March 2024

Mar 12,2024 New Delhi: Health and Chemicals & Fertilisers minister Mansukh Mandaviya on Tuesday said the credit assistance scheme of SIDBI for Jan Aushadi Kendra operators will strengthen and help in further expanding the network. The loan from SIDBI will be made available to small operators of Jan Aushadi Kendra without any collateral, he said after launching the scheme and a dedicated website for this. The scheme of SIDBI will help operators of Jan Aushadi Kendra for starting business or expansion, he added. The credit guarantee on such loans whether working capital or term loan is being provided by Credit Guarantee Fund Trust For Micro And Small Enterprises (CGTMSE). The government has set a target to have 25,000 Janaushadhi Kendras across the country by March 31, 2026. Till January 31, 2024, about 10,624 Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs) were functional across the country. In 2022-23, the Pharmaceuticals & Medical Devices Bureau of India (PMBI) registered sales of Rs 1,235.95 crore which led to savings of around Rs 7,416 crore to the citizens. Around 1,965 generic drugs and 293 surgical items are sold through the outlets at affordable rates. Source: Healthworld

Mar 13,2024 By Harry Sumnall, Liverpool John Moores University and Ian HamiltonHonorary Fellow, Department of Health Sciences, University of York New York: There has been a significant rise in deaths linked to the commonly prescribed anxiety drug, pregabalin. While in 2018 there were 187 deaths linked to pregabalin in England and Wales, this number was more than double in 2022 – with 441 deaths linked to the drug. Recent press reports have framed these deaths as signalling a “US-style opioid epidemic” caused by a medicine that “destroys lives”. This is not an equitable comparison, given hundreds of thousands of Americans have died due to opioids. These reports may only serve to cause undue panic about the drug, especially among those who have been prescribed it. Pregabalin (also known by the brand names Lyrica and Alzain) is used to treat a variety of health conditions, including epilepsy, nerve pain and anxiety. The drug was first approved for use in Europe and the US in 2004. Pregabalin has rewarding properties, and can produce feelings of euphoria, calmness and relaxation. These effects may explain why even people who don’t have a prescription seek out pregabalin. Pregabalin on its own is typically not dangerous, although as with all medication there are potential side effects – including confusion and headaches. It can also carry the risk of dependence, especially if taken long term. But where pregabalin can become dangerous, whether used as prescribed or not, is if it’s taken alongside other drugs that it interacts negatively with. Pregabalin should ideally be avoided alongside other opioids, certain sleep aids, benzodiazepines (another class of anxiety drug), muscle relaxants and even certain diabetes and epilepsy drugs. Most fatalities attributed to pregabalin are due to interactions with other drugs, leading to a suppression of breathing. An analysis of pregabalin deaths in England between 2004-2020 has shown that in over 90 per cent of deaths, the presence of other opioids (including methadone or morphine) was detected. However, in only a quarter of cases were these opioids actually prescribed to the person. This suggests that people were probably sourcing these drugs through illicit means and not through their doctor. Likewise, it’s not clear from the data whether pregabalin had been prescribed, or if the person sourced it without a prescription. Although this data only goes up to 2020, it’s likely that the picture is similar for the recent deaths linked to pregablin. Source: Healthworld

