses produtos”, alertou a Anvisa.

“Essa decisão deve ser avaliada com a ajuda de profissionais de saúde qualificados e envolve diversos fatores, incluindo a condição atual de saúde, a qualidade da alimentação e a prática de atividade física. Se houver necessidade de suplementar, cabe aos profissionais de saúde a orientação sobre o tipo de suplemento, a quantidade, quando e como tomar.”

Riscos

De acordo com a agência, a maior parte dos perigos associados ao consumo de suplementos alimentares está ligada a produtos irregulares – seja pela presença de substâncias não avaliadas pelos órgãos reguladores ou por falhas nas condições de fabricação.

Os riscos, entretanto, não se restringem a produtos clandestinos. Segundo a Anvisa, itens devidamente legalizados também podem prejudicar a saúde quando consumidos em desacordo com as necessidades do paciente e as instruções de uso.

“Diante disso, vale reforçar a importância de consultar rigorosamente as indicações do fabricante, respeitando dosagens, advertências e restrições informadas no rótulo e na embalagem de cada produto.”

United States has denied former Barcelona Mayor Ada Colau permission to travel to Puerto Rico, where she was due to take part in a municipalist forum next month, a decision that sources close to her link to her pro-Palestinian activism.

Ada Colau, a candidate for the Frente Amplio, had planned to attend the Ciudades Valientes meeting on November 3 and 4 in the municipality of Caguas in central Puerto Rico. When she applied for the digital travel authorization known as ESTA (Electronic System for Travel Authorization), U.S. authorities approved the members of her delegation but denied her request. She was then advised to attend an in-person interview at the U.S. embassy in Madrid.

According to people close to Colau, the interview held two weeks ago focused on her position on the conflict in Gaza. “The entire interview was about the Flotilla and her pro-Palestinian activism, with a lot of insistence on the three days she was held in Israel,” they said.

RELATED: U.S. Expands Social Media Review for Visa Applicants Starting October

After the interview, U.S. authorities issued a final denial, citing “suspicion that she wants to migrate illegally to the country.”

“This is a clear case of political censorship. And it is a disgrace, because while we see that Javier Milei can travel freely to our country to insult the press and citizens in general, his friend Donald Trump bans me from entering a country like Puerto Rico, which is a colony occupied by the United States,” Colau said.

Ada Colau governed Barcelona between 2015 and 2023. She had traveled to the Caribbean archipelago in April 2024 to discuss urban planning, access to housing, human rights and the role of women in politics. During that visit, at a conference on government and citizen participation, she advocated for truth, justice and reparation in the face of European colonization in Latin America.

The prohibition echoes other restrictions imposed by Washington on figures critical of its foreign policy. The same administration has repeatedly denied a visa to Palestinian leader Mahmoud Abbas to attend the United Nations General Assembly. In Colau’s case, the stated rationale of immigration risk collides with a documented history of official visits and public conferences.

Event Agenda Unchanged

The decision keeps the event in Caguas and preserves the original schedule rather than postponing or relocating it.

The Puerto Rican collective confirmed that its upcoming event will keep its original agenda, and that the political leader will participate remotely. “Ada will be present, one way or another, because ideas and courage do not require visas to cross the borders imposed on us to divide us,” they affirmed.

“Colau is one of the founding voices of the international municipalist movement that inspires this meeting and her physical absence will be felt, but we maintain our commitment to the exchange of experiences,” the organizers said, rejecting the ban.

“Her physical absence will be felt, but we maintain our commitment to the exchange of experiences. Our collaboration with Ada and with the Sentit Comú Foundation remains just as strong and Brave Cities will take place as planned,” the League stated in a public communiqué.

For her supporters, the case exposes the double standard at the heart of the colonial relationship. The denial of entry, they insist, is not a security measure but a political sentence delivered through administrative channels.

Organizers say the work continues, and that Colau’s ideas will still shape the conversations in Caguas even in her in-person absence. The entry ban, however, ensures that a voice critical of U.S. policy will not speak from the island that Washington governs as a colony.

