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Lilly Notches Second Cholesterol Win with RNA Silencer

By Tristan Manalac Data from an early-stage study showed that Eli Lilly’s investigational RNA silencing therapeutic lepodisiran can induce sharp and durable reductions in serum lipoprotein(a) levels, the company revealed in a read-out presented over the weekend at the 2023 Scientific Sessions of the American Heart Association. These findings come nearly three months after the Indianapolis-based pharma notched another Phase I victory, this time for its oral drug candidate muvalaplin, which strongly decreased lipoprotein(a) levels in healthy participants within 24 hours. Lipoprotein(a), also known as Lp(a), is a form of cholesterol that can cause plaques to form in arteries and block blood flow and is often tied to the risk of developing cardiovascular diseases. The first-in-human trial of lepodisiran enrolled 48 patients who were given ascending doses of the investigational therapy—from 4 mg up to 608 mg—or a placebo. At the highest dose level, lepodisiran was able to elicit a ...
- Source: drugdu
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- November 15, 2023
Collections, Aggressive Tactics, and Consequences

Don Tracy, Associate Editor The growing issue of medical debt has caused stakeholders to reevaluate tactics as the cost of pharmaceutical healthcare continues to rise. In modern times, hospitals have continuously employed aggressive tactics to collect debts from patients, especially those in low-income situations. A recent study published by The New England Journal of Medicine (NEJM) notes that these tactics include wage garnishments, selling debts to third party buyers, reporting of delinquent debts to credit bureaus, lawsuits, seizures of bank accounts, property liens, foreclosures, refusals of care, and even arrests. Politicians on both sides of the spectrum have criticized these tactics, citing the lack of charity care. Since the 1980s, hospitals have shifted away from this in favor of incessant debt collection tactics, according to the investigators. In a recent episode of the An Arm and a Leg podcast, Luke Messac, MD, PhD, discussed his experience in this area. In ...
- Source: drugdu
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- November 15, 2023
FDA deems stolen Medtronic scopes problem a Class I recall

BY SEAN WHOOLEY Conforming devices can be identified by their serial number. The FDA today issued a notice saying the recall of Medtronic (NYSE: MDT)+ McGrath Mac video laryngoscopes is Class I, the most serious kind. Medtronic in October warned on stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties. The company initiated a recall as a result of the stolen, defective products. The company informed the public of the illegal offering of the devices by third parties through various social media platforms. Affected products failed to pass Medtronic’s rigorous tests established for the product. The company did not release them for sale, distribution or importation. Potential adverse effects from defective scopes include hypoxia, hypercapnia, tissue damage/trauma and/or a delay to treatment. More details on the Medtronic recall The recall affects 5,709 devices in the U.S., distributed between July 5, 2019, and July 14, 2022. Medtronic’s ...
- Source: drugdu
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- November 15, 2023
Victoria Atkins MP takes over UK’s department of Health and Social Care

The UK Prime Minister, Rishi Sunak, has confirmed that Victoria Atkins has been appointed Secretary of State for Health and Social Care amid a cabinet shake-up. The Conservative MP for Louth & Horncastle was appointed to the position today (13 November) during a cabinet reshuffle that saw the previous incumbent, Steve Barclay, removed from his position. From 2017 to 2021 Victoria Atkins was the Parliamentary Under Secretary of State for Crime, Safeguarding and Vulnerability at the Home Office, and then moved on to become Financial Secretary to the Treasury between 27 October and 13 November 2022. Initially a barrister by trade and with no formal background in the healthcare trade, her husband Paul Kenward is Managing Director of British Sugar, a firm licensed to grow cannabis for use in children’s epilepsy medication. Now, Atkins will have to helm the government department as it navigates a winter of disruption and potential ...
- Source: drugdu
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- November 15, 2023
Merck’s Keytruda combination receives CHMP recommendation for biliary tract cancer

Merck & Co – known as MSD outside the US and Canada – has announced that the European Medicines Agency’s human medicines committee has recommended its Keytruda (pembrolizumab) in combination with chemotherapy to treat biliary tract cancer (BTC). The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the anti-PD-1 therapy be used alongside gemcitabine and cisplatin for the first-line treatment of adults with locally advanced unresectable or metastatic BTC. BTC is a group of rare and highly aggressive cancers in the liver, gallbladder and bile ducts. Approximately 211,000 people are diagnosed with the disease each year globally and about 70% of BTC patients are diagnosed at an advanced stage, at which point the prognosis is poor. The CHMP’s positive opinion was supported by results from the late-stage KEYNOTE-966 trial, in which the Keytruda/chemotherapy combination demonstrated a significant overall survival benefit in these patients versus chemotherapy alone. ...
- Source: drugdu
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- November 15, 2023
GSK’s momelotinib recommended by CHMP to treat myelofibrosis patients with anaemia

