PSM News

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

Mar 03,2024 Panaji: GMC has set a shining example of innovation by becoming the first hospital in the country to use a gold-coated implant for a knee-replacement procedure. At an orthopaedics conference Global Medial Pivot Knee Summit – held in North Goa, GMC’s achievement in the treatment of arthritis was announced. The replacement procedure was performed on Saturday. Dr Shivanand Bandekar, GMC dean and the head of the orthopaedics department, along with an orthopaedic surgeon from the US, Dr Neil Sheth, used the gold-coated implant for a 56-year-old female patient. Usually, titanium or cobalt- and chromium-based alloys are used for implants. “We (GMC) are the first in the country to have the new technology which offers implant longevity and a better quality of life to a patient,” Bandekar told TOI. “The new method is designed specifically to match the natural anatomy of the patient.” The cost difference between regular and gold-coated implants is not huge. A new implant will cost less than Rs 1 lakh, maybe Rs 80,000, and it has longer utility,” Bandekar said. The new implants are expected to last for 30 years, the regular implants have a lifespan of 15-20 years. Regular implants, on average, cost Rs 60,000. The costs rise depending on the quality of the material. Bandekar said since the new implants are being produced by a domestic company under the Make in India initiative, their availability should not be a problem. A gold-coated implant, Bandekar said, reduces friction to a large extent, leading to faster adoption of the foreign object into the body. Also, the procedure for a knee-replacement surgery remains the same whether a regular or a gold-plated implant is used. “For the latest procedure, however, we used a new method called a window operation, in which an incision smaller than usual is made,” Bandekar said. “But other aspects did not change. Even the time taken for the procedure did not alter.” While a surgery duration will differ from surgeon to surgeon, Bandekar said, he finishes a total kneereplacement process in 35 to 40 minutes. “If the procedure is required on both knees, more than an hour is required,” he said. At GMC, monthly kneereplacement surgeries range between 30 and 35. The number of those seeking knee replacements could go up if patients stopped waiting until their condition deteriorated. “Unlike in the foreign countries, patients here do not come for treatment early. A doctor is consulted only when the knee pain is unbearable and walking becomes extremely difficult,” Bandekar said. As for the conference, around 100 orthopaedic surgeons were in attendance. Source: Healthworld

Mar 09,2024 A man who was given a few months to live has experienced a remarkable recovery from his aggressive brain cancer, leaving doctors astonished, reports The Sun. Ben Trotman, a 41-year-old from West Sussex, received the devastating diagnosis of glioblastoma in October 2022, prompting him to move up his wedding to January. Doctors informed Ben and his now-wife Emily that most patients only survive for nine months. The sudden change from good health to a terminal prognosis was a lot for the couple to process. However, Ben had the opportunity to participate in a groundbreaking clinical trial that utilizes the patient’s own immune system to combat the tumor. Following the completion of the treatment, Ben is now nearly free of the disease, with the tumor shrinking in a way that was previously unheard of.In recent years, several notable individuals, including TV presenter Annabel Giles, campaigner Laura Nuttall, and former Labour cabinet minister Tessa Jowell, lost their lives to stage four glioblastoma. In response to this devastating disease, Labour MP Dame Siobhain McDonagh, sister of Baroness McDonagh, is advocating for more patients to participate in clinical trials each year in order to find a cure. The current standard treatment for glioblastoma involves six weeks of radiotherapy followed by six months of chemotherapy, which Dame Siobhain McDonagh believes falls short of being a true gold standard. In contrast, the new immunotherapy treatment, which was tested in a clinical trial, proved to be highly effective for Ben. Although he experienced a headache after taking the drug, doctors explained that it was a positive sign indicating the activation of his immune system. While the trial ended for Ben due to a lack of eligible referrals from the NHS, Dr. Mullholland, the lead researcher, believes that this approach can be used in future trials. In fact, he has established a Glioblastoma Research Group and laboratory at UCL Cancer Institute, where he aims to combine cutting-edge drugs from the pharmaceutical industry with the latest advancements in scientific research to ultimately find a cure for this devastating disease. Source: Healthworld

Mar 10,2024 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 09,2024 Denmark: Novo Nordisk is very comfortable it will be able to launch the pill version of its experimental weight loss drug amycretin this decade, the drugmaker’s head of development told Reuters on Friday, a day after it announced strong early trial data on it. “I never commit to timelines but I would be very comfortable to say at the very least within this decade,” Martin Holst Lange said in an interview. Novo shares surged more than 8 per cent to record highs on Thursday when the company told investors a Phase I trial of the pill version of amycretin showed participants lost 13.1 per cent of their weight after 12 weeks, a bigger reduction early on than from Wegovy. Shares in the drugmaker, which surpassed Tesla Inc in market value on Thursday, were down 0.9 per cent on Friday but were still set for a 7.1 per cent gain this week. Investors said the news shows the Danish company, originally known as an insulin maker, has more in its pipeline beyond its hugely successful Wegovy. Its shares have risen more than three-fold since June 2021 when it launched Wegovy in the United States. It hopes both its new experimental obesity drugs cagrisema and amycretin will have higher efficacy in terms of weight-loss than Wegovy. Cardiac Benefits After 12 weeks on amycretin in the trial, more than 80 per cent of the participants were still on the drug, Lange said, describing it as an “impressive” retention rate which would suggest that the doses were safe and patients were tolerating it well without major side effects. Lange added that it also “would be a likely scenario” that the new drugs would have similar cardiac benefits as Wegovy. Wegovy belongs to a class of drugs known as GLP-1 agonists, originally designed to treat Type 2 diabetes, that have been shown to regulate blood glucose levels and suppress appetite. Following the success of Wegovy, companies are working on other promising weight-loss therapies such as amycretin, which in addition to binding to the same gut hormone as Wegovy — GLP-1 — also targets a hormone called amylin in the pancreas that affects hunger. Novo in August said a large study had shown Wegovy also had a clear cardiovascular benefit, boosting the company’s hopes of moving beyond its image as a lifestyle drug. Those results have led to a debate over whether the long-term medical benefits of weight-loss drugs are enough to reduce the overall burden on healthcare systems and the cost of treating heart disease in overweight and obese people. Novo’s current plan is to advance the development of amycretin in its oral and injectable form simultaneously, and it gives a regulatory advantage to deliver safety data on both versions at the same time, Lange said. Source: Pharma