Puerto Rico has been under U.S. control since 1898, after the Treaty of Paris, and since 1952 has held the status of a commonwealth with its own constitution, although the United States retains exclusive control over immigration, customs, defense and currency. ESTA was required because of the island’s colonial status. Puerto Rico is a U.S. territory, and ESTA applies to travelers from visa-waiver countries such as Spain who enter U.S. territory.

Rights groups have often criticized U.S. visa denials based on political views, while U.S. officials typically say such decisions follow immigration law and are not open to public discussion.

• Visa is rolling out a new "V" to pop on mobile screens as people move to contactless payments.
• It's the company's first refresh of this size since 2021.
• Other brands have increasingly leaned on symbols and pared-down names for better mobile visibility.

Visa is betting that less is more when it comes to how it shows up to customers.

Starting Wednesday, the letter "V" will replace "Visa" in the center of its credit cards and on its digital properties, the company exclusively told Business Insider.

Visa's move signals that after 50 years of using the name, it feels it has enough brand recognition to be represented by a single letter. The change is also meant to pop more on small screens as people conduct more of their lives on their mobile devices.

In addition to the "V," Visa is introducing a new font, called Visa Sans, lopping off the serif in the first letter of "Visa."

The changes were developed by Visa's in-house creative studio and Base Design. It's Visa's first significant refresh since 2021, when it introduced a blue, white, and yellow flag-like brand symbol and a new font. With the new "V," that brand symbol will go away.

"There was an opportunity for us to modernize that and make it feel fresh, particularly for the next generation of consumers," Frank Cooper III, CMO of Visa, told CMO Insider. "We think it marries well with the evolution of the brand overall."

Cooper said the process took about a year.

"We do not have an awareness issue. We have deep trust. Playing around with the brand positioning is no light matter," he said.

Other big brands have increasingly leaned on symbols and pared-down names for better visibility on smaller screens.

Mastercard dropped its name from its logo in 2019. Google introduced a sans-serif logo and a new, four-color "G" icon in 2015.

Dan Nicholas, design director at creative studio Super Okay, said the move to a singular V aligns with a mobile-first approach that tech and media brands like Verizon and The New York Times have taken, in which they adopt a single letter as an icon.

He said the move simplifies Visa's appearance but could undermine brand recognition.

"What remains to be seen in the rollout is how Visa manages this new equity," he said. "If thoughtfully and strategically executed and invested in over the next few years, we can see it becoming a strong way for the brand to express itself."

Visa sees its visual changes as a companion to an effort to associate itself with culture and aspiration. It enlisted celebrities like Pharrell Williams for its "Power of Small Steps" campaign and has a partnership with the FIFA World Cup that extends through 2030. This year's World Cup campaign promoted its contactless payment option to emphasize that Visa's long-running slogan, "everywhere you want to be," was more than just a physical destination.

"We see that phrase now as representing both a physical destination and a personal aspiration," Cooper said.

A decisão foi publicada nesta segunda-feira (19) no Diário Oficial da União. 

Notícias relacionadas:

• Anvisa determina apreensão de lote falsificado de toxina botulínica.
• Anvisa proíbe canetas emagrecedoras sem registro vendidas na internet.
• Anvisa aprova novo medicamento para tratar lúpus.

A suspeita é que sejam produtos falsificados.

Em nota, a Anvisa informou que a própria detentora do registro do produto, Beaufour Ipsen Farmacêutica Ltda., identificou unidades do lote com características divergentes das do medicamento original.

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• Congresso aprova exame obrigatório para exercício da medicina.

De acordo com a agência, os produtos não podem ser vendidos, distribuídos nem utilizados.

The H-1B visa system is one of high stakes, shifting rules, and little certainty.

Over the past year, Business Insider has spoken to more than 20 H-1B visa holders and hopefuls about their decisions to opt in, push through, and sometimes give up on the H-1B American Dream as the Trump administration has become increasingly hostile to foreign workers.

As part of our H-1B Fallout series, published one year after the Trump administration introduced a $100,000 payment for some new H-1B petitions, we are telling the stories of people navigating the visa system. Some left the US and returned to their home countries, while others rebuilt elsewhere or are still trying to build a career in the US.

