PSM News

Apr 04,2024 New Delhi: Experts are sounding the alarm over the potential for a bird flu pandemic that could be significantly more devastating than the COVID-19 crisis, with the H5N1 strain posing a particularly dire threat. According to recent briefings, virus researchers have indicated that H5N1 is inching “dangerously close” to triggering a global pandemic, with the White House saying it is actively “monitoring” the evolving situation. The urgency of the matter was underscored by the discovery of multiple H5N1 infections across a variety of mammals, including cows, cats, and humans, which raises concerns about the virus mutating to become more easily transmissible among humans. This development comes on the heels of a dairy farm worker in Texas testing positive for the virus, along with infections reported in 12 herds of cows across six states and three cats in Texas that succumbed to the virus, a Daily Mail report said. Dr Suresh Kuchipudi, a prominent bird flu researcher, warned that we are nearing the threshold of a potential pandemic caused by H5N1. He emphasised that the virus has already shown the ability to infect a wide range of mammalian hosts, including humans, making it a formidable pandemic threat. Echoing this sentiment, John Fulton, a pharmaceutical industry consultant, highlighted the grave implications of H5N1 mutating while maintaining its high fatality rate, which could result in a pandemic far worse than COVID-19. “This appears to be 100 times worse than COVID, or it could be if it mutates and maintains its high case fatality rate,” Fulton said. The World Health Organisation has estimated the fatality rate for H5N1 at a staggering 52 percent, based on the data collected since 2003. In contrast, COVID-19’s fatality rate is significantly lower, emphasising the potential severity of a widespread H5N1 outbreak. Recent cases since 2020 show that nearly 30 percent of individuals infected with the new strain of H5N1 have died. As the situation unfolds, the White House and health experts are urging for increased vigilance and preparedness. The White House press secretary assured the public that the health and safety of Americans are a top priority and that measures are being taken to monitor and address the bird flu outbreak. Beyond the immediate health risks, the spread of H5N1 has broader economic implications, particularly for the dairy and poultry industries. With infected cattle showing symptoms and a requirement to cull infected birds, there could be a significant impact on the supply and pricing of milk and eggs. Source: Healthworld

Apr 06,2024 London: The U.S. Food and Drug Administration on Friday allowed the use of cell therapy Abecma from Bristol-Myers Squibb and 2seventybio in less severely affected patients with a type of blood cancer. The decision comes after a panel of expert advisers voted in favor of Abecma’s use as an earlier treatment for multiple myeloma, a common form of cancer that affects older adults. The cell therapy is already approved in the U.S. to treat patients with multiple myeloma who have received four or more prior lines of treatment. The health regulator is also reviewing cancer cell therapy, Carvykti, from Johnson & Johnson and its partner Legend Biotech for use in less severely affected patients. The FDA is set to decide on it by April 5. Abecma and Carvykti belong to a class of treatments known as chimeric antigen receptor (CAR) T-cell therapies that work by modifying white blood cells known as T-cells to attack cancer. Bristol Myers ‘ application included late-stage data that showed Abecma helped extend the time before disease progression by 13.3 months on average in patients whose cancer has returned or stopped responding to at least two prior treatments. This compared to 4.4 months progression-free survival seen in trial patients who received standard of care. Analysts estimate $601 million in sales for Abecma in 2024, according to LSEG data. The current standard of care includes use of non CAR-T therapies or regimens in less severely affected patients. Approved medications for the condition include J&J’s Darzalex and generic cancer drugs such as pomalidomide and bortezomib. Source: Pharma

Apr 06,2024 New Delhi: Drug firm Sanofi on Friday said it has obtained approval for IMOVAX-Polio, an alternative injectable vaccine, to replace the Inactivated Polio Vaccine (IPV) ShanIP in India. IMOVAX-Polio is an alternative IPV vaccine that has been used in more than 100 countries for over 40 years, a Sanofi India spokesperson told PTI. The vaccine has the same composition/formulation as ShanIPV, the spokesperson added. “We wish to assure all stakeholders that there will be no shortage of IPV vaccines in India on our account, towards safeguarding the nation’s status of remaining polio-free. We remain fully committed to fulfilling our public health mission in India,” the spokesperson noted. To ensure that there is no interruption to the availability of IPV vaccines, the French firm has already obtained approvals for IMOVAX-Polio. “…Sanofi has had to adapt its strategy and portfolio to these (emerging) trends. Accordingly, Sanofi Healthcare India Pvt Ltd (SHIPL) announced that by the end of 2023, it will discontinue ShanIPV, which was only filled and packaged at our factory in Hyderabad, India,” the spokesperson added. Launched in India in 2015, ShanIPV is a trivalent inactivated injectable vaccine. Under the government’s immunisation programme, the vaccine was injected in two stages – at six weeks and 14 weeks of age. Sanofi and Serum Institute of India are the leading suppliers of IPV vaccines in India. Source: Pharma

