Drugmakers take sides in Amgen, Regeneron fight over antibody patents

Christopher Newman Editor “This is a showdown about whether the most valuable patents in the entirety of the patent system are valid,” one law expert said. The nearly decade-long patent feud between Amgen and rivals Sanofi and Regeneron has divided the biopharmaceutical industry, with drugmakers taking different sides in a U.S. Supreme Court case that could have far-reaching effects.  At issue are patents for powerful cholesterol-lowering medicines known as PCSK9 inhibitors. Regeneron and Sanofi brought the first, Praluent, to market in 2015. Amgen followed one month later with a similar medicine, called Repatha. The drugs work by boosting liver cells’ ability to hoover up LDL, or “bad,” cholesterol.   Amgen has long claimed Sanofi and Regeneron infringed on patents it secured for Praluent. The fight has slowly winded its way through the U.S. legal system to reach the Supreme Court. There, judges could disrupt the $160 billion-per-year market for antibodies by deciding how broadly ...

• Source: drugdu
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• April 25, 2023

A new report released by Becton, Dickinson and Company (BD) reveals that women are looking to be better informed about sexually transmitted infections (STIs). The survey, conducted with cooperation from the Harris Poll, found that 77% of women feel they are knowledgeable about vaginal diseases such as yeast infections, yet only 60% know about diagnosis and treatment options available for STIs. The medtech company is responsible for testing kits BD Vaginal Panel and the BD CTGCTV2 assay, which screen for vaginitis and the three most common nonviral STIs in women who are symptomatic. The survey of 1,000 U.S. women over 18 years old revealed that almost half of them saw a healthcare provider for a routine gynecological exam within the past year or more. Another 40% of women said they’d had gynecological care within the past 12 months. Of the women who see healthcare providers for gynecological care, 82% felt ...

• Source: drugdu
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• April 25, 2023

Too much insulin can be as dangerous as too little

Just over a century has passed since the discovery of insulin, a time period during which the therapeutic powers of the hormone have broadened and refined. Insulin is an essential treatment for type 1 diabetes and often for type 2 diabetes, as well. Roughly 8.4 million Americans use insulin, according to the American Diabetes Association. One hundred years of research have greatly advanced medical and biochemical understanding of how insulin works and what happens when it is lacking, but the reverse, how potentially fatal insulin hyper-responsiveness is prevented, has remained a persistent mystery. In a new study, published in the April 20, 2023 online edition of Cell Metabolism, a team of scientists at the University of California San Diego School of Medicine, with colleagues elsewhere, describe a key player in the defense mechanism that safeguards us against excessive insulin in the body. “Although insulin is one of the most essential hormones, ...

• Source: drugdu
• 117
• April 25, 2023

How alcohol consumption contributes to chronic pain

Chronic alcohol consumption may make people more sensitive to pain through two different molecular mechanisms—one driven by alcohol intake and one by alcohol withdrawal. That is one new conclusion by scientists at Scripps Research on the complex links between alcohol and pain.   The research, published in the British Journal of Pharmacology on April 12, 2023, also suggests potential new drug targets for treating alcohol-associated chronic pain and hypersensitivity.   “There is an urgent need to better understand the two-way street between chronic pain and alcohol dependence,” says senior author Marisa Roberto, Ph.D., the Schimmel Family Chair of Molecular Medicine, and a professor of neuroscience at Scripps Research. “Pain is both a widespread symptom in patients suffering from alcohol dependence, as well as a reason why people are driven to drink again.”   Alcohol use disorder (AUD), which encompasses the conditions commonly called alcohol abuse, alcohol dependence and alcohol addiction, ...

• Source: drugdu
• 117
• April 25, 2023

Apellis’ immune system drug hits a setback in ALS

Jacob Bell Senior Reporter In the latest setback for ALS research, Apellis Pharmaceuticals, a Massachusetts-based drug company, has discontinued a portion of a key clinical trial testing one of its medicines as a treatment for the nerve-destroying disease. The “MERIDIAN” trial began in the fall of 2020, ultimately enrolling around 250 participants who were given either a placebo or Apellis’ medicine, known as pegcetacoplan, over a two-year period. Following that period, participants could join a so-called “open-label extension” study, in which everyone would have access to the drug. But Apellis has chosen to stop that latter study, based on feedback from an external group of advisers who reviewed the data available and concluded further treatment with the drug was unwarranted. Analysts at the investment bank Mizuho Securities were the first to report this development. According to the analyst Graig Suvannavejh, Apellis announced the study discontinuation through a “company communication” that clarified that the ...