In a statement, a White House spokesperson said the goal of the $100,000 H-1B fee is to focus on sponsoring "truly highly specialized temporary labor." A Department of State spokesperson said the US is unapologetic about its "America first visa policies" and that the administration is working with partners to facilitate necessary visas. A Department of Labor spokesperson said the administration is protecting American jobs and increasing wages.

Keep reading to see what life has been like for people affected by the US's immigration policy changes.

Soumi Chanda, 35

Soumi Chanda had spent 13 years building a life in the US when a 2025 layoff put her H-1B status at risk.

Chanda moved from Kolkata to Spokane, Washington, in 2013 for graduate school. She was selected for an H-1B on her first attempt in 2021 — "pure luck," she said — and Amazon later took over her sponsorship, prompting her move to Seattle.

When Amazon laid her off, Chanda had 60 days to find a new sponsor or leave the country. "Sixty days sounded impossible from the start," she said. Her search came as debate intensified over the proposed fee. "Even with Amazon on my résumé, I didn't get a single interview the following month," she said.

When preparing to leave the US, Chanda made her two cats her priority. She spent weeks arranging their international travel and paid roughly $5,000 for paperwork, along with thousands more to break her lease, dispose of her belongings, and secure last-minute travel. In total, she estimates the move cost her $18,000.

Now back in Kolkata, she's still working out whether India will be her long-term home. "There's plenty here I value, and other things, as a feminist, I find harder to reconcile."

Even with Amazon on my résumé, I didn't get a single interview the following month.

Read: She was picked for an H-1B visa on her first try, but got laid off

Luciana Pereyra, 26

Luciana Pereyra moved from Peru to the US at 17 on a tennis scholarship. After graduating, she landed a marketing role at Ohio State. Her H-1B was approved in April 2024. She described that time as living in "survival mode," knowing that losing a job could also mean losing her home.

In December 2025, Pereyra said HR contacted her to say that her position would end the following month. She had 60 days to find another employer to sponsor her visa or leave the country. "I treated the job search like the last match of my career," she said.

She focused on university jobs, but the timing worked against her: Many campuses closed for winter break as her grace period began. She said two promising opportunities fell through after prospective employers raised concerns about securing a visa amid the proposed H-1B fees.

Pereyra returned to Peru in March. In Lima, she freelances for a US marketing client, coaches tennis, and is building a small business. She said she would consider moving to the US again, but only if it came with "a real path to permanent residency."

I treated the job search like the last match of my career.

Read: She played college tennis, earned 2 degrees, then lost her H-1B job

Mohamed Zeeshan, 33

Recent changes to US immigration policy have made Mohamed Zeeshan, a green card holder, more concerned about whether immigrants like him can build stable lives in the country.

He's seen relatives and friends consider countries such as Germany and Australia, rather than the US, because of the difficulty of securing jobs and visas after graduation. The instability surrounding H-1B visas — including the proposed $100,000 fee for new applicants — has reinforced his concerns.

Zeeshan self-petitioned for a green card and received it in 2023, enabling him to live in the US without needing employer sponsorship.

In 2025, he started his own consulting firm. Over the past year, Zeeshan said he has watched the immigration landscape become more uncertain.

He still plans to become a US citizen but says that if he had to rely on an H-1B visa today, he doesn't think he'd do it: "When you're on an H-1B here in the US, you're kind of always on tenterhooks."

"You don't know if you're going to be here next month or two months or three months down the line. That's a very difficult position to be in."

His wife is still waiting for her green card, and the couple is holding off on having children until they have more clarity about her status.

When you're on an H-1B here in the US, you're kind of always on tenterhooks.

Read: He moved to the US on a green card and wouldn't do the same on an H-1B

Vivienne Yang, 31

Vivienne Yang found out she was being laid off from her H-1B-sponsored job while she was on vacation in Japan in October 2024.

She spent the rest of the trip speaking with immigration and labor lawyers, emailing her employer, and trying to enjoy sightseeing with her partner.