Apr 06,2024 Hyderabad: Dr Reddy’s Laboratories Ltd and Bayer have entered into a partnership to market and distribute a second brand of chronic heart failure drug Vericiguat in India. Under the terms of this agreement, Bayer has granted non-exclusive rights to Dr Reddy’s under the brand name Gantra. Vericiguat, a soluble guanylate cyclase (sGC) stimulator, in India, is indicated, along with guideline-based medical therapy, in adults with symptomatic chronic heart failure with reduced ejection fraction (less than 45 per cent), following a recent event of worsening heart failure which required hospitalisation or outpatient intravenous (IV) diuretics. Vericiguat works on a pathway not currently targeted by existing heart failure treatments and can reduce the combined risk of cardiovascular death and heart failure hospitalisation in such patients, Dr Reddy’s said. Shweta Rai, managing director, Bayer Zydus Pharma and country division head (CDH) for Bayer’s Pharmaceuticals business in South Asia said, “Despite therapy, chronic heart failure patients can experience disease progression that disrupts their lives and leads to worsening heart failure events. Vericiguat can help slow down disease progression, reduce hospital admissions and improve their chances of survival.” “The introduction of a second brand of Vericiguat in India, through our partnership with Dr Reddy’s is a reaffirmation of our commitment to making innovative healthcare solutions accessible to as many patients as possible.” MV Ramana, CEO, Branded Markets (India and Emerging Markets), Dr Reddy’s said: “Strengthening our chronic therapy portfolio in India continues to be a focus area for us. Vericiguat is a first-in-class sGC stimulator indicated for adults with symptomatic, chronic HF and ejection fraction less than 45 per cent following worsening heart failure.” “The addition of Vericiguat bolsters our heart failure management portfolio that includes Cidmus, Daplo and beta blockers. The partnership with Bayer is part of Dr Reddy’s continuous efforts to make innovative medicines available to patients in India through strategic collaborations,” he said. Ramana said Dr Reddy’s will use its strengths in marketing and distribution to widen access to this novel treatment in metros and beyond into tier-I and tier-II towns in India. India is estimated to have between 8-10 million people with heart failure, making it one of the largest populations with this condition. Source: Pharma

Apr 02,2024 New Delhi: Two domestic drugmakers are set to start production of penicillin G and clavulanic acid this year, supported by the government’s production-linked-incentive (PLI) scheme, a development seen boosting India’s efforts to cut dependence on China for crucial drugs. Industry executives told ET that the decks have been cleared for Hyderabad-based Aurobindo Pharma and Mumbai-headquartered Kinvan to begin production of the key starting materials (KSMs) penicillin G and clavulanic acid, respectively, and that their first batches will come this year. Penicillin G is used in making several antibiotics while clavulanic acid is used for manufacturing Amoxyclav, a combination drug whose most popular brand is Augmentin. India stopped producing the two input drugs about three decades ago and since then it has relied on China for their supplies. “As of now, we are largely dependent on China. With the initiative of the production-linked-incentive scheme, companies like Aurobindo are coming up with fermentation-based products like PenG,” said Ravi Uday Bhaskar, director general, Pharmaceutical Export Promotion Council (Pharmexcil). “We will be in a better position in the coming few months.” Aurobindo’s PenG plant is expected to start trial production this month and move into commercial production in a few months, the people cited earlier said. The ₹2,400-crore plant has been commissioned in Andhra Pradesh. It has a production capacity of 15,000 tonnes per annum. The government initiated the PLI scheme which is aimed at boosting domestic manufacturing of active pharmaceutical ingredients (APIs)/ KSMs, widening its scope to encourage export of these raw materials. India’s pharmaceuticals industry is the third largest in the world, but is dependent on China for crucial raw materials. The PLI scheme seeks to reduce this dependency and ensure adequate domestic supply of bulk drugs and APIs. The focus on self-reliance became sharper following the disruptions in global supply due to COVID-19. Dinesh Dua, former chairman of Pharmexcil, said that China is a major player in penicillin G and the initiative of starting its production in India will be a major victory for India. “About 30,000 metric tonnes of penicillin is imported from China. China ensured closure of production in the entire world, including India, on account of huge government support in terms of subsidies, infrastructure support, ease of doing business (EODB) in regulatory landscape, cheap labour, etc.,” Dua said. “This new initiative by India, however, is a major victory for India as it is going to compress demand from China.” Source: Pharma

