Pandemic talks extended as deadline passes
Countries trying to strike a landmark global agreement on handling future pandemics decided to keep negotiating for another fortnight after their deadline passed on Friday.
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Bed confirmed on Call but denied on Spot: Hospital directed to tender apology to patient
Kolkata: The West Bengal Clinical Establishment Regulatory Commission (WBCERC) has asked AMRI Mukundapur to tender an apology letter to a complainant for refusing to admit an elderly without making proper provisions for her. The complainant is the son of a 68-year-old who was admitted to the AMRI Hospitals (Now Manipal) in Dhakuria and Mukundapur 12 times.
The complainant stated that as AMRI Mukundapur was 35 km from home, he asked if beds were available. After receiving a positive response to his query, he arranged an ambulance and took his mother to the hospital.
On reaching the hospital, he was informed that general bed admission was not required and the patient should be admitted in the general ward. However, at that time there were no beds available. The complainant alleged that despite informing him that a bed was available, he was denied admission and the authorities were rude and unpathetic towards them. The commission stated, “Maybe there were no beds when the patient reached the hospital but it was available when he enquired. As far as the complaint of misbehavior is concerned, there is no proof of it.”
However, the commission pointed out that the Manipal has four hospitals in Kolkata, they should have arranged for an ambulance and sought a bed in one of its hospitals. chairperson Ashim Kumar Banerjee stated that the hospital sent a response via mail on Friday night and termed the complaint as frivolous and unfounded.
“We find it unacceptable that the hospital refused treatment to a patient who has been there 12 times and did not even make any other arrangements. moreover, a response copy was not sent to the complainant. We have denounced the hospital and asked for a written apology. We have asked AMRI authorities to donate Rs 10,000 to Narendrapur blind school. The hospital should send a receipt of the donation and an apology letter to the complainant,” added Banerjee.
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National Sickle Cell Anaemia Elimination Mission remains close to PM Modi’s heart
New Delhi: During a public address in Maharashtra’s tribal district of Nandurbar, Prime Minister Narendra Modi reiterated his party’s commitment to combating sickle cell anaemia in the country.
“Congress has never cared for tribal brothers and sisters. Sickle cell anaemia is a big threat in tribal areas. But Congress didn’t pay much attention to this disease. It is the BJP that has launched a campaign to eradicate sickle cell anaemia from the root. So that no poor person is malnourished, we have also been concerned about this,” said PM Modi.
According to an IANS report, Having spent a long time among the tribal communities in different parts of the country over the past many decades, PM Modi has stated earlier that the tribal society is “not just a government statistic” but a “matter of empathy and emotional concern” for the BJP.
This isn’t the first time PM Modi has underscored his determination to eliminate sickle cell anaemia, a genetic blood disease prevalent among India’s tribal population, affecting over 2.5 lakh children and their families annually.
Last July, while launching the Sickle Cell Anaemia Elimination Mission, he made it clear that the campaign for freedom from the hereditary disease – “which was not even an issue for the previous governments due to their indifference towards the tribal society” – will become the main mission of the ‘Amrit Kaal’.
The government led by him, PM Modi assured, is working in a “mission mode” to liberate the tribal families – and the entire country – from Sickle Cell Anaemia by 2047 when the nation celebrates 100 years of independence.
This is being done by increasing the number of blood banks for patients requiring blood transfusions and opening new facilities for bone marrow transplantations.
PM Modi’s deep understanding of the debilitating impact that Sickle Cell Anaemia has on the human body comes from intense interactions he had not just with the tribal communities but also world’s leading experts since long before he became the Chief Minister of Gujarat, reports news agency IANS.
“Even after I became the Chief Minister of Gujarat, I started many campaigns in this regard. When I visited Japan after becoming the Prime Minister, I met a Nobel laureate scientist there. I came to know that he had done a lot of research on sickle cell disease. I also sought his assistance in finding a cure for sickle cell anaemia,” he said, last year.
PM Modi was referring to his 2014 meeting with Japan’s stem cell pioneer and 2012 Nobel Prize winner Shinya Yamanaka at the Centre for iPS Cell Research and Application in Kyoto during which he expressed concern over the prevalence of sickle cell anaemia among tribal communities across India.
PM Modi and the top BJP leadership have also been mentioning about the government working tirelessly to eradicate many other serious diseases since coming to power in 2014.
This includes working towards completely eliminating tuberculosis by 2025 and making sure that cases of Kala-azar, malaria, leprosy and meningitis reduce by a significant number.
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Kite, Arcellx announce advances in Anito-Cel Multiple Myeloma Program
Redwood City: Kite, a Gilead Company, and Arcellx, Inc. have announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program.
“Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder,” the release stated.
The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody.
