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US-based biotechnology company <keyword id="323030" type="COMPANY" weightage="20" keywordseo="Novavax">Novavax</keyword>'s protein-based vaccine has shown overall 90 per cent efficacy against Covid-19, results of Phase-3 trials have shown. The vaccine NVX-CoV2373 is already being locally manufactured by the company's <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword> partner Pune-based <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII) under the brand name Covovax. In the US-based Phase-3 trials, NVX-CoV2373 also demonstrated 100 per cent protection against moderate and severe disease. "Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional Covid-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe Covid-19 infection," said Stanley C Erck, President and Chief Executive Officer, Novavax, in a statement. "Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines," Erck added. In August 2020, Novavax and SII announced an agreement under which the US biotechnology company had given SII the licence to manufacture and supply the vaccine in low- and middle-income countries. In March 2021, CEO <keyword id="383467" type="PERSON" weightage="20" keywordseo="Adar-Poonawalla">Adar Poonawalla</keyword> said Covovax will be launched by September this year. "Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and Serum Institute of India," said Adar Poonawalla. "Hope to launch by September 2021!" the CEO of the world's biggest Covid-19 vaccine maker said. The US-based Phase-3 trials began in December 2020 and enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease. The study "confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile", said Gregory M Glenn, MD, President of Research and Development, Novavax. The company will file for regulatory authorisations in the third quarter. After receiving the approvals, Novavax will reach a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021, the statement said. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies. It contains purified protein antigen and can neither replicate, nor can it cause Covid-19. The vaccine can be stored at 2 to 8 degrees Celsius, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials. The two-shot vaccine is also being evaluated in Phase 3 trials in the UK that demonstrated efficacy of 96.4 per cent against the original virus strain, 86.3 per cent against the B117 (Alpha) variant and 89.7 per cent overall. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55 per cent efficacy overall in HIV-negative participants and 48.6 per cent efficacy against the B1351 (Beta) variant, and a Phase 1/2 study in the US and Australia. The company is also conducting trials in adolescents between ages 12 and 18. SEE ALSO <a target="_blank" class="c-link" href="https://www.businessinsider.in/stock-market/news/adani-group-under-sebi-scanner-on-market-manipulation/articleshow/83501698.cms">Gautam Adani loses over $7 billion in net worth after questions over the meteoric rise in group stocks</a> <a target="_blank" class="c-link" href="https://www.businessinsider.in/stock-market/news/adani-group-pnb-coal-india-tcs-and-other-stocks-to-watch-out-for-on-june-14/slidelist/83499937.cms">Adani group, PNB, Coal India, TCS and other stocks to watch out for on June 14</a> <a target="_blank" class="c-link" href="https://www.businessinsider.in/cryptocurrency/news/weekly-crypto-roundup-wazirx-under-scrutiny-el-salvador-makes-bitcoin-legal-tender-and-more/slidelist/83478577.cms">Weekly crypto roundup: WazirX under scrutiny, El Salvador makes Bitcoin legal tender and more</a>

US-based biotechnology company Novavax’s COVID-19 shot is 90% effective

It is said that every newborn faces a potential risk until the baby has been screened for <keyword id="1144427" type="UNKNOWN" weightage="100" keywordseo="medical-conditions">medical conditions</keyword>. A <keyword id="2024251" type="UNKNOWN" weightage="100" keywordseo="Genetic-screening">genetic screening</keyword> of the newborn means enhanced <keyword id="2024262" type="UNKNOWN" weightage="100" keywordseo="Biotechnological-capacity">biotechnological capacity</keyword>, which ensures fast, accurate and expanded testing going beyond routine disorders. <keyword id="2024252" type="UNKNOWN" weightage="100" keywordseo="Newborn-screening">Newborn screening</keyword> (<keyword id="116258" type="ORGANIZATION" weightage="100" keywordseo="NBS">NBS</keyword>) has been made compulsory in 52 countries across the world, bringing down <keyword id="153995" type="UNKNOWN" weightage="100" keywordseo="infant-mortality">infant mortality</keyword> and disabilities in children. 
 Simply put, newborn screening (NBS) programme includes testing every newborn soon after its birth, to identify serious or life-threatening conditions which may lead to mental/physical retardation or even early death. The affected baby looks healthy at birth as there is no external defect and these disorders cannot be diagnosed until specifically tested for. However, India is yet to implement a <keyword id="2024264" type="UNKNOWN" weightage="100" keywordseo="National-newborn-screening-programme">national newborn screening programme</keyword> even though 5-15% of newborns fall prey to <keyword id="120871" type="UNKNOWN" weightage="100" keywordseo="Metabolic-disorders">metabolic disorders</keyword>. 
 Understandably, not too many Indian start-ups operate in the NBS space and the <keyword id="49685" type="UNKNOWN" weightage="100" keywordseo="Genetic">genetic</keyword> screening of newborns is rarely done in the country at a macro level. But here is one Mumbai-based start-up that has doing it for over a year now. <keyword id="2024246" type="UNKNOWN" weightage="100" keywordseo="Navigene">Navigene</keyword> has developed a unique and <keyword id="2024273" type="UNKNOWN" weightage="100" keywordseo="Non-invasive-preventive-genetic-screening">non-invasive preventive genetic screening</keyword> service for newborns and adults, which can be implemented at a mass scale. Its primary focus is <keyword id="2024274" type="UNKNOWN" weightage="100" keywordseo="Non-invasive-preventive-testing">non-invasive preventive testing</keyword> including <keyword id="2024278" type="UNKNOWN" weightage="100" keywordseo="Newborn-genetic-screening">newborn genetic screening</keyword>, <keyword id="2024275" type="UNKNOWN" weightage="100" keywordseo="Metabolic-fingerprinting">metabolic fingerprinting</keyword>, <keyword id="2024279" type="UNKNOWN" weightage="100" keywordseo="Prenatal-screening">prenatal screening</keyword> and more, besides offering <keyword id="2024280" type="UNKNOWN" weightage="100" keywordseo="Diagnostic-testing">diagnostic testing</keyword> (<keyword id="2024281" type="UNKNOWN" weightage="100" keywordseo="Cytogenetics">cytogenetics</keyword> &amp; <keyword id="1284857" type="ORGANIZATION" weightage="100" keywordseo="Molecular-Genetics">molecular genetics</keyword>). <keyword id="2024283" type="UNKNOWN" weightage="100" keywordseo="Navigene-Baby-Screen">Navigene Baby Screen</keyword>, the start-up’s flagship product, screens the newborns for 110 genetic and metabolic disorders on the very 3rd day after birth and the company claims it is one of the most comprehensive screening tests in the world. Here is a snapshot that captures the start-up’s operations, vision and viability. 
 
