PharmaFocus Today – Page 365 – media

Intercept’s NASH dreams may be dashed after FDA panel votes against Ocaliva’s approval bid

It looks like Intercept Pharmaceuticals’ Ocaliva still has a tough road ahead in nonalcoholic steatohepatitis (NASH) after a panel of FDA advisers voiced concerns with the company’s application package. During a one-day meeting of the FDA’s Gastrointestinal Drugs Advisory Committee, panelists voted 12 to 2—with 2 abstentions—that the benefits of Ocaliva 25 mg, also known as Obeticholic acid, or OCA, don’t outweigh the risks in NASH patients with stage 2 or 3 fibrosis. Further, in response to the question about a potential accelerated approval, panelists voted 15 to 1 against that regulatory pathway for the drug. Many of the nay-sayer’s concerns came down to Intercept’s use of a surrogate endpoint in its clinical trial. Panelists’ concerns also centered on the potential for OCA to cause drug-induced liver injury. While the FDA isn’t beholden to the advice of its advisory committees, the regulator often follows its experts’ lead. Intercept’s NASH candidate ...
- Source: drugdu
- 129
- May 23, 2023
Lung association calls for more Black Americans to join clinical trials in pharma-backed effort

Beth Snyder Bulik Senior Editor The American Lung Association is doubling down on efforts to encourage more Black Americans to join lung cancer clinical trials. The new pharma-sponsored “Awareness, Trust and Action” initiative aims to put those three words into action with a national campaign that includes digital posts and social media. The first posts are slated to go up on Saturday, which is Clinical Trials Awareness Day. Daiichi Sankyo, Genentech, Merck, Novartis and Novocure provided financial support for the project. Cedric “Jamie” Rutland “We have to do a better job of recruiting Black Americans into clinical trials and letting them know why,” said pulmonologist Cedric “Jamie” Rutland, a national volunteer medical spokesperson for the American Lung Association. “And not only that, but teaching Black Americans what lung cancer is, what the risk factors are, why they have risk factors living in heavily polluted areas … We have to ...
- Source: drugdu
- 142
- May 23, 2023
AstraZeneca’s dapagliflozin recommended by NICE

Treatment concerns up to 150,000 patients in England with chronic heart failure The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AstraZeneca’s dapagliflozin. The therapy, also known as Forxiga, is as an option among adults with symptomatic chronic heart failure with mildly reduced or preserved ejection fraction. Currently, there are no disease-modifying treatments for this specific condition and, thus, dapagliflozin becomes the first NICE-recommended treatment for this population. Meanwhile, evidence from a clinical trial demonstrated that adding dapagliflozin to standard care with diuretics effectively decreases the combined risk of dying from cardiovascular causes or the need attend hospital with heart failure. This was compared during the study with placebo in addition to standard care. Helen Knight, director of medicines evaluation at NICE, reflected: “Until now there have been no treatments available to delay or slow the progression of this type of heart failure. “The ...
- Source: drugdu
- 132
- May 23, 2023
CureVac seeks to accelerate vaccine infringement case against Pfizer and BioNTech

Paul Schloesser Associate Editor CureVac is going on the offensive against Pfizer and BioNTech, saying that it will seek to accelerate its litigation around patents related to the manufacture of the Covid-19 vaccine Comirnaty. The German biotech company announced Friday that the case, which originally launched in the US last summer, has been transferred from the federal district court of Massachusetts to the eastern district court in Virginia as part of an effort to speed up the litigation, potentially allowing for a trial as soon as next year. On top of that transfer going through, CureVac filed a 94-page document Friday, filled with a broader counterclaims that say Pfizer and BioNTech infringed on nine of its US patents — eight of which it claims are owned by CureVac and the ninth by CureVac Manufacturing. These patents range from producing mRNA to vaccine design and manufacturing. CureVac first filed a lawsuit ...
- Source: drugdu
- 144
- May 23, 2023
Cholera outbreak kills 10 in S.Africa

An outbreak of cholera has killed at least 10 people near South Africa’s capital of Pretoria, health authorities said Sunday, urging the public to be “extra vigilant”. The Department of Health in Pretoria’s Gauteng province said 95 people visited a local hospital since Monday showing cholera symptoms, including diarrhea, stomach cramps and nausea. Lab tests on Sunday confirmed at least 19 were cases of cholera, the department said in a statement, adding 37 people were still undergoing treatment. The victims included a three-year-old child and nine adults. Nomantu Nkomo-Ralehoko, the provincial head for health, said additional staff, including medics and nurses, were being mobilized to deal with the outbreak, which was centered in Hammanskraal, an area north of Pretoria. “We would like to reiterate and urge the public to avoid known or suspected contaminated food, water and surfaces and wash hands thoroughly with soap before handling food or after using ...
- Source: drugdu
- 128
- May 23, 2023
NICE recommends Cara’s Kapruvia to treat CKD-associated pruritus

Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) have announced that the US’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia (difelikefalin) to treat chronic kidney disease (CKD)-associated pruritus. Kapruvia has been recommenced to treat moderate-to-severe CKD-associated pruritus in adult patients who are undergoing haemodialysis. This will allow patients in Northern Ireland, England, and Wales to get access to Kapruvia. The recommendation from NICE follows the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorisation of Kapruvia for the same indication in April last year. Cara Therapeutics president and CEO Christopher Posner said: “We are pleased that Kapruvia will be available to CKD patients in England, Wales and Northern Ireland who are undergoing haemodialysis and suffering from moderate-to-severe CKD-associated pruritus. “Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus ...
- Source: drugdu
- 220
- May 23, 2023
First diagnostic test for long COVID is available to patients across Australia

The first diagnostic test for long COVID is now available to patients across Australia. The test can help physicians diagnose long COVID by differentiating it from other diseases with similar symptoms, and to design personalized treatment approaches. Persistent COVID, or long COVID, is a multiorgan symptomatic complex with symptoms persisting over time. It affects patients who have suffered from acute COVID-19 infection. It is estimated by the US Centers for Disease Control that about 20% – 30% of patients who have suffered from COVID-19 may develop long COVID. The typical symptoms of long COVID, such as fatigue, brain fog, shortness of breath, insomnia, and a wide range of cardiovascular issues, are certainly not unique to one condition. A diagnostic test to identify patients with long COVID, using objective measures of immune biomarkers, is an essential first step for treatment. The simple blood-based test was developed by diagnostic testing company IGeneX ...
- Source: drugdu
- 123
- May 23, 2023
Study finds significant amount of clotting in the arteries of patients with STEMI and COVID-19

The latest analysis from The North American COVID-19 STEMI (NACMI) was presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions. The findings show patients with an ST-elevated myocardial infarction, or STEMI, and COVID-19 had a significant amount of clotting in their arteries both before and after intervention. Importantly, clots were seen in multiple arteries in close to 30% of patients, a phenomenon observed in less than 5% of patients with heart attacks who do not have COVID-19. In the United States, someone experiences a heart attack every 40 seconds (CDC). Of these patients, more than 25% will experience a more severe type of heart attack, an ST-elevated myocardial infarction, or STEMI caused by the sudden, total blockage of a coronary artery. Pre-COVID-19 mortality in STEMI patients was below 5% (JACC). Previous NACMI research has shown that mortality jumps to 20% to ...
- Source: drugdu
- 218
- May 22, 2023
Hand-gesture decoding using data from noninvasive brain imaging

Researchers from University of California San Diego have found a way to distinguish among hand gestures that people are making by examining only data from noninvasive brain imaging, without information from the hands themselves. The results are an early step in developing a non-invasive brain-computer interface that may one day allow patients with paralysis, amputated limbs or other physical challenges to use their mind to control a device that assists with everyday tasks. The research, recently published online ahead of print in the journal Cerebral Cortex, represents the best results thus far in distinguishing single-hand gestures using a completely noninvasive technique, in this case, magnetoencephalography (MEG). “Our goal was to bypass invasive components,” said the paper’s senior author Mingxiong Huang, PhD, co-director of the MEG Center at the Qualcomm Institute at UC San Diego. Huang is also affiliated with the Department of Electrical and Computer Engineering at the UC San ...
- Source: drugdu
- 147
- May 22, 2023
Novel gene-editing strategy leverages unusual genetic alteration to block HIV spread in cells

Genetic alterations that give rise to a rare, fatal disorder known as MOGS-CDG paradoxically also protect cells against infection by viruses. Now, scientists at the Lewis Katz School of Medicine at Temple University have harnessed this unusual protective ability in a novel gene-editing strategy aimed at eliminating HIV-1 infection with no adverse effects on cell mortality. The new approach, described online April 28 in the journal Molecular Therapy—Nucleic Acids, is based on a combination of two gene-editing constructs, one that targets HIV-1 DNA and one that targets a gene called MOGS—defects in which cause MOGS-CDG. In cells from persons infected with HIV-1, the Temple researchers show that disrupting the virus’s DNA while also deliberately altering MOGS blocks the production of infectious HIV-1 particles. The discovery opens up new avenues in the development of a cure for HIV/AIDS. Proper MOGS function is essential for glycosylation, a process by which some cellular ...
- Source: drugdu
- 122
- May 22, 2023

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