Mar 11,2024 Bhopal: A division bench of MP high court recalled its order passed on November 28, 2023, on a contempt petition in which it had held the additional chief secretary, health & gas relief, Mohd Suleman and two officials of National Informatics Centre (NIC) prima facie guilty of contempt and asked for framing of charges against rest of the respondents for non-compliance of the supreme court order of August, 2012 and subsequent directions of the MP high court issued from time to time for better medical care of Bhopal gas victims. The bench of Justice Sheel Nagu and Justice Vinay Saraf said that the order is being recalled on the sole ground that the contempt alleged was of civil nature and not of criminal nature, where charges need to be framed. The court further said that after an overall assessment of the entire scenario, which is prevailing in the instant case and the connected matters, instead of adjudicating upon contemnors being guilty for punishment or not, it would be appropriate that assistance of the Monitoring Committee is sought. It is thus directed that each respondent or his/her representative, who should not be below the rank of class-1 gazette centetted officer should appear on the next date of meeting of the Monitoring Committee to enable the Monitoring Committee to assess present state and extent of compliance of order of the supreme court dated 09.08.2012 and various directions passed by this court and thereafter prepare report under various heads showing compliance/non compliance The Monitoring Committee is requested to assist this court by submitting report as enumerated above as expeditiously as possible list in the third week of April, 2024. The supreme court in its order of August 2012, had constituted a monitoring committee headed by retired judge of MP high court Justice V K Agrawal to keep a watch on medical facilities being provided to Bhopal gas victims in gas relief hospitals and later also brought Bhopal Memorial Hospital & Research Centre (BMHRC) under its jurisdiction. The committee was asked to submit a quarterly report to the bench of MP high court which hears the PIL on proper medical care of gas victims which the apex court had transferred to the MP high court after its order of August 2012, enumerating 20 points to ensure a proper medical care of gas victims. The NGOs working among the gas victims led by Bhopal Gas Peedit Mahila Udyog Sangthan and Bhopal Gas Peedit Sangharsh Sahyog Samiti had filed the contempt petition against concerned officials of the state/central government alleging non-compliance of the supreme court order of 2012 and subsequent directions of the high court on the PIL. The officers made respondents in the case against whom action for contempt of court was proposed included Rajesh Bhushan, secretary, ministry of health & family welfare, Govt of India, Arti Ahuja, secretary, ministry of chemical & fertilisers, Govt of India, Iqbal Singh Bains, former chief secretary, govt of MP, Mohd Suleman, secretary gas relief, govt of MP, R Rama Krishnan, senior deputy director general, ICMR, Dr Prabha Desikan, director, BMHRC, Dr Rajnarayan Tiwari, director, NIREH, Bhopal, Amar Kumar Sinha, state Information officer, NIC, and Vijay Kumar Vishwakarma, also state information officer, NIC, Bhopal. Source: Healthworld

Mar 11,2024 New Delhi: Scientists have discovered a new class of antiviral drugs with the potential to prevent or treat COVID-19 infections in a future outbreak. In a study published in the journal Nature, the researchers show that SARS-CoV-2 – the virus that causes COVID-19 – activates a pathway in cells that stops the production of peroxisomes and interferon, both key parts of the normal immune response. The team from the University of Alberta in Canada successfully tested the new class of antiviral drugs that stimulate interferon production to reverse that effect. Interferon stops infected cells from producing more virus by shutting down the infected cell, which often results in cell death, and then acts on the surrounding cells to prevent them from being infected, the researchers said. The study builds on the team’s earlier research that showed how HIV has evolved to activate the Wnt/β-catenin signaling pathway in cells as a way to stop the body from producing peroxisomes, which trigger interferon production. The team tried 40 existing drugs that target the Wnt/β-catenin signaling pathway. Most were originally developed and tested for treating cancer, which often responds to boosted interferon production. Three of the drugs significantly reduced the amount of virus found in the lungs, and one of the drugs was also effective at reducing inflammation and other clinical symptoms in mice. “We saw, in some cases, a 10,000-fold reduction in the amount of virus produced in a test tube, and when we went into a mouse model, the drugs prevented severe weight loss and the mice recovered much quicker,” said study lead author Tom Hobman, a professor at the University of Alberta. During a viral outbreak, people who might have been exposed or who have already developed early symptoms would take a four- or five-day course to prime their peroxisome levels and limit the severity and spread of the disease. “The beauty of this approach is that in the absence of viral infection, there’s no interferon produced. We see these drugs potentially serving as first-line drugs against emerging viruses,” Hobman added. Source: Healthworld