Who runs Navigene (navigene.in): Two co-founders – Dr <keyword id="2024250" type="UNKNOWN" weightage="100" keywordseo="Rishi-Dixit">Rishi Dixit</keyword> (MD &amp; CEO) and Dr <keyword id="1888201" type="PERSON" weightage="100" keywordseo="Vrushali-Joshi">Vrushali Joshi</keyword> (CTO) – and the early-stage incubation and <keyword id="6357097" type="COMPANY" weightage="80" keywordseo="venture-capital">venture capital</keyword> firm, <keyword id="720080" type="COMPANY" weightage="100" keywordseo="IncuCapital">IncuCapital</keyword>. An MBBS and MBA, Dr Rishi has a deep understanding of the healthcare marketing space and also worked with start-ups. Before starting Navigene, he was head of sales &amp; strategy at a start-up in the similar domain. Prior to that, he was manager, health analytics, with ICICI Prudential Life insurance. Dr Vrushali holds a Ph.D. from Mumbai University and is a leading geneticist with more that 15 years of experience. She is also a government-certified genetic counsellor. 
 Navigene was set up by the two co-founders in April 2012, along with IncuCapital’s senior venture partners’ team of <keyword id="2024248" type="UNKNOWN" weightage="100" keywordseo="Surojit-Nandy">Surojit Nandy</keyword>, <keyword id="6393254" type="PERSON" weightage="100" keywordseo="Manish-Kumar">Manish Kumar</keyword> and <keyword id="2024247" type="UNKNOWN" weightage="100" keywordseo="Prashant-Maharaj">Prashant Maharaj</keyword>. The company started operations in November that year. Currently, it boasts a state-of-the-art testing facility and central lab in Mumbai where all samples are flown in from different parts of the country and also from global destinations. This facility also serves as the head office while 2-3 sales people are assigned to each location. Weekly sales meetings are generally held at local CCDs – a good example of asset-light sales offices. 
 But going forward, the start-up plans to open sales offices in Delhi, Bangalore and Hyderabad – small facilities for operational and logistics management. As sample collection is generally done by the people themselves or the <keyword id="6355907" type="UNKNOWN" weightage="100" keywordseo="Medical-facilities">medical facilities</keyword>, the Navigene staff simply picks them up from homes/hospitals and courier them to the HO in Mumbai. 
 
What inspired the venture: The knowledge that non-traditional, highly accurate and revolutionary ways of medical diagnosis is possible through genetic screening and diagnostic techniques. Navigene was founded to bring these advanced <keyword id="684042" type="TECHNOLOGY" weightage="100" keywordseo="medical-technologies">medical technologies</keyword> to India. 
 
What’s the pitch: Early and accurate prediction/diagnosis of disorders and ailments in newborns and adults, through <keyword id="2024271" type="UNKNOWN" weightage="100" keywordseo="Preventive-genetic-screening">preventive genetic screening</keyword> – so that every individual has the opportunity to manage his/her health. “Over the years, we have learnt a great deal about how genes function and how they can cause certain problems. Now is the time to use that knowledge in exciting new ways to prevent and treat <keyword id="6377700" type="UNKNOWN" weightage="100" keywordseo="health-problems">health problems</keyword>,” says Dr Rishi. 
 
How it works: Navigene currently caters to the B2B segment – <keyword id="796241" type="UNKNOWN" weightage="100" keywordseo="corporate-hospitals">corporate hospitals</keyword>, high-end nursing homes with birthing facilities, NICUs (<keyword id="1145483" type="UNKNOWN" weightage="100" keywordseo="neonatal-intensive-care-units">neonatal intensive care units</keyword>) and state-of-the-art <keyword id="2024290" type="UNKNOWN" weightage="100" keywordseo="Paediatric-facilities">paediatric facilities</keyword>. It also works with individual obstetricians/gynaecologists and paediatricians. The start-up typically approaches medical facilities who, in turn, offer/recommend these services to their clients. Once a client registers for the tests, he/she is given the sample collection kit and the rest of the testing procedure follows. 
 
As for newborn screening, parents get the kit as soon as they register and after the birth of the baby, either the hospital staff or the parents collect the urine sample of the baby on the 3rd day. It is then sent Navigene’s central lab in Mumbai where the sample is analysed and reports are sent within 4 days. If the report detects any abnormality, the concerned doctor/hospital/parents are immediately informed and further consultation could be arranged with medical experts. Genetic counselling for the parents is also offered in such cases. 
 
Show me the money: As of now, the start-up has a B2B revenue model in place while the B2C space is essentially serviced through its partners who can reach out to more people. Navigene charges fee per sample testing and its flagship solution, Navigene Baby Screen (NBS), which tests urine sample for 110 disorders, costs Rs 5,000. But to make it more affordable for Tier II cities and smaller medical facilities, customised packages start from Rs 900 for tracking 3-4 basic disorders and can go up to Rs 2,700 for screening 31 commonest disorders that affect infants in the first few months. The company has also tied up with a leading stem cell company for instant access to a large B2C market. “Plus, we want to work with the state governments when they start running the NBS programme at the state-run hospitals, but we will keep the packages small,” says Dr Rishi. 
 
The market size is also huge as around 30 million babies are born in India every year. “As of now, we are targeting 40 cities in India where our addressable market (a fraction of the urban population in these cities) is around 30 lakh babies a year. We aim to cover most of them over the next 3 years through our proprietary sales channel,” adds Dr Rishi. 
 
Claim to fame: A value driver in a critical industry while expansion is its forte. Navigene is a pioneer of sorts, bringing crucial preventive health screening for newborn babies at an affordable price. The start-up is currently doing 500 samples a month and targeting 10,000 samples in the next 3 years. 
 Navigene raised an undisclosed seed round with the help of its institutional co-promoter IncuCapital in August 2012 and it will be raising Series A <keyword id="6357455" type="EVENT" weightage="100" keywordseo="Funding">funding</keyword> in the next 2-3 months. The money will be utilised to grow its presence pan-India and also in other geographies such as South-east Asia and <keyword id="48890" type="COUNTRY" weightage="80" keywordseo="Latin-America">Latin America</keyword>. “We can’t disclose the names just now, but these would be all bigger and more developed countries. We are also talking to a few players in Latin America, which can lead to substantial global expansion,” says Surojit Nandy of IncuCapital. As for pan-India expansion, the company plans to reach 40 cities in next the 3 years through its own B2B sales force. 
 The start-up has hit <keyword id="2024302" type="UNKNOWN" weightage="100" keywordseo="Operational-breakeven">operational breakeven</keyword> in December 2013, within 11 months from starting its sales operations. But it is not really looking at that as a landmark. “We don’t intend to remain operationally cash-positive as we are growing at a breakneck speed and want to keep investing in the growth. That’s the reason we are looking at the Series A funding soon,” says Dr Rishi. 
 “We are also working on some breakthrough <keyword id="2024304" type="UNKNOWN" weightage="100" keywordseo="Screening-products">screening products</keyword> around <keyword id="350054" type="TECHNOLOGY" weightage="100" keywordseo="metabolomics">metabolomics</keyword> in areas like oral &amp; <keyword id="16070" type="ORGANIZATION" weightage="80" keywordseo="breast-cancer">breast cancer</keyword>, and adult metabolic disorders. So a big chunk of the Series A money will be used for product development. We will <keyword id="47916" type="UNKNOWN" weightage="80" keywordseo="invest">invest</keyword> a good amount in Capex and Opex to further strengthen our testing portfolio,” he adds. 
 
Biggest challenge: According to Dr Rishi, there’s no real competition here as very few companies in India focus on genetics (metabolomics). As for the newborn screening business, a few labs who do screening through blood sample testing could be competitors, but they use an entirely different technology platform and can track a maximum of 45 disorders. However, creating awareness among prospective clients is currently the biggest challenge. <keyword id="1912844" type="UNKNOWN" weightage="100" keywordseo="patient-education">Patient education</keyword> is virtually non-existent in India while the cost of reaching them at a micro level could be huge. “That’s why we are opting for online registrations, which will reduce operational costs,” he notes. “Then there are other screening products we are working on. When they hit the market, we should be way ahead of others,” concludes Dr Rishi.