Mar 13,2024 Illinois: A collaborative research between a bariatric and transplant surgery team has provided fresh hope for individuals with end-stage renal disease (ESRD) and obesity. The study’s authors investigated the results of metabolic and bariatric surgery in ESRD patients, as well as whether such surgery might enhance their eligibility for kidney transplantation. The findings are reported in the Journal of the American College of Surgeons. “Obesity is a worsening problem in the United States, significantly impacting transplant eligibility. We established the CORT initiative – a collaborative for obesity research in transplantation – recognising the urgent need to address this issue, especially in underserved populations who suffer the most from obesity-related diseases,” said corresponding study author Anil Paramesh, MD, MBA, FACS, professor of surgery, urology, and paediatrics and director of the kidney and pancreas transplant programs at Tulane University School of Medicine. Patients with ESRD face many difficulties without a transplant; their only alternative is to prolong life through dialysis, a process that is not only costly and time-intensive but also significantly diminishes the quality of life, Dr Paramesh noted. The study, conducted between January 2019 and June 2023, followed 183 ESRD patients referred for bariatric surgery, with 36 undergoing weight loss surgery and 10 subsequently receiving kidney transplants . Results showed a 27 per cent reduction in average BMI at the time of transplant, alongside improvements in hypertension and diabetes management. This improvement in the management of comorbid conditions enhanced patients’ overall health and transplant viability. With obesity being a major cause of transplant exclusion, this collaborative program represents a path forward for patients who previously would be ineligible, Dr Paramesh said and may help pave the way for increased patient education and access. “We’ve seen that bariatric surgery is not just about weight loss; it significantly improves other serious conditions like diabetes, high blood pressure, and sleep apnea. This approach not only helps in reducing the patients’ weight to a level where they can safely receive a transplant but also addresses the broader issue of health care disparities, particularly affecting Black and lower-income individuals,” said Dr Paramesh. However, the study also faced challenges, including a high drop-off rate of patients unwilling or unable to undergo surgery, and unique postoperative complications such as hypotension. “Our findings indicate a pressing need to enhance patient education and support, making sure that potential candidates understand the benefits of weight loss surgery and its role in improving their eligibility for transplant,” said Dr Paramesh. Source: Healthworld

Mar 13,2024 London: Merck & Co said on Wednesday it plans to conduct clinical trials testing its human papillomavirus (HPV) vaccine Gardasil 9 to evaluate the efficacy and safety of a single-dose regimen compared to the approved three-dose regimen. The company said it plans to conduct two separate trials testing Gardasil 9 in men and women 16-26 years old to examine whether a single dose of the vaccine provides comparable long-term protection when compared with the approved three-dose regimen. The large, multi-year trials are expected to start enrollment in the fourth quarter of 2024, according to Merck. The drugmaker also plans to begin human trials for an experimental HPV vaccine in the fourth quarter that is designed to offer broader protection by targeting multiple HPV types. The U.S. Food and Drug Administration first approved Gardasil 9 in 2014 to prevent certain cancers, including cervical, vulvar, vaginal and anal cancers, and diseases caused by nine variants of HPV. Gardasil 9 is now approved for use in women and men aged 9 through 45 years. HPV causes about 36,000 cancer cases in both men and women every year in the United States, according to government data. Source: Pharma

Mar 14,2024 BRUSSELS – EU lawmakers have gone part of the way to meeting pharmaceutical industry concerns about the exclusivity period for new medicines after reaching a compromise on the biggest overhaul of EU pharmaceutical rules in 20 years, a parliament proposal showed. A European parliamentary committee is set to vote on its position on March 19 before a plenary vote on April 11. The legislation, proposed by the European Commission in April last year, aims to slash the time it takes to approve new medicines, incentivise production of medicines for antibiotic-resistant bacteria, improve patient access and “future-proof” the rules to account for technological leaps like artificial intelligence. Europe’s pharmaceutical industry has been critical of the proposal. The Brussels industry group, EFPIA, has cautioned that it risks speeding up a decline in innovation and research on the continent, already down by 25%. At issue is the new linking of a medicine’s exclusivity period to access across all 27 member states, where the length of approval can vary by years. In the draft compromise, seen by Reuters, committee members have agreed to raise baseline data protection to 7.5 years with one extra year of incentives if the medication meets “unmet medical needs”, and if clinical trials are held in the EU. A company would also receive three years of market protection from generics, taking the total exclusivity period to a maximum 11.5 years, up from 10 years as proposed by the Commission. Further, parliament’s position would shift the onus of launching a new medicine to member states who would first have to request the new medication, rather than obliging a company to initiate the process in 27 countries at once. As for orphan diseases – which are very rare and therefore less immediately lucrative for the pharmaceutical industry – the baseline exclusivity would be nine years, unchanged from the Commission proposal, and 11 years if a new medicine fulfils an unmet medical need, up from the Commission proposal of 10 years. To “future-proof” the legislation against technological advances, the committee would keep a so-called “regulatory sandbox” proposed by the Commission with extra safeguards. “Regulatory sandboxes can provide…a structured context for experimentation, enable where appropriate in a real-world environment the testing,” the document said, “especially in the context of digitalisation or the use of artificial intelligence and machine learning.” EU member states have fallen behind in trawling through the mega proposal and will not start discussions on exclusivity and incentives until next week. (Reporting by Julia Payne; editing by Mark Heinrich) Source: Healthworld