Kite’s facility in Frederick, Maryland will manufacture anito-cel for this trial. This follows the completion of the technical transfer from a third-party contract manufacturing organization to Kite, as well as the transfer of the Investigational New Drug (IND) application for anito-cel, which has been cleared by the U.S. Food and Drug Administration.
“We are pleased to start the Phase 3 pivotal trial, iMMagine-3, in the second half of this year given the tremendous unmet need that remains in patients with relapsed and/or refractory multiple myeloma,” said Cindy Perettie, Executive Vice President, Kite. “As we prepare for this pivotal program, we look forward to leveraging our manufacturing expertise to further position anito-cel as a potential best-in-class cell therapy. We know manufacturing quality, reliability and speed are critically important as every day matters for these patients.”
“Our global iMMagine-3 trial will evaluate anito-cel as a second through fourth line treatment in patients with multiple myeloma who were previously exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “The iMMagine-3 study allows us to maximize the impact of anito-cel as it captures what will become the largest second line patient population based on the current treatment paradigm, as anti-CD38 therapies move to front line treatment. This population represents an emerging significant unmet clinical need allowing us to provide access to a unique patient population. In addition, the completion of the technical transfer to Kite allowed us to accelerate our development program and launch iMMagine-3 globally, which will enable broader and earlier patient access to anito-cel.”
Arcellx and Kite, a Gilead Company, formed a global strategic collaboration to co-develop and co-commercialize Arcellx’s anito-cel candidate for the treatment of patients with relapsed or refractory multiple myeloma currently in a pivotal Phase 2 trial. Kite and Arcellx will jointly develop and commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States.
Read also: USFDA approves Biktarvy label update with data for pregnant adults with HIV: Gilead Sciences
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Sanofi, Novavax ink pact to co-commercialize COVID vaccine, develop novel flu-COVID combination vaccines
Paris: Sanofi has entered into a co-exclusive licensing agreement with Novavax, a biotechnology company headquartered in Maryland, US to develop a diverse portfolio of best-in-class vaccines.
The terms of the agreement include: a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea where Novavax has existing partnership agreements); a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority (<5%) equity investment in Novavax.
Jean-Francois Toussaint, Global Head of Vaccines R&D said, “With flu and COVID-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-COVID-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses. We’re excited by the prospect of combining Novavax’s adjuvanted COVID-19 vaccine that has shown high efficacy and favorable tolerability, with our rich portfolio of differentiated flu vaccines that have demonstrated superior protection against flu and its serious complications. Improved tolerability and thermostability, without compromise on efficacy, are what regulators, recommending bodies, and patients will demand.”
John Jacobs, CEO, Novavax said, “This collaboration is important for Novavax and for global public health. Our new partnership combines Novavax’s proprietary recombinant protein and nanoparticle technologies, Matrix adjuvant, and R&D expertise with Sanofi’s world-class leadership in launching and commercializing innovative vaccines. Together, we can broaden access to both our COVID-19 vaccine and our adjuvant to ensure more individuals can benefit from the protection vaccines can provide. Novavax is now in a stronger position to refocus our efforts on leveraging our technology platform and novel adjuvant in research and development and pipeline expansion to help advance our mission of developing life-saving vaccines to fight infectious diseases.”
Under the terms of the licensing agreement, Novavax will receive an upfront payment of $500 million and up to $700 million in development, regulatory and launch milestones, up to $1.2 billion in total. The Company will receive tiered double-digit percentage royalty payments on sales by Sanofi of COVID-19 vaccines and flu-COVID-19 combination vaccines. Starting in 2025, Sanofi will book sales of Novavax’s adjuvanted COVID-19 vaccine and will support certain R&D, regulatory, and commercial expenses.
Further, Sanofi will be solely responsible for development and commercialization of any novel flu-COVID-19 combination vaccine containing a Sanofi flu vaccine. Outside of the collaboration, each party may develop and commercialize their own flu-COVID-19 vaccines and adjuvanted products at their own cost. Novavax is entitled to additional launch and sales milestones opportunities of up to $200 million plus mid-single digit royalties for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax’s Matrix-M adjuvant technology. In addition, Sanofi will take a minority (<5%) equity investment in Novavax.
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Kauvery Hospital doctors save limb of 29-year-old Bangladeshi woman
Chennai: A 29-year-old woman from Bangladesh, grappling with persistent pain and swelling in her right knee, discovered renewed hope and healing at Kauvery Hospital Vadapalani.
Her journey from despair to recovery embodies the compassionate care and advanced medical expertise that define Kauvery Hospital’s commitment to patients.
For two months, the young woman endured discomfort in her right knee, with the pain worsening over time and impeding her daily activities. Simple tasks like walking became excruciating, leading to a sense of despair.
According to an ANI report, Upon visiting Kauvery Hospital Vadapalani, she underwent thorough investigations, leading to a diagnosis of aggressive form of Giant Cell Tumor (GCT) in her right distal femur with pathological fracture. Dr Ravi Kumar Kirubanandan, Orthopaedic Surgeon and his expert team of doctors identified limb preservation as the optimal solution for her condition.