Yang, who is from Taiwan, managed to get her employment extended for a few weeks, allowing her to fly back to New York. She then switched to a B-2 tourist visa so she could stay in the US longer and search for another job. She went through over 20 job interviews in the next year, all of them unsuccessful.

So, she decided to pivot.

Yang was accepted into a New York acting program, but her application for a US student visa was denied after she returned to Taiwan to apply for it in December 2025. Her American partner now looks after her two cats in Brooklyn while she remains in Taiwan, living with her family and working as a content creator, business English coach, and freelance consultant.

She has put her US plans on hold. "I don't want to deal with visa issues anytime soon," she said.

"Now I can move on with my life without any regrets because I know I have tried," she said. "I have a better understanding of what living abroad looks like and what American dream looks like in reality."

I have a better understanding of what living abroad looks like and what American Dream looks like in reality.

Read: She lost her job and left behind her American dream — and her cats

Watch: Vivienne Yang on letting go of her American dream

Ananya Joshi, 26

Ananya Joshi's plans to build a career in the US came apart in 2025, when a visa setback and a sudden layoff pushed her to look for a future elsewhere.

Joshi had moved from India to Illinois to pursue a master's degree. After graduating in 2024, she joined a Chicago startup developing cultivated meat as a scientist, working on an F-1 Optional Practical Training, or OPT visa.

She was enjoying the work until she learned that her employer could not complete E-Verify, which employers must use to sponsor an extension of STEM graduates' OPT.

From May through July 2025, Joshi interviewed for jobs around the world. She received offers in Canada and Germany and ultimately chose Germany. "Having gone through so much, I realized I needed that stability," she said.

In January, she moved to Rostock, about three hours north of Berlin, to join another lab-grown-meat startup. These days, Joshi is taking German classes and adjusting to what she describes as a slower work culture. She's also learning to navigate a long-distance relationship with her boyfriend, who remains in the US.

Joshi said she would still like to return to the US, but said, "I can't forget what I went through."

I realized I needed that stability.

Read: Her American dream hit a visa roadblock; she found a job in Germany

Watch: H-1B visa hopeful had her life upended, moved to Germany

Gu Yichen, 31

Gu Yichen's path to working in the US began in high school, when he spent a year as an exchange student in Yacolt, a small town in Washington State. He later attended college in the US, interning at Amazon before joining the company full-time after graduation.

With a STEM degree, Gu had three chances to enter the H-1B lottery. He was selected on his third try.

In late 2022, Gu left Amazon for a job at Google, despite his manager's warning that the market was becoming unstable. He was laid off the following month, before he had done "a single day of real work."

Gu faced pressure to find a new employer within the 60-day grace period. Rather than take a stopgap role, he returned to China for a break before ultimately rejoining his former Amazon team in the US on an I-140, an immigration petition that can support a green-card application.

He has since applied for a green card, hoping it will give him "more freedom in both my personal life and my career."

Over the past year, he said the biggest challenge has remained the same: His ability to stay in the US is tied to his job. "I've been thinking what kind of life I really want to live and what is my real interest in life."

I've been thinking what kind of life I really want to live and what is my real interest in life.

Read: Google laid him off a month after hiring him; he was on an H-1B visa

Disha Lamba, 28

Leaving a six-figure data-scientist job in New York and returning to India in May was not an easy decision for Disha Lamba, but she says being closer to her family — and free from the limits of an employment visa — made it worthwhile.

Lamba moved to the US in 2021 to pursue a master's degree. She later joined CVS Health as a data scientist and learned that she had been selected in the H-1B lottery in March 2026.

By then, however, Lamba had already decided to move home. Though she had a fulfilling job and social life in New York, she struggled with the distance from her parents.

The prospect of managing an H-1B long-term reinforced her decision. Lamba was concerned about the difficulty of obtaining visa stamps to travel, as well as the limits the visa can place on changing employers, taking a career break, or pursuing additional income.

"Anything comes with its pros and cons. H-1B has its pros but also has its cons. I wasn't OK with the cons of being in these restrictions," she said.