Apr 03,2024 London: The U.S. FDA approved Vanda Pharmaceuticals’ drug to treat manic and mixed episodes associated with a type of bipolar disorder, the company said on Tuesday, marking the second approval for the treatment. Shares of the Washington, D.C.-based company jumped 16 per cent after the bell. Fanapt, which was initially approved in 2009 as a treatment for schizophrenia, faces a potential loss of exclusivity in 2027. The decision could help revive prescriptions for Fanapt, which has seen sales declining in recent quarters due to increased competition. With the approval, the drug can be used to treat adults with Bipolar I disorder, in which patients experience manic episodes that last at least seven days, or severe manic symptoms like extreme mood swings. The approval is based on a late-stage trial in which the company’s drug, chemically known as Iloperidone, helped reduce severity of core symptoms of mania when tested across 400 patients. About 40 million people worldwide suffer from bipolar disorder, according to the World Health Organization. Sales of Vanda’s sleep disorder drug Hetlioz have also been falling due to increased competition from cheaper versions. Fanapt’s sales fell 4.1 per cent to $91 million in 2023, while sales of Hetlioz declined 37.3 per cent to $100.2 million. Both the drugs accounted for more than 99 per cent of the company’s total revenue last year. Source: Pharma

Apr 04,2024 New Delhi: The Union Ministry of Health and Family Welfare has refuted the news reports in a section of media indicating that medicine prices will witness a significant hike by up to 12 per cent from April, 2024. These reports further claim that more than 500 medicines will be affected by this increase in price, which is also false, misleading and malicious. As per the provisions of Drug Price Control Orders (DPCO) 2013, drugs are categorised as scheduled and non-scheduled formulations. The formulations which are listed in Schedule-I of DPCO 2013 are scheduled formulations and the formulations that are not specified in Schedule-I of DPCO 2013 are non-schedule formulations. National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals annually revises the ceiling prices of scheduled medicines on the basis of Wholesale Price Index (WPI). The scheduled medicines included in the Schedule-I of the DPCO, 2013 are essential medicines. During the calendar year 2023 over the corresponding period in 2022, the annual change in WPI with base year 2011-12 was (+) 0.00551 per cent as per data published by Department for Promotion of Industry and Internal Trade (DPIIT). Accordingly, the Authority in its meeting held on 20.03.2024 has approved the WPI increase @ (+) 0.00551 per cent for the scheduled medicines. The ceiling prices on 923 medicines are effective as on date. Based on the above mentioned WPI factor of (+) 0.00551 per cent, there will be no change in the prevailing ceiling prices for 782 medicines and the existing ceiling prices will continue to prevail up to 31.03.2025. Fifty-Four medicines with ceiling price ranging from ₹90 to ₹261 will have miniscule increase of ₹0.01 (one paisa). As the permissible price increase is miniscule, the companies may or may not avail this increase. Thus, in the year FY 2024-25, there will be almost no change in the ceiling price of medicines based on WPI. The WPI increase is the maximum increase permissible as per the DPCO, 2013 and the manufacturers may or may not avail this increase, keeping in view the market dynamics. The companies adjust their Maximum Retail Price (MRP) depending upon the ceiling price of their medicines, as MRP (excluding GST) can be any price which is less than the ceiling price. The revised prices will be applicable from 1st April 2024 and the detail of revised prices is available on NPPA’s website www.nppaindia.nic.in. In case of non-scheduled formulation, a manufacturer is at liberty to fix the price. However, no manufacturer of non-scheduled formulation can increase the MRP by more than 10 per cent during preceding 12 months under Para 20 of DPCO, 2013, the ministry clarified. Source: Healthworld

