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AstraZeneca’s heart failure treatment approved for expanded use in US

AstraZeneca’s (AZ) Farixga (dapagliflozin) has been approved for extended use in the US, meaning adult patients with heart failure (HF) can benefit from the treatment regardless of their left ventricular ejection fraction status (LVEF). Farxiga, sold as Forxiga in certain markets, was previously approved in the US for HF patients with reduced ejection fraction (HFrEF) which is equal to or less than 40%. HF affects approximately seven million people in the US and is associated with substantial morbidity and mortality, with chronic HF the leading cause of hospitalisation for those over the age of 65. Roughly half of all HF patients have mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF), with few therapeutic options available. As well as the greater risk of death and hospitalisations, patients with HFmrEF or HFpEF experience an especially high burden of symptoms and physical limitations. The US Food and Drug Administration’s (FDA) ...
- Source: drugdu
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- May 12, 2023
BMS, after last year’s West Coast purge, lays off 48 in New Jersey

While smaller biotech outfits have certainly taken the brunt, the layoff deluge of the past year hasn’t spared big pharmas either. Now, after unveiling more than 250 job cuts in San Diego in September, Bristol Myers Squibb is turning its staff reduction campaign northeast. Starting at the end of May, BMS will roll out job cuts for 48 employees in Princeton, New Jersey, according to a new Worker Adjustment and Retraining Notification (WARN) alert filed with the state. The BMS site in question is a 650,000-square-foot facility that houses employees from the commercial team, plus commercialization and late-stage development partners from the R&D unit. The plant also hosts members of BMS’ global product development and supply teams, according to the company’s website. It’s not immediately clear what types of roles will be affected. Putting the cuts into context, Bristol’s business model is “evolving to support our mission to discover, develop and deliver innovative ...
- Source: drugdu
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- May 11, 2023
First Of Its Kind Urine Biomarker Methylation Test Predicts Bladder Cancer Recurrence

By LabMedica International staff writers Bladder EpiCheck is the first urine biomarker methylation test of its kind to be FDA cleared for NMIBC surveillance (Photo courtesy of Nucleix) Bladder cancer ranks as the sixth most common cancer in the U.S., with around 700,000 individuals living with the disease and over 80,000 new cases detected each year. The majority of these cases are classified as non-muscle invasive bladder cancer (NMIBC). Although NMIBC can be treated surgically and therapeutically, it has a high recurrence rate (up to 70% over five years), necessitating frequent monitoring to detect high-grade recurrence and treat it promptly. The standard of care involves regular and invasive cystoscopies, which patients undergo up to four times annually for a minimum of five years or, in some cases, for their entire lives. Now, a simple, objective urine test for recurrent bladder cancer is set to become commercially available in the ...
- Source: drugdu
- 117
- May 11, 2023
Gilead notches trial win in high-stakes HIV patent case against US government

It’s extremely unusual for the U.S. government to go after a pharmaceutical company for alleged patent infringement, much less take the case to trial. But in the government’s case against Gilead Sciences, the California drugmaker has come out on top.After years of litigation, Gilead prevailed following the trial in a Delaware federal court. The jury found the patents at issue were invalid, The New York Times reports.With that, the company doesn’t have to pay the more than $1 billion that the government sought with its patent infringement case. The company is “pleased” with the decision, Gilead’s executive vice president of corporate affairs and general counsel Deb Telman said in an emailed statement. “Today’s decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it,” Telman said. “Gilead will continue to champion collaborations, including our efforts with the ...
- Source: drugdu
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- May 11, 2023
Most antidepressants prescribed for chronic pain lack reliable evidence of efficacy or safety, scientists warn

Most antidepressants used for chronic pain are being prescribed with “insufficient” evidence of their effectiveness, scientists have warned. A major investigation into medications used to manage long-term pain has found that harms of many of the commonly recommended drugs have not been well studied. Published in the Cochrane Database of Systematic Reviews, the study led by scientists from several UK universities including Southampton and Newcastle, examined 176 trials consisting of nearly 30,000 patients involved in assessments which prescribed antidepressants for chronic pain. Among the drugs studied were amitriptyline, fluoxetine, citalopram, paroxetine, sertraline, and duloxetine—with only the latter showing reliable evidence for pain relief. One third of people globally are living with chronic pain, World Health Organization data shows, with many prescribed antidepressants for relieving symptoms. Lead author Professor Tamar Pincus from the University of Southampton said, “This is a global public health concern. Chronic pain is a problem for millions ...
- Source: drugdu
- 117
- May 11, 2023
Novavax surges after biotech company unveils job cuts, positive vaccine data