After resigning, Lamba moved back to live with her parents and brother. She took a two-month career break and secured a short-term contract role, but she's still looking for a permanent job. Nonetheless, she's still happy about her decision.

"Every moment when I get to hug my parents, that's when I realize, no, this was all worth it," she said.

H-1B has its pros but also has its cons.

Read: She moved back to India to be near family and leave H-1B limits behind

Sunjana Ramana, 27

After three failed attempts to obtain an H-1B visa, Sunjana Ramana is reinventing her "American Dream."

Ramana moved from Hyderabad, India, to New York in 2021 for her master's degree. After graduating in 2023, she joined a global insurance company. Her employer entered her in the H-1B lottery in 2023, 2024, and 2025. She was not selected.

When her work authorization ended in early 2026, Ramana had to leave the US.

"When I didn't get the visa, I was really, really clueless. I thought that was the end of everything that I had built for three years," she said, adding, "but I realized just a couple of months later that there are so many additional options that I didn't know existed."

Instead of returning to India, Ramana secured a 2-year UK visa that is not tied to one employer. She chose London as her base, where she could pursue the entrepreneurship she had wanted to explore in the US.

Ramana was accepted into Antler's founder-in-residence program and spent two months building Flax, a two-person tech company that helps AI founders and builders. In May, she moved into a product-management role in fintech.

"I want to go back and tell my younger self not to associate the 'dream' with America or a country for that matter, because it doesn't matter where you are. The dream should be aligned to you and your goals."

When I didn't get the visa, I was really, really clueless. I thought that was the end of everything that I had built for three years

Read: She left the US when she didn't get an H-1B visa. Now, she's living a new dream.

Madhur Mehta, 36

An H-1B selection brought immediate relief for Madhur Mehta this year, but it has not resolved the uncertainty that shapes his and his fiancée's plans in the US.

Mehta moved to the US in 2021, earned a master's degree in 2023, and was eligible for three years of student work authorization. Amazon offered him both a job and sponsorship.

He joined the company in 2025 as a program manager.

But over the past year, while the company was trying to get him an H-1B, Mehta grew concerned about changes to the lottery. He began exploring backup plans for his US life, including an EB-1A visa and opportunities in Canada and Australia.

He learned he was selected for an H-1B in March, potentially giving him the chance to work and remain in the US for another three years.

"It was a big relief," he said, adding, "It's like someone has taken a 100-pound load off your mind," he said.

Mehta's fiancée, who is also from India, has one remaining chance in the H-1B lottery before her work authorization expires.

"It's hard, you know, obviously you can't plan," Mehta said, adding, "unless we are both very clear on what our visa status is."

It's like someone has taken a 100-pound load off your mind.

Read: He got an H-1B visa, but uncertainty makes it hard to plan his future

Shreya Mishra Reddy, 34

Shreya Mishra Reddy left the US in January after not being selected for an H-1B visa. Her plan was to leave the country and keep applying for US jobs from abroad.

That plan, however, started to feel unrealistic after the Trump administration proposed the $100,000 fee on some H-1B applicants.

Though the fee has been challenged in court and is not being enforced, she said the uncertainty changed her mind: "I've decided not to pursue H-1B or any role in the US right now."

Reddy had moved to the US in 2021 for a master's degree in engineering management at Duke University. After graduating, she was hired by Visa, but her student work authorization expired before she could secure an H-1B visa.

She's now in Toronto with her husband on a tourist visa and weighing whether to base herself in Canada or India. During a career break, Reddy has been writing a fiction book and building a handloom brand while exploring fintech roles.

In March, Reddy was accepted into a master's program in psychology at the University of Pennsylvania. She decided not to attend, citing uncertainty around student visas and the US job market.

She said she's optimistic about her future and wishes she'd been more open to opportunities in other countries earlier, rather than banking everything on the US.

"I was thinking that H-1B would pan out for me, it didn't, and it's something that I definitely regret."

I was thinking that H-1B would pan out for me, it didn't, and it's something that I definitely regret.