Apr 05,2024 New Delhi: Pune-based Serum Institute of India (SII) is ready to ramp up capacity of injectable poliomyelitis vaccine (IPV) to fill up the vacuum caused by France’s Sanofi’s shuttering of manufacturing plants in India. In an interview to Vikas Dandekar and Teena Thacker, SII CEO Adar Poonawalla said the company gives half of the total 20 million doses of IPV to the government’s immunisation programme. With SII currently being the sole supplier for IPV, he said it will take 3-4 months notice to provide additional doses of the vaccine. Edited excerpts: Sanofi has already closed its manufacturing sites in India. Have you got any heads up from the government yet to fill in the gap? Typically, for these vaccines they have a tendering process. When the next tendering process starts, we will certainly supply and we have done this in the past when other manufacturers have stopped supplies or shut down facilities. We can supply any quantities of the vaccine that they may be in shortage of. We have ample supply coming from Dutch facility-Bilthoven Biologicals (BBio) where we import the bulk and we fill it in India. Yes, this is absolutely right and I agree with Sanofi that it is not viable because the price is so low. It just doesn’t make sense for most companies to make vaccines and supply at the current prices.SII has chosen to do it only as a service to the nation and this is very important to note. If we were only looking at it commercially, we would have stopped making this product a long time back. This is very important and we’re selling it at cost. In fact, at the moment, we are selling IPV below our cost. If there was another alternative, I would happily not make it. We’ve been supplying around 50 per cent and Sanofi has been doing around 50 per cent. And now with them shutting down, we will pretty much be the only supplier for injectable polio vaccine till some other Indian companies also make it after a few years. In light of that, and with this in mind, we have made sure that we have enough stock for the Indian population as and when the health ministry floats new tenders or asks us for any extra vaccine, we can give it with 3 months’ notice. Sanofi is under the obligation and commitment to fulfil their orders. They have made a statement that they will fulfil their commitments and if they can’t, then we are always there to support the health ministry and give them additional vaccines. But the ministry has to tell us. It’s not fair for me to say what they should do. Or what Sanofi should do. So let’s wait for a few months and see. But the main thing I wanted to clarify is that there is no shortage for the country of this vaccine because Serum can make it and it’s available. It will take at least 3-4 months from the time I receive a phone call or a written order. We have been making this product for the last 10 years since we acquired the company in the Netherlands. India started procuring IPV only a few years ago. Since then, we have been the 50 per cent supplier, and the quantity is not very large. Around 20-25 million doses a year is what the government takes. So we were supplying 10 -12 million doses, and now our production is much higher, so if the government needs 20-25 million doses from us, we can easily give it. Source: Healthworld

Apr 04,2024 Chennai : Apollo Hospitals unveiled the fourth edition of its flagship annual report, “Health of Nation”. The report deep dives into the prevalence and growth of Non-Communicable Diseases (NCDs) in India, and highlights the importance of preventive health measures. The report highlighted the concerning rise of NCDs in India, including cancer, diabetes, hypertension, cardiovascular diseases, and mental health issues, all of which significantly impact the nation’s overall health. Particularly the escalating incidence of cancer in India compared to global rates, making India the “cancer capital of the world”. The report further predicts a potential surge in healthcare burdens due to conditions such as pre-diabetes, prehypertension, and mental health disorders manifesting at increasingly younger ages. Highlighting the importance of regular health screenings, the report underscores their role in reducing Blood Pressure (BP) and body mass index (BMI) levels, thereby lowering the risk of cardiac-related ailments. Apollo’s data further finds that while there continues to be a need to increase the penetration of health checks in India, people are increasingly choosing more comprehensive health checks today than before, a positive step towards safeguarding one’s health and wellness. Indicating that the report demonstrated a significant need for immediate interventions to fight, prevent and reverse the growing epidemic of cancer, diabetes, hypertension and obesity among others, Dr Preetha Reddy, Vice Chairperson, Apollo Hospitals, said, “The importance of health in our nation’s development cannot be overstated. With our Health of Nation report, we hope to draw attention and awareness to the ever-increasing burden of non-communicable diseases and strongly believe that the entire healthcare ecosystem and the nation needs to come together and have a unified outlook so that we can combat NCDs in the truest sense. The need to educate the public and create individualised preventive healthcare solutions has never been greater. By prioritizing investments in health infrastructure, promoting preventive healthcare measures, and addressing health inequities, we will be able to unlock the full potential of our nation and pave the way for inclusive and sustainable development.” Sharing the deep insights of the report, Dr Madhu Sasidhar , President and CEO, Apollo Hospitals, said, “The significant rise of NCDs, especially over the past few decades, represents a profound shift in the global health landscape, posing formidable challenges to individuals, communities, and nations. Innovation in preventive healthcare and boosting accessibility must become a priority for the entire healthcare industry. At Apollo Hospitals, we are actively integrating technology to break healthcare delivery barriers to offer highly personalized and effective services. From our AI-backed preventive healthcare program to a vast screening footprint, we are committed to leveraging the power of technology to improve disease prevention, increase the accuracy of diagnoses, and create world-class patient-centric treatment methodologies that shape the future of healthcare. As we navigate the complex challenges of the 21st century, let us recognize that health remains our most valuable asset and a healthy population serves as the bedrock of a prosperous and resilient society.” In an effort to empower Indians with an accurate and unbiased understanding of their health, Apollo has launched a digital health risk assessment called ‘ProHealth Score ’. This free risk score evaluates factors such as family history, lifestyle, and current symptoms, it generates a personalized numeric indicator of your health status. Additionally, it provides simple corrective measures to guide you toward better health. Elucidating about how ProHealth risk score, which aims to raise awareness about the contributing factors to this health crisis and advocate for proactive measures to address the growing impact of NCDs on the population, Dr Sathya Sriram, Chief Executive Officer, Apollo Preventive Health, said, “The tool is designed to assist people in making informed decisions. A QR code which can be scanned will have a questionnaire on family history, lifestyle generates a personalized numeric indicator of your health status helps to understand their current health status and enables them to make informed lifestyle shifts.” Source: Healthworld

