CuraTeQ Biologics s.r.o. receives positive opinion for biosimilar Dazublys from EMA
CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers.
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells.
Aurobindo Pharma's Vice Chairman and Managing Director Mr. Nithyananda Reddy said, "The CHMP's positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts in building biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies."
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Time of India
8 hours ago
- Time of India
Magic Johnson's wife Cookie Johnson proved to be the greatest support system throughout his HIV diagnosis
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The Hindu
2 days ago
- The Hindu
Should HIV/AIDS testing be made mandatory before marriage?
In July, Meghalaya Health and Family Welfare Minister Mazel Ampareen Lyngdoh announced that the State may follow Goa in making HIV/AIDS test mandatory for all before marriage. The problem is multi-disciplinary; it is not merely a question of health, but also involves considerations of human rights, stigma, and free will. Should HIV/AIDS testing be made mandatory? N. Kumarasamy and Jahnabi Goswami discuss the question in a conversation moderated by Ramya Kannan. Edited excerpts: Is it possible to implement mandatory testing for HIV before marriage? What are the advantages of such a move? N. Kumarasamy: Regarding HIV, making anything mandatory is not acceptable. The HIV and AIDS (Prevention and Control) Act, 2017, clearly mandates counselling before testing, and testing only with the consent of a patient. As per the law of the land, once you do the testing, everything must be kept confidential. If they test positive, patients should be linked to the appropriate antiretroviral treatment centres. The next question will be whether they can get married — that has also been dealt with by the 2017 law. Today, based on science, we know that if a HIV-positive person is put on antiretroviral treatment, the viral load goes to an undetectable level within 2-3 months. Studies have shown that a person who has an undetectable level of viral load will not transmit infections sexually to their partners. The person will also not develop any HIV-related complications such as opportunistic infections, tuberculosis (TB), and various other comorbid conditions, and maintain a normal immunity level. Mandatory HIV testing without the consent of such a person will be a human rights violation. And doing so will also increase stigma. For all these reasons, mandatory testing cannot take place. HIV testing should be offered to as many people as possible — mainly to those who are at risk and also people who believe that they may be at risk. It should be offered. Consent is important. And testing, if done, should be done while maintaining appropriate confidentiality. Jahnabi Goswami: Yes, the viral load can be managed with drugs. But I still think HIV testing should be made mandatory before marriage. There are a number of cases we know where people who have been infected, but are not taking antiretrovirals regularly, get married because of family and societal pressure. The spouse finds out only later, or perhaps when she or he tests positive for HIV. The children are likely to be affected too. In India we believe in matching horoscopes before the wedding. Why not a HIV test, to see if the couple are compatible at all? Such a test will also ensure the health of the family. Will this move actually empower women? Jahnabi Goswami: My agenda is not women or male empowerment per se. In the north-east, specifically, there have been a number of cases where the (HIV positive) status was concealed. Injecting drug use is responsible for nearly 64% of HIV infections in the north-east. Men (injecting drug users) clean up for three months, get married and don't inform their wives. A few months later, they bring their wives too to test. Even today, we had such a case. This happens regularly. In fact, I believe that to safeguard women and girls, it is essential to go in for mandatory testing, with counselling. About confidentiality and consent, I want to point out that in practice, doctors are forcefully testing for HIV. Even if you go for a small dental procedure — sometimes they counsel, sometimes they don't, and force you to do HIV test. Sometimes it is good counselling and sometimes it is of bad quality. Will the HIV test, if it comes negative, provide a false sense of security? N. Kumarasamy: While you are doing appropriate testing, you are also counselling a patient to find out the duration of exposure. That also helps you determine the window period when testing should be offered. That is the reason you counsel someone. If you force someone to do a test, they may go to a lab and get it done. The test report can be negative but the person might really be positive (for HIV) leading to transmission of infection. If testing is done with appropriate consent, counselling, and confidentiality, I'm sure people are not going to refuse it. Goa also proposed mandatory testing some years ago, but it is still not a reality... N. Kumarasamy: Yes, it is not implemented in