Read: She gave up on H-1B amid $100K fee; now she's weighing Canada or India

Watch: Why an H-1B visa hopeful decided to give up on work in the US

I was thinking that H-1B would pan out for me, it didn't, and it's something that I definitely regret.

Read: I changed course on my H-1B plans because of the proposed $100,000 fee. Why I'm optimistic about my life outside the US.

Watch: Why an H-1B visa hopeful decided to give up on work in the US

Dados da Associação da Indústria Farmacêutica de Pesquisa (Interfarma) mostram que a posição brasileira no ranking de países que mais fazem esses testes subiu da 18ª para 12ª, de 2025 até o primeiro semestre de 2026. A associação também projeta que a 10ª posição possa ser alcançada em pouco tempo, com os novos investimentos previstos, superiores a R$ 2 bilhões anuais. 

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• Saúde aprova protocolo para tratar crianças com hemofilia A.
• Entenda o linfoma não Hodgkin, câncer que causou morte de Netinho.
• Anvisa proíbe canetas emagrecedoras sem registro vendidas na internet.

As pesquisas clínicas são uma etapa fundamental para o desenvolvimento de novos medicamentos, tecnologias e procedimentos de saúde. Geralmente contemplam três fases em que essas inovações são testadas em um número crescente de pessoas, para comprovar se são seguras e eficazes. Isso só acontece depois de testes bem sucedidos em laboratório e animais. 

No Brasil, as pesquisas clínicas só são permitidas após aprovação de um comitê de ética, responsável por resguardar os direitos dos participantes, e da Agência Nacional de Vigilância Sanitária (Anvisa), que verifica se os procedimentos pretendidos atendem aos requisitos de boas práticas. 

Novos prazos

A nova lei criou o Sistema Nacional de Ética em Pesquisa com Seres Humanos, reorganizando os fluxos de trabalho dos comitês, e encurtou os prazos de análise. Agora, o parecer ético deve ser emitido em até 30 dias úteis, e a avaliação da Anvisa, em até 90 dias úteis, excluindo prazos de recurso e esclarecimentos. 

A presidente da Roche Brasil, Lorice Scalise, lembra que nos casos de pesquisas multicêntricas, que recrutam voluntários em diversas cidades, somente o prazo de análise ética poderia se estender por um ano, e só depois a análise sanitária era iniciada. Hoje, os dois processos podem ocorrem em paralelo. 

"Vamos supor que tem dez centros participando de um estudo. Antes a gente precisava da aprovação do comitê de ética local de cada centro de pesquisa. Agora um comitê acreditado é responsável por fazer a comunicação com os demais e dar o parecer final", explica. 

Scalise avalia que a lei simplificou a análise regulatória sem perder o rigor. "A Anvisa é uma das agências mais renomadas, é referência no mundo inteiro. A gente ainda tem alguns gargalos de fila (de processos para análise), mas todas as questões estão sendo trabalhadas. Hoje, a gente tem um excelente processo", acrescenta. 

De acordo com a presidente da Roche Brasil, a redução dos prazos aumentou a atratividade do Brasil, que já é um destino valorizado para pesquisas clínicas por causa da diversidade genética dos voluntários, o que produz resultados confiáveis para populações variadas. 

A nova legislação também possibilita que o país receba mais ensaios de Fase 1 e Fase 2, que envolvem uma quantidade menor de pessoas, mas têm exigências mais rígidas, já que a segurança do medicamento em humanos ainda está sendo avaliada. 

Somente a Roche pretende investir cerca de R$590 milhões por ano em pesquisas clínicas no país. Entre os estudos já em andamento, há novas medicações sendo testadas no Brasil para Alzheimer, Parkinson, câncer de mama, lúpus, e uma nova opção de caneta emagrecedora.

A diretora de investigação clínica da farmacêutica, Danielle Galbiatti, destaca que essas cifras também promovem o desenvolvimento do setor científico do país:

"É um movimento de união com centros de pesquisa, laboratórios. Com essa projeção e a vinda de novos estudos, existe a necessidade de capacitar os profissionais e as unidades" 

Com isso, a indústria também vem investindo na capacitação de centros das regiões Norte e Nordeste, para diminuir a concentração do Sul e Sudeste e garantir mais diversidade genética, social e cultural. "Um estudo é um ambiente controlado. O centro de pesquisa tem que ter uma equipe muito bem estruturada, porque esse paciente precisa de uma assistência diferente", complementa Galbiatti.