Mar 13,2024 Mumbai: Dealing with existing infectious diseases like tuberculosis and dengue will prepare the country better for tackling the next pandemic or unknown pathogen, said Dr Soumya Swaminathan, former chief scientist of the World Health Organisation, here on Tuesday. She was speaking after receiving the Yashwantrao Chavan National Award, instituted by the city-based Yashwantrao Chavan Centre. “How do we invest more in science and technology so that we can build platforms and build more tools we need so that when we are faced with an outbreak, we don’t waste any time, we are ready to go with the tools that we already have at our hand….But I think that to prepare for the next pandemic we should deal with the infectious disease we have today,” Swaminathan said. “Why should we wait for the next new virus?” she asked, noting that diseases like TB, malaria, dengue and chikungunya are still killing a lot of people in India and elsewhere. The COVID-19 pandemic opened our minds to science and technology, she said. “If this knowledge is used to tackle the existing infectious diseases then we will be even stronger to tackle, to deal with something that is unknown, what we call as pathogen X or disease X,” she said. It would require a national mission, certain goals and targets to be set, investment, partnerships and collaborations, Swaminathan said. India is in the best position to do this as it has all of the above ingredients, only everyone needs to come together and set a goal to make infectious diseases history, she added. “Any infectious disease that has been eliminated has been done through vaccines. We have conquered smallpox, and polio is on the edge (of disappearing) with a few cases, and in just two countries — Pakistan and Afghanistan…. thanks to vaccines. We can do it, it is not impossible. Some pathogens are easier than others to develop vaccines (for)…It’s not easy to develop vaccines, but with the new insights we have, today it should be possible to do that,” she added. Swaminathan, the daughter of the father of the Green Revolution in India M S Swaminathan, received the award comprising Rs five lakh and a citation from NCP (SP) chief Sharad Pawar, who is the president of the Chavan Centre. The annual award is given to individuals or organisations that have made significant contributions to national integration, preservation of constitutional values and advancement of India’s social and economic development. The award selection committee headed by senior nuclear scientist Dr Anil Kakodkar chose Dr Soumya Swaminathan, a paediatrician and clinical researcher renowned for her extensive work on HIV and tuberculosis, for the honour, an official of the centre said. Source: Healthworld

Mar 13,2024 London: TheU.S. Food and Drug Administration’s staff reviewers said on Tuesday they were unclear if Geron’s blood disorder drug provided a clear benefit to patients in a late-stage trial and raised multiple safety concerns with the treatment. Shares of the California-based company fell 11.5 per cent following the release of the briefing documents, ahead of a meeting of the FDA’s independent advisers scheduled for Thursday. Geron is seeking approval of the injectable drug, called imetelstat, for treating transfusion-dependent anemia in patients with a group of blood cancers called myelodysplastic syndromes (MDS). The drug, if approved, will compete with Bristol Myers Squibb’s Reblozyl, which was greenlit by the FDA last year for the same disease indication. While imetelstat met the main goal of increasing independence from transfusion at eight weeks in a late-stage study, the FDA’s staff said the “clinical meaningfulness” of the data was unclear. “The general consensus among MDS experts has been that only a 16-week or longer period of transfusion independence is clinically meaningful,” the agency’s staff said. Last year in January, Geron’s CEO John Scarlett told Reuters that the company anticipates a peak market potential of $1.2 billion for the treatment in the United States and some key EU countries by 2030. The FDA staff on Tuesday said the late-stage study on imetelstat did not show a “disease-modifying effect” in either extending survival or helping drive disease remission. It also highlighted a high rate of low red blood cell count. Geron earlier said the adverse effects were not uncommon, adding “the side effects are short lived and reversible”. Wedbush analyst Robert Driscoll said it was expected that the briefing documents would lean negative, and believes Geron will be able to provide a strong case against the points made by the FDA. The regulator, which usually follows the advice of its panel but is not bound to do so, is expected to make a decision on the drug by June 16. (Reporting by Christy Santhosh and Pratik Jain in Bengaluru; Editing by Shailesh Kuber) Source: Pharma