This Start-up Provides Genetic Screening For
Newborns, Adults; To Raise Series A Funding In 2-3 Months

The World Transhumanist Association (<keyword id="60248" type="COMPANY" weightage="20" keywordseo="WTA">WTA</keyword>) has provided a formal definition of <keyword id="1928718" type="UNKNOWN" weightage="20" keywordseo="transhumanism">transhumanism</keyword>: “The intellectual and cultural movement that affirms the possibility and desirability of fundamentally improving the human condition through applied reason, especially by developing and making widely available technologies to eliminate aging and to greatly enhance human intellectual, physical, and <keyword id="2743741" type="UNKNOWN" weightage="20" keywordseo="psychological-capacities">psychological capacities</keyword>.” 
 In practice, <keyword id="2743742" type="UNKNOWN" weightage="20" keywordseo="Transhumanists">transhumanists</keyword> support the possibilities of improving (and engineering) of human beings that has become possible because of technologies such as gene therapy, nanotechnology, biotechnology, information technology and cognitive science. Additionally, transhumanists also believe that other speculated future technologies like simulated reality, artificial intelligence, super intelligence, mind uploading, chemical brain preservation and cryonics (the low temperature preservation of animals (including humans) who cannot be sustained by today’s medicines, with the hope that healing and revival may be possible in the future). They believe that humans can and should use these technologies to become more than human. 
 
Reception and critics in the West 
Most objections to the ideology of transhumanism argue that it represents the extreme (and to them, unacceptable) human attempt to substitute themselves for God. In 2002, the Vatican issued a statement called Communion and Stewardship: Human Persons Created in the Image of God, in which it is stated that "Changing the genetic identity of man as a human person through the production of an infrahuman being is radically immoral". The same statement also argued that the creation of a superhuman or spiritually superior being is "unthinkable", since true improvement can come only through religious experience. 
 
Liberal and left-leaning critics in the modern Western Academy have also attacked transhumanism for other reasons. In his 2002 book Our Posthuman Future, Liberal economist and philosopher Francis Fukuyama identified transhumanism as one of the world's most dangerous ideas. He said that it may undermine the egalitarian ideals of democracy through a crucial modification of human nature itself. Left-leaning German philosopher Jürgen Habermas argued (in his 2003 book The Future of Human Nature) that embryo-stage genetic modification would undermine moral autonomy of the species-ethic (as the latter would become subject to another's unilaterally imposed specifications). Other critics have argued that attempts to significantly alter human biology also threaten the social order. 
 
<keyword id="2743740" type="UNKNOWN" weightage="20" keywordseo="Transhumanism-in-India">Transhumanism in India</keyword> 
When one considers the number of problems confronting India – ranging from medicine (drugs, care for disabled people, genetic diseases, etc.), agriculture (low-yield crops, pests) and fields – the kinds of sciences and technologies that transhumanism specifically supports sound very promising. Because there are any number of these problems in India that could potentially be alleviated by adopting a number of these very promising technologies. 
 
Another reason that is cited for the potential success of transhumanist technologies in India is that Indic religions are perceived to generally be more open to the idea of human improvement (through technology) than Western Christianity. Zoltan Istvan (founder of the US Transhumanist Party and candidate for the 2016 US Presidential election on behalf of this party) says, “Many transhuman goals, like trying to overcome human death, go against the grain of Western religions and their sacred texts. But Hinduism, Buddhism, and various other Eastern religions can be conducive for transhumanism and its goals.” 
 
Another circumstance that is often cited by world transhumanists and futurists (that apparently makes India a fertile place for such an ideology and technologies) is very interesting indeed. India offers a great deal of freedom to science and technology companies for them to do creative work. “In the United States, for example, it takes sometimes a decade to get a drug or certain type of technology approved by the government, into production, and then into the public's hands. In India, there is far less scientific bureaucracy and government approval. It is felt that, due to these reasons, transhumanist technologies will probably grow a lot faster in places like India rather than in the West”, adds Istvan 
 
Will this ideology survive, gain traction, or succeed wildly in India? 
There is no doubt that transhumanist technologies have the potential to solve or at least alleviate a great many of India’s contemporary problems. To a certain extent, a lot of the creative energy being expended by Indian scientists and technologists (in fields such as medicine, genetics, agriculture) are certainly contributing to this effort. Indeed, some of the supposedly beneficial circumstances (such as the bureaucratic one cited by Zoltan Istvan) may even seem charming. However, perhaps we will need to wait and watch with skepticism what is actually achieved by these technologies on the ground. We will have to be on our guard, just as M. K. Gandhi was during his time. Where ever there are specific instances of success (such as in genetic medicine or certain genetically-modified crops) we should be grateful for those achievements. 
 
However, whether we adopt such technologies (and such an ideology) in toto – I think that some of M. K. Gandhi’s skepticism would be handy – and we should certainly adopt it for now.