Ela acredita que essa capacitação também será impulsionada pelo Programa Nacional de Inovação em Saúde, lançado em julho pelo governo federal. Entre os princípios do programa constam o fortalecimento da base científica nacional, a integração com o setor produtivo, e o incentivo ao desenvolvimento de tecnologias "emergentes e disruptivas", que sejam de interesse do Sistema Único de Saúde. 

América Latina

Os esforços do Brasil estão alinhados com uma agenda de toda a América Latina. O diretor estratégico do Conselho Administrativo da Fundação de Pesquisa e Inovação da Costa Rica, Mario Urcuyo, declarou no evento que a profissionalização dos centros de pesquisa da região é "a parte mais importante" para enfrentar a grande concentração de investigações clínicas nos Estados Unidos e na Europa. 

"Temos um desafio muito importante, porque nem sempre contamos com coordenadores e monitores de pesquisa. Não existem carreiras profissionais específicas para essas funções e precisamos desenvolver essa estrutura ao longo do tempo", acrescentou. 

De acordo com ele, proporcionar que mais profissionais atuem em pesquisa clínica também gera benefícios para os pacientes em geral:

"Proporciona ferramentas para melhorar a qualidade da assistência, porque os profissionais passam a ter acesso aos mais elevados padrões de qualidade, exigidos para a realização das pesquisas"

Urcuyo defendeu ainda que as pesquisas clínicas oferecem uma grande oportunidade para pessoas com doenças graves acessarem medicamentos promissores de forma antecipada, ao participar dos testes. 

Benefício

A pesquisadora do Centro Médico Nacional 20 de Novembro, referência em pesquisa e tratamentos de alta complexidade do México, Fedra Irazoque, acrescentou que mesmo os participantes incluídos no grupo de comparação, e que portanto não recebem a substância pesquisada, são beneficiados: 

"Estar no grupo placebo não significa ficar sem receber nenhum medicamento, mas sim receber o melhor tratamento já existente. E após algumas semanas, esse paciente também passa a receber a molécula ativa e pode se beneficiar da mesma forma"

Fedra defende que marcos regulatórios, como o que foi aprovado no Brasil, sejam estabelecidos a nível regional. "Não é possível que o Brasil tenha uma regulamentação, a Costa Rica outra, o México outra, sem que cheguemos a um acordo para agilizar esse processo. Assim, poderíamos alcançar uma representatividade muito mais significativa"

*O evento foi realizado pela farmacêutica Roche e a repórter participou a convite da empresa

A decisão também se aplica aos produtos Retatrutude 120 mg, Caneta Retatrutide 60 mg, Tirzepatide 150mg e Caneta Tirzepatide 75 mg, comercializados na página https://www.zphcstore.com.br/, sob responsabilidade da ZPH Contabilidade.

Notícias relacionadas:

• Anvisa proíbe suplementos alimentares de origem desconhecida.
• Anvisa aprova novo medicamento para tratar lúpus.
• Malária: Anvisa autoriza teste em humanos de vacina 100% brasileira.

Em nota, a Anvisa informou que os produtos não podem ser fabricados, importados, distribuídos, divulgados nem utilizados.

“A medida visa a prevenir a utilização pela população, com fundamento no risco sanitário decorrente da disponibilização ao consumo de produtos sem comprovação de regularidade, qualidade, segurança e eficácia.”

Sem autorização

A resolução da Anvisa também proíbe os seguintes produtos, anunciados e vendidos por empresa de origem desconhecida:

• NAD+ Liberty Pharma
• Retatrutida Liberty Pharma
• Glow GHK-Cu Liberty Pharma
• Tirzepatida Liberty Pharma
• GHK-Cu Liberty Pharma

“Vale destacar a retatrutida, à venda na internet, é uma substância que ainda não possui registro em nenhum país do mundo. Isso porque a empresa que desenvolve os estudos a respeito do medicamento sequer solicitou o registro à Anvisa ou em qualquer agência reguladora internacional.”

