PharmaFocus Today – Page 314 – media

New AI system could revolutionize the diagnosis of valvular heart disease

AI (artificial intelligence) may sound like a cold robotic system, but Osaka Metropolitan University scientists have shown that it can deliver heartwarming-;or, more to the point, “heart-warning”-;support. They unveiled an innovative use of AI that classifies cardiac functions and pinpoints valvular heart disease with unprecedented accuracy, demonstrating continued progress in merging the fields of medicine and technology to advance patient care. The results will be published in The Lancet Digital Health. Valvular heart disease, one cause of heart failure, is often diagnosed using echocardiography. This technique, however, requires specialized skills, so there is a corresponding shortage of qualified technicians. Meanwhile, chest radiography is one of the most common tests to identify diseases, primarily of the lungs. Even though the heart is also visible in chest radiographs, little was known heretofore about the ability of chest radiographs to detect cardiac function or disease. Chest radiographs, or chest X-Rays, are performed in ...
- Source: drugdu
- 114
- July 9, 2023
Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001)

SUZHOU, China, July 7, 2023 /PRNewswire/ — Transcenta Holding Limited (“Transcenta”) (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has received approvals from China CDE (Center for Drug Evaluation) and South Korea MFDS (Ministry of Food and Drug Safety) to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment of patients with HER2 negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. In addition, we are in the process of EU and FDA regulatory interaction. Gastric cancer (GC) is the 4th leading cause of cancer death worldwide, accounting for about 7.7% of all cancer related mortality. The five year survival rate for gastric cancer is still around 30%. Nivolumab, an anti-PD-1 antibody, has been approved globally for the first line treatment ...
- Source: drugdu
- 178
- July 9, 2023
Safety Concerns About New Weight Loss Drugs Brew as Demand Soars

By Heather McKenzie Pictured: Physician with notepad/iStock, Everyday better to do everything you love The European Medicines Agency recently flagged a safety signal regarding the potential for glucagon-like peptide-1 receptor agonists to cause thyroid cancer. The documentation—the first step taken by the regulator toward investigation of potential adverse events in approved products—comes as demand for the popular diabetes and weight loss drugs reaches a fever pitch. The safety signal reported by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in April covers a range of glucagon-like peptide-1 receptor (GLP-1) agonists, including semaglutide, the key ingredient in Novo Nordisk’s Wegovy, Ozempic and Rybelsus. Supplemental information was also requested from Eli Lilly, Sanofi and AstraZeneca, all of which manufacture drugs in this class. GLP-1 is a hormone that stimulates insulin secretion after eating, enabling a feeling of fullness and regulating blood sugar. GLP-1 agonists mimic the effects of this hormone, making them an ...
- Source: drugdu
- 112
- July 9, 2023
FTC intervenes to correct Medtronic’s ‘erroneous assertions’ in antitrust case

Dive Brief The Federal Trade Commission has intervened in a legal case to correct what it called “erroneous assertions and mistaken legal points” made by Medtronic. In an amicus brief filed Monday, the FTC rebuts aspects of Medtronic’s defense against accusations made by Applied Medical Resources in an antitrust case. The FTC has taken no position on the accuracy of the allegations but filed the brief because it said Medtronic made “wrong” arguments with “broad implications for antitrust enforcement” in its filing to dismiss Applied’s claims. Dive Insight Applied Medical filed a lawsuit against Medtronic earlier this year. The manufacturer of bipolar energy devices accused Medtronic of conspiring to bundle devices for cutting tissue and sealing vessels “in a way that is unhealthy for competition, hospitals, and patients in need of medical treatment.” Medtronic called the claims “baseless” and moved to dismiss the case. The argument for dismissing the case ...
- Source: drugdu
- 116
- July 8, 2023
Kidney transplant recipients may benefit from new fluid therapy

A major clinical trial has found a simple change to world practice for kidney transplants could deliver real benefits for recipients and reduce their need for dialysis by 25 per cent. The BEST-Fluids trial was conducted by the Australasian Kidney Trials Network (AKTN) in collaboration with researchers from The University of Queensland, The University of Adelaide, and The University of Sydney. ATKN chair and UQ Professor David Johnson said the trial assessed the use of an intravenous fluid containing sodium, potassium, magnesium and chloride in proportions similar to human blood – instead of the usual practice of using normal saline (sodium chloride and water). David Johnson, UQ Professor, said, “Of those study participants who received intravenous Plasma-Lyte 148, 30 per cent needed dialysis after their transplants, compared to 40 per cent for those given normal saline. This is a significant improvement in outcomes for those undergoing kidney transplant surgery.” Royal ...
- Source: drugdu
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- July 8, 2023
EMA-endorsed statement targets Covid-19 vaccine misinformation