Mar 29,2024 New Delhi: Researchers from the Indian Institute of Technology- Guwahati in collaboration with the University of Animal and Fishery Sciences, Kolkata have formulated three ingenious treatment solutions for a certain type of knee injury that has historically proven difficult to treat. By developing these key regenerative therapies, the researchers have provided possible alternative solutions to manage the problem of a knee meniscus tear , an injury to tissue in one’s knee joints. Trauma to the knee meniscus, a cushioning tissue in the knee joint, is a commonly occurring yet complex problem. It can be caused during day-to-day activities by sudden accidents, mishaps while playing sports, or simply aging. A tear in this crucial tissue can make it difficult for an individual to walk, run or participate in daily activities. However, these new developments signal a significant advancement in treating knee injuries, providing a solution that is custom-made for each patient and could also potentially prevent future complications such as osteoarthritis. The three different approaches have been published in three manuscripts across two International journals, Applied Materials Today and Advanced Biology, co-authored by Prof. Biman B. Mandal, Department of Biosciences and Bioengineering, along with his research scholars, Ashutosh Bandyopadhyay, Baishali Ghibhela, and Sayanti Shome, from IIT Guwahati, and collaborators Dr Debajyoti Pal, Dr Samsamul Hoque and Prof. Samit K. Nandi from the University of Animal and Fishery Sciences, Kolkata. Speaking about the research, Prof. Biman B. Mandal, Department of Biosciences and Bioengineering, IIT Guwahati, said, “We have developed regenerative treatment approaches that would be tailored for the patient and help in rapid healing meniscus tears or replacing parts of the damaged tissue. Our problem statement also accounts for the shape and size variability of the meniscus in patients of different age groups and is a source of growth factors for better healing.” Healing the knee meniscus naturally is a slow and difficult process because of its restricted blood supply. Surgically removing the injured tissue may cause joint discomfort and osteoarthritis in the long run. This causes movement constraints, pain, and livelihood issues for millions in India and across the globe. The team from IIT Guwahati has created three hydrogel formulations that are blends of silk fibroin and other polymers, which they envision can be used by doctors in clinics, to treat the meniscus injury. These components, especially silk, are well known for their strength, bioactivity and flexibility. They are also cost-effective compared to other materials such as commercially available polyurethane and collagen meniscus implants. Out of the three, one is an injectable hydrogel, which can be injected in a minimally invasive manner directly into the meniscus site to expedite the healing of smaller injuries. When it comes to treating larger full thickness complex meniscus tissue injuries, the researchers have additionally created two 3D bio-printable inks that can be 3D printed into implants. Source: Healthworld