Alegações terapêuticas

Por fim, a publicação atinge ainda diversos produtos fabricados pela empresa Cris Barden Naturopatia Ltda. que, segundo a Anvisa, não têm registro, notificação ou cadastro.

“Os itens são divulgados com alegações relacionadas, entre outras, a ações antifúngica, antimicrobiana, anti-inflamatória, ao alívio de dores, à desparasitação, à desintoxicação e ao fortalecimento da imunidade, ou seja, finalidade compatível com medicamento.” 

Veja a lista de itens:

• Kit Detox – Desparasitar – Desinflamar – Desintoxicar – Infantil de 1 a 5 Anos;
• Kit Detox Desparasitação – Desparasitar – Desinflamar – Desintoxicar;
• Kit Carvão Pulverizado da Casca do Coco;
• Carvão Ativado Vegetal da Casca do Coco Premium 120 g;
• Kit Detox com Quelação;
• Kit Detox Prevenção | Prata e Ouro Coloidal + Carvão Pulverizado;
• Kit Composto Emagrecedor para 3 Meses;
• Ouro Coloidal;
• Prata Coloidal.

>> Clique aqui e leia a publicação da Resolução no Diário Oficial da União.

Notícias relacionadas:

• Anvisa aprova novo medicamento para tratar lúpus.

“Os produtos não podem ser fabricados, importados, distribuídos, divulgados nem utilizados”, informou a agência no comunicado. 

A Agência Brasil não conseguiu contato com a PSM Pennaforte Produtos Naturais Ltda. O espaço segue aberto para manifestação.

Em nota, a Anvisa informou que o obinutuzumabe é um anticorpo monoclonal humanizado que promove eliminação massiva e prolongada dos linfócitos B, células que desempenham papel central nos processos fisiológicos anormais que levam ao desenvolvimento do lúpus.

Notícias relacionadas:

• Malária: Anvisa autoriza teste em humanos de vacina 100% brasileira.
• Anvisa libera fabricação de produtos de limpeza da Unilever.

“Os benefícios demonstrados da nova indicação incluem redução da atividade da doença, menor ocorrência de exacerbações e redução sustentada da exposição a corticosteroides.”

A agência ressaltou ainda que, apesar da disponibilidade de terapias convencionais e biológicas para o tratamento da doença, existe uma parcela significativa de pacientes que permanece em estágio ativo constante.

“Essas pessoas sofrem com surtos recorrentes ou se tornam dependente do uso contínuo de corticosteroides – medicamentos que carregam efeitos colaterais importantes a longo prazo.”

Riscos

O Ministério da Saúde alerta que, se não tratado corretamente, o lúpus pode levar a complicações graves em diversos órgãos e tecidos do corpo humano, podendo provocar a morte do paciente. As principais complicações costumam ocorrer nos seguintes órgãos:

• rins: a falência dos rins está entre as principais causas de morte por complicações do lúpus nos primeiros cinco anos após o diagnóstico. Alguns sintomas são comuns nessa fase são irritação, coceira generalizada, dores no peito, falta de ar, náuseas, vômito e edemas.
• cérebro: se a doença tiver chegado ao cérebro, o paciente pode apresentar sintomas específicos como dor de cabeça, confusão, tontura, mudanças de comportamento, alucinações, acidentes vasculares cerebrais (AVC) e convulsões.
• vasos sanguíneos: anemia, aumento no risco de sangramentos e inflamação dos vasos (vasculite) estão entre as principais complicações possíveis decorrentes do lúpus.
• pulmões: o lúpus também pode levar à pleurisia, uma inflamação dos tecidos que revestem os pulmões e a caixa torácica. O quadro pode provocar muita dor durante a respiração.
• coração: em alguns casos, pode ocorrer também a inflamação dos músculos do coração e das artérias, aumentando significativamente as chances de infarto.