• Source: drugdu
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• April 25, 2023

In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk’s Wegovy

The stakes are getting even higher for the fight between Eli Lilly and Novo Nordisk for supremacy in the multibillion-dollar obesity market. Lilly on Friday quietly registered a new phase 3b trial on clinicaltrials.gov. The study, coded SURMOUNT-5, will pit Lilly’s Mounjaro against Novo’s Wegovy in patients with obesity or overweight with weight-related health conditions. The trial aims to enroll 700 participants from 61 sites in the U.S., Canada, South America and several European countries, according to the post. The study is currently expected to officially start next Friday and last for about 78 weeks, with an estimated primary completion date in February 2025. On the study’s primary endpoint, investigators will compare the percentage weight changes between the two drugs by week 72 from baseline. However, it’s not immediately clear whether Lilly is designing SURMOUNT-5 as a superiority study to show Mounjaro is better than Wegovy or just to show ...

• Source: drugdu
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• April 25, 2023

Study finds lack of high certainty evidence on the efficacy and safety of analgesics for low back pain

      Despite nearly 60 years of research, there is still a lack of high certainty evidence on the effectiveness and safety of commonly used painkillers (analgesics) for short bouts of low back pain, finds an analysis of the evidence published by The BMJ.   The researchers say that until higher quality trials comparing analgesics with each other are published, “clinicians and patients are advised to take a cautious approach to manage acute non-specific low back pain with analgesic medicines.”   Analgesics such as paracetamol, ibuprofen, and codeine are widely used to treat acute non-specific low back pain, defined as pain lasting less than six weeks. But evidence for their comparative effectiveness is limited.   To fill this knowledge gap, researchers trawled scientific databases for randomized controlled trials comparing analgesic medicines with another analgesic, placebo, or no treatment in patients reporting acute non-specific low back pain.   From an ...

• Source: drugdu
• 125
• April 24, 2023

Withdrawal of financial incentives for NHS GPs in Scotland linked to reductions in quality of care

Ending performance-related payments for NHS GPs in Scotland was associated with a decline in the quality of some aspects of care compared with England where financial incentives have continued, finds a study published by The BMJ today.   The researchers say further research is needed to better understand the full impact of withdrawal and the accompanying refocusing of quality improvement resources.   The NHS Quality and Outcomes Framework (QOF) pay-for-performance scheme began in 2004. It was designed to remunerate general practices for providing good quality care across a range of key areas such as cancer, diabetes, heart disease, mental health, and obesity.   In 2016, Scotland abolished the QOF to reduce the bureaucratic burden on GPs and to free-up their time for patients, but continued collecting performance data for some QOF indicators for the next three years. Researchers were therefore able to use this data to evaluate the impact of ...

• Source: drugdu
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• April 24, 2023

High fitness levels may reduce the risk of cardiovascular death

High fitness levels may reduce the risk of death from cardiovascular disease in men with high blood pressure, according to a 29-year study published today in the European Journal of Preventive Cardiology, a journal of the ESC. Nearly 1.3 billion adults aged 30 to 79 years worldwide have high blood pressure (hypertension). Hypertension is a major risk factor for heart attack and stroke and a leading cause of premature death globally. Previous studies have shown that high cardiorespiratory fitness is linked with greater longevity. This study examined the interplay between blood pressure, fitness and risk of death from cardiovascular disease.   The study included 2,280 men aged 42 to 61 years living in eastern Finland and enrolled in the Kuopio Ischaemic Heart Disease Risk Factor Study. Baseline measurements were conducted between 1984 and 1989. These included blood pressure and cardiorespiratory fitness, which was assessed as maximal oxygen uptake while riding ...

• Source: drugdu
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• April 24, 2023

Short exposure to bright light before night shift may help reduce fatigue and errors

Nurses exposed to 40 minutes of bright light before their night shifts feel less fatigued and make fewer errors at work, according to a study led by McGill University. The nurses also slept better after their shifts.   “Healthcare workers are experiencing high levels of fatigue due to staffing shortages, difficult schedules, and heavy workloads. Further, the cost of medical errors has been estimated at tens of billions of dollars per year in North America,” says Jay Olson, the senior author of the recent study in Sleep Health, who completed his PhD at McGill University and is now a Postdoctoral Fellow at the University of Toronto. “Our study shows that feasible changes, such as getting light exposure before the night shift, may help reduce fatigue and its effects on performance at work, something which could benefit both the nurses and their patients.”   Light exposure leads to a significant reduction ...

• Source: drugdu
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• April 24, 2023