Transhumanism in India: Between faith and modernity

For technology to change the global balance of power, it needn't be new. It must simply be known.Since 2017, the Chinese Communist Party has laid out careful plans to eventually dominate the creation, application, and dissemination of generative artificial intelligence — programs that use massive datasets to train themselves to recognize patterns so quickly that they appear to produce knowledge from nowhere. According to the CCP's plan, by 2020, China was supposed to have "achieved iconic advances in AI models and methods, core devices, high-end equipment, and foundational software." But the release of OpenAI's ChatGPT in fall 2022 caught Beijing flat-footed. The virality of ChatGPT's launch asserted that US companies — at least for the moment — were leading the AI race and threw a great-power competition that had been conducted in private into the open for all the world to see.There is no guarantee that America's AI lead will last forever. China's national tech champions have joined the fray and managed to twist a technology that feeds on freewheeling information to fit neatly into China's constrained information bubble. Censorship requirements may slow China's AI development and limit the commercialization of domestic models, but they will not stop Beijing from benefiting from AI where it sees fit. China's leader, Xi Jinping, sees technology as the key to shaking his country out of its economic malaise. And even if China doesn't beat the US in the AI race, there's still great power, and likely danger, in it taking second place."There's so much we can do with this technology. Beijing's just not encouraging consumer-facing interactions," Reva Goujon, a director for client engagement on the consulting firm Rhodium Group's China advisory team, said. "Real innovation is happening in China. We're not seeing a huge gap between the models Chinese companies have been able to roll out. It's not like all these tech innovators have disappeared. They're just channeling applications to hard science."In its internal documents, the CCP says that it will use AI to shape reality and tighten its grip on power within its borders — for political repression, surveillance, and monitoring dissent. We know that the party will also use AI to drive breakthroughs in industrial engineering, biotechnology, and other fields the CCP considers productive. In some of these use cases, it has already seen success. So even if it lags behind US tech by a few years, it can still have a powerful geopolitical impact. There are many like-minded leaders who also want to use the tools of the future to cement their authority in the present and distort the past. Beijing will be more than happy to facilitate that for them. China's vision for the future of AI is closed-sourced, tightly controlled, and available for export all around the world.In the world of modern AI, the technology is only as good as what it eats. ChatGPT and other large language models gorge on scores of web pages, news articles, and books. Sometimes this information gives the LLMs food poisoning — anyone who has played with a chatbot knows they sometimes hallucinate or tell lies. Given the size of the tech's appetite, figuring out what went wrong is much more complex than narrowing down the exact ingredient in your dinner that had you hugging your toilet at 2 a.m. AI datasets are so vast, and the calculations so fast, that the companies controlling the models <a target="_blank" href="https://www.nytimes.com/2024/05/21/technology/ai-language-models-anthropic.html">do not know why they spit out bad results, and they may never know</a>. In a society like China — where information is tightly controlled — this inability to understand the guts of the models poses an existential problem for the CCP's grip on power: A chatbot could tell an uncomfortable truth, and no one will know why. The likelihood of that happening depends on the model it's trained on. To prevent this, Beijing is feeding AI with information that encourages positive "social construction."China's State Council wrote in its 2017 Next Generation Artificial Intelligence Development Plan that AI would be able to "grasp group cognition and psychological changes in a timely manner," which, in turn, means the tech could "significantly elevate the capability and level of social governance, playing an irreplaceable role in effectively maintaining social stability." That is to say, if built to the correct specifications, the CCP believes AI can be a tool to fortify its power. That is why this month, the Cyberspace Administration of China, the country's AI regulator, launched a chatbot trained entirely on Xi's political and economic philosophy, "Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era" (snappy name, I know). Perhaps it goes without saying that ChatGPT is not available for use in China or Hong Kong.<div type="image" title="Xi Jinping" height="1359" width="2000" msid="110639288" hostid="261" sizebytes="132198"></div>For the CCP, finding a new means of mass surveillance and information domination couldn't come at a better time. Consider the Chinese economy. Wall Street, Washington, Brussels, and Berlin have accepted that the model that helped China grow into the world's second-largest economy has been worn out and that Beijing has yet to find anything to replace it. Building out infrastructure and industrial capacity no longer provides the same bang for the CCP's buck. The world is pushing back against China's exports, and the CCP's attempts to drive growth through domestic consumption have gone pretty much nowhere. The property market is distorted beyond recognition, growth has plateaued, and deflation is lingering like a troubled ghost. According to Freedom House, a human-rights monitor, Chinese people demonstrated against government policies in record numbers during the fourth quarter of 2023. The organization logged 952 dissent events, a 50% increase from the previous quarter. Seventy-eight percent of the demonstrations involved economic issues, such as housing or labor. If there's a better way to control people, Xi needs it now.Ask the Cyberspace Administration of China's chatbot about these economic stumbles, and you'll just get a lecture on the difference between "traditional productive forces" and "new productive forces" — buzzwords the CCP uses to blunt the trauma of China's diminished economic prospects. In fact, if you ask any chatbot operating in the country, it will tell you that Taiwan is a part of China (a controversial topic outside the country, to say the least). All chatbots collect information on the people who use them and the questions they ask. The CCP's elites will be able to use that information gathering and spreading to their advantage politically and economically — but the government doesn't plan to share that power with regular Chinese people. What the party sees will not be what the people see."The Chinese have great access to information around the world," Kenneth DeWoskin, a professor emeritus at the University of Michigan and senior China advisor to Deloitte, told me. "But it's always been a two-tiered information system. It has been for 2,000 years."To ensure this, the CCP has constructed a system to regulate AI that is both flexible enough to evaluate large language models as they are created and draconian enough to control their outputs. Any AI disseminated for public consumption must be registered and approved by the CAC. Registration involves telling the administration things like which datasets the AI was trained on and what tests were run on it. The point is to set up controls that embrace some aspects of AI, while — at least ideally — giving the CCP final approval on what it can and cannot create."The real challenge of LLMs is that they are really the synthesis of two things," Matt Sheehan, a researcher and fellow at the Carnegie Endowment for International Peace, told me. "They might be at the forefront of productivity growth, but they're also fundamentally a content-based system, taking content and spitting out content. And that's something the CCP considers frivolous."In the past few years, the party has shown that it can be ruthless in cutting out technology it considers "frivolous" or harmful to social cohesion. In 2021, it barred anyone under 18 from playing video games on the weekdays, paused the approval of new games for eight months, and then in 2023 announced rules to reduce the public's spending on video games.But AI is not simply entertainment — it's part of the future of computation. The CCP cannot deny the virality of what OpenAI's chatbot was able to achieve, its power in the US-China tech competition, or the potential for LLMs to boost economic growth and political power through lightning-speed information synthesis.Ultimately, as Sheehan put it, the question is: "Can they sort of lobotomize AI and LLMs to make the information part a nonfactor?"Unclear, but they're sure as hell going to try.For the CCP to actually have a powerful AI to control, the country needs to develop models that suit its purpose — and it's clear that China's tech giants are playing catch-up.The e-commerce giant Baidu claims that its chatbot, <a target="_blank" href="https://www.businessinsider.com/chinas-chatgpt-reportedly-bans-users-from-mentioning-winnie-the-pooh-2023-5">Ernie Bot</a> — which was released to the public in August — has 200 million users and 85,000 enterprise clients. To put that in perspective, OpenAI generated 1.86 billion visits in March alone. There's also the Kimi chatbot from Moonshot AI, a startup backed by Alibaba that launched in October. But both Ernie Bot and Kimi were only recently overshadowed by ByteDance's Doubao bot, which also launched in August. According to Bloomberg, it's now the most downloaded bot in the country, and it's obvious why — Doubao is cheaper than its competitors."The generative-AI industry is still in its early stages in China," Paul Triolo, a partner for China and technology policy at the consultancy Albright Stonebridge Group, said. "So you have this cycle where you invest in infrastructure, train, and tweak models, get feedback, then you make an app that makes money. Chinese companies are now in the training and tweaking models phase."The question is which of these companies will actually make it to the moneymaking phase. The current price war is a race to the bottom, similar to what we've seen in the Chinese technology space before. Take the race to make <a target="_blank" href="https://www.businessinsider.com/china-xi-jinping-crush-tesla-elon-musk-american-ev-industry-2024-2">electric vehicles</a>: The Chinese government started by handing out cash to any company that could produce a design — and I mean any. It was a money orgy. Some of these cars never made it out of the blueprint stage. But slowly, the government stopped subsidizing design, then production. Then instead, it started to support the end consumer. Companies that couldn't actually make a car at a price point that consumers were willing to pay started dropping like flies. Eventually, a few companies started dominating the space, and now the Chinese EV industry is a manufacturing juggernaut. Similar top-down strategies, like China's plan to <a target="_blank" href="https://www.businessinsider.com/china-xi-jiinping-future-tech-global-economy-semiconductors-military-failing-2022-9">advance semiconductor production</a>, haven't been nearly as successful. Historically, DeWoskin told me, party-issued production mandates have "good and bad effects." They have the ability to get universities and the private sector in on what the state wants to do, but sometimes these actors move slower than the market. Up until 2022, everyone in the AI competition was most concerned about the size of models, but the sector is now moving toward innovation in the effectiveness of data training and generative capacity. In other words, sometimes the CCP isn't skating to where the puck's going to be but to where it is.There are also signs that the definition of success is changing to include models with very specific purposes. OpenAI CEO Sam Altman said in a recent interview with the Brookings Institution that, for now, the models in most need of regulatory overhead are the largest ones. "But," he added, "I think progress may surprise us, and you can imagine smaller models that can do impactful things." A targeted model can have a specific business use case. After spending decades analyzing how the CCP molds the Chinese economy, DeWoskin told me that he could envision a world where some of those targeted models were available to domestic companies operating in China but not to their foreign rivals. After all, Beijing has never been shy about using a home-field advantage. <a target="_blank" href="https://www.businessinsider.com/china-xi-jinping-crush-tesla-elon-musk-american-ev-industry-2024-2">Just ask Elon Musk</a>.To win the competition to build the most powerful AI in the world, China must combat not only the US but also its own instincts when it comes to technological innovation. A race to the bottom may simply beggar China's AI ecosystem. A rush to catch up to where the US already is — amid investor and government pressure to make money as soon as possible — may keep China's companies off the frontier of this tech."My base case for the way this goes forward is that maybe two Chinese entities push the frontier, and they get all the government support," Sheehan said. "But they're also burdened with dealing with the CCP and a little slower-moving."This isn't to say we have nothing to learn from the way China is handling AI. Beijing has already set regulations for things like deepfakes and labeling around authenticity. Most importantly, China's system holds people accountable for what AI does — people make the technology, and people should have to answer for what it does. The speed of AI's development demands a dynamic, consistent regulatory system, and while China's checks go too far, the current US regulatory framework lacks systemization. The Commerce Department announced an initiative last month around testing models for safety, and that's a good start, but it's not nearly enough. If China has taught us anything about technology, it's that it doesn't have to make society freer — it's all about the will of the people who wield it. The Xi Jinping Thought chatbot is a warning. If China can make one for itself, it can use that base model to craft similar systems for authoritarians who want to limit the information scape in their societies. Already, some Chinese AI companies — like the state-owned iFlytek, a voice-recognition AI — have been hit with US sanctions, in part, for using their technology to spy on the Uyghur population in Xinjiang. For some governments, it won't matter if tech this useful is two or three generations behind a US counterpart. As for the chatbots, the models won't contain the sum total of human knowledge, but they will serve their purpose: The content will be censored, and the checks back to the CCP will clear.That is the danger of the AI race. Maybe China won't draw from the massive, multifaceted AI datasets that the West will — its strict limits on what can go into and come out of these models will prevent that. Maybe China won't be pushing the cutting edge of what AI can achieve. But that doesn't mean Beijing can't foster the creation of specific models that could lead to advancements in fields like hard sciences and engineering. It can then control who gets access to those advancements within its borders, not just people but also multinational corporations. It can sell tools of control, surveillance, and content generation to regimes that wish to dominate their societies and are antagonistic to the US and its allies.This is an inflection point in the global information war. If social media harmfully siloed people into alternate universes, the Xi bot has demonstrated that AI can do that on steroids. It is a warning. The digital curtain AI can build in our imaginations will be much more impenetrable than iron, making it impossible for societies to cooperate in a shared future. Beijing is well aware of this, and it's already harnessing that power domestically, why not geopolitically? We need to think about all the ways Beijing can profit from AI now before its machines are turned on the world. Stability and reality depend on it.<a target="_blank" rel="" href="https://www.businessinsider.com/author/linette-lopez">Linette Lopez</a> is a senior correspondent at Business Insider.