“Losing a limb can be devastating, both physically and emotionally. By preserving her limb, we not only saved her from further suffering but also ensured her quality of life in the long term,” says Dr Aravindan Selvaraj, Co-founder and Executive Chairman of Kauvery Hospital.
The patient underwent limb preservation surgery, where her right distal femur was replaced. This innovative approach not only eradicated the tumor but also restored her mobility and hope. Following the successful surgery, the young woman regained her ability to walk, reclaiming her life from the clutches of despair.
The significance of limb preservation goes beyond physical function. For this young woman, it meant escaping the grip of depression and embracing a future filled with possibilities. Without her limb and in turn lack of mobility, she would have also faced increased risks of osteoporosis and continued psychological distress, reports news agency ANI.
This success story highlights the importance of empathy-driven healthcare and the transformative impact of limb preservation surgery. At Kauvery Hospital Vadapalani, every patient is treated with compassion and respect, ensuring not just medical recovery, but a return to a fulfilling life.
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COVID vaccine maker Novavax erases doubts about its ability to remain in business
Novavax, the manufacturer of a COVID-19 vaccine, has dispelled uncertainties about its business continuity by rescinding a “going concern” notice.
In February last year, Novavax had raised doubts about its ability to remain in business and announced plans to slash spending as it worked to prepare for a fall vaccination campaign.
The company also said on Friday that its revenue rose to $94 million in the first quarter, from $81 million in the same period in 2023, as per latest Reuters report.
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Submit Source Data of Phase III CT Report: CDSCO Panel Tells Eris Lifesciences on Metoprolol Succinate plus Dapagliflozin FDC
New Delhi: Reviewing the Phase III clinical trial report of fixed-dose combination (FDC) drug, Metoprolol Succinate sustained released 25mg/50mg plus Dapagliflozin 5mg/10mg tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Eris Lifescience to submit source data of the Phase III clinical trial report of the proposed drug.
This came after Eris Lifescience presented the proposal along with the Phase III clinical trial report before the committee.
Metoprolol is a selective beta-1 blocker commonly employed as the succinate and tartrate derivatives depending if the formulation is designed to be of immediate release or extended release. Metoprolol is a beta-1-adrenergic receptor inhibitor specific to cardiac cells with negligible effect on beta-2 receptors. This inhibition decreases cardiac output by producing negative chronotropic and inotropic effects without presenting activity towards membrane stabilization nor intrinsic sympathomimetics.
Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. By inhibiting SGLT2, dapagliflozin blocks the reabsorption of filtered glucose in the kidney, increasing urinary glucose excretion and reducing blood glucose levels. Its mechanism of action is independent of pancreatic β cell function and modulation of insulin sensitivity. Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction.
At the recent SEC meeting for Cardiovascular held on 23rd April 2024, the expert panel reviewed the proposal presented by the drug major Eris Lifscience along with the Phase III clinical trial report of the cardiovascular drug combination Metoprolol Succinate plus Dapagliflozin tablets.
After detailed deliberation, the committee opined that Eris Lifscience should submit source data of the Phase III clinical trial report to CDSCO for review by the committee.
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Kerala placed on high alert as West Nile Virus cases identified in Kozhikode, Thrissur, Malappuram
West Nile virus (WNV), a concerning mosquito-borne arbovirus from the Flaviviridae family and part of the Japanese encephalitis antigenic complex, has been reported in Kerala. With 12 confirmed and four suspected cases emerging in just the last week, the state has been placed on high alert. The virus, primarily transmitted through mosquito bites, has been identified in the districts of Malappuram, Kozhikode, and Thrissur.
Health Minister Veena George, speaking to Down to Earth, stated that although a recent death in Palakkad is suspected to be linked to WNV, confirmation is pending test results from the National Institute of Virology in Pune. The virus is known to be spread by mosquitoes after they bite infected birds, typically migratory ones.
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National Institute of Nutrition terms earthen cookware as safest utensil for cooking food
The National Institute of Nutrition (NIN) has released updated “Dietary Guidelines for Indians,” reflecting new scientific findings, lifestyle changes, common diseases, and dietary habits. A significant update in these guidelines is the endorsement of earthen cookware as the safest option for cooking. According to NIN, earthen pots are not only eco-friendly but also conducive to nutritious cooking with less oil.
The guidelines also address the use of various types of cookware. It advises against storing acidic foods in containers made from aluminum, iron, unlined brass, or copper due to safety concerns. While stainless steel is generally safe as it does not leach harmful substances, non-stick pans pose risks if used above 170°C or if their coating is damaged. Similarly, granite stone cookware is safe unless it features a Teflon coating, in which case it should not be used at high temperatures.
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