Goa. But there is wide testing happening in the State. There is no mandatory testing before a wedding. The thing is they cannot implement this because this will cause human rights violations. The same thing is happening in Meghalaya. If you look at the reports on rising infections, perhaps the State is ranked 5th or 6th where a significant number of infections is through injecting drug use and also through sexual contact. But I think it is possible to learn from other States, especially from southern India — Tamil Nadu, Kerala, and Andhra Pradesh — as well as Maharashtra. The ideal way to contain this infection is to do appropriate HIV testing as much as possible in a variety of settings with proper consent and then link those tested people to the treatment. That will reduce infectiousness in the country and also lead to a reduction in new infections in Meghalaya. Jahnabi Goswami: I think it will definitely happen because the situation is quite different in Meghalaya. To understand it, you should understand the circumstances and people of the State. In Meghalaya, certain groups in the Christian community still think it is taboo to use a condom even if it is recommended by law. (The HIV Act promotes safe sex practices.) In fact, implementing the HIV/AIDS Act in Meghalaya is really difficult. Also, culturally and socially, they have provisions for extramarital affairs and living together. These are quite common among the youth. Simultaneously, HIV is a big discriminator in Meghalaya and no one has actually accepts HIV-positive men or women. How do we address the stigma that is still associated with HIV? N. Kumarasamy: Stigma started in India because it (HIV) was first detected in a commercial sex worker, so it was attributed to multi-partner sex. But this is not true, as we have seen. HIV is still an incurable disease. The way to address stigma today is to make sure that common people are aware that we now have treatment available. Even if it is not curable, it is permanently controllable. In our research studies in Chennai, we showed that treating one partner will prevent transmission if the viral load goes down. The message U=U (undetectable is untransmittable) does work. Such scientific messages can remove stigma from the community, so that as many people as possible will test and be linked to treatment. Someone who is already on treatment will do well, and not transmit infection to the others. Addressing stigma is not an easy thing. Over 30 years of taking care of people with HIV and their families at our centre here, we realise that each one is different. Much is based on their education, how they were raised, and whether they live in the village or city. All this will have to be wrapped up in several rounds of counselling. Jahnabi Goswami: As Dr. Kumarasamy has said, stigma is associated not with the disease, but with where the infection arises from. The impression is that people who are in sex work will get HIV; people who do drugs will get HIV. That is where the stigma comes from. We should constantly try to reduce stigma. The government, people who are infected, like me, and those working in the field should work hard to erode the stigma. If someone has cancer, they say without any hesitation that their family members died of cancer. If they are diabetic, they say they don't use sugar. And if they have hypertension, they don't mind asking you not to put salt in their food. But people who have HIV or people who have TB do not talk openly about it because these are seen as behavioral issues. We must remove the stigma and make it comfortable for HIV-positive people to talk about their status. I do believe we have to involve counsellors to tell people that they will not transmit because they are on treatment, that U=U; and involve more people with HIV as role models to reduce stigma and discrimination. The quality of counselling should be improved for sure. Listen to the conversation
India Today
3 days ago
- India Today
Covid-19 no longer a barrier to organ donation, but here's what has changed
When Covid-19 first gripped the world in early 2020, it brought a wave of uncertainty, not just about treatment and prevention, but about other critical areas of healthcare, including organ someone who had recovered from Covid safely donate a kidney or liver? Would traces of the virus still linger in their body and harm a transplant recipient?Five years on, medical experts say the answer is 'Yes, people who have recovered from Covid-19 can safely donate organs,' says Dr. Ajeet Singh, Head of Critical Care Medicine at Aakash Healthcare. 