Mar 13,2024 London: Pfizer said on Tuesday its drug, Adcetris , extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen. The New York-based drugmaker last year struck a deal to acquire Seagen and its targeted cancer therapies to reinforce its pipeline in the face of a steep fall in COVID-19 product sales and generic competition for some top-selling drugs. The company, which has U.S. and Canadian commercialisation rights for Adcetris, reported total sales of $46 million from the drug last year. Pfizer said on Tuesday it plans to discuss with regulators a submission for approval to treat these patients. A potential greenlight for Adcetris for the most common type of lymphoma will pave the way for the eighth approval for the drug and beef up an oncology portfolio that already has more than 25 approved therapies. The combination therapy consisting of Adcetris and two other drugs was statistically significant compared to a placebo in extending survival in patients with lymphoma known as diffuse large B-cell lymphoma. The trial tested 230 patients whose cancer does not express a protein known as CD30 and returns after a period of remission or does not respond to treatment. The drug, when compared to a combination of two other drugs plus placebo, also showed improvements in both secondary study goals of progression-free survival, or how long before the disease begins to worsen. It also showed improvements in overall response rate, or proportion of patients who have a partial or complete response to the therapy. Source: Pharma

Feb 28,2024 NEW DELHI: A cataract surgery could cost up to Rs 10,000 per eye in a govt hospital and Rs 30,000-1,40,000 in a private facility. Supreme Court Tuesday took strong exception to this disparity and inability of the Centre to implement a 14-year-old law-Clinical Establishment (Central Government) Rules-mandating notification of a standard rate in consultation with states for treatment and procedures of ailments in metros, cities and towns. Govt told SC though it had repeatedly written to states on this, they didn’t respond. SC said citizens have a fundamental right to healthcare and the Centre can’t shirk its responsibility on this ground. It asked Union health secretary to call a meeting of his state counterparts to ensure notification of a standard rate within a month. “If Union govt fails to find a solution, then we will consider petitioner’s plea for implementing CGHS-prescribed standardised rates,” SC warned. A PIL by NGO ‘Veterans Forum for Transparency in Public Life’ through advocate Danish Zubair Khan had sought a direction to Centre to determine rate of fee chargeable from patients in terms of Rule 9 of Clinical Establishment (Central Govt) Rules, 2012. Under the Rules, all hospitals and clinical establishments, to keep intact their registration, must “display rates charged for each type of service provided and facilities available for benefit of patients at a conspicuous place in vernacular as well as in English language; and charge rates for each type of procedures and services within range of rates determined and issued by Centre from time to time, in consultation with state govts.” Petitioner told a bench of Justices B R Gavai and Sandeep Mehta that Centre acted promptly in notifying standardised rates for treatment of patients during Covid and that if states did not cooperate in framing range of rates for treatment of ailments, it could use powers under central laws to unilaterally notify fees to be charged for different procedures. Source: TOI

Mar 07,2024 Paris, Mar 06, 2024 -A German man who deliberately got vaccinated for Covid-19 a whopping 217 times did not report any side effects from his many jabs, according to researchers studying possibly the “most vaccinated person in history”. The immune system of the 62-year-old man from the central German city of Magdeburg — who has not been named — is still firing on all cylinders, the researchers said in The Lancet Infectious Diseases journal. They said the man voluntarily received so many shots against all medical advice, and warned against jumping to far-reaching conclusions from this single case. The man first came to the attention of the German-led researchers due to news reports in 2022, when he had only received 90 jabs. Media reports at the time said the man was suspected of getting so many doses to collect the completed vaccination cards, which could then be forged and sold to people who did not want to be vaccinated. A public prosecutor in Magdeburg opened an investigation into allegations of fraud over the case but no criminal charges were filed, according to the scientific paper published earlier this week. The prosecutor collected evidence of 130 vaccinations over nine months, it added. But the man claims to have received 217 vaccine doses of eight different Covid vaccines — including all mRNA versions — over 29 months. Kilian Schober, a virologist at Germany’s University of Erlangen-Nuremberg and study co-author, said in a statement that when they contacted the man, he was “very interested” in undergoing a range of tests to examine the effect of so many vaccinations. Source: Healthworld