America's tech battle with China is about to get ugly

Three cases of <keyword id="1609796" type="General" weightage="100" keywordseo="omicron" source="Orion">Omicron</keyword> subvariant BF.7, apparently the strain driving <keyword id="1334" type="General" weightage="50" keywordseo="china" source="Orion">China</keyword>'s current surge of Covid cases, have been detected in <keyword id="3658" type="General" weightage="50" keywordseo="india" source="Orion">India</keyword> so far, official sources said Wednesday. The first case of BF.7 in India was detected in October by Gujarat Biotechnology Research Centre. So far, two cases have been reported from Gujarat while one case has been reported from Odisha, they said. In the Covid review meeting chaired by <keyword id="700200" type="General" weightage="50" keywordseo="union-health" source="Orion">Union Health</keyword> Minister <keyword id="2607815" type="General" weightage="50" keywordseo="mansukh-mandaviya" source="Orion">Mansukh Mandaviya</keyword> Wednesday, experts said although there is no overall increase in Covid caseload as of now, there is a need for continued surveillance to keep a track of existing and emerging variants. According to official sources here, Chinese cities are currently hit by the highly transmissible Omicron strain, mostly BF.7 which is the main variant spreading in Beijing and is contributing to a wider surge of Covid infections in that country. "The BF.7's high transmissibility in China might be attributed to a low level of immunity in the Chinese population from the previous infection and possibly vaccination too," an official source said. BF.7 is a sub-lineage of the Omicron variant BA.5 and has the strongest infection ability since it is highly transmissible, has a shorter incubation period, and has a higher capacity to cause reinfection or infect even those vaccinated. It has already been detected in several other countries, including the US, the UK and European nations such as Belgium, Germany, France and Denmark. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/new-omicron-subvariants-account-for-nearly-70-new-covid-cases-in-us/articleshow/96392001.cms">New Omicron subvariants account for nearly 70% new Covid cases in US</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/is-covid-19-making-a-comeback-china-us-japan-witness-an-increase-in-cases/slidelist/96392747.cms">Is Covid-19 making a comeback? China, US &amp; Japan witness an increase in cases</a>

3 cases of Omicron subvariant BF.7, driving China's Covid surge, detected in India