Novavax’s stock jumped around 30% on Tuesday after the biotech company unveiled promising new vaccine data and a broad cost-cutting push that includes major layoffs. The announcements are a sign of hope for investors after last quarter, when the company raised doubts about its ability to stay in business and decided not to provide full-year guidance. Novavax’s stock closed Tuesday at $9.52. The company’s share price is down more than 7% so far this year, giving it a market value of nearly $821 million. Novavax is now betting on its cost controls and new vaccines to help it stay afloat, forecasting 2023 sales of $1.4 billion to $1.6 billion, according to its first-quarter earnings report. The Gaithersburg, Maryland-based company said its combination vaccine targeting Covid and the flu produced a strong immune response against the viruses and was well tolerated in a phase two trial. Novavax shared similar trial results ...
- Source: drugdu
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- May 11, 2023
Chatbots are infiltrating healthcare. What now?

Lisette Hilton | Healthcare practices are already using chatbots to help with administrative tasks like scheduling appointments or requests for prescription refills. And while users say the current generative artificial intelligence (AI) technology falls short for safely treating patients, a recent survey of healthcare practices suggests 77% of users predict chatbots will be able to treat patients within the next decade. According to Software Advice’s 2023 Medical Chatbot Survey of 65 healthcare providers or practice owners who use live chatbots on their websites, which was conducted in March 2023, more than three quarters of those surveyed are extremely or somewhat confident in chatbots’ ability to assess patients’ symptoms. Chris R. Alabiad, MD, professor of clinical ophthalmology and ophthalmology residency program director at Bascom Palmer Eye Institute, Miami, FL, has tested the use of ChatGPT (Open AI) in the academic and clinical settings. He piloted the use of ChatGPT at Bascom ...
- Source: drugdu
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- May 11, 2023
Most effective treatment for excessive daytime sleepiness found

McMaster University researchers Dena Zeraatkar and Tyler Pitre have found that the drug solriamfetol is the most effective treatment for excessive daytime sleepiness (EDS) for people with obstructive sleep apnea (OSA). The standard treatment for OSA is a positive airway pressure (PAP) mask that uses compressed air to support lung airways during sleep. However, some people with OSA still experience EDS and may benefit from anti-fatigue medication. Zeraatkar and Pitre published their results in the Annals of Internal Medicine. “The most important thing that people with OSA should do is use their PAP machine, but if they are still sleepy there are options in the form of medications that can reduce their tiredness.” Tyler Pitre, first author, resident physician in internal medicine at McMaster University and incoming respirology fellow at the University of Toronto “Fifteen to 30 per cent of people in North America have a diagnosis ...
- Source: drugdu
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- May 11, 2023
Spikevax approved for use in children aged 6 months to 5 years

Spikevax, the COVID-19 vaccine from Moderna, has today been authorized for use in children aged 6 months to 5 years. The vaccine has been authorized in this new age group after it has been found to meet our standards of safety, quality and effectiveness, with no new safety concerns identified. This followed advice from the Commission on Human Medicines, which carefully reviewed the evidence. This is the second COVID-19 vaccine to be authorized in this age group; the Pfizer/BioNTech vaccine (Comirnaty), was authorized in Great Britain for infants and children aged 6 months to 4 years on 6 December 2022. For this age group, the vaccine is given as a primary series of two 25-microgram injections in the upper arm or in the thigh, approximately one month apart. In reaching their decision, the MHRA’s experts carefully reviewed data from an ongoing clinical trial involving 6,388 children aged 6 months to ...
- Source: drugdu
- 133
- May 11, 2023
Life Bio, Forge to develop gene therapies for aging-linked diseases

Life Biosciences has announced a cGMP manufacturing collaboration with Forge Biologics for advancing the development of new gene therapies to treat aging-related diseases. This partnership aims to help advance the company’s partial epigenetic reprogramming platform for aging-related diseases, such as its lead programme that targets the ophthalmic indications. Through the alliance, Forge Biologics will provide cGMP manufacturing, toxicology, adeno-associated virus (AAV) process development, and analytical services to Life Biosciences. Life Biosciences will use the platform processes of Forge Biologics, including the HEK293 suspension Ignition Cells and per adenovirus helper plasmid. The company stated that all the development and AAV manufacturing works will take place at Forge Biologics’ 200,000ft2 gene therapy facility, called Hearth, located in Columbus, Ohio, US. Life Biosciences CEO Jerry McLaughlin said: “We are delighted to be working with the Forge team, whose expertise in gene therapy manufacturing is unmatched. “We believe we’re on the cusp of revolutionising ...
- Source: drugdu
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- May 11, 2023

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