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Study examines the role of hydrocortisone in the management of adult patients with septic shock

Sepsis is a global health priority affecting 55 million patients worldwide and causing 11 million deaths annually. Treatment for sepsis may include prompt recognition, source control, antibiotics, fluids, vasopressors, and adjunctive therapies. Corticosteroids have been evaluated as adjunctive therapy for septic shock for more than 50 years. Despite this substantive body of research, uncertainty persists about the effects of corticosteroids on mortality. In a study publishing May 22, 2023 in the New England Journal of Medicine: Evidence, an international team of researchers from UC San Francisco, Raymond Poincaré AP-HP Hospital, Versailles SQY University, Paris-Saclay University and Inserm, and the George Institute for Global Health in Sydney, studied the role of hydrocortisone in the management of adult patients with septic shock. They found that while the effect of hydrocortisone was modest in terms of overall survival, it was associated with a decrease in the need for vasopressor drugs and improvement in ...
- Source: drugdu
- 102
- May 24, 2023
Bayer’s blockbuster hopeful Nubeqa, AstraZeneca’s Forxiga pick up nods from England’s NICE

Bayer has blockbuster hopes for prostate cancer med Nubeqa, and a new endorsement from the U.K.’s National Institute for Health and Care Excellence (NICE) provides another milestone toward that goal. After an approval last November to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC), Bayer inked a deal with officials in England to make the drug available to certain patients under an early access program. Now, thanks to NICE’s endorsement in combination with androgen deprivation therapy and the chemotherapy docetaxel, the drug will be available to more patients in England and Wales, Bayer said in a release. Already, a “few hundred” patients with mHSPC have received the drug, according to Bayer. The drug scored its mHSPC approval in England last November thanks to late-stage data showing that the combination cut the risk of death by 32.5% compared with placebo. Previously, the drug had carried a NICE endorsement to treat patients ...
- Source: drugdu
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- May 24, 2023
Krystal Gets First FDA Approval for Redosable Gene Therapy, Rare Skin Disease

By Tristan Manalac Pictured: Blue sign outside FDA building/JHVEPhoto/Adobe Stock The FDA has approved Krystal Biotech’s topical gene therapy beremagene geperpavec-svdt, now to be marketed as Vyjuvek, for the treatment of the rare skin disease dystrophic epidermolysis bullosa, the company announced Friday. Vyjuvek’s label covers its use in dystrophic epidermolysis bullosa (DEB) patients aged six months and above bearing mutations in the COL7A1 gene. Friday’s approval makes Vyjuvek therapy the first-ever redosable gene therapy and the first DEB therapeutic to hit the market. “Until now, there have been no approved treatment for DEB in the United States, and patients, families and physicians were limited to palliative care,” Andy Orth, chief commercial officer at Krystal Biotech, said in an investor call Friday evening, adding that there are likely around 3,000 DEB patients in the U.S., of whom some 1,100 have confirmed diagnoses, according to claims analytics. The company expects to launch ...
- Source: drugdu
- 115
- May 24, 2023
New clues to why some people suppress HIV without drugs

Some HIV patients are naturally able to keep the virus fully in check without any medicinal help, a phenomenon that has intrigued scientists for decades. New research appears to identify at least one reason why: an abnormally powerful version of an infection-fighting white blood cell called CD8+ T cell. CD8+ T cell’s are a type of T cell, a normal feature in everyone’s immune system. T cells typically amass in the lymph nodes of an HIV-infected patient. But among “spontaneous controllers”—those with the rare ability to automatically corral HIV and prevent it from triggering illness—investigators found that CD8+ T cells appear significantly more adept at identifying and stopping HIV. “About one in 300 people are able to control HIV without the need for medications,” noted study author Dr. Bruce Walker, director of the Ragon Institute of MGH, MIT and Harvard, an immune system research center in Cambridge, Mass. It appears ...
- Source: drugdu
- 215
- May 24, 2023
Blueprint’s Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

In a development that’s set to change the lives of many patients, Blueprint Medicines’ Ayvakit has finally won its long-awaited FDA approval to treat indolent systemic mastocytosis (SM). The drug won its original approval in 2021 to treat the advanced form of the disease, which affects only 5% to 10% of those with SM. Now, Ayvakit can reach the majority of SM patients, who suffer from the disease’s indolent form. The larger patient pool comprises approximately 30,000 U.S. patients, but so far only about half are diagnosed, Blueprint’s chief operating officer Christy Rossi told Fierce Pharma in an interview. Indolent SM patients often end up “living their lives in a bubble,” Rossi said. Physicians can treat symptoms, which range across organ systems from skin lesions to brain fog, but until now there was no option to treat the underlying disease. Enter Ayvakit. The drug targets a mutation called KIT D816V, ...
- Source: drugdu
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- May 24, 2023
Study helps clarify the underlying cause of chest symptoms in angina

An intensive study into the treatment of angina has found that the use of tests for small blood vessel function in the heart clarify the underlying cause of the condition. Patients referred to hospital by their General Practitioner (GP) for assessment of chest pain were invited into the study if a heart scan had ruled out blocked heart arteries. The trial showed that the common underlying cause of chest symptoms in angina sufferers was myocardial ischaemia with no obstructive arteries (INOCA), which wasn’t diagnosed by a standard CT heart scan. The diagnosis was clarified using the tests where INOCA was 4 times more likely, while ‘normal’ results were half as less likely to detect small vessel disease. The study, funded by the British Heart Foundation and the Chief Scientist Office of the Scottish Government and sponsored by the NHS Golden Jubilee, was carried out by heart specialists from the University ...
- Source: drugdu
- 124
- May 23, 2023
WHO launches global network to detect infectious disease threat

The World Health Organization on Saturday launched a global network to help swiftly detect the threat from infectious diseases, like COVID-19, and share the information to prevent their spread. The International Pathogen Surveillance Network (IPSN) will provide a platform for connecting countries and regions, improving systems for collecting and analyzing samples, the agency said. The network aims to help ensure infectious disease threats are swiftly identified and tracked and the information shared and acted on to prevent catastrophes like the COVID pandemic. The network will rely on pathogen genomics to analyze the genetic code of viruses, bacteria and other disease-causing organisms to understand how infectious and deadly they are and how they spread. The data gathered will feed into a broader disease surveillance system used to identify and track diseases, in a bid to contain outbreaks and to develop treatments and vaccines. ‘Ambitious’ goals WHO chief Tedros Adhanom Ghebreyesus hailed ...
- Source: drugdu
- 133
- 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
- 127
- May 23, 2023
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
- 116
- 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
- 126
- May 23, 2023

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