<ul class="summary-list"><li>China's slowing economy is chipping away at some American companies' revenues.</li><li>DuPont, Danaher, and Procter &amp; Gamble reported second-quarter revenue and volume drops in China.</li></ul><a href="https://www.businessinsider.com/china-economy-deflation-markets-property-real-estate-housing-beijing-2023-8">China's economy has been worsening</a>, and some American businesses are feeling the pain.<a href="https://www.businessinsider.com/china-economy-july-misses-expectations-no-youth-unemployment-stat-2023-8">Economic data released Tuesday</a> showed the world's second-largest economy performed below analyst expectations in terms of industrial production, retail sales, and exports. China's July economic report <a href="https://www.businessinsider.com/china-economy-key-interest-rate-deepest-cut-since-2020-july-2023-8">didn't mention youth-unemployment statistics</a> after it soared to 21.3% in the second quarter, citing economic and social changes.While Chinese manufacturing and construction are struggling to recover, some American companies with strong ties to China <a href="https://www.wsj.com/articles/chinas-worsening-economy-is-hurting-corporate-america-a3657373" target="_blank" rel="noopener">are also feeling the effects</a>. Some leading chemical and manufacturing companies have reported weaker second-quarter sales, with some cutting their outlook for the second half of the year, saying conditions may worsen. And with falling consumer prices, some companies fear China may slip further into deflation, even as the country's central bank has implemented interest-rate cuts to incentivize lending.For many Americans, this may mean more-expensive cars and personal-care products. If companies with a large presence in China lose enough revenue and China continues slowing, that could drag the US economy down as well and lead to layoffs.Many American CEOs hoped that China's reopening in December would be a major turnaround in revenues for the region, though many have been left underwhelmed. Citigroup, whose <a href="https://www.citigroup.com/global/news/press-release/2023/second-quarter-2023-results-key-metrics" target="_blank" rel="noopener">net income fell 36%</a> last quarter overall from the prior year, said <a href="https://www.citigroup.com/rcs/citigpa/storage/public/2Q23%20Earnings%20Transcript.pdf" target="_blank" rel="noopener">in an earnings call</a> that China's decelerated growth was the "biggest disappointment."Thermo Fisher Scientific, an American biotechnology company, <a href="https://ir.thermofisher.com/investors/news-events/news/news-details/2023/Thermo-Fisher-Scientific-Reports-Second-Quarter-2023-Results/" target="_blank" rel="noopener">cut its end-of-year forecasts</a> because of slowing economic activity in China."We think it's appropriate to assume that this condition remains in place for the remainder of the year," Stephen Williamson, the company's chief financial officer, <a href="https://www.fool.com/earnings/call-transcripts/2023/07/26/thermo-fisher-scientific-tmo-q2-2023-earnings-call/" target="_blank" rel="noopener">said</a> in an earnings call.Its rival Danaher <a href="https://investors.danaher.com/2023-07-25-Danaher-Reports-Second-Quarter-2023-Results" target="_blank" rel="noopener">also cut its annual sales-growth forecast</a>, saying that growth in China — which makes up about 13% of total revenue — fell 10% during the quarter. CEO Rainer Blair <a href="https://www.marketbeat.com/earnings/transcripts/92859/" target="_blank" rel="noopener">said on an earnings call</a> that China orders were down 40% in the second quarter and down 50% in June because of excess capacity and declining foreign investment.Major chemical companies have also been hit. Dow's second-quarter net income <a href="https://investors.dow.com/en/news/news-details/2023/Dow-reports-second-quarter-2023-results/default.aspx#:~:text=GAAP%20earnings%20per%20share%20was,%240.58%20in%20the%20prior%20quarter." target="_blank" rel="noopener">dropped 70% overall</a> because of weaker sales volume. <a href="https://www.fool.com/earnings/call-transcripts/2023/07/25/dow-dow-q2-2023-earnings-call-transcript/" target="_blank" rel="noopener">On an earnings call</a>, its chief financial officer, Howard Ungerleider, said: "In China, while we are experiencing growth, the anticipated economic rebound following the end of zero-COVID restrictions has yet to fully materialize."Dow's rival DuPont also reported a drop in China sales from existing operations, <a href="https://www.dupont.com/news/dupont-reports-second-quarter-2023-results.html" target="_blank" rel="noopener">a 14% year-over-year fall</a>. CEO Edward Breen <a href="https://www.fool.com/earnings/call-transcripts/2022/08/02/dupont-de-nemours-inc-dd-q2-2022-earnings-call-tra/" target="_blank" rel="noopener">said on an earnings call</a> that growth might pick up soon, though the company cut its growth outlook for the second half of the year.The Ohio manufacturing company Procter &amp; Gamble <a href="https://www.pginvestor.com/financial-reporting/press-releases/news-details/2023/PG-Announces-Fourth-Quarter-and-Fiscal-Year-2023-Results/default.aspx" target="_blank" rel="noopener">reported a 1% drop in volumes</a> last quarter driven mainly by weaker demand in the Greater China region. Additionally, <a href="https://www.intc.com/news-events/press-releases/detail/1637/intel-reports-second-quarter-2023-financial-results" target="_blank" rel="noopener">Intel</a> and <a href="https://d1io3yog0oux5.cloudfront.net/_7cbeeb3e45a790b2feb818f57909ed9f/3m/news/2023-07-25_3M_Reports_Second_Quarter_2023_Results_Proactive_1790.pdf" target="_blank" rel="noopener">3M</a>, both of which expect strong overall results for the rest of the year, both continued to see a slow recovery in China amid weaker demand.Some automotive companies with a large American presence lowered their outlook as <a href="https://www.reuters.com/business/autos-transportation/chinas-car-sales-fall-2nd-month-july-price-war-continues-2023-08-08/" target="_blank" rel="noopener">China's car sales fell</a> for the second month in July, down 2.6% from last year. <a href="https://global.toyota/pages/global_toyota/ir/financial-results/2024_1q_summary_en.pdf" target="_blank" rel="noopener">Toyota</a> and <a href="https://usa.nissannews.com/en-US/releases/release-bd81b337f84531d64cb35f5c1813896e-nissan-reports-april-june-results-for-fiscal-year-2023?selectedTabId=releases" target="_blank" rel="noopener">Nissan</a> reported some challenges in China in the second quarter.To be sure, some American companies have performed well in China over the past few months. <a href="https://affiliate.insider.com?h=7f342d016ba3db2d105d04083b278c1d705b5c86af3231559cb76232ece4757f&amp;postID=64dce1fa46fab8f2273bca46&amp;site=bi&amp;u=https%3A%2F%2Fwww.apple.com%2Fnewsroom%2F2023%2F08%2Fapple-reports-third-quarter-results%2F%23%3A~%3Atext%3DCUPERTINO%252C%2520CALIFORNIA%2520Apple%2520today%2520announced%2C5%2520percent%2520year%2520over%2520year." target="_blank" rel="noopener">Apple reported</a> record revenue last quarter for the Greater China region, while Starbucks China's <a href="https://investor.starbucks.com/press-releases/financial-releases/press-release-details/2023/Starbucks-Reports-Q3-Fiscal-2023-Results/default.aspx#:~:text=Net%20revenues%20for%20the%20North,4%25%20over%20the%20past%2012" target="_blank" rel="noopener">revenue grew 51%</a> year over year. <a href="https://marriott.gcs-web.com/static-files/a7b1ac01-1614-4aff-9163-bf01cc02731d" target="_blank" rel="noopener">Marriott also saw</a> sales boom as domestic travel continued to accelerate.Despite efforts by China to build new infrastructure and spur property investments, <a href="https://www.wsj.com/articles/china-cuts-rates-to-prop-up-flagging-recovery-6fe3ec72?mod=article_inline" target="_blank" rel="noopener">The Wall Street Journal reported</a>, some economists are skeptical the initiatives can reverse the trend in China's economy. Beijing may issue about $140 billion in special Treasury bonds to assist struggling local governments, the Journal reported.The International Monetary Fund previously forecast China would account for <a href="https://www.imf.org/en/Blogs/Articles/2023/05/01/asia-poised-to-drive-global-economic-growth-boosted-by-chinas-reopening" target="_blank" rel="noopener">about 35%</a> of global growth in 2023, though that may not be the case anymore. For many US companies, the decision to keep investing in China in hopes of a recovery or to focus more on other markets may be more important than ever.