GSK’s momelotinib has been recommended for approval by the European Medicines Agency’s human medicines committee as the first treatment option specifically indicated for myelofibrosis patients with moderate-to-severe anaemia. The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be used to treat disease-related splenomegaly or symptoms in adult patients with moderate-to-severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Eligible patients will also have either not been treated with JAK inhibitors before or have been treated with Novartis’ Jakavi (ruxolitinib), GSK said. Myelofibrosis is a rare blood cancer that can lead to severely low blood counts, with about 40% of patients having moderate-to-severe anaemia at the time of diagnosis and nearly all patients developing anaemia at some point in the course of their disease. Transfusions are often required by myelofibrosis patients with anaemia and more than 30% will discontinue treatment ...
- Source: drugdu
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- November 15, 2023
Novo Nordisk says Wegovy can help heart disease patients—and not just because it produces weight loss

Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack in some patients. Perhaps even more importantly, Novo said this weekend in Philadelphia at the American Heart Association (AHA) Scientific Sessions that the cardiovascular benefits gained from Wegovy aren’t due solely to weight loss. The phase 3 SELECT trial showed that use of Wegovy versus placebo lowered the risk of a non-fatal heart attack by 28% and the risk of progression of chronic kidney disease and renal death by 22%. Additionally in the study—which included nondiabetic obese and overweight patients with established cardiovascular disease—Wegovy was found to reduce the risk of heart-related death by 15% and the risk of death by any cause by ...
- Source: drugdu
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- November 15, 2023
Acon receives first FDA clearance for over-the-counter COVID-19 antigen test

Dive Brief The Food and Drug Administration has cleared the first over-the-counter COVID-19 antigen test via a traditional premarket review pathway. Acon Laboratories secured the 510(k) clearance for its Flowflex COVID-19 Antigen Home Test. The firm received emergency use authorization (EUA) in 2021 and, by following in the footsteps of Cue Health’s de novo molecular test, converted that approval into a conventional clearance. The clearance gives Americans another fully authorized test ahead of an infectious respiratory disease season in which testing volumes are forecast to be down compared to prior years. Dive Insight The EUA program enabled the FDA to quickly make COVID-19 tests available in the U.S. during the public health emergency. Today, the administration maintains EUAs on 65 antigen tests and 276 molecular diagnostic tests for COVID-19. While the EUAs remain in effect, the FDA is encouraging manufacturers to transition to its normal pathways now that the acute ...
- Source: drugdu
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- November 14, 2023
New hope for TB patients as UNITE4TB launches clinical trial program

Today, UNITE4TB, an international public-private partnership striving to fast-track the development of innovative Tuberculosis (TB) treatments, announced the start of its phase 2B/C clinical trial program with the first participant enrolled at its trial site in Cape Town, South Africa. The announcement is a major milestone for the project and the TB community as a whole, helping to advance TB science and enhance the efficiency with which new treatments are delivered. The TB challenge TB is a major threat to public health, being among the leading causes of death worldwide. In 2021, the disease claimed the lives of 1.6 million people, making it the second leading infectious killer after COVID-19. Drug-resistant TB and long treatment regimens have increased the urgency for action and investment in TB research. For people affected by TB, the most important outcome is rapid access to better regimens of shorter treatment duration and with fewer side ...
- Source: drugdu
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- November 14, 2023
Optum Rx Moves Eight Preferred Insulin Products to Lowest Cost Tier

Eight rapid-, short-, and long-acting insulin products will move to tier one preferred status, which limits out-of-pocket spending to $35 or less for patients with diabetes. Optum Rx, the pharmacy benefit manager unit of UnitedHealth, announced that it is moving eight rapid-, short-, and long-acting insulin products to tier one preferred status, which offers the lowest cash price that consumers pay.1 The move, which goes into effect on January 1, 2024, will limit out-of-pocket spending to $35 or less for insulin product for patients with diabetes. Image credit: Aleksandra Gigowska | stock.adobe.com “I’ve seen firsthand how high prices for insulin and other necessary medications can cause patients to limit or skip doses,” said Patrick Conway, MD, MSc, chief executive officer of Optum Rx, in a press release.1 “Medicine that people can’t afford is useless, and by taking this important next step to change our formulary, we will lower costs and ...
- Source: drugdu
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- November 14, 2023

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