'We have come a long way in understanding this virus and its effects. A donor who has recovered and tests negative poses no risk to the recipient.'A landmark study from Washington University School of Medicine in St. Louis, US, backs this up. It found that kidneys from donors who had previously tested positive for Covid were safe for transplantation, with no traces of the virus being passed from donor to recipient."As a physician, during the early part of Covid-19 pandemic, concerns led to exclusions of the fear of viral transmission of Covid to the recipients through organs, possibility of persistent infection even after recovery and interruptions in viability of organs by inflammation or damage. There was high risk in immunosuppressed recipients, and residuals could not be ruled out by limited testing. Safety issues regarding health care workers and the shortage of resources were other causes of blanket bans," Dr. Vikas Agarwal, Director and HOD, Robotic Urology, Aakash Healthcare, tells this notion changed. An analysis by the United Network for Organ Sharing (UNOS) found that organ transplants from donors who had tested positive for Covid-19 had similar graft survival rates to those from donors without the India, a multicentre study on 31 kidney transplants from living donors who had recovered from Covid-19 reported no virus transmission or unusual complications in reviews have confirmed the safety of using COVID-recovered donors, provided they test negative before the transplant. In the case of heart and lung transplants, short-term safety data is reassuring, and long-term outcomes are already being THE PANDEMIC CHANGED ORGAN DONATION RULESDuring the peak of the pandemic, organ donation practices underwent a drastic shift. Many hospitals suspended donations from Covid-positive patients, and even those who had recovered, due to fear of possible transmission.'Initially, we were extremely cautious. Any donor with a Covid history was automatically ruled out,' says Dr. Rajiv Kumar Sethia, Director & Head of Urology, Kidney Transplant & Robotic Surgery at Asian adds, however, that that because research and "with all the safety checks we have in place today, organ donations from patients who have recovered from Covid-19 are completely safe.'advertisementHospitals now follow strict screening protocols to ensure donors are fully recovered and test negative before proceeding with a protocols require donors to undergo a SARS-CoV-2 PCR test using a nasopharyngeal swab, with a negative result obtained within three days before organ retrieval. Donors' symptoms, exposure history, and recovery from COVID-19 must also be carefully reviewed and immunosuppressed recipients, additional precautions are taken through universal microbiologic screening, including organ-specific tests such as bronchoalveolar lavage (BAL) for lung also check the donor's medical history, symptoms, and exposure to Covid, and make sure their recovery is well-documented."In high-risk cases, like for people with weakened immune systems, extra tests are done — including organ-specific checks such as a lung fluid test for lung transplants. In many cases, there is also a waiting period of 21 to 90 days after the donor's recovery before the transplant goes ahead," says Dr. Vikas and intestines, however, are bound to be more restrictive, as the risk of viral persistence is more. "For lung transplants, bronchoalveolar lavage (BAL) is required in addition to regular swab tests, and a delay of six to seven weeks after recovery is recommended," adds Dr. kidneys, liver, and heart transplants, standard negative PCR testing is generally sufficient, with fewer additional transplants have minimal restrictions unless there is systemic infection. These guidelines continue to be updated as new evidence ONGOING TRANSPLANT GAPWhile this scientific clarity is good news, India continues to face a deep mismatch between the number of organs needed and those country performs the third-highest number of transplants in the world, after the US and China, but the per capita rate remains to The Lancet Regional Health – Southeast Asia, more than 2 lakh people in India develop end-stage kidney failure each year. Yet only about 11,000 kidney transplants are carried out annually, leaving thousands dependent on dialysis or without any Ajeet points to two major challenges: the shortage of organ donors and the difficulty of transporting organs to rural and smaller towns in time.'Most transplants in India still happen in private hospitals. We need stronger public systems where more people can access transplants without worrying about costs," he CULTURAL AND AWARENESS BARRIEREven when organ donation is medically possible, many families hesitate to donate a loved one's organs after death. In this, usually religious beliefs, lack of awareness, and fear of the process are among the biggest in small towns face a lot of hesitation when it comes to organ donations. We need better awareness and simpler legal procedures so that more people can come forward to donate," says Dr. Sunita Kapoor, Director & Laboratory Head at City X-ray Scan & TO LESSEN THE GAPTo bridge the gap between demand and availability, Dr. Sunita says that besides widespread awareness about the importance of deceased organ donation, we also need to simplifying the legal process for consenting to organ donation."Investing in public transplant infrastructure so that life-saving surgeries are not limited to those who can afford private care," she Covid-19 no longer stands in the way of safe organ donation, India still faces deep systemic, cultural, and logistical challenges in ensuring that life-saving organs reach the patients who need them most.- Ends