China's tanking economy is costing major US companies and could throw cold water on America's economic boom

Biotechnology major Bharat Biotechs BSL-3 (Biosafety Level-3) facilities will play a pivotal role in empowering the company's plans to ramp-up production of India's first indigenously developed Covid-19 vaccine. Accordingly, the biotechnology major plans to produce 700 million doses of <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword> per annum. The vaccine is regarded as one of the safest in the world and highly efficient against the UK, SA, Brazilian and the new Indian double mutant strain of Covid-19 virus. In a conversation with IANS, Krishna Ella, Chairman and Managing Director of <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> International said the capacity expansion process has been initiated across multiple facilities since early 2021. Presently, the company manufactures 20 million doses per month of Covaxin which are supplied to the <keyword id="210071" type="COMPANY" weightage="20" keywordseo="Ministry-of-Health">Ministry of Health</keyword> for the national vaccine rollout. "Manufacturing scale up has been carried out in a stepwise manner across multiple facilities at Hyderabad, and Bangalore," he said. "Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines." Notably, Bharat Biotech is able to expand Covaxin manufacturing capacity mainly due to the availability of four new specially designed BSL-3 facilities. In industry parlance, a BSL-3 facility is equipped to safely handle infectious biological pathogens in the highest stringent environmentally controlled manufacturing facility. At present, the company has four facilities BSL-3 facilities two in Hyderabad and two in Bengaluru. "These facilities have been repurposed due to a strong pre-existing expertise in development of <keyword id="11129299" type="UNKNOWN" weightage="20" keywordseo="viral-vaccines">viral vaccines</keyword> and know-how applied to manufacture, test and release the highly purified inactivated viral vaccine." The company has recently entered into a 'Master Collaborative Agreement' (<keyword id="6355225" type="COMPANY" weightage="20" keywordseo="mca">MCA</keyword>) with <keyword id="1906647" type="COMPANY" weightage="20" keywordseo="CSIR-Indian-Institute-of-Chemical-Technology">CSIR-Indian Institute of Chemical Technology</keyword> (CSIR-IICT), to collaborate on the development of novel platform technologies in developing a synthetic process route for adjuvant molecule 'TLR 7/8' for Covaxin. Bharat Biotech uses a proprietary adjuvant Algel-IMDG, that has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses. The synthesis and manufacture of the <keyword id="11174611" type="COMPANY" weightage="20" keywordseo="imdg">IMDG</keyword> component has been successfully indigenised and will be manufactured at commercial scale within the country. This is the first instance where a novel adjuvant has been commercialised in India. Besides, the company has secured long term components, packing materials and single use consumables supplies for the manufacturing ramp-up To further increase bulk capacity Bharat Biotech has entered into agreements with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. "The technology transfer process is well underway and IIL has adequate capabilities to manufacture inactivated viral vaccines at commercial scale and under required 'GMP' standard." "We are also looking forward to getting into manufacturing partnerships in other countries." Currently, Covaxin has received 'Emergency Use Authorizations' in several countries across the globe with another 60 in process. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/covid-19-vaccine-india-needs-a-separate-queue-for-second-dose/articleshow/82304003.cms">India may end up wasting millions of COVID-19 vaccine doses if there is no separate queue for second shots</a> <a href="https://www.businessinsider.in/science/health/news/if-you-have-just-recovered-from-covid-19-experts-say-you-dont-need-to-join-in-on-the-rush-for-vaccination-immediately/articleshow/82302460.cms">If you have just recovered from COVID-19, experts say you don't need to join in on the rush for vaccination immediately</a> <a href="https://www.businessinsider.in/careers/news/atlassian-says-its-employees-only-need-to-come-into-the-office-4-times-a-year-under-its-new-team-anywhere-policy/articleshow/82304516.cms">Atlassian says its employees only need to come into the office 4 times a year under its new 'Team Anywhere' policy</a>

Bharat Biotech's BSL-3 aims to produce 700 million doses of Covaxin per annum

<ul><li>Biotechnology major <keyword id="6358361" type="DEFINITION" weightage="20" keywordseo="biocon">Biocon</keyword> on Monday said it will launch biologic drug Itolizumab for the treatment of moderate to severe COVID-19 patients at a price of around 8,000 per vial. </li><li>The company has received approval from the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. </li><li>Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications, Biocon had earlier said in a regulatory filing. </li></ul> Biotechnology major Biocon on Monday said it will launch biologic drug Itolizumab for the treatment of moderate to severe COVID-19 patients at a price of around 8,000 per vial. As most patients need 4 vials, the cost of the therapy is around Rs 32,000, Mazumdar-Shaw said. The company has received approval from the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications, Biocon had earlier said in a regulatory filing. "Until the vaccine comes, we certainly need life saving drugs. I think what we are doing across the world is to see how we can either repurpose drugs or develop new drugs to treat this pandemic," Biocon Executive Chairperson Kiran Mazumdar-Shaw said in a virtual press conference. Even if we get a vaccine by the end of this year or early next year, there is no guarantee that there will not be reinfection, there is no guarantee that it will work the way we expect it to work, so we must be in a state of preparedness, she added. "When COVID happened, we said it actually gives us a very strong case to try it (Itolizumab) for COVID, because we do believe that the unique mechanism of action that it has can help us deal with this storm that we have seen is killing patients,'' Mazumdar-Shaw said. Itolizumab is approved for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19, she added. On being asked if the company is ramping up the capacity to manufacture more vials on account of the pandemic, she said: "We have the manufacturing capacity and the supply and distribution network in place, however post this approval we are looking to ramp up production capacity to meet the expected surge in demand. Our aim is to reach a larger number of patients across the country". The drug will be manufactured and formulated as an intravenous injection at the company's bio-manufacturing facility at Biocon Park, Bengaluru. When asked about the steps the company is taking to ensure availability of the drug, Mazumdar-Shaw said: "Alzumab is already in market, we will be supplying to hospitals as per protocol against a medical prescription and patient consent form. Currently, there is a huge demand and Biocon wants to ensure Itolizumab first reaches those patients who need them the most". AKT BAL

Biocon to launch drug for COVID-19 patients at ₹ 8,000 per vial

<ul><li>Novavax said Thursday it initiated a Phase 3 trial of its <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword> <keyword id="24209" type="PERSON" weightage="60" keywordseo="vaccine">vaccine</keyword> in the UK.</li><li>The trial will enroll up to 10,000 volunteers across the UK to assess the NVX-CoV2373 vaccine candidate.</li><li>Novavax has scaled up its manufacturing capacity in anticipation of developing a successful COVID-19 vaccine, and will be able to produce up to 2 billion annualized doses once capacity has been brought online by mid-2021.</li><li>Novavax surged as much as 15% in Friday trades.</li><li><a href="https://www.businessinsider.com/?hprecirc-bullet?utm_source=markets&amp;utm_medium=ingestgest" target="_blank" rel="noopener">Visit Business Insider's homepage for more stories</a>.</li></ul><a href="https://markets.businessinsider.com/stocks/nvax-stock">Novavax</a> surged on Friday after the biotechnology company <a href="https://www.globenewswire.com/news-release/2020/09/24/2098981/0/en/Novavax-Initiates-Phase-3-Efficacy-Trial-of-COVID-19-Vaccine-in-the-United-Kingdom.html">said Thursday that it initiated a Phase 3 trial</a> for its COVID-19 vaccine candidate in the UK.Novavax, in partnership with the UK Government's Vaccines Taskforce, will enroll up to 10,000 individuals in the trial over the next 4 to 6 weeks."The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries," Novavax said.Read More: <a href="https://www.businessinsider.com/morgan-stanley-3-airline-stocks-to-buy-european-travel-recovery-2020-9?utm_source=markets&amp;utm_medium=ingestgest" target="_blank" rel="noopener">Europe is heading back into lockdown, but when travel resumes, these are the 3 European airline stocks to own, Morgan Stanley says</a>Investors are likely putting more focus on successful COVID-19 vaccine developments after <keyword id="6354298" type="DEFINITION" weightage="60" keywordseo="Stocks">stocks</keyword> took a hit this week, partly due to a steady uptick in COVID-19 cases across the globe. In the scenario that Novavax succeeds in developing an effective COVID-19 vaccine candidate, it is at the ready to produce billions of doses.According to the company, it continued to scale up manufacturing capacity, and will be able to produce up to 2 billion annualized doses by mid-2021.The firm has partnered with Endo International to help produce the clinical and market-ready vaccines, it announced Friday. Novavax CEO Stanley Erck <a href="https://www.prnewswire.com/news-releases/endo-announces-fill-finish-manufacturing-and-services-agreement-for-novavax-covid-19-vaccine-candidate-301138018.html">said he expects</a> a Phase 3 trial of its COVID-19 vaccine candidate "to get underway very soon" in the US. Shares of Novavax jumped as much as 15% to $117.35 in Friday trades. Shares of Novavax are up 2,474% year-to-date as investors pin hope on Novavax to develop a successful COVID-19 vaccine. <div type="image" title="nvax chart.JPG" height="696" width="861" msid="78318262" hostid="261"></div>