In an age where Covid-19 vaccine misinformation is rife, the International Coalition of Medicines Regulatory Authorities (ICMRA) issued a statement tackling the exaggerations of side effect severity and frequency. The 5 July statement, which was swiftly endorsed by the European Medicines Agency (EMA), points to overwhelming evidence demonstrating a good safety profile across all age groups. There have so far been more than 13 billion vaccine doses given worldwide. ICMRA says the vast majority of side effects due to Covid-19 vaccines are mild and temporary. Any serious side effects identified by safety monitoring systems, such as myocarditis and blood clots, are very rare – meaning they occur in less than one in 10,000 people. The statement pointed towards false and misleading information being spread, especially on social media, that exaggerates the frequency and severity of side effects. The statement read: “As for all medicines, reports of medical events after Covid-19 ...
- Source: drugdu
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- July 8, 2023
FDA grants orphan drug designation to ImPact’s focal cancer therapy

The US Food and Drug Administration (FDA) has granted an orphan drug designation to ImPact Bio’s padeliporfin vascular targeted photodynamic therapy (VTP) for patients with locally advanced pancreatic cancer. Israel-headquartered ImPact Bio expects to submit an investigational new drug application (IND) later in 2023, with a Phase I trial of the treatment in patients with locally advanced pancreatic ductal adenocarcinoma also scheduled for this year, per a 5 July press release. Orphan drug designations come with certain benefits such as granting tax credits for US-based clinical trials and recommendations from the FDA on the required clinical and preclinical studies. Padeliporfin VTP is based on the combined use of the drug padeliporfin and non-thermal laser light. The drug is administered intravenously to a patient after which it is activated by a non-thermal laser light in the specific area of the tumour, per the company’s website. The light results in the drug’s ...
- Source: drugdu
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- July 8, 2023
With full Alzheimer’s approval in hand, Eisai and Biogen kick off Leqembi’s launch in earnest

It’s official: Roughly half a year after the FDA granted an accelerated nod to Eisai and Biogen’s new Alzheimer’s disease med lecanemab, the companies have converted that green light into a full-fledged, traditional approval. Now, the drug—also known as Leqembi—is set to unshackle itself from a strict coverage determination by the Centers for Medicare & Medicaid services (CMS). With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s under the traditional approval pathway, Eisai Executive Vice President Alex Scott, who oversees government affairs, said in an interview. Those benefits stand across a “broad patient group that’s generalizable to the whole Medicare population,” he added. Leqembi won an accelerated FDA approval in January based on its ability to reduce amyloid beta plaque, a marker of Alzheimer’s disease that’s believed to be ...
- Source: drugdu
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- July 8, 2023
Moderna strikes deal to develop mRNA drugs in China

Moderna on Wednesday said it struck a deal with Chinese officials to research, develop and manufacture messenger RNA medicines in the country, despite rising tensions between the U.S. and China. The Massachusetts-based biotech company signed a memorandum of understanding and a related land collaboration deal to develop drugs that will “be exclusively for the Chinese people” and won’t “be exported,” a Moderna spokesperson told CNBC. Chinese media outlet Yicai first reported on Tuesday that Moderna was slated to make its first investment in China that could be worth around $1 billion, citing unnamed sources. The outlet also reported that Moderna CEO Stéphane Bancel was visiting Shanghai. The Moderna spokesperson did not confirm the report or comment on the size of the deal. “These agreements are focused on strengthening health security by targeting unmet needs and contributing to the ecosystem of medical solutions available to patients in China,” the spokesperson said. ...
- Source: drugdu
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- July 8, 2023
Patient aggression causes lasting harm to medical receptionists

Reviewed by Danielle Ellis University of Queensland research has found verbal and physical abuse of medical receptionists by patients is rife, and causing lasting harm. Dr Fiona Willer from UQ’s Centre for Community Health and Wellbeing led a review of 20 studies across five countries, analysing aggression faced by receptionists in medical clinics and doctor’s surgeries. Our findings show receptionists are frequently subjected to verbal abuse from patients such as shouting, swearing, accusatory language and racist and sexist insults. They also face armed and unarmed physical violence. Patient aggression towards medical receptionists is so frequent it’s become accepted as a normal workplace hazard, which is extremely concerning.” Dr Fiona Willer from UQ’s Centre for Community Health and Wellbeing The research found the behavior severely affected the receptionists’ health and wellbeing. “They reported workplace stress, absenteeism, burnout, lasting psychological trauma and even physical harm,” Dr Willer said. “Only a small proportion ...
- Source: drugdu
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- July 8, 2023

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