Novavax surges 15% after it begins phase 3 trial of COVID-19 vaccine

New Delhi, Nov 27 () Biotechnology major Biocon on Wednesday said that US health regulator has approved its and Mylan's supplemental biologics licence application for a drug substance to be manufactured at its new facility in Bengaluru.
 "Biocon and Mylan's supplemental biologics licence application (sBLA)..for pegfilgrastim drug substance to be manufactured in Biocon's new Biologics manufacturing facility has been approved by the US Food and Drug Administration (USFDA)," the company said in a filing to BSE.
 This additional approval of its new manufacturing facility for pegfilgrastim in Bengaluru will enable the biotechnology major to enable its arm Biocon Biologics and Mylan to scale up capacity multi-fold and address the growing market opportunities in US and other global markets, the company said.
 Biocon Biologics CEO Christiane Hamacher said, "This approval will help us better meet global patient needs for Fulphila, a high quality biosimilar pegfilgrastim co developed with Mylan and manufactured by Biocon Biologics".
 Biocon Biologics, through its partner Mylan, has commercialised three of its co-developed biosimilars in developed markets like the US, Canada, the European Union and Australia.
 The USFDA had conducted pre-approval inspection of this new drug substance manufacturing facility from September 10-19, 2019.
 Shares of the company were trading at Rs 277.45 apiece in morning trade on BSE. SID ANS
ANS

Biocon, Mylan get USFDA nod for pegfilgrastim drug substance licence

<ul class="summary-list"><li><keyword id="44612" type="CITY" weightage="60" keywordseo="Pfizer">Pfizer</keyword> on Tuesday reported its financials for the first three months of 2021. </li><li>The pharmaceutical company brought over $3 billion from sales of its <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> vaccine. </li><li>It expects to generate $26 billion in revenue from the shot through the rest of the year. </li></ul>Pfizer has sold hundreds of millions of doses of its <keyword id="8904563" type="UNKNOWN" weightage="60" keywordseo="covid-19-vaccine">COVID-19 vaccine</keyword> to the United States, and even more around the globe, resulting in more than $3.5 billion in revenue during the first three months of 2021, the company <a href="https://markets.businessinsider.com/news/stocks/pfizer-stock-price-q1-earnings-covid-sales-forecast-vaccine-2021-2021-5-1030385134">said</a> Tuesday. Sales of the two-shot vaccine made up nearly a quarter of the pharmaceutical giant's first-quarter revenues of $14.6 billion, easily its biggest income driver, though the company has been tight-lipped about how those sales translate to profits.Shares of Pfizer were little changed in early trading Tuesday following the results.Pfizer now expects to deliver a total of 1.6 billion vaccine doses in 2021, generating $26 billion in revenue. That's up significantly from previous forecasts of $15 billion. The company now says 2021 revenues will fall between $70.5 billion and $72.5 billion, a more than $10 billion increase over prior guidance. Read more: <a href="https://www.businessinsider.com/covid-variants-called-escape-mutants-could-throw-us-back-into-lockdown-2021-5">How coronavirus variants called 'escape mutants' threaten to undo all our progress</a>The vaccine tailwinds from the shot will likely carry on into 2022. In April, Pfizer CEO Albert Bourla <a href="https://www.businessinsider.com/pfizer-third-shot-likely-vaccine-booster-ceo-albert-bourla-2021-4">said</a> people may need a booster shot 12 months after their first dose. And the company said Tuesday it expects to have the capacity to produce 3 billion doses in 2022. "Based on what we've seen, we believe that a durable demand for our <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword> vaccine - similar to that of the flu vaccines - is a likely outcome," Bourla said in a prepared commentary ahead of a call with investors. Pfizer did not specify how much it has profited from its vaccine, largely the winner of the world's race to inoculate against the virus, but said it continues to expect margins in the high 20 percents. That would indicate a profit of roughly $900 million from January through March, and up to $6.5 billion for the year. BioNTech, the German biotechnology firm that co-developed Pfizer's shot, also stands to bring in billions from the vaccine, as the two companies split vaccine sales. Other drug companies like <a href="https://www.businessinsider.com/johnson-and-johnson-covid-19-vaccine-arguably-the-best-2021-2">Johnson &amp; Johnson</a> and <a href="https://www.businessinsider.com/pfizer-astrazeneca-vaccine-side-effects-not-as-bad-as-trials-2021-4">AstraZeneca</a> have pledged not to profit on their vaccines until the pandemic is under control. Pfizer has said it will not profit from the sale of its vaccine to poorer countries.

Pfizer brought in $3.5 billion from COVID-19 vaccine sales in the first 3 months of 2021

New Delhi, April 16 () Pharma and biotechnolgy industry leaders on Thursday stressed on the need for more testing across the country while hailing the government's move to contain the spread of COVID-19 pandemic.This pandemic has put spotlight on science, scientists and biotechnology, Biocon Chairperson Kiran Mazumdar-Shaw said while addressing an online conference organised by the Department of Biotechnology and School of Engineering &amp; Applied Sciences at Bennett University."What we need today is to understand the pandemic and find ways of testing the presence of the virus and ultimately develop a vaccine to counter the virus," she said.It was realised that there is a shortage of testing kits in the country, and there are people who could develop these kits.India has started the manufacturing of indigenous kits to face the challenge of their insufficient availability, Mazumdar-Shaw said in the conference on 'Combating COVID-19: Biotech to the Rescue'.Expressing that the number of tests being done in the country is very small, Sanofi Healthcare Pvt Ltd Chairman Varaprasad Reddy said: "Situation In India is very pathetic regarding the testing. There is lack of test kits. The government has to procure test kits... We are not testing enough".My appeal to the government is to import test kits, some startups in the country are also making the test kits as these viruses keep coming, but India must be well prepared for it, testing should come first and then drugs and vaccines, as developing them is a long drawn process, he added.In similar vein, Molbio CEO Sriram Natarajan said that currently, the country does not have enough kits for COVID testing and though the company is planning to deliver to the larger areas of the country it has capacity constraints.Mylab Discovery Solutions Pvt Ltd's MD Hasmukh Rawal said: "As the research on vaccine is going to take some time, diagnosis is going to play a major role".Distancing and diagnosis are going to be main factors to control the spread of the COVID-19. India's diagnostic response has been been apt. It is ensuring that the right product with the right quality is reaching the market, he added.Highlighting the role being played in current pandemic crisis, Organisation of Pharmaceutical Producers of India (OPPI) DG KG Ananthakrishnan said today more than ever the world is looking at innovative research solutions for the treatment of the disease. India has done a good job in containment but could have done better in testing."We need to create a environment that promotes innovation," Ananthakrishnan said. AKT BALBAL

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